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Item 1. Financial Statements

2025-11-06 compared with 2025-08-05 · 626 added, 678 removed, 1286 unchanged (50% of the section changed)

FINANCIAL STATEMENTS

AND SUBSIDIARIES

Consolidated Balance Sheets

September 30,

Current assets:

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Total current assets

Property and equipment, net of accumulated depreciation of $ 1,254,975 and $ 1,223,297 respectively

Property and equipment, net of accumulated

depreciation of $ 1,269,098 and $ 1,223,297 respectively

Liabilities and Stockholders’ Equity

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Stockholders’ equity:

Common stock, par value $ 0.0001 per share, 75,000,000 shares authorized;

5,374,431 and 5,348,276 issued and 5,374,095 and 5,347,940 outstanding, respectively

Common stock, par value $ 0.0001

per share, 75,000,000 shares authorized;

5,420,592 and 5,348,276

issued and 5,420,256 and 5,347,940

outstanding, respectively

Additional paid-in capital

9 unchanged sentences

Consolidated Statements of Operations and Comprehensive Income (Loss)

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

License revenue

9 unchanged sentences

( 7,855,578 )

Other income (loss):

( 2,700,514 )

Other income:

Interest and investment income

Unrealized loss on warrant liability

Unrealized gain on warrant liability

Total other income

Income (loss) before income tax expense

Loss before income tax expense

( 3,186,832 )

1 unchanged sentence

( 7,257,221 )

( 1,773,150 )

Income tax expense

Net loss attributable to common shareholders Net income (loss) attributable to common shareholders

Net loss attributable to common shareholders

$ ( 3,186,832 )

1 unchanged sentence

$ ( 7,257,421 )

Basic earnings (loss) per share attributable to common stock

$ ( 1,773,831 )

Basic loss per share attributable to common stock

Weighted average common shares outstanding, basic

Diluted earnings (loss) per share attributable to common stock

Diluted loss per share attributable to common stock

Weighted average common shares outstanding, diluted

Comprehensive income (loss):

Net income (loss)

$ ( 3,186,832 )

1 unchanged sentence

$ ( 7,257,421 )

$ ( 1,773,831 )

Net unrealized income (loss) on marketable investment securities

Comprehensive income (loss)

Comprehensive loss

$ ( 3,180,962 )

1 unchanged sentence

$ ( 7,261,932 )

$ ( 1,771,148 )

accompanying notes to consolidated financial statements

1 unchanged sentence

Consolidated Statements of Changes in Stockholders’ Equity

the Three and Six Months Ended June 30, 2025 and 2024

Additional Paid-In Capital

Other Comprehensive Income (Loss)

the Three and Nine Months Ended September 30, 2025 and 2024

Number of Shares

Paid-In Capital

Comprehensive Income (Loss)

Accumulated Deficit

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Treasury Stock

Additional Paid-In Capital

Other Comprehensive Income (Loss)

Accumulated Deficit

Stockholders’ Equity

Balances at March 31, 2024

Number of Shares

Comprehensive

Income (Loss)

Stockholders’

Balances at June 30, 2024

$ 220,582,158

1 unchanged sentence

( 2,218,818 )

Unrealized net income on marketable investment securities

Stock-based compensation

Costs associated with ATM Offering

Balances at June 30, 2024

Balances at September 30, 2024

$ 220,690,052

1 unchanged sentence

Treasury Stock

Additional Paid-In Capital

Other Comprehensive Income (Loss)

Accumulated Deficit

Number of Shares

Comprehensive

Stockholders’

2 unchanged sentences

$ ( 199,777,214 )

Unrealized net loss on marketable investment securities

( 1,773,831 )

Unrealized net income on marketable investment securities

Stock-based compensation

Common stock sold through ATM offering

Balances at June 30, 2024

Common stock sold through ATM offering, net of costs

Balances at September 30, 2024

$ 220,690,052

2 unchanged sentences

Treasury Stock

Paid-In Capital

Comprehensive Income (Loss)

Accumulated Deficit

Stockholders’ Equity

Balances at March 31, 2025

Number of Shares

Comprehensive

Income (Loss)

Stockholders’

Balances at June 30, 2025

( 203,839,451 )

1 unchanged sentence

( 3,186,832 )

Unrealized net loss on marketable investment securities

Unrealized net income on marketable investment securities

Stock-based compensation

Common stock sold through ATM offering

Balances at June 30, 2025

Vesting of restricted stock units

Common stock sold through ATM offering, net of costs

Balances at September 30, 2025

$ 221,195,546

2 unchanged sentences

Treasury Stock

Paid-In Capital

Comprehensive Income (Loss)

Accumulated Deficit

Stockholders’ Equity

Number of Shares

Comprehensive

Income (Loss)

Stockholders’

Balances at December 31, 2024

5 unchanged sentences

( 7,257,421 )

Net income (loss)

( 4,070,589 )

Unrealized net loss on marketable investment securities

1 unchanged sentence

Vesting of restricted stock units

Common stock sold through ATM offering

Balances at June 30, 2025

Common stock sold through ATM offering, net of costs

Balances at September 30, 2025

$ 221,195,546

5 unchanged sentences

Consolidated Statements of Cash Flows

Six Months Ended June 30,

Nine Months Ended September 30,

Cash flows from operating activities:

Net income (loss)

$ ( 7,257,421 )

Adjustments to reconcile net income (loss) to cash provided by (used in) operating activities:

$ ( 1,773,831 )

Adjustments to reconcile net loss to cash used in

operating activities:

Depreciation expense

Stock-based compensation expense

Non-cash loss on change in fair value of warrant liability

Non-cash gain on change in fair value of warrant liability

Amortization of discounts on marketable investment securities

3 unchanged sentences

Accounts payable

( 1,110,630 )

Accrued expenses

1 unchanged sentence

( 6,841,214 )

( 2,923,160 )

Cash flows from investing activities:

Purchase of property and equipment

Purchases of marketable investment securities

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Cash provided by financing activities

Net increase (decrease) in cash and cash equivalents

Net decrease in cash and cash equivalents

( 2,304,886 )

( 1,028,817 )

Cash and cash equivalents at beginning of period

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Supplemental disclosure of non-cash investing and financing activity:

Net unrealized loss on available-for-sale securities

Net unrealized gain (loss) on available-for-sale securities

accompanying notes to consolidated financial statements

LIPOCINE INC.

to Condensed Consolidated Financial Statements

of Presentation

Basis of Presentation

accompanying unaudited condensed consolidated financial statements included herein have been prepared by Lipocine Inc.

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in accordance with rules and regulations of the SEC.

Operating results for the three and six months ended June 30, 2025 are not necessarily

indicative of the results that may be expected for any future period or for the year ending December 31, 2025.

Operating results for the three and nine months ended September 30, 2025 are not

necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2025.

unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial

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Company believes that its existing capital resources, together with interest thereon, will be sufficient to meet its projected operating

requirements through at least August 5, 2026.

requirements through at least November 6, 2026.

The Company has based this estimate on assumptions that may prove to be wrong, and the

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While the Company believes it has sufficient

liquidity and capital resources to fund our projected operating requirements through at least August 5, 2026, the Company will need to

raise additional capital through the equity or debt markets or via out-licensing activities to support its operations.

liquidity and capital resources to fund our projected operating requirements through at least November 6, 2026, the Company will need

to raise additional capital through the equity or debt markets or via out-licensing activities to support its operations.

If the Company

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resources may be consumed more rapidly if it pursues additional clinical studies for LPCN 1154, LPCN 2101, LPCN 2401, LPCN 2203, LPCN

1148, LPCN 1144, and/or LPCN 1107.

Conversely, the Company’s capital resources could last longer if the Company reduces expenses,

reduces the number of activities currently contemplated under its operating plan, or terminates, modifies the design of or suspends on-going

1148, and/or LPCN 1107.

Conversely, the Company’s capital resources could last longer if the Company reduces expenses, reduces

the number of activities currently contemplated under its operating plan, or terminates, modifies the design of or suspends on-going

clinical studies.

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For the three months ended

June 30, 2025, the Company recognized licensing revenue of $ 500,000 and royalty revenue of approximately $ 123,000 .

September 30, 2025, the Company recognized royalty revenue of approximately $ 115,000 .

Revenue recognized in the three months ended September

30, 2025 was 100 % from one major customer, Verity Pharma.

For the nine months ended September 30, 2025, the Company recognized licensing

revenue of $ 500,000 and royalty revenue of approximately $ 331,000 .

Revenue recognized during the nine months ended September 30, 2025

was 60 % and 40 %, respectively, from two major customers, Aché and Verity Pharma.

For the three months ended September 30, 2024,

the Company did not recognize any licensing or royalty revenue.

For the nine months ended September 30, 2024, the Company recognized

licensing revenue of $ 7.5 million relating to the Verity License Agreement, approximately $ 140,000 of royalty revenue from the Verity

License Agreement, and $ 67,000 of royalty revenue from the license agreement with Antares Pharma (“Antares”).

Revenue recognized

in the three months ended June 30, 2025 was 80 % and 20 %, respectively, from two major customers, Aché Laboratórios Farmacêuticos

(“Aché”) and Verity Pharma.

For the six months ended June 30, 2025, the Company recognized licensing revenue

of $ 500,000 and royalty revenue of approximately $ 217,000 .

Revenue recognized during the six months ended June 30, 2025 was 70 % and 30 %,

respectively, from two major customers, Aché and Verity Pharma.

For the three months ended June 30, 2024, the company recognized

royalty revenue of approximately $ 90,000 .

Revenue recognized in the three months ended June 30, 2024 was 100 % from one major customer,

Verity Pharma.

For the six months ended June 30, 2024, the Company recognized licensing revenue of $ 7.5 million relating to the Verity

License Agreement, approximately $ 140,000 of royalty revenue from the Verity License Agreement, and $ 67,000 of royalty revenue from the

license agreement with Antares Pharma (“Antares”).

Revenue recognized in the six months ended June 30, 2024 was 99 % from

one major customer, Verity Pharma.

in the nine months ended September 30, 2024 was 99 % from one major customer, Verity Pharma.

Loss per Share

earnings (loss) per share is calculated by dividing net income (loss) available to common shareholders by the weighted average number

of common shares outstanding during the period.

Diluted earnings (loss) per share is based on the weighted average number of common shares

outstanding plus, where applicable, the additional potential common shares that would have been outstanding related to dilutive options,

warrants and unvested restricted stock units to the extent such shares are dilutive.

following table sets forth the computation of basic and diluted earnings (loss) per share of common stock for the three and six months

ended June 30, 2025 and 2024:

loss per share is calculated by dividing net loss available to common shareholders by the weighted average number of common shares outstanding

during the period.

Diluted loss per share is based on the weighted average number of common shares outstanding plus, where applicable,

the additional potential common shares that would have been outstanding related to dilutive options, warrants and unvested restricted

stock units to the extent such shares are dilutive.

following table sets forth the computation of basic and diluted loss per share of common stock for the three and nine months ended September

30, 2025 and 2024:

Schedule of Computation of Basic and Diluted Earnings (Loss) Per Share of Common Stock

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Months Ended September 30,

Basic earnings (loss) per share attributable to common stock:

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$ ( 7,257,421 )

$ ( 1,773,831 )

Weighted avg.

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$ ( 7,257,421 )

$ ( 1,773,831 )

Effect of dilutive securities on net earnings (loss):

Common stock warrants

Total net income (loss) for purpose of calculating diluted net income

(loss) per common share

$ ( 2,205,716 )

$ ( 2,984,204 )

Total net income (loss) for purpose of calculating diluted net income (loss) per common share

$ ( 3,186,832 )

Total net income (loss) for purpose of calculating diluted

net income (loss) per common share

$ ( 2,356,899 )

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Stock options

Restricted stock units

Dilutive securities

1 unchanged sentence

Diluted earnings (loss) per share attributable to common stock

computation of diluted loss per share for the three and six months ended June 30, 2025 and 2024 does not include the following stock

options and warrants to purchase shares of common stock or unvested restricted stock units in the computation of diluted earnings (loss)

per share because these instruments were antidilutive:

computation of diluted loss per share for the three and nine months ended September 30, 2025 and 2024 does not include the following

stock options and warrants to purchase shares of common stock or unvested restricted stock units in the computation of diluted loss per

share because these instruments were antidilutive:

Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share

For the Three Months Ended

For the Six Months Ended

For the Three and Nine Months Ended

September 30,

Stock options

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The amortized cost, gross unrealized holding gains, gross unrealized holding losses, and fair value for available-for-sale

securities by major security type and class of security as of June 30, 2025, and December 31, 2024, were as follows:

securities by major security type and class of security as of September 30, 2025, and December 31, 2024, were as follows:

Schedule of Available for Sale Securities

June 30, 2025

September 30, 2025

Amortized Cost

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Gross Unrealized Holding Gains

Gross Unrealized Holding Losses

Unrealized Holding

Aggregate Fair Value

Government treasury bills

of debt securities classified as available-for-sale securities as of June 30, 2025 are as follows:

of debt securities classified as available-for-sale securities as of September 30, 2025 are as follows:

Schedule of Maturities of Debt Securities Classified as Available-for-Sale Securities

June 30, 2025

September 30, 2025

Amortized Cost

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Due within one year

were no sales of marketable investment securities during either the three or six months ended June 30, 2025 or 2024 and therefore no

realized gains or losses.

