What changed in this filing

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Item 1. Financial Statements

2026-05-07 compared with 2025-11-06 · 863 added, 991 removed, 921 unchanged (67% of the section changed)

2 unchanged sentences

Consolidated Balance Sheets

September 30,

and cash equivalents

investment securities

interest income

fee and royalties receivable

and other current assets

current assets

Cash and cash equivalents

Marketable investment securities

Accrued interest income

Prepaid and other current assets

Total current assets

Property and equipment, net of accumulated

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

Liabilities and Stockholders’ Equity

and equipment, net of accumulated depreciation of $ 1,298,893 and $ 1,284,079 respectively

and Stockholders' Equity

current liabilities

Accounts payable

Accrued expenses

Deferred revenue

Total current liabilities

Total liabilities

Commitments and contingencies (notes 8 and 11)

Stockholders’ equity:

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

Treasury stock at cost, 336 shares

Accumulated other comprehensive income

Accumulated deficit

and contingencies (notes 8 and 10)

Stockholders’

stock, par value $ 0.0001 per share, 75,000,000 shares

7,475,451 and 6,158,779 issued and 7,475,115 and 6,158,443 outstanding, respectively

paid-in capital

stock at cost, 336 shares

other comprehensive income

( 213,068,261 )

( 209,396,367 )

Total stockholders’ equity

Total liabilities and stockholders’ equity

stockholders’ equity

liabilities and stockholders’ equity

accompanying notes to consolidated financial statements

AND SUBSIDIARIES

Consolidated Statements of Operations and Comprehensive Income (Loss)

Three Months Ended September 30,

Nine Months Ended September 30,

License revenue

Consolidated Statements of Operations and Comprehensive Loss

Months Ended March 31,

Royalty revenue

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( 2,090,184 )

( 7,855,578 )

( 2,700,514 )

Other income:

Interest and investment income

Unrealized gain on warrant liability

Interest and investment

Total other income

Loss before income tax expense

( 3,186,832 )

( 2,218,818 )

Loss before income tax

( 3,671,894 )

1 unchanged sentence

Income tax expense

Net loss attributable to common shareholders

$ ( 3,186,832 )

$ ( 2,218,818 )

Net loss attributable to

common shareholders

$ ( 3,671,894 )

$ ( 1,864,873 )

Basic loss per share attributable to common stock

Basic loss per share attributable to common

Weighted average common shares outstanding, basic

Diluted loss per share attributable to common stock

Diluted loss per share attributable to common

Weighted average common shares outstanding, diluted

Comprehensive income (loss):

$ ( 3,186,832 )

$ ( 2,218,818 )

$ ( 7,257,421 )

$ ( 1,773,831 )

Net unrealized income (loss) on marketable investment securities

Comprehensive loss:

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$ ( 1,864,873 )

Net unrealized loss on

marketable investment securities

Comprehensive loss

$ ( 3,683,533 )

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Consolidated Statements of Changes in Stockholders’ Equity

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

Number of Shares

Paid-In Capital

Comprehensive Income (Loss)

Accumulated Deficit

Stockholders’ Equity

Stockholder’s Equity

Treasury Stock

Number of Shares

the Three Months Ended March 31, 2026 and 2025

Comprehensive

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Stockholders’

Balances at June 30, 2024

$ 220,582,158

$ ( 199,332,227 )

( 2,218,818 )

Unrealized net income on marketable investment securities

Stock-based compensation

Balances at September 30, 2024

$ 220,690,052

$ ( 201,551,045 )

Treasury Stock

Number of Shares

Comprehensive

Stockholders’

Balances at December 31, 2023

$ 220,171,250

$ ( 199,777,214 )

( 1,773,831 )

Unrealized net income on marketable investment securities

Stock-based compensation

Common stock sold through ATM offering, net of costs

Balances at September 30, 2024

$ 220,690,052

$ ( 201,551,045 )

Stockholder’s Equity

Treasury Stock

Number of Shares

Comprehensive

1 unchanged sentence

Stockholders’

Balances at June 30, 2025

Balances at December 31, 2024

$ 220,789,138

1 unchanged sentence

( 1,864,873 )

Unrealized net income on marketable investment securities

( 1,864,873 )

Unrealized net loss on marketable

investment securities

Unrealized net loss on marketable investment

Stock-based compensation

Vesting of restricted stock units

Common stock sold through ATM offering, net of costs

Balances at September 30, 2025

Balances at March 31, 2025

$ 220,860,140

$ ( 201,633,735 )

