What changed in this filing

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Item 1. Financial Statements

2025-11-12 compared with 2025-08-12 · 265 added, 230 removed, 499 unchanged (50% of the section changed)

4 unchanged sentences

(in thousands, except per share data)

September 30,

Current assets:

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Common stock, par value $ 0.001 ;

32,000 shares authorized, 11,574 and 11,532 issued and outstanding as of June 30, 2025 and December 31, 2024

32,000 shares authorized, 11,574 and 11,532 issued and outstanding as of September 30, 2025 and December 31, 2024

Additional paid-in capital

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Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

Revenue, net:

1 unchanged sentence

Operating expenses:

Selling, general and administrative

General and administrative

Impairment of long-lived assets (Note 4)

Write-off of patents and trademarks

Depreciation & amortization

Depreciation and amortization

Total operating expenses

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Net Income (loss)

Earnings (loss) per common share, basic and diluted:

Net Income (loss) per common share, basic and diluted:

Continuing operations

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(Unaudited - in thousands)

Additional Paid in

Balance, January 1, 2025

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$ ( 951,924 )

Share-based compensation

Balance, September 30, 2025

$ ( 951,772 )

Additional Paid in

Balance, January 1, 2024

6 unchanged sentences

$ ( 951,465 )

Share-based compensation

Balance, September 30, 2024

$ ( 952,074 )

The accompanying notes are an integral part of

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(Unaudited - in thousands)

Six Months Ended

Nine Months Ended

September 30,

Cash flows from operating activities:

(loss) income from discontinued operations, net of income taxes

Net Income (loss)

income (loss) from discontinued operations, net of income taxes

Net loss from continuing operations

2 unchanged sentences

Impairment of long-lived assets (Note 4)

Write-off of patents and trademarks

Write-off of patents

Share-based compensation

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Net increase in cash

Cash and cash equivalents - continuing operations, beginning of period

Cash and cash equivalents, beginning of period

Total cash and cash equivalents, end of period

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IMVEXXY and BIJUVA outside of the U.S.

In July 2018, we entered into a license and supply agreement (the “Knight License Agreement”) with Knight Therapeutics Inc.

July 2018, we entered into a license and supply agreement (the “Knight License Agreement”) with Knight Therapeutics Inc.

(“Knight”) pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel.

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There were no drawdowns

in the first six months of 2025 and 2024.

In February 2024, the Company received Mayne Pharma’s calculation

of the net working capital allowances for payer rebates and wholesale distributor fees pursuant to the Transaction Agreement, which differed

significantly from the Company’s estimate of the allowances.

The Company continues to believe its estimated allowances for payer

rebates and wholesale distributor fees are reasonable.

In August 2024 and in February 2025, the Company also received information from

Mayne Pharma pertaining to the net working capital allowance for returns that differs significantly from the Company’s estimate

of the allowance.

On April 8, 2025, the Company filed a lawsuit against Mayne Pharma

in the United States District Court for the District of Delaware (the “Mayne Lawsuit”) seeking damages for breach of contract,

in the first nine months of 2025 and 2024.

In February 2024, we received Mayne Pharma’s calculation of the

net working capital allowances for payer rebates and wholesale distributor fees pursuant to the Transaction Agreement, which differed

significantly from our estimate of the allowances.

We continue to believe our estimated allowances for payer rebates and wholesale distributor

fees are reasonable.

In August 2024 and in February 2025, we also received information from Mayne Pharma pertaining to the net working

capital allowance for returns that differs significantly from our estimate of the allowance.

On April 8, 2025, we filed a lawsuit against Mayne Pharma in

the United States District Court for the District of Delaware (the “Mayne Lawsuit”) seeking damages for breach of contract,

breach of the implied covenant of good faith and fair dealing, fraudulent inducement, and unjust enrichment related to Mayne Pharma’s

actions in relation to the License Agreement and the Transaction Agreement, primarily relating to the net working capital allowances

and certain actions or inactions by Mayne Pharma relating thereto.

On June 20, 2025, the Company filed an amended complaint against

Mayne Pharma and on July 22, 2025, Mayne Pharma filed a motion to dismiss the Mayne Lawsuit.

On May 30, 2025, Mayne Pharma filed a lawsuit against the Company in

the United States District Court for the District of Delaware (the “Mayne Countersuit” and, together with the Mayne Lawsuit,

the “Mayne Lawsuits”) seeking damages for breach of contract and fraudulent inducement related to the Transaction Agreement.

On July 28, 2025, the Company filed a motion to dismiss the Mayne Countersuit.

As of June 30, 2025, the Company believed no additional

accrual was required for such claims, as the Company could not reasonably estimate a range of loss.

actions in relation to the License Agreement and the Transaction Agreement, primarily relating to the net working capital allowances and

certain actions or inactions by Mayne Pharma relating thereto.

