What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-05-14 compared with 2024-11-19 · 269 added, 248 removed, 72 unchanged (88% of the section changed)

Management’s Discussion and Analysis of Financial Condition and Results of Operations Forward-Looking Statements

This quarterly report contains forward-looking statements.

Forward-looking

statements are projections of events, revenues, income, future economic performance or management’s plans and objectives for our

future operations.

Management’s Discussion and Analysis

of Financial Condition and Results of Operations Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements.

Forward-looking statements are projections of events, revenues, income, future economic performance or management’s plans and objectives

for our future operations.

In some cases, you can identify forward-looking statements by terminology such as “may”, “should”,

7 unchanged sentences

These risks include, by way of example and not in limitation:

uncertainty of profitability based upon our history of losses;

• legislative

or regulatory changes concerning skincare research and therapies;

related to failure to obtain adequate financing on a timely basis and on acceptable terms

to continue as going concern;

related to our operations and uncertainties related to our business plan and business strategy;

in economic conditions;

• uncertainty

with respect to intellectual property rights, protecting those rights and claims of infringement

of other’s intellectual property;

• competition;

• cybersecurity

the uncertainty of profitability based upon our history of losses;

legislative or regulatory changes concerning skincare research and therapies;

risks related to failure to obtain adequate financing on a timely basis and on acceptable terms to continue as going concern;

risks related to our operations and uncertainties related to our business plan and business strategy;

changes in economic conditions;

uncertainty with respect to intellectual property rights, protecting those rights and claims of infringement of other’s intellectual property;

cybersecurity concerns.

This list is not an exhaustive list of the factors that may affect any

14 unchanged sentences

Company Overview

We, through our wholly owned subsidiary Skinvisible

Pharmaceuticals Inc., are a pharmaceutical research and development (“R&D”) company that has developed and patented an

innovative polymer delivery system, Invisicare® and formulated over forty topical skin products, which we out-license globally.

were incorporated in 1998 and target an estimated $80 billion global skincare and dermatology market and a $30 billion global over-the-counter

market as well as other healthcare / medical and consumer goods markets.

The Company is also exploring new opportunities in large medical

markets outside of the dermatology market such as obesity and other potential markets where a topical or transdermal solution would be

a viable alternative.

With the research and development complete on

forty products and numerous patents issued (technology and product patents), we are ready to monetize our investment.

Our business model

will continue to be to out-license our patented prescription and over-the-counter (“OTC”) products featuring Invisicare to

established manufacturers and marketers of brands internationally and to maximize profits from the products we have already out-licensed.

The opportunity for us to license our products

continues to be a viable model as the need for pharmaceutical companies to access external R&D companies for new products due to their

own downsizing or elimination of internal R&D departments.

The demand for our products is enhanced due to the granting of key US and

international patents and the completed development of a number of unique products.

We, through our wholly owned subsidiary Skinvisible Pharmaceuticals Inc.,

are a pharmaceutical research and development (“R&D”) company that has developed and patented an innovative polymer delivery

system, Invisicare® and formulated over forty topical skin products, which we out-license globally.

We were incorporated in 1998 and

target an estimated $80 billion global skincare and dermatology market and a $30 billion global over-the-counter market as well as other

healthcare / medical and consumer goods markets.

The Company is also exploring new opportunities in large medical markets outside of the

dermatology market such as obesity and other potential markets where a topical or transdermal solution would be a viable alternative.

With the research and development complete on forty products and numerous

patents issued (technology and product patents), we are ready to monetize our investment.

Our business model will continue to be to out-license

our patented prescription and over-the-counter (“OTC”) products featuring Invisicare to established manufacturers and marketers

of brands internationally and to maximize profits from the products we have already out-licensed.

The opportunity for us to license our products continues to be a viable

model as the need for pharmaceutical companies to access external R&D companies for new products due to their own downsizing or elimination

of internal R&D departments.

The demand for our products is enhanced due to the granting of key US and international patents and the

completed development of a number of unique products.

Our Flagship Product

Pivotal to our success is our patented polymer

delivery system technology Invisicare.

Invisicare is a patented polymer delivery system that enhances the delivery of active ingredients

for topically applied skin care products.

Its patented technology has a unique formula and process for combining active ingredients with

a delivery system that extends the duration of time the product remains on the skin and active.