Additionally, during the three months ended June 30, 2025 and 2024, $ 4.5 million and $ 11.5 million of marketable

investment securities matured, respectively, and during the six months ended June 30, 2025 and 2024, $ 8.7 million and $ 18.2 million of

marketable investment securities matured, respectively.

The Company determined there were no other-than-temporary impairments for either

the three or six months ended June 30, 2025 or 2024.

were no sales of marketable investment securities during either the three or nine months ended September 30, 2025 or 2024 and therefore

no realized gains or losses.

Additionally, during the three months ended September 30, 2025 and 2024, $ 5.9 million and $ 6.7 million of

marketable investment securities matured, respectively, and during the nine months ended September 30, 2025 and 2024, $ 14.6 million and

$ 24.9 million of marketable investment securities matured, respectively.

The Company determined there were no other-than-temporary impairments

for either the three or nine months ended September 30, 2025 or 2024.

Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent

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The following table presents the placement in the fair value hierarchy of assets

and liabilities that are measured at fair value on a recurring basis as of June 30, 2025 and December 31, 2024:

and liabilities that are measured at fair value on a recurring basis as of September 30, 2025 and December 31, 2024:

Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis

Fair value measurements at reporting date using

June 30, 2025

September 30, 2025

Level 1 inputs

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in circumstances that caused the transfer.

There were no transfers into or out of Level 1, Level 2, or Level 3 for the three and six

months ended June 30, 2025.

There were no transfers into or out of Level 1, Level 2, or Level 3 for the three and nine

months ended September 30, 2025.

tax provision for interim periods is determined using an estimate of the Company’s effective tax rate for the full year adjusted

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annual effective tax rate, and if the estimated tax rate changes, the Company makes a cumulative adjustment.

June 30, 2025 and December 31, 2024, the Company had a full valuation allowance against its deferred tax assets, net of expected reversals

of existing deferred tax liabilities, as it believes it is more likely than not that these benefits will not be realized.

(7) Contractual

Verity Pharmaceuticals, Inc.

September 30, 2025 and December 31, 2024, the Company had a full valuation allowance against its deferred tax assets, net of expected

reversals of existing deferred tax liabilities, as it believes it is more likely than not that these benefits will not be realized.

Contractual Agreements

Pharmaceuticals, Inc.

January 12, 2024, the Company entered into the Verity License Agreement with GSL and Verity Pharma, pursuant to which the Company granted

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case within the Licensed Verity Territory.

In June 2025, Verity Pharma filed a New Drug Submission (“NDS”)

for TLANDO in Canada.

The Verity License Agreement also provides GSL with a license to develop and commercialize

TLANDO XR (LPCN 1111), the Company’s potential once-daily oral product candidate for testosterone replacement therapy in the Licensed

Verity Territory.

Under the Verity License Agreement, the Company retains rights to TLANDO in applications outside of the Field and to

the development and commercialization rights outside of the United States and Canada.

The Company retains rights to TLANDO XR in applications

outside of the Field and to development and commercialization rights in the field outside of the United States and Canada.

execution of the Verity License Agreement, GSL agreed to pay the Company a license fee of $ 11.0 million consisting of an initial payment

of $ 2.5 million which was received on signing of the Verity License Agreement, $ 5.0 million which was received on February 1, 2024, $ 2.5

which was received on December 30, 2024, and $ 1.0 million to be paid no later than January 1, 2026.

The Company is also eligible to receive

development and sales milestone payments of up to $ 259.0 million in the aggregate, depending primarily on the achievement of certain

sales milestones in a single calendar year with respect to all products licensed by GSL under the Verity License Agreement.

Verity License Agreement, GSL is generally responsible for expenses relating to the development (including the conduct of any clinical

trials) and commercialization of licensed products in the Field in the Licensed Verity Territory, while the Company is generally responsible

for expenses relating to development activities outside of the Field and/or the Licensed Verity Territory.

In June 2025, Verity Pharma filed a New Drug Submission (“NDS”) for TLANDO in

The Verity License Agreement also provides GSL with a license to develop and commercialize TLANDO XR (LPCN 1111), the Company’s

potential once-daily oral product candidate for testosterone replacement therapy in the Licensed Verity Territory.

Under the Verity License

Agreement, the Company retains rights to TLANDO in applications outside of the Field and to the development and commercialization rights

outside of the United States and Canada.

The Company retains rights to TLANDO XR in applications outside of the Field and to development

and commercialization rights in the field outside of the United States and Canada.

execution of the Verity License Agreement, GSL agreed to pay the Company a license fee of $ 11.0

million consisting of an initial payment of $ 2.5

million which was received on signing of the Verity License Agreement, $ 5.0

million which was received on February 1, 2024, $ 2.5

million which was received on December 30, 2024, and $ 1.0

million to be paid no later than January 1, 2026.

The Company is also eligible to receive development and sales milestone payments

of up to $ 259.0

million in the aggregate, depending primarily on the achievement of certain sales milestones in a single calendar year with respect

to all products licensed by GSL under the Verity License Agreement.

Under the Verity License Agreement, GSL is generally responsible

for expenses relating to the development (including the conduct of any clinical trials) and commercialization of licensed products

in the Field in the Licensed Verity Territory, while the Company is generally responsible for expenses relating to development

activities outside of the Field and/or the Licensed Verity Territory.

Company concluded that licensing revenue recognized in conjunction with the Verity License Agreement met the requirements under ASC 606,

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when it is probable that we will receive license payments under the terms of the Verity License Agreement.

the Verity License Agreement with Verity Pharma, during the three months ended June 30, 2025 and 2024, the Company recognized royalty

revenue of $ 123,000 and $ 90,000 , respectively, and for the six months ended June 30, 2025 and 2024, $ 217,000 and $ 140,000 , respectively.

The Company also recognized $ 7.5 million in license revenue during the six months ended June 30, 2024 under the Verity License Agreement.

the Verity License Agreement with Verity Pharma, during the three months ended September 30, 2025 and 2024, the Company recognized royalty

revenue of approximately $ 115,000 and $ 0 , respectively, and for the nine months ended September 30, 2025 and 2024, approximately $ 331,000

and $ 140,000 , respectively.

The Company also recognized $ 7.5 million in license revenue during the nine months ended September 30, 2024

under the Verity License Agreement.

September 2024, the Company entered into a Distribution and License Agreement (the “SPC License Agreement”) with SPC Korea

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agreed transfer price.

Aché Laboratórios Farmacêuticos S.A .

Laboratórios Farmacêuticos S.A .

April 2025, the Company entered into a License and Supply Agreement (the “Aché License Agreement”) with Aché,

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an agreed transfer price.

Abbott Products, Inc.

Products, Inc.

March 29, 2012, the Company terminated its collaborative agreement with Solvay Pharmaceuticals, Inc.

(later acquired by Abbott Products,

(later acquired by Abbott

Products, Inc.

(“Abbott”)) for TLANDO.

As part of the termination, the Company reacquired the rights to the intellectual property from

All obligations under the prior license agreement have been completed except that the Company will owe Abbott a perpetual 1 %

As part of the termination, the Company reacquired the rights to the intellectual

property from Abbott.

All obligations under the prior license agreement have been completed except that the Company will owe Abbott

a perpetual 1 %

royalty on net sales.

Such royalties are limited to $ 1.0 million in the first two calendar years following product launch, after which

period there is not a cap on royalties and no maximum aggregate amount.

If generic versions of any such product are introduced, then

royalties are reduced by 50 %.

Such royalties are limited to $ 1.0

million in the first two calendar years following product launch, after which period there is not a cap on royalties and no maximum

aggregate amount.

If generic versions of any such product are introduced, then royalties are reduced by 50 %.

TLANDO was commercially launched on June 7, 2022.

The Company incurred royalty expense of approximately $ 10,000

$ 10,000 and $ 7,000 during the three months ended June 30, 2025 and 2024, respectively.

during the three months ended September 30, 2025 and 2024, respectively.

The Company incurred royalty expense of approximately

$ 18,000 and $ 16,000 during the six months ended June 30, 2025 and 2024, respectively.

during the nine months ended September 30, 2025 and 2024, respectively.

Contract Research and Development

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as advisors to the Company.

The Company incurred expenses of approximately $ 1.3 million and $ 1.1 million for the three months ended June

30, 2025 and 2024, respectively, and approximately $ 1.4 million and $ 2.9 million for the six months ended June 30, 2025 and 2024, respectively,

under these agreements and has recorded these expenses in research and development expenses.

The Company incurred expenses of approximately $ 2.1 million and $ 740,000 for the three months ended September

30, 2025 and 2024, respectively, and approximately $ 3.5 million and $ 3.7 million for the nine months ended September 30, 2025 and 2024,

respectively, under these agreements and has recorded these expenses in research and development expenses.

Company has a non-cancelable operating lease for office space and laboratory facilities in Salt Lake City, Utah.

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has been extended through February 28, 2026.

minimum lease payments under the non-cancelable operating lease as of June 30, 2025 are:

minimum lease payments under the non-cancelable operating lease as of September 30, 2025 are:

Schedule of Future Minimum Rental Payments for Operating Leases

Total minimum lease payments

Company’s rent expense was $ 94,000 and $ 92,000 for the three months ended June 30, 2025 and 2024, respectively.

Company’s rent expense was $ 94,000 and $ 92,000 for the three months ended September 30, 2025 and 2024, respectively.

The Company’s

rent expense was $ 187,000 and $ 182,000 for the six months ended June 30, 2025 and 2024, respectively.

(9) Stockholders’

rent expense was $ 281,000 and $ 274,000 for the nine months ended September 30, 2025 and 2024, respectively.

(9) Stockholders’ Equity

June 4, 2025, the Company held its annual general meeting of shareholders, at which a proposal to amend the Company’s Amended and

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Sales Agreement at any time upon ten days’ prior notice.

the three and six month ended June 30, 2025, the Company sold 23,739 shares of common stock pursuant to the A.G.P.

Sales Agreement at

a weighted average price of $ 3.29 per share, for aggregate gross proceeds of $ 78,000 , and net proceeds of $ 76,000 , after deducting sales

the nine months ended September 30, 2025, the Company sold 68,691 shares of common stock pursuant to the A.G.P.

Sales Agreement at a

weighted average price of $ 3.26 per share, for aggregate gross proceeds of $ 224,000 , and net proceeds of $ 217,000 , after deducting sales

agent commission.

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aggregate offering price of up to the amount the Company registered on an effective registration statement pursuant to which the offering

During the three months and six months ended June 30, 2024, the Company sold 32,110 shares of its common stock pursuant to

the Cantor Sales Agreement.

On April 24, 2024, the Cantor Sales Agreement was terminated.

During 2024, the Company sold 32,110 shares of its common stock pursuant to the Cantor Sales Agreement.

On April 24, 2024,

the Cantor Sales Agreement was terminated.

Rights Agreement

November 13, 2015, the Company and American Stock Transfer & Trust Company, LLC, as Rights Agent, entered into a Rights Agreement

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of twice the Purchase Price.

Company will be entitled to redeem the Rights at $ 0.001 per Right at any time prior to the time an Acquiring Person becomes such.

terms of the Rights are set forth in the Rights Agreement, which is summarized in the Company’s Current Report on Form 8-K dated

November 13, 2015.

The rights plan was originally set to expire on November 12, 2018;

however, on November 5, 2018 our Board approved

an Amended and Restated Rights Agreement pursuant to which the expiration date was extended to November 5, 2021, and again on November

2, 2021, the Company adopted a Second Amended and Restated Rights Agreement pursuant to which the expiration date was extended to November

On October 22, 2024, the Company adopted a Third Amended and Restated Rights Agreement pursuant to which the expiration date

was extended to October 22, 2027, unless the rights are earlier redeemed or exchanged by the Company.

