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Item 1. Business

2026-03-31 compared with 2025-04-14 · 247 added, 215 removed, 40 unchanged (92% 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 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.

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.

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

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 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

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

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.

We generate revenue by:

• LICENSING :

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 royalties.

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

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.

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 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.

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

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.

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

We believe this announcement is important as:

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.

further announced that the study will be conducted by Dr.

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 Saudi 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 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;

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 May 20, 2025, Quoin announced that it has been

granted an Orphan Drug Designation in Europe by the European Medicines Agency (EMA) for its lead product QRX003 in Netherton Syndrome.

Orphan Drug Designation in Europe affords the Company

incentive benefits including scientific advice on study protocols, various fee reductions and access to EU grants.

If approved, QRX003

will be granted 10 years of market exclusivity in Europe for the treatment of Netherton Syndrome.

On June 24, 2025, Quoin announced that the FDA granted

a Rare Pediatric Disease (RPD) Designation for QRX003, for the treatment of Netherton Syndrome.

The designation reinforces the potential of QRX003

as a therapeutic candidate for a profoundly underserved pediatric population.

The FDA’s Rare Pediatric Disease Designation program

is intended to encourage the development of new therapies for serious and life-threatening diseases that primarily affect individuals

under 18 years of age.

If a New Drug Application (NDA) for QRX003 is approved, upon reauthorization of the program Quoin may be eligible

to receive a Priority Review Voucher (PRV), which can be redeemed to receive priority review for another marketing application or may

be sold or transferred.

On January 27, 2026 Quoin Pharmaceuticals Announced

USA - Quoin Pharmaceuticals Announces “FDA Grants Fast Track Designation for QRX003 for the Treatment of Netherton Syndrome” .

Fast Track Designation facilitates development and expedites regulatory review of therapies addressing serious conditions with significant

unmet medical need.

Fast Track Designation follows Pediatric Rare Disease and Orphan Drug Designation previously granted by the FDA and

Orphan Drug Designation granted by the European Medicines Agency for QRX003 in Netherton Syndrome.

QRX003 lotion (4%) currently being

evaluated in two late-stage whole-body clinical trials for treatment of Netherton Syndrome.

Saudi Arabia - Quoin Pharmaceuticals Files

Breakthrough Medicine Designation Application in Saudi Arabia for QRX003 in Netherton Syndrome.

If granted, QRX003 could be approved for

sale and reimbursement in Saudi Arabia as the first ever approved treatment for Netherton Syndrome.

Japan - Quoin Pharmaceuticals Announces

Submission to Japanese MHLW for Orphan Drug Designation for QRX003 and has been approved for both Fast Track and Regulatory Review Status

for QRX003 for Netherton Syndrome.

On March 25, 2026 Quoin Pharmaceuticals Ltd.

provided a clinical

and regulatory update from its recent constructive Type C meeting with the U.S.

Food and Drug Administration (FDA) for its lead product

candidate, QRX003, for the treatment of Netherton Syndrome (NS):

Key highlights from the meeting include:

FDA indicated that a single Phase 3 study may be sufficient

to support marketing approval for QRX003 for Netherton Syndrome, which is an alternative to the traditional expectation for two Phase

3 studies in NS patients originally proposed by the Company.

FDA expressed openness to an alternative innovative clinical

trial design such as a randomized withdrawal or a randomized delayed start for a pivotal Phase 3 study.

Such trial design would likely

not include a traditional upfront vehicle or placebo control.

Based on the feedback from the meeting, Quoin is implementing

FDA recommendations consistent with the meeting outcomes, ensuring its readiness to advance toward registrational Phase 3 development.

Quoin will submit clinical data from the ongoing Phase 2 and pediatric investigator studies and plans to request a meeting to discuss

this data prior to initiating the Phase 3 pivotal program for QRX003 to gain alignment with FDA on the design of the program.

Quoin remains

on track to complete patient recruitment into its Phase 3 program by the end of 2026 and to potentially file for FDA approval for QRX003

as the first treatment for Netherton Syndrome in 2027.

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.

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.

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

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

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

On September 18, 2025, the Company signed a new agreement

with Ovation Science.

Ovation Science retains exclusive global rights to use Skinvisible’s Invisicare® technology with cannabinoids

for topical/transdermal products, including new formulations with THC-V targeting obesity and metabolic health.

The agreement covers confidential

know-how and a pending PCT patent application for transdermal delivery of glucose-controlling agents.

The collaboration aims to address

gastrointestinal side effects in obesity treatments and capitalize on a projected $150 billion market by 2035 (Morgan Stanley, 2025).

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 technology.

Nevertheless, our current and potential competitors

7 unchanged sentences

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 regulations.

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.

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.

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.

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

14 unchanged sentences

environmental regulation in the normal operation of our business.

Currently, we have two employees, including our

Director and CEO Terry Howlett.

Currently, we have two employees, including our Director

and CEO Terry Howlett.

We conduct our operations through our wholly owned

1 unchanged sentence

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