Invisicare is specifically formulated to

carry water insoluble active and certain cationic active ingredients in water-based products without the use of alcohol, silicones, waxes,

or other organic solvents.

Products utilizing Invisicare have the proven ability to bond active ingredients to the skin for up to four

hours and longer.

They are non-occlusive and allow normal skin respiration and perspiration while moisturizing and protecting against

exposure from a wide variety of environmental irritants.

When topically applied, these formulated products

adhere to the skin's outer layers, forming a protective bond, resisting wash-off, and delivering targeted levels of therapeutic or cosmetic

skincare agents to the skin.

They allow enhanced delivery performance for a variety of skincare agents resulting in improved efficacy,

longer duration of action, reduced irritation and lower dosage of active agent required.

The "invisible" polymer compositions

wear off as part of the natural exfoliation process of the skin's outer layer cells.

The advantage of products formulated with Invisicare

is (1) Invisicare’s ability to bind active ingredients (the drug) to the skin, forming a protective bond on the skin, for extended

periods of time;

(2) Invisicare can deliver targeted levels (high or low) of therapeutic or cosmetic ingredients to the skin in a controlled

(3) Invisicare can help to reduce the irritation of some active ingredients due to how it controls the slower release of that

active ingredient;

and (4) Invisicare science proves that it provides a protective skin barrier which helps retain the natural moisture

content of the skin, while still allowing it to breathe.

These benefits present an excellent opportunity for clear scientific advantages

and marketing messages which resonate with physicians and consumers.

Pivotal to our success is our patented polymer delivery system technology

Invisicare is a patented polymer delivery system that enhances the delivery of active ingredients for topically applied skin

care products.

Its patented technology has a unique formula and process for combining active ingredients with a delivery system that extends

the duration of time the product remains on the skin and active.

Invisicare is specifically formulated to carry water insoluble active

and certain cationic active ingredients in water-based products without the use of alcohol, silicones, waxes, or other organic solvents.

Products utilizing Invisicare have the proven ability to bond active ingredients to the skin for up to four hours and longer.

non-occlusive and allow normal skin respiration and perspiration while moisturizing and protecting against exposure from a wide variety

of environmental irritants.

When topically applied, these formulated products adhere to the skin's

outer layers, forming a protective bond, resisting wash-off, and delivering targeted levels of therapeutic or cosmetic skincare agents

They allow enhanced delivery performance for a variety of skincare agents resulting in improved efficacy, longer duration

of action, reduced irritation and lower dosage of active agent required.

The "invisible" polymer compositions wear off as part

of the natural exfoliation process of the skin's outer layer cells.

The advantage of products formulated with Invisicare is (1) Invisicare’s

ability to bind active ingredients (the drug) to the skin, forming a protective bond on the skin, for extended periods of time;

(2) Invisicare

can deliver targeted levels (high or low) of therapeutic or cosmetic ingredients to the skin in a controlled release;

(3) Invisicare can

help to reduce the irritation of some active ingredients due to how it controls the slower release of that active ingredient;

Invisicare science proves that it provides a protective skin barrier which helps retain the natural moisture content of the skin, while

still allowing it to breathe.

These benefits present an excellent opportunity for clear scientific advantages and marketing messages which

resonate with physicians and consumers.

We generate revenue by:

We develop topical prescription

and over-the-counter products enhanced with Invisicare to license to pharmaceutical and consumer goods companies around the world for

an upfront fee and ongoing royalties.

We develop topical prescription and over-the-counter

products enhanced with Invisicare to license to pharmaceutical and consumer goods companies around the world for an upfront fee and ongoing

CO-DEVELOPMENT :

We assist pharmaceutical

clients in the early development of the most optimal formulation, which they then take forward into clinical testing.

We assist pharmaceutical clients in the early development

of the most optimal formulation, which they then take forward into clinical testing.

LIFE CYCLE MANAGEMENT :

We provide cost-effective

solutions to global pharmaceutical companies by reformulating their products coming off patent with a new Invisicare patent and new product

benefits and line extensions.

Pharmaceutical companies are under a lot of pressure to develop innovative strategies to counteract the

revenue loss from their drugs coming off patent.

License Agreement with

On October 17, 2019, we entered an Exclusive

License Agreement with Quoin Pharmaceuticals, Inc., a Delaware corporation (“Quoin”) pursuant to which we granted Quoin a

license to certain patents for the development of products for commercial sale.