On June 20, 2025, we filed an amended complaint against Mayne Pharma

and on July 22, 2025, Mayne Pharma filed a motion to dismiss the Mayne Lawsuit.

On May 30, 2025, Mayne Pharma filed a lawsuit against us in the United

States District Court for the District of Delaware (the “Mayne Countersuit” and, together with the Mayne Lawsuit, the “Mayne

Lawsuits”) seeking damages for breach of contract and fraudulent inducement related to the Transaction Agreement.

On July 28, 2025,

we filed a motion to dismiss the Mayne Countersuit.

As of September 30, 2025, we believed no additional accrual was required for such

claims, as we could not reasonably estimate a range of loss.

The outcome of this matter is uncertain at this point.

the Company cannot reasonably estimate a range of loss, and accordingly, the Company has not accrued any additional liability associated

with Mayne Pharma’s allowance calculation for payer rebates and wholesale distributor fees, particularly as the Company believes

the outcome of this matter to be intertwined with the resolution of the net working capital allowance for returns.

As of June 30, 2025, the Company also believed no additional accrual

was required for amounts that may be owed for the allowance for returns under the Transaction Agreement.

The Company has not recorded

any contingent gains or receivables for any such allowances.

Management continues to monitor the unresolved and pending net working capital

items as changes to estimated amounts owed or amounts due from Mayne Pharma may be material.

we cannot reasonably estimate a range of loss, and accordingly, we have not accrued any additional liability associated with Mayne Pharma’s

allowance calculation for payer rebates and wholesale distributor fees, particularly as we believe the outcome of this matter to be intertwined

with the resolution of the net working capital allowance for returns.

As of September 30, 2025, we also believed no additional accrual was

required for amounts that may be owed for the allowance for returns under the Transaction Agreement.

We have not recorded any contingent

gains or receivables for any such allowances.

Management continues to monitor the unresolved and pending net working capital items as

changes to estimated amounts owed or amounts due from Mayne Pharma may be material.

Mayne Pharma has also made certain indemnification demands under the

Transaction Agreement, which the Company disputes.

As of June 30, 2025, the Company believed no additional accrual was required for such

claims, as the Company could not reasonably estimate a range of loss.

Transaction Agreement, which we dispute.

As of September 30, 2025, we believed no additional accrual was required for such claims, as

we could not reasonably estimate a range of loss.

If Mayne Pharma’s sales of Licensed Products grow more slowly

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Adoption of new accounting standards

In July 2025, the FASB issued ASU 2025-05, “Financial Instruments-Credit

Losses (Topic 326):

Measurement of Credit Losses for Accounts Receivable and Contract Assets,” which provides a practical expedient

related to the estimation of expected credit losses for accounts receivable and current contract assets that arise from transactions accounted

for under Accounting Standards Codification (“ASC”) 606, “Revenue Recognition.” ASU 2025-05 requires an

entity to disclose whether it has elected to use the practical expedient.

An entity that makes the accounting policy election is required

to disclose the date through which subsequent cash collections are evaluated.

The requirements of ASU 2025-05 are effective for annual

periods beginning after December 15, 2025, and interim periods beginning in the first quarter of 2026.

Early adoption is permitted in

both interim and annual reporting periods in which financial statements have not yet been issued or made available for issuance.

is currently in the process of evaluating the effects of this pronouncement on its consolidated financial results and related disclosures.

As of December 2024, we have adopted Financial Accounting Standards

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Retrospective application is permitted for all prior periods presented in the financial statements.

The Company is evaluating the impact of ASU 2024-03 on our financial reporting disclosures.

In December 2023, the FASB issued ASU 2023-09, “Income Taxes

(Topic 740) - Improvements to Income Tax Disclosures.” ASU 2023-09 enhances the transparency and decision usefulness of income tax

disclosures by requiring consistent categories and greater disaggregation of information in the rate reconciliation and income taxes paid

disaggregated by jurisdiction.

ASU 2023-09 will be effective for the Company in its income tax disclosure included in its 2025 Annual

Report on Form 10-K and will be applied on a prospective basis.

We are evaluating the impact of ASU 2024-03 on our financial reporting disclosures.

In December 2023, the FASB issued ASU 2023-09, “Income

Taxes (Topic 740) - Improvements to Income Tax Disclosures.” ASU 2023-09 enhances the transparency and decision usefulness of

income tax disclosures by requiring consistent categories and greater disaggregation of information in the rate reconciliation and

income taxes paid disaggregated by jurisdiction.