Stockholder’s Equity

Treasury Stock

Number of Shares

Stockholders’

Comprehensive

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( 3,671,894 )

Unrealized net loss on marketable investment securities

Unrealized net loss on marketable investment

Stock-based compensation

Option exercises

Vesting of restricted stock units

Common stock sold through ATM offering, net of costs

Balances at September 30, 2025

Common stock sold through ATM offering, net

Balances at March 31,

$ 235,937,414

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$ ( 213,068,261 )

accompanying notes to condensed consolidated financial statements

accompanying notes to consolidated financial statements

AND SUBSIDIARIES

Consolidated Statements of Cash Flows

Nine Months Ended September 30,

Months Ended March 31,

Cash flows from operating activities:

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$ ( 1,864,873 )

Adjustments to reconcile net loss to cash used in

Adjustments to reconcile

net loss to cash used in

operating activities:

Depreciation expense

Stock-based compensation expense

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

Amortization of discounts on marketable investment securities

Changes in operating assets and liabilities:

Stock-based compensation

Amortization of discounts

on marketable investment securities

Changes in operating assets

and liabilities:

Accrued interest income

Prepaid and other current assets

License and royalties receivable

Prepaid and other current

Accounts payable

( 1,110,630 )

Accrued expenses

Cash used in operating activities

Cash used in operating

( 2,257,137 )

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Cash flows from investing activities:

Purchase of property and equipment

Purchases of marketable investment securities

Purchases of marketable

investment securities

( 15,204,139 )

( 5,082,073 )

Maturities of marketable investment securities

Net cash provided by investing activities

Cash flows from financing activities:

Net proceeds from sale of common stock through ATM

Cash provided by financing activities

Net decrease in cash and cash equivalents

Maturities of marketable

investment securities

Net cash used in investing

( 9,904,139 )

Cash flows from financing activities:

Net proceeds from sale

of common stock through ATM

Proceeds from stock option

Cash provided by financing

Net decrease in cash and

cash equivalents

( 2,851,330 )

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Cash and cash equivalents at end of period

Supplemental disclosure of cash flow information:

Income taxes paid

Supplemental disclosure of non-cash investing and financing activity:

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

Supplemental disclosure

of non-cash investing and financing activity:

Net unrealized loss on

available-for-sale securities

accompanying notes to consolidated financial statements

LIPOCINE INC.

to Condensed Consolidated Financial Statements

Basis of Presentation

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 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.

Operating results for the three months ended March 31, 2026 are not necessarily

indicative of the results that may be expected for any future period or for the year ending December 31, 2026.

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 November 6, 2026.

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

Company could utilize its available capital resources sooner than it currently expects.

While the Company believes it has sufficient

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

is unsuccessful in raising additional capital, its long-term ability to continue as a going concern will become a risk.

Company’s operating plan may change, and the Company 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, the Company’s capital

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

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.

requirements through at least May 7, 2027.

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

could utilize its available capital resources sooner than it currently expects.

While the Company believes it has sufficient liquidity

and capital resources to fund our projected operating requirements through at least May 7, 2027, 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 is unsuccessful

in raising additional capital, its long-term ability to continue as a going concern will become a risk.

Further, the Company’s

operating plan may change, and the Company 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, the Company’s capital resources may be consumed

more rapidly if it pursues additional clinical studies for LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203, LPCN 2401, LPCN 1148, and/or LPCN

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.

January 12, 2024, the Company entered into a License Agreement (the “Verity License Agreement”) with Gordon Silver Limited

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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.

million which was received on December 30, 2024, and $ 1.0 million which was received on January 5, 2026.

The Company is also eligible

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in the Licensed Verity Territory.

addition to the Verity License Agreement, the Company entered into a license agreement in the territories of South Korea, the Gulf Corporation

addition to the Verity License Agreement, the Company entered into a license agreement in the territories of South Korea, the Gulf Cooperation

Council, or GCC, and Brazil.

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such changes become known.

Note 7 for a description of the Verity License Agreement, the SPC License Agreement (as defined below), the Pharmalink Distribution Agreement

(as defined below), and the Aché License Agreement (as defined below).

See Note 11 for a description of the agreement with Spriaso,

a related party.

Note 7 for a description of the Verity License Agreement, the SPC License Agreement, the Pharmalink Distribution Agreement, and the Aché

License Agreement.

See Note 11 for a description of the agreement with Spriaso, a related party.

distinct license performance obligations, upfront license fees are recognized when the Company satisfies the underlying performance obligation.