In exchange for the license, Quoin paid us a license fee

of one million USD dollars (USD $1,000,000) (the “License Fee”) and will additionally pay a single digit royalty interest

of all net sales on the licensed products subject to adjustment in certain situations.

The agreement also requires that Quoin make a milestone

payment of $5 million to us upon achieving the first to occur of either FDA or European Union regulatory approval for one product licensed.

In addition, and upon the successful

approval in the US or European Union, whichever occurs first, Skinvisible is entitled to receive a single digit royalty percentage of

Quoins net sales revenues for any licensed product covered by the patent rights licensed under the License Agreement.

Plus, Quoin also

agreed to pay Skinvisible 25% of any revenues they receive as royalties in the event that they sublicense any licensed products to a third

On June 6, 2022, the Company announced that its

licensee Quoin and its product QRX003, was the first Invisicare delivery technology product to receive U.S.

FDA Acceptance of Investigational

New Drug Application and that Quoin was actively working towards obtaining necessary FDA and other regulatory approvals for marketing

the product in the United States and other countries.

On February 14, 2024, the Company announced that

there was significant progress in Quoin's clinical trials for product formulations containing Invisicare targeting Netherton Syndrome.

The trials focus on the innovative formulation "QRX003," powered by Skinvisible’s Invisicare® proprietary drug delivery

The updates include:

Initial Data and Clean Safety Profile:

The trials have demonstrated positive initial data

and a clean safety profile, leading to the implementation of an optimization plan.

• Optimization

Plan Implementation:

Quoin has increased the size of both clinical trials significantly and

adjusted dosing frequency to twice-daily from once-daily for both trials.

• Elimination

of Lower Dose:

In the blinded trial, a lower dose has been eliminated based on the positive

outcomes observed.

Quoin's press release highlights protocol amendments aimed at enhancing the data

set and potentially expediting regulatory approval.

believe these protocol amendments could ultimately result in the generation of a highly compelling data set, which could support regulatory

filings and approval for QRX003 as the first treatment for Netherton Syndrome.

March 4, 2024, Quoin announced a further milestone:

it received FDA Clearance to recruit teen subjects into both ongoing Netherton Syndrome

clinical studies.

We provide cost-effective solutions to global

pharmaceutical companies by reformulating their products coming off patent with a new Invisicare patent and new product benefits and line

Pharmaceutical companies are under a lot of pressure to develop innovative strategies to counteract the revenue loss from

their drugs coming off patent.

License Agreement with Quoin

On October 17, 2019, we entered an Exclusive License Agreement with Quoin

Pharmaceuticals, Inc., a Delaware corporation (“Quoin”) pursuant to which we granted Quoin a license to certain patents for

the development of products for commercial sale.

In exchange for the license, Quoin paid us a license fee of one million USD dollars (USD

$1,000,000) (the “License Fee”) and will additionally pay a single digit royalty interest of all net sales on the licensed

products subject to adjustment in certain situations.

The agreement also requires that Quoin make a milestone payment of $5 million to

us upon achieving the first to occur of either FDA or European Union regulatory approval for one product licensed.

In addition, and upon the successful approval in the US or European Union,

whichever occurs first, Skinvisible is entitled to receive a single digit royalty percentage of Quoins net sales revenues for any licensed

product covered by the patent rights licensed under the License Agreement.

Plus, Quoin also agreed to pay Skinvisible 25% of any revenues

they receive as royalties in the event that they sublicense any licensed products to a third party.

On June 6, 2022, the Company announced that its licensee Quoin and its

product QRX003, was the first Invisicare delivery technology product to receive U.S.

FDA Acceptance of Investigational New Drug Application

and that Quoin was actively working towards obtaining necessary FDA and other regulatory approvals for marketing the product in the United

States and other countries.

On February 14, 2024, the Company announced that there was significant

progress in Quoin's clinical trials for product formulations containing Invisicare targeting Netherton Syndrome.

The trials focus on the

innovative formulation "QRX003," powered by Skinvisible’s Invisicare® proprietary drug delivery technology.

Positive Initial Data and Clean Safety Profile:

The trials have demonstrated positive initial data and a clean safety profile, leading to the implementation of an optimization plan.