ASU 2023-09 will be effective for us in our income tax disclosure included in our

2025 Annual Report on Form 10-K and will be applied on a prospective basis.

However, retrospective application is permitted.

Early adoption is also

The Company is evaluating the impact of ASU 2023-09 on the Company’s income tax disclosures and on its condensed consolidated

financial statements.

adoption is also permitted.

We are evaluating the impact of ASU 2023-09 on our income tax disclosures and on the condensed

consolidated financial statements.

Estimates and assumptions

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Additionally, the related assets and liabilities have been reported

as assets and liabilities of discontinued operations in our condensed consolidated balance sheets as of June 30, 2025 and December 31,

as assets and liabilities of discontinued operations in our condensed consolidated balance sheets as of September 30, 2025 and December

As described in Note 1, the acquisition of net working capital by Mayne

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Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

General and administrative expenses

Total operating expenses

Operating income (loss) from discontinued operations

Operating loss from discontinued operations

Other income, net

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The following table presents the carrying amounts of the classes of

assets and liabilities of discontinued operations as of June 30, 2025 and December 31, 2024 (in thousands):

assets and liabilities of discontinued operations as of September 30, 2025 and December 31, 2024 (in thousands):

September 30, 2025

December 31, 2024

Current liabilities of discontinued operations:

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Our prepaid and other current assets consisted of the following as

of June 30, 2025 and December 31, 2024 (in thousands):

of September 30, 2025 and December 31, 2024 (in thousands):

September 30, 2025

December 31, 2024

Capitalized legal

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The following provides information about our license rights and other

intangible assets, net as of June 30, 2025 and December 31, 2024 (in thousands):

June 30, 2025

intangible assets, net as of September 30, 2025 and December 31, 2024 (in thousands):

September 30, 2025

December 31, 2024

Gross Carrying Amount

Accumulated Amortization

Gross Carrying Amount

Accumulated Amortization

Intangible assets subject to amortization:

Hormone therapy drug patents

Hormone therapy drug patents applied and pending approval

Hormone therapy drug patents applied

and pending approval

Intangible assets subject to amortization

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We recorded, in continuing operations, amortization expense related

to patents of $ 95 thousand and $ 180 thousand for the three months ended June 30, 2025 and 2024, respectively, and $ 190 thousand and $ 313

thousand for the six months ended June 30, 2025 and 2024, respectively.

The Company conducts regular reviews of the individual patents and

During the three months ended March 31, 2025, we recorded $ 88 thousand in write-off of patents pending approval as a result

of our review.

For the six months ended June 30, 2024, the Company determined it had an indicator of impairment, as it had abandoned the

legal right and title to a portion of its granted patent portfolio and had ceased pursuit of a portion of its pending patents based on

input from its licensing partners.

The Company recognized an impairment loss of $ 1,261 thousand related to those abandoned patents and

applications, which is classified as an impairment of long-lived assets on the Company’s condensed consolidated statements of operations.

to patents of $ 96 thousand and $ 96 thousand for the three months ended September 30, 2025 and 2024, respectively, and $ 287 thousand and

$ 409 thousand for the nine months ended September 30, 2025 and 2024, respectively.

We conduct regular reviews of the individual patents and portfolios.

the nine months ended September 30, 2025, we recorded $ 120 thousand in write-off of patents pending approval as a result of our review.

For the six months ended June 30, 2024, we determined there was an indicator of impairment, as we had abandoned the legal right and

title to a portion of our granted patent portfolio and had ceased pursuit of a portion of the pending patents based on input from our

licensing partners.

We recognized an impairment loss of $ 1,261 thousand related to those abandoned patents and applications, which is

classified as an impairment of long-lived assets on our condensed consolidated statements of operations.

Our intangible assets subject to amortization are expected to be amortized

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following (in thousands):

2025 December 31,

September 30, 2025 December 31, 2024

Payroll and related costs $ 256 $ 118

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Of the $ 5.5 million, $ 2.0 million increased the allowance for net working capital allowances remaining to be trued up.

The Company’s estimate of the allowance for payer rebates and

wholesale distributor fees was determined in accordance with the Transaction Agreement which establishes the process for the determination

of net working capital.

In February 2024, the Company received Mayne Pharma’s calculation of the net working capital allowances

for payer rebates and wholesale distributor fees which differed significantly from the Company’s estimate of the allowances.

Company continues to believe its estimated allowances for payer rebates and wholesale distributor fees are reasonable.

In August 2024

and February 2025, the Company also received information from Mayne Pharma pertaining to the net working capital allowance for returns

that differs significantly from the Company’s estimate of the allowance.