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Sales-based and minimum royalties are generally due within 45 days after the end of each quarter in which they are earned.

Revenue – Customer Prepayment for Inventory

of March 31, 2026 and March 31, 2025, the Company has recorded deferred revenue of $ 320,000 related to a one-time non-refundable, non-creditable

upfront prepayment received from SPC Korea (“SPC”) in consideration for TLANDO product inventory that has not yet been delivered

or transferred.

This prepayment is recognized as a contract liability in accordance with ASC 606, Revenue from Contracts with Customers ,

because the Company has an obligation to transfer inventory in the future.

Revenue associated with this advance payment will be recognized

when the inventory is transferred to the customer, which will occur upon shipment of the inventory.

The deferred revenue is expected

to be recognized as revenue within 60 days of SPC’s receipt of marketing authorization for TLANDO in South Korea (the “SPC

Territory”), which is expected to occur in 2027.

The Company periodically evaluates deferred revenue balances to ensure they appropriately

reflect remaining performance obligations and expected fulfillment timelines.

Concentration

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For the three months ended

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

March 31, 2026, the Company recognized royalty revenue of approximately $ 119,000 relating to the Verity License Agreement.

For the three

months ended March 31, 2025, the Company recognized royalty revenue of approximately $ 94,000 relating to the Verity License Agreement.

The revenue recognized for the three months ended March 31, 2026 and 2025 was from one major customer, Verity Pharma.

(3) Loss per Share

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:

Basic 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 months ended

March 31, 2026 and 2025:

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

Three Months Ended September 30,

Months Ended September 30,

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

Net income (loss)

$ ( 3,186,832 )

$ ( 2,218,818 )

Months Ended March 31,

Basic loss per share attributable

to common stock:

$ ( 3,671,894 )

1 unchanged sentence

Weighted avg.

common shares outstanding

Basic earnings (loss) per share attributable to common stock

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

Net income (loss)

$ ( 3,186,832 )

$ ( 2,218,818 )

$ ( 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

shares outstanding

Basic loss per share attributable to common

Diluted loss per share attributable

to common stock:

$ ( 3,671,894 )

$ ( 1,864,873 )

Total net loss for purpose of calculating

diluted net loss per common share

$ ( 3,671,894 )

1 unchanged sentence

Weighted avg.

common shares outstanding

Weighted average effect of dilutive securities:

Stock options

Restricted stock units

Dilutive securities

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

Diluted earnings (loss) per share attributable to common stock

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

shares outstanding

Total shares for purpose of calculating

diluted net loss per common share

Diluted loss per share attributable to common

computation of diluted loss per share for the three months ended March 31, 2026 and 2025 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 and Nine Months Ended

September 30,

Three Months Ended

Stock options

Unvested restricted stock units

Antidilutive securities excluded from computation of earnings per share, amount

Marketable Investment Securities

Marketable Investment

Company has classified its marketable investment securities as available-for-sale securities, all of which are debt securities.

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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 September 30, 2025, and December 31, 2024, were as follows:

securities by major security type and class of security as of March 31, 2026, and December 31, 2025, were as follows:

Schedule of Available for Sale Securities

September 30, 2025

Amortized Cost

Gross Unrealized Holding Gains

Gross Unrealized Holding Losses

Aggregate Fair Value

Holding Losses

Government treasury bills

December 31, 2024

Amortized Cost

Gross Unrealized Holding Gains

Unrealized Holding

Aggregate Fair Value

Government treasury bills

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

of debt securities classified as available-for-sale securities as of March 31, 2026 are as follows:

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

September 30, 2025

Amortized Cost

Aggregate Fair Value

Due within one year

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.

were no sales of marketable investment securities during either the three months ended March 31, 2026 or 2025 and therefore no realized

gains or losses.

Additionally, during the three months ended March 31, 2026 and 2025, $ 5.3 million and $ 4.2 million of marketable investment

securities matured, respectively.

Company evaluates its available-for-sale debt securities for credit losses at each reporting date.

As of March 31, 2026, the Company’s

available-for-sale portfolio consisted of U.S.

Treasury bills with maturities due within one year.

The Company concluded that any unrealized

losses were not attributable to credit and, accordingly, no allowance for credit losses was recorded and no impairment was recognized

in earnings during the three months ended March 31, 2026 or 2025.