Optimization Plan Implementation:

Quoin has increased the size of both clinical trials significantly and adjusted dosing frequency to twice-daily from once-daily for both trials.

Elimination of Lower Dose:

In the blinded trial, a lower dose has been eliminated based on the positive outcomes observed.

Protocol Amendments:

Quoin's press release highlights protocol amendments aimed at enhancing the data set and potentially expediting regulatory approval.

We believe these protocol amendments could ultimately result in the generation

of a highly compelling data set, which could support regulatory filings and approval for QRX003 as the first treatment for Netherton Syndrome.

On March 4, 2024, Quoin announced a further milestone:

it received FDA

Clearance to recruit teen subjects into both ongoing Netherton Syndrome clinical studies.

We believe this announcement is important as:

• Clearance to include teen patients in both Quoin’s open

label and placebo-controlled studies are expected to significantly expand the number of eligible subjects, potentially expedite recruitment

and lead to a more robust data set.

• This development represents the first ever inclusion of non-adult

subjects in Netherton Syndrome clinical studies conducted under an open Investigational New Drug Application.

• It is believed that the inclusion of this patient population

in Quoin’s studies will be a critical component of the development of a robust data set that could result in regulatory approval

with a broad label as QRX003 is being tested both as monotherapy and in conjunction with off-label treatments.

On June 27, 2024, Quoin announced an International Expansion of ongoing clinical trials for Netherton Syndrome in Saudia Arabia.

is currently treating Netherton patients who are eligible for recruitment into Quoin studies.

On October 22, 2024 Quoin announced Further

International Expansion of Ongoing Clinical Trials for Netherton Syndrome with Two Additional Clinical Sites to be Opened in the United

Kingdom where Both Sites are Recognized Centers of Excellence for Netherton Syndrome in the UK.

On November 5, 2024 Quoin Pharmaceuticals

initiates clinical testing of lead product in pediatric Netherton Syndrome patient.

This clinical assessment is being performed on a pediatric

patient at children’s health Ireland in Dublin;

the first evaluation of QRX003, powered by Skinvisible’s Invisicare technology,

in a pediatric patient.

Clearance to include teen patients in both Quoin’s open label and placebo-controlled studies are expected to significantly expand the number of eligible subjects, potentially expedite recruitment and lead to a more robust data set.

This development represents the first ever inclusion of non-adult subjects in Netherton Syndrome clinical studies conducted under an open Investigational New Drug Application.

It is believed that the inclusion of this patient population in Quoin’s studies will be a critical component of the development of a robust data set that could result in regulatory approval with a broad label as QRX003 is being tested both as monotherapy and in conjunction with off-label treatments.

On June 27, 2024, Quoin announced an International Expansion of ongoing

clinical trials for Netherton Syndrome in Saudia Arabia.

The site is currently treating Netherton patients who are eligible for recruitment

into Quoin studies.

On October 22, 2024, Quoin announced further International Expansion of

ongoing clinical trials for Netherton Syndrome with two additional clinical sites to be opened in the United Kingdom where both sites

are recognized Centers of Excellence for Netherton Syndrome in the UK.

On November 5, 2024, Quoin Pharmaceuticals initiated clinical testing of

its lead product in a pediatric Netherton Syndrome patient.

This clinical assessment is being performed on a pediatric patient at children’s

health Ireland in Dublin;

the first evaluation of QRX003, powered by Skinvisible’s Invisicare technology, in a pediatric patient.

On December 19, 2024, Quoin Pharmaceuticals announced FDA clearance to

initiate a new additional Netherton Syndrome (NS) clinical study for QRX003.

The company further announced that the study will be conducted

Amy Paller, of Northwestern University.

It is planned that up to eight subjects will be enrolled into the study and will have QRX003

applied twice daily to greater than 80% of their entire body surface area (BSA) over a 12-week period.

By comparison, in Quoin’s

ongoing open-label and double-blind clinical studies, QRX003 is applied to approximately 20% of the subject’s BSA, typically the

arms and lower leg.

This new study, designed to mimic how NS patients will use QRX003 if approved, represents the most extensive use of

QRX003 in a clinical setting to date.

It is anticipated that the data generated from this study will be used to supplement the data package

to support the potential regulatory approval of QRX003 as a treatment for NS.