On April 8, 2025, the Company filed the Mayne Lawsuit

seeking damages for breach of contract, breach of the implied covenant of good faith and fair dealing, fraudulent inducement, and

unjust enrichment related to Mayne Pharma’s actions in relation to the License Agreement and the Transaction Agreement,

primarily relating to the net working capital allowances and certain actions or inactions by Mayne Pharma relating thereto.

20, 2025, the Company filed an amended complaint against Mayne Pharma, and on July 22, 2025 Mayne Pharma filed a motion to dismiss

the Mayne Lawsuit.

On May 30, 2025, Mayne Pharma filed the Mayne Countersuit seeking damages

for breach of contract and fraudulent inducement related to the Transaction Agreement.

On July 28, 2025, the Company filed a motion to

dismiss the Mayne Countersuit.

As of June 30, 2025, the Company believed no additional accrual was required for such claims, as the Company

could not reasonably estimate a range of loss.

Our estimate of the allowance for payer rebates and wholesale distributor

fees was determined in accordance with the Transaction Agreement which establishes the process for the determination of net working capital.

In February 2024, we received Mayne Pharma’s calculation of the net working capital allowances for payer rebates and wholesale distributor

fees pursuant to the Transaction Agreement, which differed significantly from our estimate of the allowances.

We continue to believe our

estimated allowances for payer rebates and wholesale distributor fees are reasonable.

In August 2024 and in February 2025, we also received

information from Mayne Pharma pertaining to the net working capital allowance for returns that differs significantly from our estimate

of the allowance.

On April 8, 2025, we filed a lawsuit against Mayne Pharma in

the United States District Court for the District of Delaware (the “Mayne Lawsuit”) seeking damages for breach of contract,

breach of the implied covenant of good faith and fair dealing, fraudulent inducement, and unjust enrichment related to Mayne Pharma’s

actions in relation to the License Agreement and the Transaction Agreement, primarily relating to the net working capital allowances and

certain actions or inactions by Mayne Pharma relating thereto.

On June 20, 2025, we filed an amended complaint against Mayne Pharma

and on July 22, 2025, Mayne Pharma filed a motion to dismiss the Mayne Lawsuit.

On May 30, 2025, Mayne Pharma filed a lawsuit against the us in the

United States District Court for the District of Delaware (the “Mayne Countersuit” and, together with the Mayne Lawsuit, the

“Mayne Lawsuits”) seeking damages for breach of contract and fraudulent inducement related to the Transaction Agreement.

July 28, 2025, we filed a motion to dismiss the Mayne Countersuit.

As of September 30, 2025, we believed no additional accrual was required

for such claims, as we could not reasonably estimate a range of loss.

The outcome of this matter is uncertain at this point.

the Company cannot reasonably estimate a range of loss, and accordingly, the Company has not accrued any additional liability associated

with Mayne Pharma’s allowance calculation for payer rebates and wholesale distributor fees, particularly as the Company believes

the outcome of this matter to be intertwined with the resolution of the net working capital allowance for returns.

As of June 30, 2025, the Company also believed no additional accrual

was required for amounts that may be owed for the allowance for returns under the Transaction Agreement.

The Company has not recorded

any contingent gains or receivables for any such allowances.

Management continues to monitor the unresolved and pending net working capital

items as changes to estimated amounts owed or amounts due from Mayne Pharma may be material.

Mayne Pharma has also made certain indemnification

demands under the Transaction Agreement, which the Company disputes.

As of June 30, 2025, the Company believed no additional accrual was

required for such claims, as the Company could not reasonably estimate a range of loss.

we cannot reasonably estimate a range of loss, and accordingly, we have not accrued any additional liability associated with Mayne Pharma’s

allowance calculation for payer rebates and wholesale distributor fees, particularly as we believe the outcome of this matter to be intertwined

with the resolution of the net working capital allowance for returns.

As of September 30, 2025, we also believed no additional accrual was

required for amounts that may be owed for the allowance for returns under the Transaction Agreement.

We have not recorded any contingent

gains or receivables for any such allowances.

Management continues to monitor the unresolved and pending net working capital items as

changes to estimated amounts owed or amounts due from Mayne Pharma may be material.

Mayne Pharma has also made certain indemnification demands under the

Transaction Agreement, which we dispute.

As of September 30, 2025, we believed no additional accrual was required for such claims, as

we could not reasonably estimate a range of loss.

Legal proceedings

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We have incurred and recorded legal costs amounting to $ 2,334 thousand in prepaid

expenses and other current assets as of June 30, 2025, for the IMVEXXY Paragraph IV legal proceeding since we believe that we will successfully

prevail in this legal proceeding.

Upon the successful conclusion of the legal proceeding, the related capitalized legal costs will be

reclassified to patents, in license rights and other intangible assets, net, in the accompanying condensed consolidated balance sheets,

and such costs will be amortized over the remaining useful life of the patents.