The Company will be entitled to redeem the

Rights at $ 0.001 per Right at any time prior to the time an Acquiring Person becomes such.

The terms of the Rights are set forth in the

Rights Agreement, which is summarized in the Company’s Current Report on Form 8-K dated November 13, 2015.

The rights plan was originally

set to expire on November 12, 2018;

however, on November 5, 2018 our Board approved an Amended and Restated Rights Agreement pursuant

to which the expiration date was extended to November 5, 2021, and again on November 2, 2021, the Company adopted a Second Amended and

Restated Rights Agreement pursuant to which the expiration date was extended to November 1, 2024.

On October 22, 2024, the Company adopted

a Third Amended and Restated Rights Agreement pursuant to which the expiration date was extended to October 22, 2027, unless the rights

are earlier redeemed or exchanged by the Company.

Share-Based Payments

Company recognizes stock-based compensation expense for grants of stock option awards, restricted stock units and restricted stock under

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Stock-based compensation cost that has been expensed in the statements of

operations amounted to approximately $ 65,000 and $ 102,000 , respectively, for the three months ended June 30, 2025 and 2024, and approximately

$ 136,000 and $ 202,000 , respectively for the six months ended June 30, 2025 and 2024.

The expense is allocated as follows:

operations amounted to approximately $ 53,000 and $ 108,000 , respectively, for the three months ended September 30, 2025 and 2024, and

approximately $ 189,000 and $ 309,000 , respectively for the nine months ended September 30, 2025 and 2024.

The expense is allocated as

of Employee Service Share-based Compensation, Allocation of Recognized Period Costs

Three Months Ended June 30,

Six Months Ended June 30,

Months Ended September 30,

Research and development

General and administrative

Company issued 8,820 stock options during each of the three months ended June 30, 2025 and 2024, and 25,191 and 34,446 stock options

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

Company did not issue any stock options during each of the three months ended September 30, 2025 and 2024, and issued 25,191 and 34,446 stock

options during the nine months ended September 30, 2025 and 2024, respectively.

assumptions used in the determination of the fair value of stock options granted are as follows:

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The volatility factor is based solely on the Company’s trading history.

options granted during the six months ended June 30, 2025 and 2024, the Company calculated the fair value of each option grant on the

respective dates of grant using the following weighted average assumptions:

options granted during the nine months ended September 30, 2025 and 2024, the Company calculated the fair value of each option grant

on the respective dates of grant using the following weighted average assumptions:

Schedule of Key Assumption of Fair Value of Stock Options Granted

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estimated by management, additional adjustments to compensation expense may be required in future periods.

of June 30, 2025, there was approximately $ 320,000 of total unrecognized compensation cost related to unvested stock option compensation

of September 30, 2025, there was approximately $ 245,000 of total unrecognized compensation cost related to unvested stock option compensation

granted under the Company’s stock option plan.

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and will be adjusted for subsequent changes in estimated forfeitures.

Additionally, as of June 30, 2025, there was $ 68,000 of total unrecognized

compensation costs related to unvested restricted stock units that have either time-based or performance vesting.

Additionally, as of September 30, 2025, there was $ 65,000 of total

unrecognized compensation costs related to unvested restricted stock units that have either time-based or performance vesting.

April 2014, the Board adopted the 2014 Stock and Incentive Plan (“2014 Plan”) subject to shareholder approval which was received

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An aggregate of 600,000

shares of common stock are authorized for issuance under the 2014 Plan, with 197,655 shares remaining available for grant as of June

shares of common stock are authorized for issuance under the 2014 Plan, with 204,066 shares remaining available for grant as of September

summary of stock option activity is as follows:

Schedule of Stock Option Activity

Outstanding stock options

Number of shares

Weighted average exercise price

stock options

average exercise price

Balance at December 31, 2023

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Options forfeited

Options cancelled

Balance at December 31, 2024

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Options forfeited

Options cancelled

Balance at June 30, 2025

Options exercisable at June 30, 2025

Balance at September 30, 2025

Options exercisable at September 30, 2025

following table summarizes information about stock options outstanding and exercisable:

of Share-based Compensation of Stock Options Outstanding and Exercisable

As of June 30, 2025

Options outstanding

Options exercisable

Number outstanding

Weighted average remaining contractual life (Years)

Weighted average exercise price

Aggregate intrinsic value

Number exerciseable

Weighted average remaining contractual life (Years)

Weighted average exercise price

Aggregate intrinsic value

As of June 30, 2024

Options outstanding

Options exercisable

Number outstanding

Weighted average remaining contractual life (Years)

Weighted average exercise price

Aggregate intrinsic value

Number exerciseable

Weighted average remaining contractual life (Years)

Weighted average exercise price

Aggregate intrinsic value

of September 30, 2025

average remaining contractual life (Years)

average exercise price

intrinsic value

average remaining contractual life (Years)

average exercise price

intrinsic value

of September 30, 2024

average remaining contractual life (Years)

average exercise price

intrinsic value

average remaining contractual life (Years)

average exercise price

intrinsic value

intrinsic value for stock options is defined as the difference between the current market value and the exercise price.

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Summary of Restricted Stock Unit Activity

Number of Unvested Restricted Stock Units

of Unvested Restricted Stock Units

Balance at December 31, 2024

Balance at June 30, 2025

Number of Unvested Restricted Stock Units

Balance at September 30, 2025

of Unvested Restricted Stock Units

Balance at December 31, 2023

Balance at June 30, 2024

weighted average grant date fair value of restricted stock units awarded during the six months ended June 30, 2024 was $ 3.61 per share.

Balance at September 30, 2024

weighted average grant date fair value of restricted stock units awarded during the nine months ended September 30, 2024 was $ 3.61 per

Stock Warrants

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The warrants expired in November of 2024 and the related

warranty liability was extinguished.

the three and six months ended June 30, 2024, the Company recorded a non-cash loss of approximately $ 84,000 and $ 125,000 from the change

in fair value of the November 2019 Offering warrants.

The fair value of the warrants on June 30, 2024 was determined using the Black

Scholes option pricing model with the following Level 3 inputs (as defined in the November 2019 Offering) include (i) volatility of 110.64 %,

(ii) risk free interest rate of 5.45 %, (iii) strike price of $ 8.50 , (iv) fair value of common stock of $ 8.24 , and (v) expected life of

warrant liability was extinguished.

the three and nine months ended September 30, 2024, the Company recorded a non-cash gain of approximately $ 138,000 and $ 13,600 from the

change in fair value of the November 2019 Offering warrants.

The fair value of the warrants on September 30, 2024 was determined using

the Black Scholes option pricing model with the following Level 3 inputs (as defined in the November 2019 Offering) including (i) volatility

of 107.82 %, (ii) risk free interest rate of 4.87 %, (iii) strike price of $ 8.50 , (iv) fair value of common stock of $ 4.49 , and (v) expected

life of 0.1 years.

Additionally,

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the February 2020 offering expired in February 2025 and no warrants were exercised during 2025 prior to their expiration.

common stock warrants were exercised during either the three or six months ended June 30, 2025 or 2024.

As of June 30, 2024, there were

113,795 warrants outstanding, with a weighted average exercise price of $ 8.72 per share and a remaining life of 0.5 years, with an aggregate

intrinsic value of $ 0 .

As of June 30, 2025, there are no warrants outstanding.

common stock warrants were exercised during either the three or nine months ended September 30, 2025 or 2024.

As of September 30, 2024,

there were 113,795 warrants outstanding, with a weighted average exercise price of $ 8.72 per share and a remaining life of 0.25 years,

with an aggregate intrinsic value of $ 0 .

As of September 30, 2025, there are no warrants outstanding.

and Contingencies

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During the three

and six months ended June 30, 2025, and 2024, the Company did not receive any revenue from Spriaso.

Spriaso filed its first NDA and as

an affiliated entity of the Company, using up the one-time waiver for user fees for a small business submitting its first human drug

application to the FDA.

Spriaso is considered a variable interest entity under the FASB ASC Topic 810-10, Consolidations, however the

Company is not the primary beneficiary and has therefore not consolidated Spriaso.

and nine months ended September 30, 2025, and 2024, the Company did not receive any revenue from Spriaso.

Spriaso filed its first NDA

and as an affiliated entity of the Company, using up the one-time waiver for user fees for a small business submitting its first human

drug application to the FDA.

Spriaso is considered a variable interest entity under the FASB ASC Topic 810-10, Consolidations, however

the Company is not the primary beneficiary and has therefore not consolidated Spriaso.

Segment Reporting

segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed

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single reporting segment.

A reconciliation to the consolidated net income (loss) for the three and six months ended June 30, 2025 and

2024 is included in the table below.

A reconciliation to the consolidated net income (loss) for the three and nine months ended September 30, 2025

and 2024 is included in the table below.

Schedule of Significant Expense Categories

Three Months Ended June 30,

Six Months Ended June 30,

Months Ended September 30,

Total revenues

Program expenses (1)

LPCN 1154 (1)

Lead clinical candidate

Other research and development programs

Program expenses (1)

Non-program expenses (2)

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( 7,855,578 )

Other income (loss) (3)

( 2,700,514 )

income (loss) (3)

Net income (loss)

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$ ( 7,257,421 )

external research and development expenses.

general and administrative expenses, information technology, infrastructure, facilities, and intellectual property, and legal and

professional fees.

interest income and loss on warrant liability.

$ ( 1,773,831 )

Includes external research and development expenses.

Includes general and administrative expenses, information technology, infrastructure, facilities, and

intellectual property, and legal and professional fees.

Includes interest income and loss on warrant liability.

Accounting Pronouncements

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2024, filed with the SEC on March 13, 2025 (the “2024 Form 10-K”), our first quarter report on Form 10-Q filed with the SEC

on May 8, 2025, as well as the financial statements and related notes contained therein.

on May 8, 2025, our second quarter report on Form 10-Q filed with the SEC on August 5, 2025, as well as the financial statements and

related notes contained therein.

used in the discussion below, “we,” “our,” and “us” refers to Lipocine.

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Factors that might cause

such differences include, but are not limited to, those discussed in Part I, Item 1A (Risk Factors) of our 2024 Form 10-K and Item 1A

of our Form 10-Q for the quarter ended March 31, 2025 filed with the SEC on May 8, 2025.

Except as required by applicable law, we assume

no obligation to revise or update any forward-looking statements for any reason.

such differences include, but are not limited to, those discussed in Part I, Item 1A (Risk Factors) of our 2024 Form 10-K, Item 1A of

our Form 10-Q for the quarter ended March 31, 2025 filed with the SEC on May 8, 2025, and Item 1A of our Form 10-Q for the quarter ended

June 30, 2025 filed with the SEC on August 5, 2025.

Except as required by applicable law, we assume no obligation to revise or update

any forward-looking statements for any reason.

of Our Business

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Aché an exclusive license to commercialize our TLANDO product with respect to the Field, specific to the Aché Territory.

commercialization partners are planning to file marketing approval applications in Canada, one or more of the GCC countries,

South Korea and Brazil in 2025 and/or 2026.

Verity Pharma filed a NDS for TLANDO in Canada in June 2025, and our other ex-U.S.

commercialization

partners are planning to file marketing approval applications in one or more of the GCC countries, South Korea and Brazil in 2025 and/or

clinical development pipeline candidates include:

LPCN 1154 for postpartum depression (“PPD”);

LPCN 2401 for improved

body composition in GLP-1 agonist use such as obesity management;

LPCN 2401 for improved body

composition in GLP-1 agonist use such as obesity management;

LPCN 2101 for epilepsy;

and LPCN 2203 for essential tremor.

addition to our clinical development product candidates, we have assets for which we expect to seek partnerships to enable further

development including TLANDO for territories outside of the United States, Canada, South Korea, the GCC and Brazil, LPCN 1148

comprising a novel prodrug of testosterone and testosterone laurate (“TL”), for the management of decompensated

cirrhosis, LPCN 1144, an oral prodrug of androgen receptor modulator for the treatment of non-cirrhotic metabolic

dysfunction-associated steatohepatitis (“MASH”) which has completed Phase 2 testing;

and LPCN 1107, potentially the

first oral hydroxy progesterone caproate (“HPC”) product indicated for the prevention of recurrent preterm birth

(“PTB”), which has completed a dose finding clinical study in pregnant women and has been granted orphan drug

designation by the FDA.

to our clinical development product candidates, we have assets for which we expect to seek partnerships to enable further development

including TLANDO for territories outside of the United States, Canada, South Korea, the GCC and Brazil, LPCN 1148 comprising a novel

prodrug of testosterone and testosterone laurate (“TL”), for the management of decompensated cirrhosis, and LPCN 1107, potentially

the first oral hydroxy progesterone caproate (“HPC”) product indicated for the prevention of recurrent preterm birth (“PTB”),

which has completed a dose finding clinical study in pregnant women and has been granted orphan drug designation by the FDA.

following chart summarizes the status of our product candidate development and partnering programs:

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The drug loaded dispersed

phase presents the drug efficiently at the absorption site (gastrointestinal tract membrane) thus improving or enabling portal and /

or lymphatic absorption post oral administration.