Quoin also announced other key developments, including:

Significant clinical improvements in both open label and pediatric studies including subject's disease classification improved from "severe" to "mild" after 6 weeks dosing;

No adverse events or safety concerns reported to date from each of Quoin's ongoing clinical studies in Netherton Syndrome subjects;

License of Netherton Syndrome product QRX003 with Invisicare delivery technology in 60 countries.

License Agreement with Ovation Science

On February 3, 2020, we entered into a License

Agreement with Ovation Science Inc.

On February 3, 2020, we entered into a License Agreement with Ovation Science

pursuant to which Skinvisible granted to Ovation Science Inc.

a license for the manufacture and distribution

rights to its hand sanitizer product, DermSafe.

a license for the manufacture and distribution rights to its hand sanitizer

product, DermSafe.

In exchange for the license, Ovation Science Inc.

agreed to pay to Skinvisible a royalty

percentage on all net sales on the licensed products subject to adjustment in certain situations plus a license fee payable in year 3

of the agreement if it chooses to continue the license.

On June 10, 2020, Ovation Science paid us the

fee otherwise due in year 3 and in exchange we extended the term of Ovation Science’s license to 6-years and granted Ovation additional

rights to its hand sanitizer products and assigned Canadian Identification Numbers 02310589 and 02355558, all DermSafe Trademarks, DermSafe

clinical data and the right to patent DermSafe where not currently patented.

In exchange for these rights, Ovation Science paid a $100,000

agreed to pay to Skinvisible a royalty percentage on all net sales

on the licensed products subject to adjustment in certain situations plus a license fee payable in year 3 of the agreement if it chooses

to continue the license.

On June 10, 2020, Ovation Science paid us the fee otherwise due in year

3 and in exchange we extended the term of Ovation Science’s license to 6-years and granted Ovation additional rights to its hand

sanitizer products and assigned Canadian Identification Numbers 02310589 and 02355558, all DermSafe Trademarks, DermSafe clinical data

and the right to patent DermSafe where not currently patented.

In exchange for these rights, Ovation Science paid a $100,000 license fee.

We completed the required assignments during the year ending December 31, 2020 and recognized $100,000 in revenue.

Patent Applications for Transdermal Delivery

for Obesity and Glucose-Controlling Agents

In May and June of 2024, we filed provisional

patent applications covering formulations that leverage Invisicare for the transdermal administration of obesity drugs and glucose-controlling

agents for diseases such as diabetes.

The patents are titled "Transdermal Delivery Composition for Delivery of CB-1 Receptor Antagonists

and/or GLP-1 Receptor Agonists, and Method of Delivery” and “Transdermal Delivery Composition for Delivery of at Least One

Glucose Controlling Agent, and Method of Delivering at Least One Glucose Controlling Agent.”

The patent applications focus on the use of Invisicare

in a transdermal delivery technology designed to incorporate CB-1 receptor antagonists and/or GPL-1 receptor agonists, with drugs known

for their potential in obesity management and for glucose-controlling agents, into a lotion that is applied topically to the skin using

a metered applicator.

Studies have demonstrated the superior transdermal penetration and controlled release of other active compounds

using Invisicare's innovative technology, with certain actives exhibiting up to a tenfold increase in transdermal delivery effectiveness.

By utilizing Invisicare, we aim to not only offer patients a convenient and effective alternative to traditional oral or injectable therapies

but to also enhance drug efficacy and potentially significantly reduce side effects as transdermal delivery avoids first-pass metabolism.

Additionally, for long-term treatment of obesity and glucose controlling agents, a transdermal delivery system could feasibly provide

a convenient method for administering maintenance doses for these medications.

We are actively pursuing strategic partnerships

with pharmaceutical and/or biotech companies to facilitate the introduction of the first transdermal obesity therapies to market and to

explore the application of its delivery platform across diverse disease domains.

Results of Operations for the Three and Nine Months Ended September

30, 2024 and 2023

Our revenue, which we combine

from product sales, royalties on patent licenses and license fees (product development fees), was $5,000 for the three months ended September

30, 2024 as compared with $5,000 for the same period ended September 30, 2023.

Our revenue, which we combine

from product sales, royalties on patent licenses and license fees (product development fees), was $15,000 for the nine months ended September

30, 2024, as compared with $15,000 for the same period ended September 30, 2023.