If Mayne Pharma is unsuccessful in this legal proceeding,

then the related capitalized legal costs for this legal preceding and any unamortized IMVEXXY patent costs that were previously capitalized

will be immediately expensed in the period in which we become aware of an unsuccessful legal proceeding.

expenses and other current assets as of September 30, 2025, for the IMVEXXY Paragraph IV legal proceeding since we believe that we will

successfully prevail in this legal proceeding.

Upon the successful conclusion of the legal proceeding, the related capitalized legal costs

will be reclassified to patents, in license rights and other intangible assets, net, in the accompanying condensed consolidated balance

sheets, and such costs will be amortized over the remaining useful life of the patents.

If Mayne Pharma is unsuccessful in this legal

proceeding, then the related capitalized legal costs for this legal preceding and any unamortized IMVEXXY patent costs that were previously

capitalized will be immediately expensed in the period in which we become aware of an unsuccessful legal proceeding.

In June 2024, Mayne Pharma received a Paragraph IV certification notice

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with respect to Teva and Sun Pharma.

On April 8, 2025, we filed a lawsuit against Mayne Pharma in the

United States District Court for the District of Delaware seeking damages for breach of contract, breach of the implied covenant of

good faith and fair dealing, fraudulent inducement, and unjust enrichment related to Mayne Pharma’s actions in relation to the

License Agreement and the Transaction Agreement, primarily relating to the net working capital allowances and certain actions or

inactions by Mayne Pharma relating thereto.

We are seeking, among other relief, money damages for all of Mayne Pharma’s

profits arising from their unlawful conduct and for any injury sustained by us as a result of Mayne Pharma’s unlawful conduct.

On June 20, 2025, we filed an amended complaint against Mayne Pharma and on July 22, 2025, Mayne Pharma filed a motion to dismiss

the Mayne Lawsuit.

On April 8, 2025, we filed a lawsuit against Mayne Pharma in the United

States District Court for the District of Delaware seeking damages for breach of contract, breach of the implied covenant of good faith

and fair dealing, fraudulent inducement, and unjust enrichment related to Mayne Pharma’s actions in relation to the License Agreement

and the Transaction Agreement, primarily relating to the net working capital allowances and certain actions or inactions by Mayne Pharma

relating thereto.

We are seeking, among other relief, money damages for all of Mayne Pharma’s profits arising from their unlawful

conduct and for any injury sustained by us as a result of Mayne Pharma’s unlawful conduct.

On June 20, 2025, we filed an amended

complaint against Mayne Pharma and on July 22, 2025, Mayne Pharma filed a motion to dismiss the Mayne Lawsuit.

On May 30, 2025, Mayne Pharma filed a lawsuit against us in the United

1 unchanged sentence

On July 28, 2025, we filed a motion to dismiss the Mayne Countersuit.

As of June 30, 2025, the Company believed no additional

accrual was required for such claims, as the Company could not reasonably estimate a range of loss.

As of September 30, 2025, we believed no additional accrual

was required for such claims, as we could not reasonably estimate a range of loss.

From time to time, we are involved in other litigations and proceedings

3 unchanged sentences

Off-balance sheet arrangements

As of June 30, 2025 and December 31, 2024 there were no off-balance

As of September 30, 2025 and December 31, 2024 there were no off-balance

sheet arrangements that have had or are reasonably likely to have current or future effects on our financial condition, changes in financial

8 unchanged sentences

the first quarter of 2025.

As of June 30, 2025, we employed one full-time employee primarily engaged in an executive position.

engaged external consultants who support our relationship with current partners and assist with certain financial, IT, legal, and regulatory

matters and the continued wind-down of our historical business operations.

As of September 30, 2025, we employed one full-time employee primarily engaged in an executive position.

have engaged external consultants who support our relationship with current partners and assist with certain financial, IT, legal, and

regulatory matters and the continued wind-down of our historical business operations.

Stockholders’ equity

As of June 30, 2025, the following table summarizes the status of our

outstanding and exercisable warrants and related transactions since December 31, 2024 (in thousands, except weighted average exercise

As of September 30, 2025, the following table summarizes the status

of our outstanding and exercisable warrants and related transactions since December 31, 2024 (in thousands, except weighted average exercise

price and weighted average remaining contractual life data):

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As of December 31, 2024 98 $ 63.33 -

As of June 30, 2025 98 $ 63.33 $ -

As of September 30, 2025 98 $ 63.33 $ -

Share-based compensation payment plans

As of June 30, 2025, 51,030 shares of common stock were subject to

outstanding awards under our share-based payment award plans and inducement grants (calculated using the base number of PSUs that may

As of June 30, 2025, 416,219 shares of common stock were available for future grants of share-based payment awards under the TherapeuticsMD,

As of September 30, 2025, 51,030 shares of common stock were subject

to outstanding awards under our share-based payment award plans and inducement grants (calculated using the base number of PSUs that may

As of September 30, 2025, 416,219 shares of common stock were available for future grants of share-based payment awards under the

TherapeuticsMD, Inc.