LPCN 1154 and other CNS product candidates.

phase presents the drug efficiently at the absorption site (gastrointestinal tract membrane) thus improving or enabling portal and/or

lymphatic absorption post oral administration.

LPCN 1154, LPCN 2101 and other CNS product candidates.

We intend to focus on the development of endogenous neuroactive steroids (“NASs”)

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oral therapeutics.

Our priority is on the development of LPCN 1154, a fast-acting oral antidepressant for postpartum depression (“PPD”)

with potential for outpatient use.

Our priority is on the development of LPCN 1154, a 48-hour treatment duration, fast-acting oral antidepressant for

postpartum depression (“PPD”) with potential for outpatient use, and we are currently evaluating an additional NAS candidate,

LPCN 2101, for epilepsy including Drug Resistant Epilepsy (“DRE”) and women with epilepsy (“WWE”).

our partners, Verity Pharma, SPC, Pharmalink, and Aché, in commercialization and/or development of our licensed oral TRT option.

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for our pipeline assets.

We are currently exploring partnerships for our liver programs including LPCN 1144, our candidate for treatment

of non-cirrhotic MASH and LPCN 1148 for the management of decompensated cirrhosis including prevention of the recurrence of overt hepatic

encephalopathy (“OHE”), and we are also exploring partnerships for LPCN 2401 for management of incretin mimetics use as an adjunct therapy to or as a monotherapy post cessation of incretin mimetics use and LPCN 1107, our candidate

for prevention of pre-term birth.

We are also exploring the possibility of licensing LPCN 1021 (known as TLANDO in the United States)

to third parties outside of the Licensed Verity Territory, the SPC Territory, the Pharmalink Territory and the Aché Territory,

although as of the date of this report, no licensing agreement has been entered into by the Company in any other territories.

We are currently exploring partnerships for LPCN 1148 for the management of decompensated cirrhosis including

prevention of the recurrence of overt hepatic encephalopathy (“OHE”), and we are also exploring partnerships for LPCN 2401

for management of incretin mimetics use as an adjunct therapy to or as a monotherapy post cessation of incretin mimetics use and LPCN

1107, our candidate for prevention of pre-term birth.

We are also exploring the possibility of licensing LPCN 1021 (known as TLANDO in

the United States) to third parties outside of the Licensed Verity Territory, the SPC Territory, the Pharmalink Territory and the Aché

Territory, although as of the date of this report, no licensing agreement has been entered into by the Company in any other territories.

Pipeline Product Candidates

pipeline of clinical development candidates includes LPCN 1154 for PPD, LPCN 2401 as an aid for improved body composition and

functionality in the management of GLP-1 agonist use in obese patients, LPCN 2101 for epilepsy, and LPCN 2203 for essential tremor.

We will continue to explore other product development candidates targeting CNS indications with a significant unmet need.

also continue efforts to enter into partnership arrangements for the continued development and/or marketing of all of our products

including but not limited to LPCN 1144, LPCN 1148, LPCN 2401, and LPCN 1107 as well as for the TRT assets outside of the Licensed

Verity Territory, the SPC Territory, and the Pharmalink Territory.

pipeline of clinical development candidates includes LPCN 1154 for PPD, LPCN 2101 for epilepsy, LPCN 2401 as an aid for improved body

composition and functionality in the management of GLP-1 agonist use in obese patients, and LPCN 2203 for essential tremor.

We will continue

to explore other product development candidates targeting CNS indications with a significant unmet need.

We will also continue efforts

to enter into partnership arrangements for the continued development and/or marketing of all of our products including but not limited

to LPCN 1148, LPCN 2401, LPCN 1144 and LPCN 1107 as well as for the TRT assets outside of the Licensed Verity Territory, the SPC Territory,

the Pharmalink Territory and the Aché Territory.

Franchise – TLANDO and LPCN 1111 (TLANDO XR)

An Oral Product for Testosterone Replacement Therapy

previously described, under the Verity License Agreement, in January 2024, we granted to Verity Pharma an exclusive,

royalty-bearing, sublicensable right and license to develop and commercialize TLANDO, our product for TRT, in the U.S.

effective February 1, 2024.

previously described, under the Verity License Agreement, in January 2024, we granted to Verity Pharma an exclusive, royalty-bearing,

sublicensable right and license to develop and commercialize TLANDO, our product for TRT, in the U.S.

and Canada effective February 1,

TLANDO received FDA approval on March 28, 2022.

Any FDA requirement to conduct certain post-marketing

studies will be the responsibility of Verity Pharma.

Further, all future development and commercialization of LPCN 1111 in the

Licensed Verity Territory will be the responsibility of Verity Pharma.

In addition, in September 2024, we granted SPC an exclusive,

royalty-bearing license to commercialize TLANDO in South Korea and in October 2024 we granted Pharmalink an exclusive license to

commercialize TLANDO in the GCC countries.

In April 2025, we granted Aché an exclusive license to commercialize and supply

TLANDO in Brazil.

Any FDA requirement to conduct certain post-marketing studies will be the responsibility

of Verity Pharma.

Further, all future development and commercialization of LPCN 1111 in the Licensed Verity Territory will be the responsibility

of Verity Pharma.

In addition, in September 2024, we granted SPC an exclusive, royalty-bearing license to commercialize TLANDO in South

Korea, in October 2024 we granted Pharmalink an exclusive license to commercialize TLANDO in the GCC countries, and in April 2025, we

granted Aché an exclusive license to commercialize and supply TLANDO in Brazil.

Proof-of-concept

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two calendar years following product launch, after which period there is no cap on royalties and no maximum aggregate amount.

versions of any such product are introduced, then royalties are reduced by 50%.

versions of any such product are introduced, then royalties will be reduced by 50%.

TLANDO was commercially launched on June 7, 2022.

the three months ended June 30, 2025 and 2024, we incurred royalty expense of approximately $10,000 and $7,000, respectively, and during

the six months ended June 30, 2025 and 2024, we incurred royalty expense of approximately $18,000 and $16,000, respectively.

During the three months ended September 30, 2025 and 2024, we incurred royalty expense of approximately $10,000 and $0, respectively,

and during the nine months ended September 30, 2025 and 2024, we incurred royalty expense of approximately $28,000 and $16,000, respectively.

TLANDO received full FDA approval, under the terms of the Verity License Agreement, Verity Pharma will need to assess the safety and

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activity of oral brexanolone, with concentration- and time-dependent post-dose changes in qEEG as follows:

● Quantitative

Electroencephalogram (“qEEG”) in healthy subjects administered single doses of

oral brexanolone, a neuroactive steroid, confirmed GABA A modulation

Electroencephalogram (“qEEG”) in healthy subjects administered single doses of oral brexanolone, a neuroactive steroid,

confirmed GABA A modulation

and durable CNS target engagement confirms effective oral delivery of bioidentical brexanolone

results support continued development of oral brexanolone for the treatment of neuropsychiatric

results support continued development of oral brexanolone for the treatment of neuropsychiatric disorders

believe through utilization of our proprietary technology we may have the ability to enable effective oral delivery of endogenous GABA A

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anxiety, and neurodegenerative diseases.

We have conducted Phase 1 pharmacokinetic (“PK”) studies for each of our three lead

NAS candidates which have demonstrated promising PK results, safety, and tolerability and we are evaluating additional undisclosed CNS-focused

We have conducted Phase 1 pharmacokinetic (“PK”) studies for each of our lead NAS

candidates which have demonstrated promising PK results, safety, and tolerability and we are evaluating additional undisclosed CNS-focused

Product Candidate for PPD

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we are developing for the treatment of PPD.

We have completed clinical oral PK studies including a pilot food effect study and a pilot

PK bridge study.

In addition, as a prelude to a LPCN 1154 definitive PK bridge study, a multi-dose study was done confirming the dosing

regimen for the PK bridge study using the scaled up “to be marketed” formulation required for New Drug Application (“NDA”)

In June 2024, we announced results from the definitive PK study which demonstrated LPCN 1154 meets bioequivalence with comparator,

IV brexanolone, meeting standard bioequivalence criteria and C trough criteria.

LPCN 1154 treatment was well-tolerated with

no sedation nor somnolence events observed in the definitive study.

completing PK studies and labeling studies such as a food effect study and PK profiling in women with PPD, we met with the FDA in

the first quarter of 2025.

In the meeting, we were advised that the FDA believes, in addition to the previously completed PK bridge

data, an efficacy and safety study of oral LPCN 1154 in the target population will be required for 505(b)(2) NDA submission.

on observed comparable exposure of LPCN 1154 and the reference drug in the PK bridge study, we have confirmed the target dosing regimen and

initiated a phase 3 safety and efficacy study and successfully dosed LPCN 1154 in the first patient in the second quarter of

We have completed clinical oral PK studies including a pilot food effect study and PK dosing

regimen confirmation studies.

In June 2024, we announced results from a dosing regimen confirmation study which demonstrated LPCN 1154

meets bioequivalence with comparator, IV brexanolone, meeting standard bioequivalence criteria and C trough criteria.

1154 treatment was well-tolerated with no sedation nor somnolence events observed in the study.

completing PK studies and labeling studies such as a food effect study and PK profiling in women with PPD, we met with the FDA in the

first quarter of 2025.

In the meeting, we were advised that the FDA believes, in addition to the previously completed PK dosing regimen

confirmation data, an efficacy and safety study of oral LPCN 1154 in the target population will be required for 505(b)(2) NDA submission.

Based on observed comparable exposure of LPCN 1154 and the reference drug in the PK bridge study, we have confirmed the target dosing

regimen and initiated a Phase 3 safety and efficacy study and, as of the end of the third quarter of 2025, we had successfully randomized

LPCN 1154 in one-third of the planned participants.

The study design includes two Drug Safety Monitoring Board reviews, the first based on

one-third enrollment and the second based on two-thirds enrollment.

are exploring the possibility of partnering with a third party for the development and/or marketing of LPCN 1154, although no partnering

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PPD can be clinically segmented by the severity of symptoms and presence of a comorbidity, including

Approximately 1 in 8 mothers suffers from PPD in the United States alone;

this equates to approximately 600,000 women being

affected by PPD annually.

PPD is a life-threatening condition with few existing treatment options.

Maternal depression and suicide can have far-reaching

consequences for child development, family functioning, and the nation’s economy.

Approximately 600,000 women are affected by PPD

annually with approximately 240,000 women diagnosed with PPD, and approximately 144,000 of those diagnosed patients treated with prescription

We believe that PPD is a significant and growing market opportunity, and increased awareness of PPD and effective therapies

is expected to increase diagnosis for symptomatic women with PPD.

Overview - PPD

is distinct from the “baby blues,” a condition that up to 70% of all new mother’s

“baby blues” tend to be short-lived emotional conditions that do

not interfere with daily activities.

of PPD include hallmarks of major depression, including, but not limited to, sadness, depressed

mood, loss of interest, change in appetite, insomnia, sleeping too much, fatigue, difficulty

thinking/concentrating, excessive crying, fear of harming the baby/oneself, and/or thoughts

of death or suicide.

is distinct from the “baby blues,” a condition that up to 70% of all new mother’s experience;

tend to be short-lived emotional conditions that do not interfere with daily activities.

of PPD include hallmarks of major depression, including, but not limited to, sadness, depressed mood, loss of interest, change in

appetite, insomnia, sleeping too much, fatigue, difficulty thinking/concentrating, excessive crying, fear of harming the baby/oneself,

and/or thoughts of death or suicide.

pregnancy, levels of endogenous NASs increase considerably along with levels of progesterone;

however, they drop sharply postpartum.