We hope to generate more

revenues from our licenses with Quoin and Ovation for the rest of 2024.

We also plan to enter into commercial arrangements with pharma

and biotech companies to exploit our patent applications that were recently filed, and we hope to generate revenue from these efforts

in the future.

We had $0 in cost of revenues for the three and nine months ended September

30, 2024, compared with $0 in cost of revenues or the three and nine months ended September 30, 2023, so our gross profit was $5,000

and $5,000 for the three and nine months ended September 30, 2024, respectively, as compared with gross profit of $15,000 and $15,000

for the three and nine ended September 30, 2023, respectively.

Our gross profit in 2024 and 2023 was due to licensing revenue, and we

hope to generate more revenues from our licenses with Quoin and Ovation for the rest of 2024 and into 2025.

Patent Applications for Transdermal Delivery for Obesity and Glucose-Controlling

In May and June of 2024, we filed provisional patent applications covering

formulations that leverage Invisicare for the transdermal administration of obesity drugs and glucose-controlling agents for diseases

such as diabetes.

The patents are titled "Transdermal Delivery Composition for Delivery of CB-1 Receptor Antagonists and/or GLP-1

Receptor Agonists, and Method of Delivery” and “Transdermal Delivery Composition for Delivery of at Least One Glucose Controlling

Agent, and Method of Delivering at Least One Glucose Controlling Agent.”

The patent applications focus on the use of Invisicare in a transdermal

delivery technology designed to incorporate CB-1 receptor antagonists and/or GPL-1 receptor agonists, with drugs known for their potential

in obesity management and for glucose-controlling agents, into a lotion that is applied topically to the skin using a metered applicator.

Studies have demonstrated the superior transdermal penetration and controlled release of other active compounds using Invisicare's innovative

technology, with certain actives exhibiting up to a tenfold increase in transdermal delivery effectiveness.

By utilizing Invisicare, we

aim to not only offer patients a convenient and effective alternative to traditional oral or injectable therapies but to also enhance

drug efficacy and potentially significantly reduce side effects as transdermal delivery avoids first-pass metabolism.

Additionally, for

long-term treatment of obesity and glucose controlling agents, a transdermal delivery system could feasibly provide a convenient method

for administering maintenance doses for these medications.

We are actively pursuing strategic partnerships with pharmaceutical and/or

biotech companies to facilitate the introduction of the first transdermal obesity therapies to market and to explore the application of

its delivery platform across diverse disease domains.

Results of Operations for the Three Months Ended March 31, 2025 and

Our revenue, which we combine from product sales, royalties on patent licenses

and license fees (product development fees), was $5,000 for the three months ended March 31, 2025 as compared with $5,000 for the same

period ended March 31, 2024.

We hope to generate more revenues from our licenses with Quoin and Ovation

We also plan to enter into commercial arrangements with pharma and biotech companies to exploit our patent applications that

were recently filed, and we hope to generate revenue from these efforts in the future.

We had $0 in cost of revenues for the three months ended March 31, 2025,

compared with $0 in cost of revenues for the three months ended March 31, 2024, so our gross profit was $5,000 and $5,000 for the three

months ended March 31, 2025 and 2024, respectively.

Operating Expenses

Operating expenses increased to $129,969 for the three months

ended September 30, 2024, from $118,110 for the same period ended September 30, 2023.

Operating expenses increased to $405,846 for the nine months

ended September 30, 2024, from $368,837 for the same period ended September 30, 2023.

Operating expenses increased to $144,852 for the three months ended March

31, 2025, from $128,184 for the same period ended March 31, 2024.

Our operating expenses for all periods consisted mainly of selling, general

and administrative expenses.

Our selling, general and administrative expenses for the nine months ended

September 30, 2024, consisted mainly of accrued salaries and wages of $262,827 and audit and accounting of $37,747.

In comparison, our

selling, general and administrative expenses for the nine months ended September 30, 2023, consisted mainly of accrued salaries and wages

of $263,329 and audit and accounting of $33,029.

Our selling, general and administrative expenses for the three months ended

March 31, 2025, consisted mainly of accrued salaries and wages of $87,942 and audit and accounting of $11,609.

In comparison, our selling,

general and administrative expenses for the three months ended March 31, 2024, consisted mainly of accrued salaries and wages of $87,942

and audit and accounting of $17,610.