2019 Stock Incentive Plan.

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Outstanding Exercisable

Awards Weighted

Price Aggregate

Value Weighted

(in Years) Options

Awards Weighted Average Exercise Price Aggregate

Value Weighted Average Remaining Contractual Life (in Years) Options

Awards Weighted

Price Aggregate

Value Weighted

Value Weighted Average Remaining Contractual Life (in Years)

As of December 31, 2024 57 $ 270.33 $ —

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Expired ( 6 ) 312.36 —

As of June 30, 2025 51 $ 265.80 $ —

As of September 30, 2025 51 $ 265.80 $ —

2.3 51 $ 265.66 $ —

The following table summarizes the status of our RSUs and related transactions

since December 31, 2024 (in thousands, except weighted average grant date fair value):

The following table summarizes the status of our RSUs and related

transactions since December 31, 2024 (in thousands, except weighted average grant date fair value):

RSUs awards outstanding

Balance, as of December 31, 2024

Balance, as of June 30, 2025

The following table summarizes the status of our PSUs and related transactions

since December 31, 2024 (in thousands, except weighted average grant date fair value):

Balance, as of September 30, 2025

The following table summarizes the status of our PSUs and related

transactions since December 31, 2024 (in thousands, except weighted average grant date fair value):

Unvested, as of December 31, 2024

Balance, as of June 30, 2025

Balance, as of September 30, 2025

Share-based payment compensation cost

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compensation costs related to previously issued options, RSU and PSUs, as well as shares of common stock issued under our employee stock

purchase plan (“ESPP”) totaling $ 1 thousand and $ 96 thousand for the three months ended June 30, 2025 and 2024, respectively,

and $ 24 thousand and $ 207 thousand for the six months ended June 30, 2025 and 2024, respectively.

As of June 30, 2025, there was no unrecognized share-based payment award

compensation cost related to unvested options, RSUs and PSUs as well as shares issuable under our ESPP.

No tax benefit was realized due

to a continued pattern of net losses.

Pursuant to the Mayne License Agreement, the Company granted Mayne

Pharma, on the Closing Date, (i) an exclusive, sublicensable, perpetual, irrevocable license to research, develop, register, manufacture,

have manufactured, market, sell, use, and commercialize the Licensed Products in the United States and its possessions and territories

and (ii) an exclusive, sublicensable, perpetual, irrevocable license to manufacture, have manufactured, import and have imported the Licensed

Products outside the United States for commercialization in the United States and its possessions and territories.

purchase plan (“ESPP”) totaling $ 0 and $ 33 thousand for the three months ended September 30, 2025 and 2024, and $ 24 thousand

and $ 240 thousand for the nine months ended September 30, 2025 and 2024, respectively.

As of September 30, 2025, there was no unrecognized share-based payment

award compensation cost related to unvested options, RSUs and PSUs as well as shares issuable under our ESPP.

No tax benefit was realized

due to a continued pattern of net losses.

Pursuant to the Mayne License Agreement, we granted Mayne Pharma, on

the Closing Date, (i) an exclusive, sublicensable, perpetual, irrevocable license to research, develop, register, manufacture, have manufactured,

market, sell, use, and commercialize the Licensed Products in the United States and its possessions and territories and (ii) an exclusive,

sublicensable, perpetual, irrevocable license to manufacture, have manufactured, import and have imported the Licensed Products outside

the United States for commercialization in the United States and its possessions and territories.

Pursuant to the Mayne License Agreement, Mayne Pharma will make one-time,

milestone payments to the Company of each of (i) $ 5.0 million if aggregate net sales of all Products in the United States during a calendar

year reach $ 100.0 million, (ii) $ 10.0 million if aggregate net sales of all Products in the United States during a calendar year reach

$ 200.0 million and (iii) $ 15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 300.0

Further, Mayne Pharma will pay to the Company royalties on net sales of all Products in the United States at a royalty rate of

8.0 % on the first $ 80 million in annual net sales and 7.5 % on annual net sales above $ 80.0 million, subject to certain adjustments, for

a period of 20 years following the Closing Date.

The royalty rate will decrease to 2.0 % on a Product-by-Product basis upon the earlier

to occur of (i) the expiration or revocation of the last patent covering a Product and (ii) a generic version of a Product launching in

the United States.

