What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2024-11-19 compared with 2024-08-15 · 104 added, 85 removed, 216 unchanged (47% of the section changed)

13 unchanged sentences

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

§ 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

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 concerns.

• cybersecurity

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

99 unchanged sentences

The updates include:

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

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 believe this announcement is important as:

7 unchanged sentences

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.

License Agreement with Ovation Science

35 unchanged sentences

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

Results of Operations for the Three and Six Months Ended June 30, 2024

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 June

30, 2024 and $5,000 for the same period ended June 30, 2023.

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 $10,000 for the six months ended June

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

3 unchanged sentences

in the future.

We had $0 in cost of revenues for the three and six months ended June 30,

2024, compared with $0 in cost of revenues for the three and six months ended June 30, 2023, so our gross profit was $5,000 and $10,000

for the three and six months ended June 30, 2024, respectively, as compared with gross profit of $5,000 and $10,000 for the three and

six ended June 30, 2023, respectively.

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.

Operating Expenses

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

ended June 30, 2024, from $117,823 for the same period ended June 30, 2023.

Operating expenses increased to $275,877 for the six months

ended June 30, 2024, from $250,727 for the same period ended June 30, 2023.

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.

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

and administrative expenses.

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

June 30, 2024, consisted mainly of accrued salaries and wages of $175,885 and audit and accounting of $31.638.

In comparison, our selling,

general and administrative expenses for the six months ended June 30, 2023, consisted mainly of accrued salaries and wages of $180,365

and audit and accounting of $25,419.

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.

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 $160,756 for the three months ended June 30, 2024,

as compared with other expenses of $163,252 for the three months ended June 30, 2023.

We had other expenses of $327,944 for the six months ended June 30, 2024,

as compared with other expenses of $1,550,404 for the six months ended June 30, 2023.

Our other expenses for the three and six months ended

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

We recorded a net loss of $303,449 for the three months ended June

30, 2024, as compared with a net loss of $276,075 for the three months ended June 30, 2023.

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

six months ended June 30, 2024, as compared with a net loss of $1,791,131for the six months ended June 30, 2023.

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.

Liquidity and Capital Resources

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 $39,974,309

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

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

aforementioned uncertainties.

As of June 30, 2024, we had total current assets

of $35,882 and total assets in the amount of $163,058.

Our total current liabilities as of June 30, 2024 were $4,023,571.

We had a working

capital deficit of $3,987,689 as of June 30, 2024, compared with a working capital deficit of $3,476,947 as of December 31, 2023.

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 six months ended June 30, 2024, as compared with $68,496 used for the six months ended June 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.

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 six months ended June 30, 2024 and 2023, respectively, for the purchase of intangible assets.

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

$55,700 for the six months ended June 30, 2024, as compared with no cash flows for financing activities

during the six months ended June 30, 2023.

$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.

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 June 30, 2024, there were no off-balance sheet arrangements.

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

Critical Accounting Policies

25 unchanged sentences

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

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

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

Recently Issued Accounting Pronouncements

5 unchanged sentences

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

What changed 10-Q

Item 2. Management’s Discussion and Analysis