We expect our operating expenses will increase in the future as the Company

begins to generate more licensing revenue.

Other Expenses

We had other expenses of $161,635 for the three months ended September

30, 2024, as compared with other expenses of $174,408 for the three months ended September 30, 2023.

We had other expenses of $489,579 for the nine months ended September 30,

2024, as compared with other expenses of $1,724,812 for the nine months ended September 30, 2023.

Our other expenses for the three and nine months ended

September 30, 2024 consisted mainly of interest expense, netted against a gain on settlement of debt and gain on derivative liability

We recorded a net loss of $286,604 for the

three months ended September 30, 2024, as compared with a net loss of $287,518 for the three months ended September 30, 2023.

a net loss of $880,425 for the nine months ended September 30, 2024, as compared with a net loss of $2,078,649 for the nine months ended

September 30, 2023.

Other Income (Expenses)

We had other income of $141,153 for the three months ended March 31,

2025, as compared with other expenses of $167,188 for the three months ended March 31, 2024.

Our other expense for the three months ended March 31, 2025 consisted mainly

of interest expense of $141,153.

Our other expenses for the three months ended March 31, 2024 consisted mainly of interest expense of

$166,408 and losses on derivative liability of $780.

The decrease in other expenses is the result of decreased debt as of March 31, 2025.

We recorded a net loss of $281,005 for the three months ended March 31,

2025, as compared with a net loss of $290,372 for the three months ended March 31, 2024.

Liquidity and Capital Resources

Going concern –

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the

satisfaction of liabilities in the normal course of business.

The Company has incurred cumulative net losses of $40,260,913 since its

inception and requires capital for its contemplated operational and marketing activities to take place.

The Company’s ability to

generate the necessary funds through licensing of its core products or the ability to raise additional capital through the future issuances

of common stock or debt is unknown.

The obtainment of additional financing, the successful development of the Company’s contemplated

plan of operations, and its transition, ultimately, to the attainment of profitable operations are necessary for the Company to continue

These factors, among others, raises substantial doubt about the Company’s ability to continue as a going concern.

consolidated financial statements of the Company do not include any adjustments that may result from the outcome of these aforementioned

uncertainties.

As of September 30, 2024, we had total current

assets of $27,404 and total assets in the amount of $148,643.

Our total current liabilities as of September 30, 2024 were $4,643,708.

We had a working capital deficit of $4,616,304 as of September 30, 2024, compared with a working capital deficit of $3,476,947 as of December

Operating activities used $52,922 in cash for

the nine months ended September 30, 2024, as compared with $73,314 used for the nine months ended September 30, 2023.

Our negative operating

cash flows for 2023 and 2024 was largely the result of our net loss for those quarter, mainly offset by changes in operating assets and

liabilities and the amortization of debt discount.

We used cash of $9,218 and $9,334 in investing

activities for the nine months ended September 30, 2024 and 2023, respectively, for the purchase of intangible assets.

Cash flow provided from financing activities was

$61,864 for the nine months ended September 30, 2024, as compared with $2,000 provided by cash flows

for financing activities during the nine months ended September 30, 2023.

The features of the debt instruments and payables

concerning our financing activities are detailed in the footnotes to our financial statements.

Based upon our current financial condition, we do not have sufficient

cash to operate our business at the current level for the next twelve months.

We intend to fund operations through increased sales and

debt and/or equity financing arrangements, which may be insufficient to fund expenditures or other cash requirements.

We plan to seek

additional financing in a private equity offering to secure funding for operations.

There can be no assurance that we will be successful

in raising additional capital.

Going concern – The accompanying financial statements have been prepared on a going

concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

Company has incurred cumulative net losses of $40,227,147 since its inception and requires capital for its contemplated operational and

marketing activities to take place.

The Company’s ability to generate the necessary funds through licensing of its core products

or the ability to raise additional capital through the future issuances of common stock or debt is unknown.

The obtainment of additional

financing, the successful development of the Company’s contemplated plan of operations, and its transition, ultimately, to the attainment

of profitable operations are necessary for the Company to continue operations.

These factors, among others, raises substantial doubt about

the Company’s ability to continue as a going concern.

The condensed consolidated financial statements of the Company do not include

any adjustments that may result from the outcome of these aforementioned uncertainties.