Mayne Pharma will pay to the Company minimum annual royalties of $ 3.0 million per year for 12 years, adjusted for inflation

at an annual rate of 3 %, subject to certain further adjustments.

Upon the expiry of the 20 -year royalty term, the licenses granted to

Mayne Pharma under the Mayne License Agreement will become a fully paid-up and royalty free license for the Licensed Products.

milestone payments to us of each of (i) $ 5.0 million if aggregate net sales of all Products in the United States during a calendar year

reach $ 100.0 million, (ii) $ 10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 200.0

million and (iii) $ 15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 300.0 million.

Further, Mayne Pharma will pay to us royalties on net sales of all Products in the United States at a royalty rate of 8.0 % on the first

$ 80 million in annual net sales and 7.5 % on annual net sales above $ 80.0 million, subject to certain adjustments, for a period of 20 years

following the Closing Date.

The royalty rate will decrease to 2.0 % on a Product-by-Product basis upon the earlier to occur of (i) the

expiration or revocation of the last patent covering a Product and (ii) a generic version of a Product launching in the United States.

Mayne Pharma will pay to us minimum annual royalties of $ 3.0 million per year for 12 years, adjusted for inflation at an annual rate of

3 %, subject to certain further adjustments.

Upon the expiry of the 20 -year royalty term, the licenses granted to Mayne Pharma under the

Mayne License Agreement will become a fully paid-up and royalty free license for the Licensed Products.

We do not expect to pay any significant federal or state income taxes

as a result of the losses recorded during the six months ended June 30, 2025 and 2024 and net operating loss carry forwards from prior

We recorded a full valuation allowance of the net operating losses

for the three and six months ended June 30, 2025 and 2024.

Accordingly, there were no provisions for income taxes for the three and six

months ended June 30, 2025 and 2024.

Additionally, as of June 30, 2025 and December 31, 2024, we maintain a full valuation allowance for

all deferred tax assets.

due to net operating loss carry forwards from prior years.

We recorded a full valuation allowance of the net operating income

and losses for the three and nine months ended September 30, 2025 and 2024.

Accordingly, there were no provisions for income taxes for

the three and nine months ended September 30, 2025 and 2024.

Additionally, as of September 30, 2025 and December 31, 2024, we maintain

a full valuation allowance for all deferred tax assets.

Earnings (loss) per common share

2 unchanged sentences

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

Income (loss) from continuing operations, net of income taxes

1 unchanged sentence

Net Income (loss)

Weighted average common shares for basic income (loss) per common share

Weighted average common shares for basic loss per common share

Effect of dilutive securities

2 unchanged sentences

Earnings (loss) per common share, discontinued operations, net of income taxes

For the three months ended June 30, 2025, the remaining balance of the

Company’s warrants and stock options were excluded from the calculation of diluted earnings per share because the weighted exercise

For the three months ended September 30, 2025, the remaining balance

of our warrants and stock options were excluded from the calculation of diluted earnings (loss) per share because the weighted exercise

prices of the warrants and stock options were greater than or equal to the average price of the common shares and were therefore anti-dilutive.

For the three months ended June 30, 2024 and for the six months ended

June 30, 2024 and 2025, respectively, since we reported a net loss from continuing operations, our potentially dilutive securities are

deemed to be anti-dilutive, accordingly, there was no effect of dilutive securities.

For the three months ended September 30, 2024 and for the nine months

ended September 30, 2024 and 2025, respectively, since we reported a net loss from continuing operations, our potentially dilutive securities

are deemed to be anti-dilutive, accordingly, there was no effect of dilutive securities.

Therefore, our basic and diluted loss per common

share and our basic and diluted weighted average common shares from continuing operations are the same for the three and six months ended

June 30, 2025 and 2024.

The following table sets forth the outstanding securities as of the

periods presented which were not included in the calculation of diluted earnings (loss) per common share during the respective three and

six months ended June 30, 2025 and 2024 (in thousands):

As of June 30,

share and our basic and diluted weighted average common shares from continuing operations are the same for the three and nine months ended

September 30, 2025 and 2024.

The following table sets forth the outstanding weighted average

securities for the periods presented which were not included in the calculation of diluted earnings (loss) per common share as of

September 30 for the respective three and nine month periods (in thousands):

Three Months Ended

September 30,

Nine Months Ended

September 30,

Stock options

7 unchanged sentences

or appointed or his earlier death or resignation.

As a director of our Company, Mr.

Roberts is entitled to receive compensation in the

same manner as our other non-employee directors, described in the section entitled “Director Compensation” in our Amendment

1 to Form 10-K for the fiscal year ended December 31, 2022, filed with the Securities and Exchange Commission on May 1, 2023, but

he has elected not to receive any compensation for his service as a non-employee director at this time.