It has been hypothesized that the rapid perinatal

decrease in circulating levels of endogenous NASs may be involved in the development of PPD.

It has been hypothesized that the rapid perinatal decrease in circulating levels of endogenous NASs may be involved in the development

The first approved treatment option for PPD was an injectable containing endogenous NASs.

may persist long after child delivery.

Additionally, approximately 40% of women relapse in

subsequent pregnancies or on other occasions.

● Psychiatric

Additionally, approximately 40% of women relapse in subsequent pregnancies or on other occasions.

comorbidities are common in patients with epilepsy.

Patients with epilepsy are at high risk

for major depressive disorders and PPD.

Reported PPD rates are higher among women with epilepsy

than the general population.

Patients with epilepsy are at high risk for major depressive disorders and PPD.

Reported PPD rates are higher among women with epilepsy than the general population.

family history and/or previous experience of depression or other mood disorders

Physiological:

rapid changes in sex hormones, stress hormones, and thyroid hormone levels during and after

rapid changes in sex hormones, stress hormones, and thyroid hormone levels during and after delivery

Environmental:

stressful life events, changes in relationships at home and at work, and/or lack of familial

believe there is considerable unmet need within women with PPD due to a lack of convenient and fast-acting oral therapies.

Serotonin Reuptake Inhibitors (“SSRIs”) have been the traditional first-line choice for women with severe PPD and require

weeks for onset of efficacy;

therefore, a need for an oral treatment option with a faster onset of action remains a significant unmet

need in treating PPD, especially in mothers with moderate to severe depression prone to harmful actions.

stressful life events, changes in relationships at home and at work, and/or lack of familial support

believe there is considerable unmet need within women with PPD due to a lack of convenient and fast-acting oral therapies with good tolerability,

especially with respect to CNS depressant effects.

Selective Serotonin Reuptake Inhibitors (“SSRIs”) have been the traditional

choice for women with severe PPD and require weeks for onset of efficacy;

therefore, a need for an oral treatment option with a faster

onset of action, short treatment duration, and improved tolerability remains a significant unmet need in treating PPD, especially in

mothers with moderate to severe depression prone to harmful actions.

brexanolone (Zulresso ® , Sage Therapeutics (“Sage”)) became the first FDA-approved treatment for postpartum

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concerns and at the end of 2024, Sage withdrew Zulresso from the market.

In addition to Zulresso, Sage received FDA approval for

zuranolone (brand name ZURZUVAE ® ) in August 2023 and Zurzuvae was launched commercially in December 2023.

a synthetic neuroactive steroid derivative, is an oral, once daily 14-day treatment for postpartum depression and is the first oral medication

approved by the FDA for the treatment of postpartum depression.

Per label, besides a long terminal half-life of approximately 19.7 to

24.6 hours and dosage modifications needed for concomitant use with CYP3A4 modulators, warnings and precautions include CNS depressant

effects, impaired ability to drive or engage in other potentially hazardous activities and embryo-fetal toxicity.

In June 2025, Sage announced the acquisition of Sage by Supernus Pharmaceuticals and Supernus’ intention to

strengthen their leading presence in neuropsychiatric conditions with Sage’s innovative commercial product, ZURZUVAE.

The transaction,

which has been approved by the boards of directors of both companies, is expected to close in the third quarter of 2025, subject to customary

closing conditions.

believe LPCN 1154 targets the current unmet need for robust, rapid relief with 48-hour dosing duration through a convenient oral therapy

candidate comprising bioidentical NASs with good tolerability.

In addition to Zulresso, Sage received FDA approval for zuranolone

(brand name ZURZUVAE ® ) in August 2023 and Zurzuvae was launched commercially in December 2023.

Zuranolone, a synthetic

neuroactive steroid derivative, is an oral, once daily 14-day treatment for postpartum depression and is the first oral medication approved

by the FDA for the treatment of postpartum depression.

Per label, besides a long terminal half-life of approximately 19.7 to 24.6 hours

and dosage modifications needed for concomitant use with CYP3A4 modulators, warnings and precautions include CNS depressant effects,

impaired ability to drive or engage in other potentially hazardous activities and embryo-fetal toxicity.

In June 2025, Sage announced

the acquisition of Sage by Supernus Pharmaceuticals and Supernus’ intention to strengthen their leading presence in neuropsychiatric

conditions with Sage’s innovative commercial product, ZURZUVAE.

The transaction closed in the third quarter of 2025.

believe LPCN 1154 targets the current unmet need for robust, rapid relief with 48-hour duration through a convenient oral therapy candidate

comprising bioidentical NASs with improved tolerability.

If approved, we believe that LPCN 1154 has the potential to be a first-line

therapy option in treating PPD, providing the following advantages over current treatment options:

faster management of depression, reduced risk of suicidal thoughts and behaviors, fewer hospitalizations, positive outcomes

in terms of mother and family relationships, and reduced financial burden.

treatment duration :

better compliance, scheduling flexibility (e.g.

weekend) with minimal family disruption, more amenable to

discreet treatment, and a quick return to normal daily activities, including breast feeding and driving.

tolerability :

fewer CNS depressant effects, better adherence to dosing regimen, more quality time for baby care, and less dependence

on caregiver support.

NAS for Epilepsy

are currently evaluating an additional NAS candidate, LPCN 2101, for epilepsy including women with epilepsy (“WWE”).

completed pre-clinical and Phase 1 studies for LPCN 2101 which demonstrated promising PK results, safety and tolerability.

our IND was accepted by the FDA for LPCN 2101 for adults with epilepsy and we plan to initiate a Phase 2 IND opening proof-of-concept

study to evaluate the safety, tolerability, and efficacy of LPCN 2101, subject to resource prioritization.

are currently evaluating an additional NAS candidate, LPCN 2101, for epilepsy including Drug Resistant Epilepsy and women with

We have completed pre-clinical and Phase 1 studies for LPCN 2101 which demonstrated promising PK results,

safety and tolerability.

In July 2022 our IND was accepted by the FDA for LPCN 2101 for adults with epilepsy and we may initiate

a Phase 2 proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 2101, subject to resource prioritization.

Overview – Epilepsy

is defined by the 1) occurrence of at least two unprovoked seizures more than 24 hours apart, 2) occurrence of one unprovoked seizure

and a probability of further seizures occurring over the next 10 years, and/or 3) diagnosis of an epilepsy syndrome.

Patients with epilepsy

have increased risk of mortality due to direct effects of seizures (e.g., status epilepticus, car accidents) and indirect effects of

seizures (e.g., suicide, cardiovascular effects).

is one of the most common neurological disorders characterized by recurrent, unprovoked seizures caused by abnormal electrical activity

in the brain.

Epilepsy is defined by the 1) occurrence of at least two unprovoked seizures more than 24 hours apart, 2) occurrence of

one unprovoked seizure and a probability of further seizures occurring over the next 10 years, and/or 3) diagnosis of an epilepsy syndrome.

Patients with epilepsy have increased risk of mortality due to direct effects of seizures (e.g., status epilepticus, car accidents) and

indirect effects of seizures (e.g., suicide, cardiovascular effects).

is a disorder of the brain that causes seizures, affecting the physical, mental, and social well-being of persons, and is associated

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About 60-65% of epilepsy is idiopathic and about 30%

of patients are refractory (i.e., epilepsy not well managed with currently available Anti-Seizure Medications (“ASMs”).

is the most common neurological disorder during pregnancy.

is estimated that approximately 900,000 childbearing (“CB”) aged women suffer from active epilepsy in the U.S.

age with epilepsy face many additional challenges due to hormonal influences on seizure activity and endocrine function throughout the

different phases of their reproductive cycles.

of patients are refractory or have DRE (i.e., epilepsy not well managed with currently available Anti-Seizure Medications (“ASMs”).

There are about 2.9 million adults and 456,000 children with active epilepsy, meaning they are either taking medication or have had a

seizure in the past year, with approximately 150,000 new diagnoses annually.

Approximately 38% of adults with epilepsy report having

a disability and the unemployment rate among adults with epilepsy is approximately 29%.

DRE is a significant clinical challenge in epilepsy

care, with high social and occupational limitations.

DRE affects 30-40% of epilepsy patients in the U.S.

and DRE contributes heavily

to the $24.5 billion annual epilepsy-related healthcare costs and DRE poses significant treatment challenges due to limited success with

medications, and need for early identification.

needs in DRE:

Many patients with DRE cycle through multiple ASMs with limited success.

Seizures may cause physical injuries,

and a minority may last long (status epilepticus) or recur in clusters and can be life-threatening.

Rescue treatments (primarily benzodiazepines)

do not prevent future seizures, they only stop the current episode.

DRE patients are at high risk of seizure recurrence within hours

or days after a cluster.

There is a lack of post-rescue medications, especially for patients who experience recurrent seizure clusters

or drug-resistant epilepsy and a need to transition effectively to maintenance therapy and sustain seizure control after acute treatment

prevents status epilepticus and to prevent patients from requiring emergency room treatment for seizure management.

There remains an

unmet need for medications with novel mechanism of action and minimal cognitive, mood, or systemic side effects, especially for patients

who experience recurrent seizure clusters or DRE.

It is estimated that approximately 1,000,000 childbearing (“CB”) aged women suffer from active epilepsy in the U.S.

of CB age with epilepsy face many additional challenges due to hormonal influences on seizure activity and endocrine function throughout

the different phases of their reproductive cycles.

Elevated estrogen or decreased progesterone levels can exacerbate seizure frequency.

these women experience hormonal and endogenous NAS imbalances, coupled with fluctuations in the blood levels of ASMs that impact control

of seizures, efficacy of oral contraceptives, any coexisting anxiety and/or depression and any associated sleep impairment.

Often, these women experience hormonal and endogenous NAS imbalances, coupled with fluctuations in the blood levels of ASMs that impact

control of seizures, efficacy of oral contraceptives, any coexisting anxiety and/or depression and any associated sleep impairment.

patients are 5-20 times more likely to develop depression.

segmentation can be categorized by epilepsy type, comorbidities and patient subgroups.

Categorization of focal epilepsy, generalized

epilepsy, combined focal and generalized epilepsy, and unknown epilepsy can guide the choice of ASM.

Special patient subgroups, including

WWE of CB age and elderly patients, require special care and management of epilepsy.

Comorbidities such as depression and anxiety may

be co-treated with therapies that do not aggravate seizures and have no drug interaction with the ASM used for epilepsy.

effective dose and monotherapy are preferred, management of patients with epilepsy is focused on controlling seizures, avoiding adverse

events, and maintaining quality of life.

Despite a wide range of ASMs available, about 30% of all people with epilepsy still fail to

respond to treatment effectively.

Women with epilepsy face specific challenges throughout their lifespan because of seizures, ASMs, and

hormonal fluctuations.

with epilepsy were once counseled to avoid pregnancy, but epilepsy is no longer considered a contraindication to pregnancy.

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Patient experiences in essential tremor:

Mapping functional impacts to existing

measures using qualitative research.

Mapping functional impacts to existing measures using qualitative research.

Pipeline Candidates

continue to pursue opportunities for partnering and/or development arrangements for the continued development and/or marketing of LPCN

2401, LPCN 1148, LPCN 1144, and LPCN 1107.

We are planning a POC study with LPCN 2401, but otherwise we do not currently anticipate conducting

any further significant development activities with respect to these products and product candidates without the participation of a partner.

There can be no guarantee that we will be able to identify or enter into partnering arrangements on terms that are beneficial to us or

Even if we do enter into partnering arrangements, such arrangements may not be sufficient to successfully develop and commercialize

these products.

2401, LPCN 1148, and LPCN 1107.

Depending on available resources and feedback received from the FDA, we may proceed with a POC study

for LPCN 2401 in the future, but otherwise we do not currently anticipate conducting any further significant development activities with

respect to these products and product candidates without the participation of a partner.

There can be no guarantee that we will be able

to identify or enter into partnering arrangements on terms that are beneficial to us or at all.

Even if we do enter into partnering arrangements,

such arrangements may not be sufficient to successfully develop and commercialize these products.

Management of Incretin Mimetic Use in Obesity Management

2401 is targeted to be a once daily oral formulation comprising a proprietary anabolic androgen receptor agonist.

expected to have a favorable benefit to risk profile as a non-invasive option for use as an adjunct to GLP-1 chronic weight

management therapies for quality weight loss and/or as a monotherapy post cessation of GLP-1 chronic weight management therapies

for weight and glycemic status maintenance with demonstrated benefits to the liver.

