What changed in this filing

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Item 1. Business

2025-04-14 compared with 2024-04-16 · 205 added, 136 removed, 50 unchanged (87% of the section changed)

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

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.

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

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.

We are 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.

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 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;

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.

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 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;

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.

benefits present an excellent opportunity for clear scientific advantages and marketing messages which resonate with physicians and

We generate revenue by:

12 unchanged sentences

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 we receive as royalties in the event that we 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

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

drug delivery technology.

License Agreement

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.

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.

The updates include:

12 unchanged sentences

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.

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,

10 unchanged sentences

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

Market research indicates there is

reasonably limited direct competition for Invisicare and patented products in terms of performance capabilities for topically administered

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.

further announced that the study will be conducted by Dr.

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.

pursuant to which Skinvisible granted to Ovation Science Inc.

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.

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.

Market research indicates there is reasonably

limited direct competition for Invisicare and patented products in terms of performance capabilities for topically administered

skin products.

Many companies are seeking unique delivery systems to enhance their portfolio and purchasing companies that have delivery

Nevertheless, our current and potential

competitors may have longer operating histories, significantly greater resources and name recognition, and a larger base of customers

than we have.

Our competitors may also be able to adopt more aggressive pricing policies and devote greater resources to the development,

marketing and sale of their products and services than we can.

To be competitive, we must continue to invest significant resources in

sales and marketing.

We may not have sufficient resources to make these investments or to develop the technological advances necessary

to be competitive, which in turn will cause our business to suffer and restrict our profitability potential.

Nevertheless, our current and potential competitors

may have longer operating histories, significantly greater resources and name recognition, and a larger base of customers than we have.

Our competitors may also be able to adopt more aggressive pricing policies and devote greater resources to the development, marketing

and sale of their products and services than we can.

To be competitive, we must continue to invest significant resources in sales and

We may not have sufficient resources to make these investments or to develop the technological advances necessary to be competitive,

which in turn will cause our business to suffer and restrict our profitability potential.

Government Regulation

Cosmetic and Skin Care Regulation

Depending upon product claims and

formulation, skin care products may be regulated as cosmetics, drugs, devices, or combination cosmetics and drugs.

The FDA has authority

to regulate cosmetics marketed in the United States under the FDCA and the Fair Packaging and Labeling Act (“FPLA”) and implementing

Depending upon product claims and formulation,

skin care products may be regulated as cosmetics, drugs, devices, or combination cosmetics and drugs.

The FDA has authority to regulate

cosmetics marketed in the United States under the FDCA and the Fair Packaging and Labeling Act (“FPLA”) and implementing

The Federal Trade Commission (the “FTC”) regulates the advertising of cosmetics under the FTCA.

The FDCA prohibits the marketing

of adulterated and misbranded cosmetics.

Cosmetic ingredients must also comply with the FDA’s ingredient, quality, and labeling

requirements and the FTC’s requirements pertaining to truthful and non-misleading advertising.

Cosmetic products and ingredients,

except for color additives, are not required to have FDA premarket approval.

Manufacturers of cosmetics are also not required to register

their establishments, file data on ingredients, or report cosmetic-related injuries to the FDA.

We will be responsible for

substantiating the safety and product claims of the cosmetic products and ingredients before marketing.

The FDA or FTC may disagree

with our characterization of one or more of the skin care products as a cosmetic or the product claims.

This could result in a

variety of enforcement actions which could require the reformulation or relabeling of our products, the submission of information in

support of the product claims or the safety and effectiveness of our products, or more punitive action, all of which could have a

material adverse effect on our business.

If the FDA determines we have failed to comply with applicable requirements under the FDCA

or FPLA, it can impose a variety of enforcement actions from public warning letters, injunctions, consent decrees, and civil

penalties to seizure of our products, total or partial shutdown of our production, and criminal prosecutions.

If any of these events

were to occur, it could materially adversely affect us.

If the FTC determines we have failed to substantiate our claims, it can

pursue a variety of actions including disgorgement of profits, injunction from further violative conduct, and consent decrees.

Domestic State and Local Government

Some states and local governments in the

United States regulate the labeling, operation, sale, and distribution of our skin care products.

To the extent additional state or local

laws apply, we intend to comply with them.

The FDCA prohibits the marketing of adulterated

and misbranded cosmetics.

Cosmetic ingredients must also comply with the FDA’s ingredient, quality, and labeling requirements and

the FTC’s requirements pertaining to truthful and non-misleading advertising.

Cosmetic products and ingredients, except for color

additives, are not required to have FDA premarket approval.

Manufacturers of cosmetics are also not required to register their establishments,

file data on ingredients, or report cosmetic-related injuries to the FDA.

We will be responsible for substantiating

the safety and product claims of the cosmetic products and ingredients before marketing.

The FDA or FTC may disagree with our

characterization of one or more of the skin care products as a cosmetic or the product claims.

This could result in a variety of

enforcement actions which could require the reformulation or relabeling of our products, the submission of information in support of

the product claims or the safety and effectiveness of our products, or more punitive action, all of which could have a material

adverse effect on our business.

If the FDA determines we have failed to comply with applicable requirements under the FDCA or FPLA,

it can impose a variety of enforcement actions from public warning letters, injunctions, consent decrees, and civil penalties to

seizure of our products, total or partial shutdown of our production, and criminal prosecutions.

If any of these events were to

occur, it could materially adversely affect us.

If the FTC determines we have failed to substantiate our claims, it can pursue a

variety of actions including disgorgement of profits, injunction from further violative conduct, and consent decrees.

Domestic State and Local Government Regulation

Some states and local governments in the United

States regulate the labeling, operation, sale, and distribution of our skin care products.

To the extent additional state or local laws

apply, we intend to comply with them.

Foreign Government Regulation

In general, we will need to comply

with the government regulations of each individual country in which our products are to be distributed and sold.

These regulations vary

in complexity and can be as stringent, and on occasion even more stringent, than FDA regulations in the United States.

The level of complexity

and stringency is not always precisely understood today for each country, creating greater uncertainty for the international regulatory

Furthermore, government regulations can change with little to no notice and may result in up-regulation of our product(s), thereby

creating a greater regulatory burden for us.

We have not yet thoroughly explored the applicable laws and regulations that we will need

to comply with in foreign jurisdictions.

As a result, it is possible that we may not be permitted to sell our products in foreign markets

or expand our business into one or more foreign jurisdictions.

Environmental

We are not subject to any significant

or material environmental regulation in the normal operation of our business.

Currently, we have two employees, including our Director

and CEO Terry Howlett.

We conduct our operations through our wholly owned subsidiary,

Skinvisible Pharmaceuticals, Inc.

In general, we will need to comply with the government

regulations of each individual country in which our products are to be distributed and sold.

These regulations vary in complexity and

can be as stringent, and on occasion even more stringent, than FDA regulations in the United States.

The level of complexity and stringency

is not always precisely understood today for each country, creating greater uncertainty for the international regulatory process.

government regulations can change with little to no notice and may result in up-regulation of our product(s), thereby creating a greater

regulatory burden for us.

We have not yet thoroughly explored the applicable laws and regulations that we will need to comply with in

foreign jurisdictions.

As a result, it is possible that we may not be permitted to sell our products in foreign markets or expand our

business into one or more foreign jurisdictions.

Environmental Laws

We are not subject to any significant or material

environmental regulation in the normal operation of our business.

Currently, we have two employees, including our

Director and CEO Terry Howlett.

We conduct our operations through our wholly owned

subsidiary, Skinvisible Pharmaceuticals, Inc.

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 1. Business