Roberts currently serves as

a Partner of Rubric.

On July 29, 2022, September 30, 2022, October 28, 2022, and May 1, 2023, we entered into subscription agreements

On December 30, 2022, in accordance with the terms of the Certificate of Designation, we redeemed all 29,000 outstanding

shares of Series A Preferred Stock previously issued to affiliates of Rubric at a purchase price of $ 1,333 per share and also paid certain

affiliates of Rubric approximately $ 3.0 million as a make-whole payment pursuant to the subscription agreements previously entered into

between us and Rubric.

On June 29, 2023, we issued and sold 312,525 shares of Common Stock to Rubric at a price per share equal to $ 3.6797

pursuant to the Subscription Agreement and received gross proceeds of $ 1.15 million, before expenses.

On November 15, 2023 Rubric drew

down an additional 877,192 shares of Common Stock at a price per share equal to $ 2.2761 .

We received gross proceeds of $ 2.0 million from

the drawdown, before expenses.

There were no drawdowns in the first six months of 2025 and 2024.

As a director, Mr.

Roberts is entitled to receive compensation in the same manner as

our other non-employee directors, described in the section entitled “Director Compensation” in our Amendment No.

10-K for the fiscal year ended December 31, 2022, filed with the Securities and Exchange Commission on May 1, 2023, but he has elected

not to receive any compensation for his service as a non-employee director at this time.

Roberts currently serves as a Partner of

On July 29, 2022, September 30, 2022, October 28, 2022, and May 1, 2023, we entered into subscription agreements with Rubric.

On December 30, 2022, in accordance with the terms of the Certificate of Designation, we redeemed all 29,000 outstanding shares of Series

A Preferred Stock previously issued to affiliates of Rubric at a purchase price of $ 1,333 per share and also paid certain affiliates of

Rubric approximately $ 3.0 million as a make-whole payment pursuant to the subscription agreements previously entered into between us and

On June 29, 2023, we issued and sold 312,525 shares of Common Stock to Rubric at a price per share equal to $ 3.6797 pursuant to

the Subscription Agreement and received gross proceeds of $ 1.15 million, before expenses.

On November 15, 2023, Rubric drew down an additional

877,192 shares of Common Stock at a price per share equal to $ 2.2761 .

We received gross proceeds of $ 2.0 million from the drawdown, before

There were no drawdowns in the first nine months of 2025 and 2024.

Business concentrations

6 unchanged sentences

our condensed consolidated financial statements.

Assets and liabilities associated with the commercial business are classified as assets

and liabilities of discontinued operations in our consolidated balance sheets.

Additional disclosures regarding discontinued operations

are provided in Note 2.

For the three and six months ended June 30, 2025, 100 % of license revenue

related to Mayne Pharma, Theramex and Knight.

As of June 30, 2025 , we had

a royalty receivable of $ 3,743 thousand relating to the short-term portion of receivable from Mayne Pharma, Theramex and Knight and $ 14,840

Liabilities associated with the commercial business are classified as liabilities

of discontinued operations in our condensed consolidated balance sheets.

Additional disclosures regarding discontinued operations are

provided in Note 2.

For the three and nine months ended September 30, 2025, 100 % of license

revenue related to Mayne Pharma, Theramex and Knight.

As of September 30, 2025 , we

had a royalty receivable of $ 3,665 thousand relating to the short-term portion of receivable from Mayne Pharma, Theramex and Knight and

$ 14,269 thousand relating to the long-term portion of royalty receivable which includes royalties recognized from the minimum annual royalty

1 unchanged sentence

Segment Reporting

The Company operates in one segment.

Accordingly, the Company’s

license revenue, net income (loss), and total assets reflect the revenue, income (loss), and assets of the Company’s single segment,

respectively.

The Company’s Chief Executive Officer is the chief operating

decision maker (“CODM”).

The CODM uses Net income (loss) in assessing the performance and in determining the allocation of

resources of the Company’s reportable segment.

The CODM is regularly provided expense information consistent with the expense categories

presented in the Company’s Condensed Consolidated Statements of Operations

The following tables present total revenue of the Company by geographic

We operate in one segment.

Accordingly, our license revenue, net income

(loss), and total assets reflect the revenue, income (loss), and assets of the single segment, respectively.

Our Chief Executive Officer is the chief operating decision maker (“CODM”).

The CODM uses Net loss in assessing the performance and in determining the allocation of resources of our reportable segment.

is regularly provided expense information consistent with the expense categories presented in the Condensed Consolidated Statements of

The following tables present total revenue by geographic location.

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

License revenue

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-Q

Item 1. Financial Statements