LPCN 2401 is expected

to have a favorable benefit to risk profile as a non-invasive option for use as an adjunct to GLP-1 chronic weight management therapies

for quality weight loss and/or as a monotherapy post cessation of GLP-1 chronic weight management therapies for weight and glycemic status

maintenance with demonstrated benefits to the liver.

2401 has potential for use as an adjunct to incretin mimetics (GLP-1/GIP agonists) including amplification of GLP-1 insulinotropic actions

which is supported by studies demonstrating the role of androgen receptor agonist in regulation of GLP-1 through:

● Enhancement

of GLP-1-mediated insulin release from β cells through genomic- and non-genomic mechanisms

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proliferation of β cells and improving insulin sensitivity

benefits of LPCN 2401 in combination with GLP-1 agonists include inducing quality weight loss by attenuation of functionality loss

through improved body composition, entailing majority of weight loss through fat mass loss, amplification/acceleration of fat mass

loss while lessening lean mass loss, a serious unmet need, especially for elderly and sarcopenic adult GLP-1 agonist users who are

most vulnerable to accelerated lean mass loss and functional decline.

benefits of LPCN 2401 in combination with GLP-1 agonists include inducing quality weight loss by attenuation of functionality and activities

of daily life loss through improved body composition, entailing majority of weight loss through fat mass loss, amplification/acceleration

of fat mass loss while lessening lean mass loss, a serious unmet need, especially for elderly and sarcopenic adult GLP-1 agonist users

who are most vulnerable to accelerated lean mass loss and functional decline.

In a recent study with 16 weeks of GLP-1 agonist use for

weight management in elderly (60 yr and above) patients, a rapid loss of lean mass was observed with a median percentage of total

body weight loss that is due to lean mass of 32% in 16 weeks.

In addition, 43% of GLP-1 users lost ≥10% Stair Climb Power from

the equivalent of almost eight years of expected age-related stair climb power loss was observed in just 4 months of GLP-1

weight management in elderly (60 yr and above) patients, a rapid loss of lean mass was observed with a median percentage of total body

weight loss that is due to lean mass of 32% in 16 weeks.

In addition, 43% of GLP-1 users lost ≥10% Stair Climb Power from baseline;

the equivalent of almost eight years of expected age-related stair climb power loss was observed in just 4 months of GLP-1 use.

as an adjunct to incretin mimetics, LPCN 2401 may help maintain or increase weight loss, particularly in diabetics, through increased

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and selection of endpoints that measure how a patient feels, functions, or survives, to potentially support such a claim.

with regulatory guidance, we plan to conduct a proof-of-concept phase 2 study for LPCN 2401 in elderly obese and overweight GLP-1 eligible

patients, with appropriate body composition and functional end points such as stair climb performance measure

plan to initiate a proof-of-concept study evaluating LPCN 2401 as an adjunct to GLP-1 agonist use in the third quarter of 2025.

may explore the possibility of partnering LPCN 2401 with a third party, although no partnering agreement has been entered into by

No assurance can be given that any license agreement will be completed, or, if an agreement is completed, that such an agreement

would be on terms favorable to us.

Pending further

regulatory guidance and available resources, we may conduct a proof-of-concept Phase 2 study for LPCN 2401 in elderly obese and overweight

GLP-1 eligible patients, with possible appropriate body composition and functional end points such as stair climb performance measure.

may initiate a proof-of-concept study evaluating LPCN 2401 as an adjunct to GLP-1 agonist after we obtain additional regulatory clarity

with respect to development path and acceptable end points for improved body composition in obesity management.

We may explore the possibility

of partnering LPCN 2401 with a third party, although no partnering agreement has been entered into by us.

No assurance can be given that

any license agreement will be completed, or, if an agreement is completed, that such an agreement would be on terms favorable to us.

and Market Overview – GLP-1 Agonist Use and Obesity Management

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Subjects were initially randomized 1:1 to 1 of 2 arms.

treatment arm was an oral dose of LPCN 1148, and the second arm was a matching placebo.

There were no restrictions on patients with respect

to background therapies, including current standard of care, diet or exercise.

The primary endpoint was a change in skeletal muscle index

at week 24 with key secondary endpoints including change in liver frailty index, rates of breakthrough OHE, and number of waitlist events,

including all-cause mortality.

Total treatment was 52 weeks, with 24-week placebo-controlled treatment subjects receiving LPCN 1148 in

the 28-week open-label extension (“OLE”) phase of the study for the duration of the study through week 52.

The treatment arm was an oral dose

of LPCN 1148, and the second arm was a matching placebo.

There were no restrictions on patients with respect to background therapies,

including current standard of care, diet or exercise.

The primary endpoint was a change in skeletal muscle index at week 24 with key

secondary endpoints including change in liver frailty index, rates of breakthrough OHE, and number of waitlist events, including all-cause

Total treatment was 52 weeks, with 24-week placebo-controlled treatment subjects receiving LPCN 1148 in the 28-week open-label

extension (“OLE”) phase of the study for the duration of the study through week 52.

July 2023 we announced that the Phase 2 study met the study primary endpoint, increased skeletal muscle index (L3-SMI) relative to placebo

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Overview – Cirrhosis

cirrhosis has caused more than 1 million deaths worldwide, and there are over 500,000 people living with decompensated cirrhosis in

cirrhosis has caused more than 1 million deaths worldwide, and there are over 500,000 people living with decompensated cirrhosis in the

Non-alcoholic fatty liver disease is the most rapidly increasing indication for liver transplant.

62% of those on the liver

transplant (“LT”) waitlist are male and the economic burden (approximately $812,500/transplant) is high and continues to

Each year about half of the approximately 17,000 people in U.S.

on the LT waitlist undergo transplant, while nearly 3,000

patients either die or are removed from the list because they were “too sick to transplant.”

62% of those on the liver transplant

(“LT”) waitlist are male and the economic burden (approximately $812,500/transplant) is high and continues to increase.

year about half of the approximately 17,000 people in U.S.

on the LT waitlist undergo transplant, while nearly 3,000 patients either

die or are removed from the list because they were “too sick to transplant.”

cirrhosis is defined as the histological development of regenerative nodules surrounded by fibrous bands.

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the frequency of HE is also increasing.

An Oral Prodrug of Bioidentical Testosterone Product Candidate for the Treatment of MASH

are exploring the possibility of partnering with a third party for LPCN 1144, although no partnering agreement has been entered into

by the Company.

No assurance can be given that any license agreement will be completed, or, if an agreement is completed, that such an

agreement would be on terms favorable to us.

Overview – MASH

is an advanced state of non-alcoholic fatty liver disease (“NAFLD”) that can progress to a cirrhotic liver or liver failure,

require liver transplant, and can result in hepatocellular carcinoma/ liver cancer, and death.

Progression of MASH to end stage liver

disease is one of the leading causes of liver failure requiring liver transplantation.

Importantly, beyond these critical conditions,

MASH and NAFLD patients additionally suffer heightened cardiovascular risk and die more frequently from cardiovascular events than from

liver disease.

NAFLD/MASH is becoming more common due to its strong correlation with obesity and metabolic syndrome, including components

of metabolic syndrome such as diabetes, cardiovascular disease and high blood pressure.

20% to 30% of the U.S.

population is estimated

to suffer from NAFLD, with a large proportion of that group, 15% to 20%, progressing to MASH, which lacks an effective therapy.

is a silent killer that affects millions in the U.S.

Diagnoses have been on the rise and are expected to increase dramatically in the

Approximately 50% of MASH patients are adult males.

In men, especially with comorbidities associated with NAFLD/MASH, testosterone

deficiency has been associated with an increased accumulation of visceral adipose tissue and insulin resistance, which could be factors

contributing to NAFLD/MASH.

There is currently no approved therapy for the treatment of MASH although there are several drug candidates

currently under development with many having clinical failures to date.

critical pathophysiologic mechanisms underlying the development and progression of MASH include reduced ability to handle lipids, increased

insulin resistance, injury to hepatocytes and liver fibrosis in response to hepatocyte injury.

MASH patients have an excessive accumulation

of fat in the liver resulting primarily from a caloric intake above and beyond energy needs.

A healthy liver contains less than 5% fat,

but a liver in someone with MASH can contain more than 20% fat.

This abnormal liver fat contributes to the progression to MASH, a liver

necro-inflammatory state that can lead to scarring, also known as fibrosis, and, for some, can progress to cirrhosis and liver failure.

have completed the LiFT Phase 2 clinical study in biopsy-confirmed non-cirrhotic MASH subjects.

The LiFT clinical study

was a prospective, multi-center, randomized, double-blind, placebo-controlled multiple-arm study in biopsy-confirmed hypogonadal and

eugonadal male MASH subjects with grade F1-F3 fibrosis and a target NAFLD Activity Score ≥ 4 with a 36-week treatment period.

LiFT clinical study enrolled 56 biopsy confirmed MASH male subjects.

Subjects were randomized 1:1:1 to one of three arms (Treatment

A was a twice daily oral dose of 142 mg testosterone equivalent, Treatment B was a twice daily oral dose of 142 mg testosterone equivalent

formulated with 217 mg of d-alpha tocopherol equivalent, and the third arm was a twice daily matching placebo).

primary endpoint of the LiFT clinical study was change in hepatic fat fraction via MRI-PDFF and exploratory liver fat/marker end

points post 12 weeks of treatment.

Additionally, key secondary endpoints post 36 weeks of treatment included assessment of histological

change for MASH resolution and/or fibrosis improvement (biopsy) as well as liver fat data (MRI-PDFF).

The LiFT clinical study

was not powered to assess statistical significance of any of the secondary endpoints.

Other important endpoints included the following:

change in liver injury markers, anthropomorphic measurements, body composition including lean mass, fat mass, and bone mineral density,

lipids, insulin resistance and inflammatory/fibrosis markers;

as well as PROs.

with LPCN 1144 post 12 weeks of treatment in the LiFT study resulted in robust liver fat reduction, assessed by MRI-PDFF, and

showed improvement of liver injury markers with no observed tolerability issues.

biopsies were performed at baseline (“BL”) and after 36 weeks of treatment (“EOS”).

Pre-specified biopsy analyses

included MASH Clinical Research Network (“CRN”) scoring as well as a continuous paired and digital technique (“Digital

Technique-Fibronest”).

All biopsy analyses were performed on the same slides and the reads for the three techniques were done independently.

Analysis sets included the MASH Resolution Set (all subjects that have BL and EOS biopsy with MASH at BL [NAS ≥4 with lobular inflammation

score ≥ 1 and hepatocyte ballooning score ≥1 at BL] (n=37)), the Biopsy Set (all subjects with baseline and EOS biopsies (n=44)),

and the Safety Set (all randomized subjects (n=56)).

LPCN 1144 treatment arms met with statistical significance the pre-specified accelerated approval regulatory endpoint of MASH resolution

with no worsening of fibrosis based on MASH CRN scoring.

Additionally, both treatment arms showed substantial improvement of the observed

MASH activity in steatosis, inflammation, and ballooning.

the 36 weeks of treatment, LPCN 1144 was well tolerated with an overall safety profile comparable to placebo.

Additionally, subjects

were given the option to have access to LPCN 1144 through an open label extension (“OLE”) study.

extension study enabled the collection of additional data on LPCN 1144 for up to a total of 72 weeks of therapy, as well as data for

36 weeks of therapy for those subjects on placebo in the LiFT study.

Key results from the OLE study are as follows:

1144 was well tolerated over 72-week exposure with no observed safety signals;

injury markers were reduced and maintained with extended LPCN 1144 treatment;

liver histology improvements support further development.

November 2021, the FDA granted Fast Track Designation to LPCN 1144 as a treatment for non-cirrhotic MASH.

The Fast Track program is designed

to accelerate the development and expedite the review of products, such as LPCN 1144, which are intended to treat serious diseases and

for which there is an unmet medical need.

had a written only response from the FDA for a LPCN 1144 Type C meeting with the FDA in January 2022 to discuss the development path

forward with LPCN 1144.

The FDA acknowledged that the NDA submission of LPCN 1144 would be via the 505(b)2 regulatory pathway and agreed

that no additional non-clinical studies are needed to support an NDA submission.