As of March 31, 2025, we had total current assets of $38,305 and total

assets in the amount of $149,554.

Our total current liabilities as of March 31, 2025 were $4,256,903.

We had a working capital deficit

of $4,218,598 as of March 31, 2025, compared with a working capital deficit of $3,615,238 as of December 31, 2024.

Operating activities used $31,720 in cash for the

three months ended March 31, 2025, as compared with $12,291 used for the three months ended March 31, 2024.

Our negative operating cash

flows for 2024 and 2025 was largely the result of our net loss for those quarters, mainly offset by changes in operating assets and liabilities

and the amortization of debt discount and amortization.

We used no cash in investing activities for the three months ended March

31, 2025 and 2024.

Cash flow provided from financing activities was $34,780 for the three

months ended March 31, 2025, as compared with $19,500 provided by cash flows for financing activities during the three months ended March

The features of the debt instruments and payables concerning our financing

activities are detailed in the footnotes to our financial statements.

Based upon our current financial condition,

we do not have sufficient cash to operate our business at the current level for the next twelve months.

We intend to fund operations through

increased sales and debt and/or equity financing arrangements, which may be insufficient to fund expenditures or other cash requirements.

We plan to seek additional financing in a private equity offering to secure funding for operations.

There can be no assurance that we

will be successful in raising additional capital.

Off Balance Sheet Arrangements

As of September 30, 2024, there were no off-balance sheet arrangements.

As of March 31, 2025, there were no off-balance sheet arrangements.

Critical Accounting Policies

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if any, of the balance that will not be collected.

As of September 30, 2024, we had not recorded a reserve for doubtful accounts.

As of March 31, 2025, we had not recorded a reserve for doubtful accounts.

Recently Issued Accounting Pronouncements

We do not expect the adoption of recently issued accounting pronouncements

to have a significant impact on our results of operations, financial position or cash flow.

In August 2020, the FASB issued ASU 2020-06, “Debt - Debt

with Conversion and Other Options (subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (subtopic 815-40),”

which reduces the number of accounting models in ASC 470-20 that require separate accounting for embedded conversion features.

a convertible debt instrument will be accounted for as a single liability measured at its amortized cost as long as no other features

require bifurcation and recognition as derivatives.

By removing those separation models, the effective interest rate of convertible debt

instruments will be closer to the coupon interest rate.

Further, the diluted net income per share calculation for convertible instruments

will require the Company to use the if-converted method.

The treasury stock method should no longer be used to calculate diluted net income

per share for convertible instruments.

The amendment will be effective for the Company for fiscal years beginning after December 15, 2021,

including interim periods within those fiscal years.

Early adoption is permitted, but no earlier than fiscal years beginning after December

15, 2020, including interim periods within those fiscal years.

We adopted this ASU for the year ended December 31 ,2022.

no impact on our financial statements for the three months ended March 31, 2025.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting

Improvements to Reportable Segment Disclosures.

The amendments in this ASU require disclosures, on an annual and interim

basis, of significant segment expenses that are regularly provided to the chief operating decision maker (“CODM”), as well

as the aggregate amount of other segment items included in the reported measure of segment profit or loss.

This ASU requires that a public

entity disclose the title and position of the CODM and an explanation of how the CODM uses the reported measure(s) of segment profit or

loss in assessing segment performance and deciding how to allocate resources.

This ASU is effective for fiscal years beginning after December

15, 2023, including interim periods within those fiscal years, with early adoption permitted.

The amendments in this ASU should be applied

retrospectively to all prior periods presented in the financial statements.

The Company adopted the ASU and determined that its adoption

did not have a material impact on the Company’s condensed consolidated financial statements and related disclosures.

in the ASU, operating segments are components of an enterprise about which discrete financial information is regularly provided to the

CODM in making decisions on how to allocate resources and assess performance for the organization.

The Company operates and manages its

business as one reportable and operating segment.

The Company’s CODM is the Chief Executive Officer.

The Company’s CODM reviews

condensed consolidated operating results to make decisions about allocating resources and assessing performance for the entire Company.

The Company does not believe that other standards, which have

been issued but are not yet effective, will have a significant impact on its financial statements.

Quantitative and Qualitative Disclosures About Market Risk

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What changed 10-Q

Item 2. Management’s Discussion and Analysis