The FDA acknowledged that subjects in the LiFT study

achieved improvements in key components associated with MASH histopathology after 36-weeks of treatment with LPCN 1144 in adult males

and agreed that the proposed multicomponent primary surrogate endpoint is acceptable for seeking approval under the accelerated approval

The FDA agreed that the proposed primary multicomponent surrogate endpoint, MASH resolution with no worsening of fibrosis, is

acceptable for seeking approval under the accelerated approval pathway and the FDA recommended a Phase 3 trial with a study duration

In July 2022, Lipocine held an End of Phase 2 meeting with the FDA for LPCN 1144 for MASH.

The FDA recommended a Phase 2

dose ranging study be conducted to identify the optimal dose prior to conducting a pivotal study.

The FDA agreed to the proposed unique

testosterone ester, testosterone laurate, for future clinical studies.

An Oral Product Candidate for the Prevention of Preterm Birth (“PTB”)

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Since our inception

through June 30, 2025, we have generated $53.8 million in revenue under our various license and collaboration arrangements and from government

We have entered into the Verity License Agreement, the SPC License Agreement, the Pharmalink Distribution Agreement, and the

Aché License Agreement with the potential for revenue from future milestones, royalties and/or product sales, but we may never

generate revenues from any of our clinical or preclinical development programs or licensed products as we may never succeed in obtaining

regulatory approval or commercializing any of these product candidates.

through September 30, 2025, we have generated $53.9 million in revenue under our various license and collaboration arrangements and from

government grants.

We have entered into the Verity License Agreement, the SPC License Agreement, the Pharmalink Distribution Agreement,

and the Aché License Agreement with the potential for revenue from future milestones, royalties and/or product sales, but we may

never generate revenues from any of our clinical or preclinical development programs or licensed products as we may never succeed in

obtaining regulatory approval or commercializing any of these product candidates.

and Development Expenses

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We expense research and development expenses as incurred.

our inception, we have spent approximately $157.8 million in research and development expenses through June 30, 2025.

our inception, we have spent approximately $160.5 million in research and development expenses through September 30, 2025.

expect to continue to incur significant costs as we develop our other product candidates, including our CNS product candidates, as well

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timing and outcome of regulatory filings and FDA reviews and actions for product candidates;

dependence on third-party manufacturers for the production of satisfactory finished products

for registration and launch should regulatory approval be obtained on any of our product

potential for future license or co-promote arrangements for our product candidates, when

such arrangements will be secured, if at all, and to what degree such arrangements would

affect our future plans and capital requirements;

effect on our product development activities of actions taken by the FDA or other regulatory

dependence on third-party manufacturers for the production of satisfactory finished products for registration and launch should regulatory

approval be obtained on any of our product candidates;

potential for future license or co-promote arrangements for our product candidates, when such arrangements will be secured, if at

all, and to what degree such arrangements would affect our future plans and capital requirements;

effect on our product development activities of actions taken by the FDA or other regulatory authorities.

change of outcome for any of these variables with respect to the development of our product development candidates could mean a substantial

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regulatory approval process, we are unable to estimate with any certainty the time or cost to complete the development of LPCN 1154,

LPCN 2401, LPCN 2101, LPCN 2203, LPCN 1148, LPCN 1144, LPCN 1111, LPCN 1107 and other product candidates.

Clinical development timelines,

the probability of success, and development costs can differ materially from expectations and results from our clinical trials may not

be favorable.

If we are successful in progressing LPCN 1154, LPCN 2401.

LPCN 2101, LPCN 2203 or other future product candidates into

later stage development, we will require additional capital.

The amount and timing of our future research and development expenses for

these product candidates will depend on the pre-clinical and clinical success of both our current development activities and potential

development of new product candidates, as well as ongoing assessments of the commercial potential of such activities.

We will continue

efforts to enter into partnership arrangements for the continued development and/or marketing of LPCN 1154, LPCN 1144, LPCN 1148, LPCN

2401, LPCN 1107, for the development and commercialization of TLANDO outside of the United States, Canada, South Korea, the GCC countries

and Brazil, and LPCN 1111 outside of the United States and Canada.

LPCN 2101, LPCN 2401, LPCN 2203, LPCN 1148, LPCN 1107 and other product candidates.

Clinical development timelines, the probability of

success, and development costs can differ materially from expectations and results from our clinical trials may not be favorable.

we are successful in progressing LPCN 1154, LPCN 2101, LPCN 2401, LPCN 2203 or other future product candidates into later stage development,

we will require additional capital.

The amount and timing of our future research and development expenses for these product candidates

will depend on the pre-clinical and clinical success of both our current development activities and potential development of new product

candidates, as well as ongoing assessments of the commercial potential of such activities.

We will continue efforts to enter into partnership

arrangements for the continued development and/or marketing of LPCN 1154, LPCN 1148, LPCN 2401, LPCN 1107, and for the development and

commercialization of TLANDO outside of the United States, Canada, South Korea, the GCC countries and Brazil.

expect to continue to incur significant research and development expenses in the future as we complete on-going clinical studies, including

studies for our CNS product candidates, including a Phase 3 study for LPCN 1154, and as we conduct future clinical studies, including

when and if we conduct Phase 2 clinical studies with LPCN 2401 or our development product candidates and when and if we conduct clinical

studies for LPCN 2101 or LPCN 2203 and/or Phase 3 clinical studies with LPCN 1144, LPCN 1148, and LPCN 1107.

We are also exploring the

possibility of licensing all of our product candidates, although we have not entered into a licensing agreement and no assurance can

be given that any license agreement will be completed, or, if an agreement is completed, that such agreement would be on terms favorable

If we are unable to raise additional capital or obtain non-dilutive financing, we may need to reduce research and development

expenses in order to extend our ability to continue as a going concern.

when and if we conduct Phase 2 clinical studies with LPCN 2101, LPCN 2401, LPCN 2203 and/or Phase 3 clinical studies with LPCN 1148 and/or

We are also exploring the possibility of licensing all of our product candidates, although we have not entered into a licensing

agreement and no assurance can be given that any license agreement will be completed, or, if an agreement is completed, that such agreement

would be on terms favorable to us.

If we are unable to raise additional capital or obtain non-dilutive financing, we may need to reduce

research and development expenses in order to extend our ability to continue as a going concern.

and Administrative Expenses

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income and expense consists primarily of interest income earned on our cash, cash equivalents and marketable investment securities and

losses on our warrant liability in 2024.

gains on our warrant liability in 2024.

of Operations

of the Three Months Ended June 30, 2025 and 2024

following table summarizes our results of operations for the three months ended June 30, 2025 and 2024:

Months Ended June 30,

and development expenses

and administrative expenses

and investment income

loss on warrant liability

recognized royalty revenue from TLANDO sales of $123,000 during the three months ended June 30, 2025, compared to royalty revenue of

$90,000 during the three months ended June 30, 2024.

License revenue of $500,000 and $0 was recognized in the three months ended June

30, 2025, and 2024, respectively.

of the Three Months Ended September 30, 2025 and 2024

following table summarizes our results of operations for the three months ended September 30, 2025 and 2024:

Months Ended September 30,

Research and development expenses

General and administrative expenses

Interest and investment income

Unrealized loss on warrant liability

recognized royalty revenue from TLANDO sales of $115,000 during the three months ended September 30, 2025, compared to royalty revenue

of $0 during the three months ended September 30, 2024.

There was no license revenue recognized in either the three months ended September

30, 2025, or 2024.

and Development Expenses

increase in research and development expenses during the three months ended June 30, 2025, as compared to the three months ended June

30, 2024 consists of a $153,000 increase in costs related to the initiation of our LPCN 2401 clinical studies, an $81,000 increase in

other research and development costs, and a $28,000 increase in personnel related costs.

increase in research and development expenses during the three months ended September 30, 2025, as compared to the three months ended

September 30, 2024 consists of a $1.35 million increase in costs primarily related to our ongoing LPCN 1154 Phase 3 clinical trial,

in addition to other clinical trials, offset by a $227,000 decrease in other research and development costs.

and Administrative Expenses

decrease in general and administrative expenses during the three months ended June 30, 2025 as compared to the three months ended June

30, 2024 primarily consists of a $350,000 decrease in business development fees and consulting expenses incurred in 2024, a $184,000

decrease in legal fees, a $40,000 decrease in Delaware franchise tax as a result of the reduction in authorized common stock from 200,000,000

down to 75,000,000 shares, a $25,000 decrease in other professional fees and general and administrative related costs, and an $18,000

decrease in corporate insurance premiums.

decrease in general and administrative expenses during the three months ended September 30, 2025 as compared to the three months

ended September 30, 2024 primarily consists of a $130,000 decrease in business development fees incurred in 2024, a $116,000

decrease in other general and administrative costs, and an $80,000 decrease in Delaware franchise tax mainly resulting from the

reduction in authorized common stock from 200,000,000 down to 75,000,000 shares, offset by a $49,000 increase in legal fees

primarily related to intellectual property expenses.

and Investment Income

decrease in interest and investment income during the three months ended June 30, 2025 compared to interest and investment income during

the three months ended June 30, 2024 was due to lower interest rates and lower cash and marketable investment securities balances in

2025 as compared to 2024.

decrease in interest and investment income during the three months ended September 30, 2025 compared to interest and investment income

during the three months ended September 30, 2024 was due to lower interest rates and lower cash and marketable investment securities

balances in 2025 as compared to 2024.

(Loss) on Warrant Liability

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2019 warrants expired in November 2024.

recorded a loss of approximately $84,000 on warrant liability during the three months ended June 30, 2024, related to the change in the

fair value of outstanding common stock warrants issued in the November 2019 Offering.

The loss in 2024 resulted from an increase in the

fair value of warrants mainly due to a higher stock price at the end of the second quarter of 2024 compared to the stock price at the

end of the first quarter of 2024.

There were also no warrants exercised during the three months ended June 30, 2024.

The warrants were

classified as a liability due to a provision contained within the warrant agreement which allowed the warrant holder the option to elect

to receive an amount of cash equal to the value of the warrants as determined in accordance with the Black-Scholes option pricing model

with certain defined assumptions upon a change of control.

of the Six Months Ended June 30, 2025 and 2024

following table summarizes our results of operations for the six months ended June 30, 2025 and 2024:

Months Ended June 30,

recorded a non-cash gain of approximately $138,000 on warrant liability during the three months ended September 30, 2024, related to

the change in the fair value of outstanding common stock warrants issued in the November 2019 Offering.

The gain in 2024 resulted from

a decrease in the fair value of warrants mainly due to a lower stock price, remaining life and interest rate at the end of the third

quarter of 2024 compared to the stock price and interest rate at the end of the second quarter of 2024.

There were also no warrants exercised

The warrants were classified as a liability due to a provision contained within the warrant agreement which allowed the

warrant holder the option to elect to receive an amount of cash equal to the value of the warrants as determined in accordance with the

Black-Scholes option pricing model with certain defined assumptions upon a change of control.

of the Nine Months Ended September 30, 2025 and 2024

following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:

Months Ended September 30,

$ (6,875,451 )

and development expenses

and administrative expenses

and investment income

loss on warrant liability

recognized revenue of $717,000 and $7.7 million during the six months ended June 30, 2025 and 2024, respectively.

Revenue during the

six months ended June 30, 2025, consists of license revenue of $500,000 compared to license revenue of $7.5 million resulting from our

Verity Licensing Agreement during the same period in 2024.

During the six months ended June 30, 2025, and 2024, we recognized royalty

revenue from TLANDO sales of $217,000 and $207,000, respectively.

Research and development expenses

General and administrative expenses

Interest and investment income

Unrealized loss on warrant liability

Income tax expense

recognized revenue of $831,000 and $7.7 million during the nine months ended September 30, 2025 and 2024, respectively.

Revenue during

the nine months ended September 30, 2025, consists of license revenue of $500,000 compared to license revenue of $7.5 million resulting

from our Verity Licensing Agreement during the same period in 2024.

During the nine months ended September 30, 2025, and 2024, we recognized

royalty revenue from TLANDO sales of $331,000 and $207,000, respectively.

and Development Expenses

decrease in research and development expenses during the six months ended June 30, 2025, as compared to the six months ended June 30,

2024 consists of a $1.6 million decrease resulting from lower costs related to our LPCN 1154 Phase III clinical study in 2025 as compared

to LPCN 1154 studies which occurred in 2024 and a $22,000 decrease in other research and development related costs and supplies in 2025,

offset by a $126,000 increase in costs related to the initiation of our LPCN 2401 clinical studies and a $28,000 increase in personnel

related costs.

decrease in research and development expenses during the nine months ended September 30, 2025, as compared to the nine months ended September

30, 2024 consists of an $809,000 decrease resulting from lower costs related to our LPCN 1154 Phase 3 clinical trial in 2025 as compared

to LPCN 1154 studies which occurred in 2024, a $128,000 decrease in TLANDO manufacturing costs, and a $93,000 decrease in other research

and development related costs and supplies in 2025, offset by a $657,000 increase in costs related to the initiation of our LPCN 2401

clinical study.

and Administrative Expenses

decrease in general and administrative expenses during the six months ended June 30, 2025 as compared to the six months ended June 30,

2024 primarily consists of a $512,000 decrease related to the one-time business development fees incurred in 2024 in conjunction with

the Verity License Agreement, a $410,000 decrease in other business development expense, a $110,000 decrease in legal fees, a $36,000

decrease in corporate insurance premiums, and a $22,000 decrease in professional fees and other general and administrative costs, offset

by a $20,000 increase in personnel related costs.

decrease in general and administrative expenses during the nine months ended September 30, 2025 as compared to the nine months ended

September 30, 2024 consists of a $540,000 decrease in business development fees, a $512,000 decrease related to

the one-time business development fees incurred in 2024 in conjunction with the Verity License Agreement, an $89,000 decrease in other

general and administrative costs, an $82,000 decrease in legal fees, an $82,000 decrease in estimated Delaware franchise taxes mainly

resulting from the reduction in authorized common stock from 200,000,000 down to 75,000,000 shares, and a $43,000 decrease in corporate

and Investment Income

decrease in interest and investment income during the six months ended June 30, 2025 compared to interest and investment income during

the six months ended June 30, 2024 was due to lower interest rates and lower cash and marketable investment securities balances in 2025

as compared to 2024.

decrease in interest and investment income during the nine months ended September 30, 2025 compared to interest and investment income

during the nine months ended September 30, 2024 was due to lower interest rates and lower cash and marketable investment securities balances

in 2025 as compared to 2024.

(Loss) on Warrant Liability

were no outstanding common stock warrants from the November 2019 Offering in 2025 as the liability had been extinguished when the November

were no outstanding common stock warrants from the November 2019 Offering in 2025 as the liability was extinguished when the November

2019 warrants expired in November 2024.

recorded a loss of approximately $125,000 on warrant liability during the six months ended June 30, 2024, related to the change in the

fair value of outstanding common stock warrants issued in the November 2019 Offering.

The loss in 2024 resulted from an increase in the

fair value of warrants mainly due to a higher stock price at the end of the second quarter of 2024 compared to the stock price at the

end of the fourth quarter of 2023.

No warrants were exercised during the six months ended June 30, 2024.

The warrants were classified

as a liability due to a provision contained within the warrant agreement which allowed the warrant holder the option to elect to receive

an amount of cash equal to the value of the warrants as determined in accordance with the Black-Scholes option pricing model with certain

defined assumptions upon a change of control.

recorded a non-cash gain of approximately $14,000 on warrant liability during the nine months ended September 30, 2024, related to the

change in the fair value of outstanding common stock warrants issued in the November 2019 Offering.

The non-cash gain in 2024 resulted

from a decrease in the fair value of warrants mainly due to the lower stock price, shorter remaining life of the warrants and lower interest

rate at the end of the third quarter of 2024 compared to December 31, 2023.

No warrants were exercised during the nine months ended September

The warrants were classified as a liability due to a provision contained within the warrant agreement which allowed the warrant

holder the option to elect to receive an amount of cash equal to the value of the warrants as determined in accordance with the Black-Scholes

option pricing model with certain defined assumptions upon a change of control.

and Capital Resources

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LPCN 2101, LPCN 2401, LPCN 2203, and any other future product candidates, including continued research efforts.

of June 30, 2025, we had $17.9 million of unrestricted cash, cash equivalents and marketable investment securities compared to $21.6

million at December 31, 2024.

of September 30, 2025, we had $15.1 million of unrestricted cash, cash equivalents and marketable investment securities compared to $21.6

million as of December 31, 2024.

April 2025, we entered into the Aché License and Supply Agreement with Aché pursuant to which we granted to Aché

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Sales Agreement at any time upon ten days’ prior notice.

the three and six months ended June 30, 2025, we sold 23,739 shares of common stock at a weighted average price of $3.29 per share pursuant

the nine months ended September 30, 2025, we sold 68,691 shares of common stock at a weighted average price of $3.26 per share pursuant

to the A.G.P.

Sales Agreement for aggregate net proceeds of approximately $76,000, after paying commissions of approximately $2,000 to

A.G.P, as sales agent.

Sales Agreement for aggregate net proceeds of approximately $217,000, after paying commissions of approximately $7,000

to A.G.P, as sales agent.

believe that our existing capital resources, together with interest thereon, will be sufficient to meet our projected operating requirements

through at least August 5, 2026, which include a Phase 3 clinical study for LPCN 1154 and a POC study for LPCN 2401, research and development

activities, and compliance with regulatory requirements.

We have based this estimate on assumptions that may prove to be wrong, and we

could utilize our available capital resources sooner than we currently expect if additional activities are performed by us including

new clinical studies for LPCN 2401, LPCN 2101, LPCN 2203, LPCN 1148, LPCN 1144, and/or LPCN 1107.

through at least November 6, 2026, which include a Phase 3 clinical study for LPCN 1154 and possibly a POC study for LPCN 2401, research

and development activities, and compliance with regulatory requirements.

We have based this estimate on assumptions that may prove to

be wrong, and we could utilize our available capital resources sooner than we currently expect if additional activities are performed

by us including new clinical studies for LPCN 2101, LPCN 2401, LPCN 2203, LPCN 1148, and/or LPCN 1107.

While we believe we have sufficient

liquidity and capital resources to fund our projected operating requirements through at least August 5, 2026, we will need to raise additional

capital at some point through the equity or debt markets or through additional out-licensing activities, either before or after August

5, 2026, to support our operations.

If we are unsuccessful in raising additional capital as necessary, our ability to continue as a going

concern will be limited.

Further, our operating plan may change, and we may need additional funds to meet operational needs and capital

requirements for product development, regulatory compliance and clinical trial activities sooner than planned.

In addition, our capital

resources may be consumed more rapidly if we pursue additional clinical studies for LPCN 1154, LPCN 2401, LPCN 2101, LPCN 2203, LPCN

liquidity and capital resources to fund our projected operating requirements through at least November 6, 2026, we will need to raise

additional capital at some point through the equity or debt markets or through additional out-licensing activities, either before or

after November 6, 2026, to support our operations.

If we are unsuccessful in raising additional capital as necessary, our ability to

continue as a going concern will be limited.

Further, our operating plan may change, and we may need additional funds to meet operational

needs and capital requirements for product development, regulatory compliance and clinical trial activities sooner than planned.

our capital resources may be consumed more rapidly if we pursue additional clinical studies for LPCN 1154, LPCN 2101, LPCN 2401, LPCN

2203, LPCN 1148, and/or LPCN 1107.

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need to ultimately raise additional capital and our requirements will depend on many factors, including the following:

scope, rate of progress, results and cost of our clinical studies, pre-clinical testing and

other related activities for all of our product candidates, including LPCN 1154, LPCN 2401,

LPCN 2101, LPCN 2203, LPCN 1148, LPCN 1144, and LPCN 1107;

cost of manufacturing clinical supplies and establishing commercial supplies, of our product

candidates and any products that we may develop;

scope, rate of progress, results and cost of our clinical studies, pre-clinical testing and other related activities for all of our

product candidates, including LPCN 1154, LPCN 2101, LPCN 2401, LPCN 2203, LPCN 1148, and LPCN 1107;

cost of manufacturing clinical supplies and establishing commercial supplies, of our product candidates and any products that we

cost and timing of establishing sales, marketing and distribution capabilities, if any;

terms and timing of any collaborative, licensing, settlement and other arrangements that

we may establish;

terms and timing of any collaborative, licensing, settlement and other arrangements that we may establish;

number and characteristics of product candidates that we pursue;

cost, timing and outcomes of regulatory approvals;

timing, receipt and amount of sales, profit sharing, milestones or royalties, if any, from

our potential products;

cost of preparing, filing, prosecuting, defending and enforcing any patent claims and other

intellectual property rights;

extent to which we acquire or invest in businesses, products or technologies, although we

currently have no commitments or agreements relating to any of these types of transactions;

timing, receipt and amount of sales, profit sharing, milestones or royalties, if any, from our potential products;

cost of preparing, filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;

extent to which we acquire or invest in businesses, products or technologies, although we currently have no commitments or agreements

relating to any of these types of transactions;

extent to which we grow significantly in the number of employees or the scope of our operations.

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and Uses of Cash

following table provides a summary of our cash flows for the six months ended June 30, 2025 and 2024:

Months Ended June 30,

used in operating activities

following table provides a summary of our cash flows for the nine months ended September 30, 2025 and 2024:

Months Ended September 30,

Cash used in operating activities

$ (6,841,214 )

used in investing activities

used in financing activities

$ (2,923,160 )

Cash provided by investing activities

Cash provided by financing activities

Cash from Operating Activities

the six months ended June 30, 2025 and 2024, net cash used in operating activities was $3.9 million and $90,000, respectively.

cash used in operating activities during the six months ended June 30, 2025, was primarily attributable to cash required to support ongoing

operations, including research and development activities related to the commencement of our LPCN 1154 Phase III clinical trial, offset

by the licensing fee received.

Net cash used in operating activities during the six months ended June 30, 2024, was primarily attributable

to cash outlays to support ongoing operations, including research and development expenses and general and administrative expenses, offset

by the cash provided by the Verity License Agreement of $7.5 million.

the nine months ended September 30, 2025 and 2024, net cash used in operating activities was $6.8 million and $2.9 million, respectively.

cash used in operating activities during the nine months ended September 30, 2025, was primarily attributable to cash required to support

ongoing operations, including research and development activities related to the commencement of our LPCN 1154 Phase 3 clinical trial,

offset by the licensing fee received.

Net cash used in operating activities during the nine months ended September 30, 2024, was primarily

attributable to cash required to support ongoing operations, including research and development expenses primarily related to our LPCN

1154 clinical studies and manufacturing scale up in addition to general and administrative expenses, offset by the cash provided by the

Verity License Agreement of $7.5 million.

Cash from Investing Activities

the six months ended June 30, 2025 and 2024, net cash provided by investing activities was $3.6 million and $663,000, respectively.

cash provided by investing activities during the six months ended June 30, 2025 and 2024, was primarily the result of the maturities

the nine months ended September 30, 2025 and 2024, net cash provided by investing activities was $4.3 million and $1.7 million, respectively.

cash provided by investing activities during the nine months ended September 30, 2025 and 2024, was primarily the result of the maturities

of marketable investments securities, net.

There were no capital expenditures during either the six months ended June 30, 2025 or 2024.

Capital expenditures during the nine months ended September 30, 2025 and 2024, were $0 and

80,000 respectively.

Cash from Financing Activities

the six months ended June 30, 2025 and 2024, net cash provided by financing activities was approximately $76,000 and $209,000, respectively.

cash provided by financing activities during the six months ended June 30, 2025 primarily resulted from the sale of 23,739 shares of

common stock at a weighted average price of $3.29 per share pursuant to the A.G.P.

the nine months ended September 30, 2025 and 2024, net cash provided by financing activities was approximately $217,000 and $209,000,

respectively.

cash provided by financing activities during the nine months ended September 30, 2025 primarily resulted from the sale of 68,691 shares

of common stock at a weighted average price of $3.26 per share pursuant to the A.G.P.

Sales Agreement.

Net cash provided by financing activities

during the six months ended June 30, 2024, primarily resulted from the sale of 32,110 shares of common stock at a weighted average price

of $6.77 per share pursuant to the Cantor Sales Agreement.

Net cash provided by financing

activities during the nine months ended September 30, 2024, primarily resulted from the sale of 32,110 shares of common stock at a weighted

average price of $6.77 per share pursuant to the Cantor Sales Agreement.

Commitments and Contingencies

25 unchanged sentences

Agreements for disclosure regarding the SPC License Agreement and the Pharmalink Distribution Agreement).

have been no significant and material changes in our critical accounting policies during the six months ended June 30, 2025, as compared

to those disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations-Critical Accounting

Policies and Significant Judgments and Estimates” in our 2024 Form 10-K.

have been no significant and material changes in our critical accounting policies during the nine months ended September 30, 2025, as

compared to those disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations-Critical

Accounting Policies and Significant Judgments and Estimates” in our 2024 Form 10-K.

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