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 September 30, 2025 and December 31, 2024:

and liabilities that are measured at fair value on a recurring basis as of March 31, 2026 and December 31, 2025:

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

Fair value measurements at reporting date using

September 30, 2025

Level 1 inputs

Level 2 inputs

Level 3 inputs

Cash equivalents - money market funds

Government treasury bills

Fair value measurements at reporting date using

December 31, 2024

Level 1 inputs

Level 2 inputs

Level 3 inputs

Cash equivalents - money market funds

value measurements at reporting date using

Cash equivalents

- money market funds

treasury bills

value measurements at reporting date using

Cash equivalents

- money market funds

Government treasury bills

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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 nine

months ended September 30, 2025.

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

March 31, 2026.

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.

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

March 31, 2026 and December 31, 2025, 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

Pharmaceuticals, Inc.

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to GSL (an affiliate of Verity Pharma) an exclusive, royalty-bearing, sublicensable right and license to commercialize the Company’s

TLANDO ® product with respect to testosterone replacement therapy in males for conditions associated with a deficiency

or absence of endogenous testosterone, as indicated in NDA No.

208088, treatment of Klinefelter syndrome, and pediatric indications relating

to testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone, in each

case within 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

TLANDO® product with respect to testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous

testosterone, as indicated in NDA No.

208088, treatment of Klinefelter syndrome, and pediatric indications relating to testosterone replacement

therapy in males for conditions associated with a deficiency or absence of endogenous testosterone (the “Field”), in each

case within the United States and Canada (the “Licensed Verity Territory”).

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.

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.

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 was received on January 5, 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.

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 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

Limited (“SPC”), pursuant to which the Company granted to SPC a non-transferable, exclusive, royalty-bearing license to commercialize

the Company’s TLANDO product with respect to the Field, specific to the country of South Korea (the “SPC Territory”).

SPC paid the Company a one-time non-refundable, non-creditable upfront fee in October 2024.

The Company also received an additional payment

for a non-refundable prepayment in consideration for TLANDO product inventory, and is eligible to receive additional payments for various

marketing authorization and sales milestones, and the Company will supply TLANDO to SPC and receive a supply price.

In addition, the

Company will receive royalties on net sales in the SPC Territory.

the Verity License Agreement with Verity Pharma, during the three months ended March 31, 2026 and 2025, the Company recognized royalty

revenue of approximately $ 119,000 and $ 94,000 , respectively.

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

to which the Company granted to SPC a non-transferable, exclusive, royalty-bearing license to commercialize the Company’s TLANDO

product with respect to the Field, specific to the SPC Territory.

SPC paid the Company a one-time non-refundable, non-creditable upfront

fee in October 2024.

The Company also received an additional payment for a non-refundable prepayment in consideration for TLANDO product

inventory, and is eligible to receive additional payments for various marketing authorization and sales milestones, and the Company will

supply TLANDO to SPC and receive a supply price.

In addition, the Company will receive royalties on net sales in the SPC Territory.

October 2024, the Company entered into a distribution and supply agreement (the “Pharmalink Distribution Agreement”) with

Pharmalink, pursuant to which the Company granted to Pharmalink a non-transferable, exclusive, license to commercialize the Company’s

TLANDO product with respect to the Field, specific to the GCC, including Saudi Arabia, Kuwait, the United Arab Emirates (“UAE”),

Qatar, Bahrain, and Oman (the “GCC Territory”).

Pharmalink paid the Company a one-time non-refundable, non-creditable upfront

The Company is eligible to receive additional payments in regulatory authorization milestones related to the marketing approval

in countries in the GCC Territory under the Pharmalink Distribution Agreement and the Company will supply TLANDO to Pharmalink at an

agreed transfer price.

Laboratórios Farmacêuticos S.A .

TLANDO product with respect to the Field, specific to the Gulf Cooperation Council Countries (“GCC”), including Saudi Arabia,

Kuwait, the United Arab Emirates (“UAE”), Qatar, Bahrain, and Oman (the “GCC Territory”).

Pharmalink paid the

Company a one-time non-refundable, non-creditable upfront fee.

The Company is eligible to receive additional payments in regulatory authorization

milestones related to the marketing approval in countries in the GCC Territory under the Pharmalink Distribution Agreement and the Company

will supply TLANDO to Pharmalink at an agreed transfer price.

Aché Laboratórios

Farmacêuticos S.A .

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

pursuant to which the Company granted to Aché an exclusive license to commercialize the Company’s TLANDO ® product

with respect to the Field, specific to Brazil (the “Aché Territory”).

Under the agreement, the Company is entitled

to receive fees upon the achievement of certain regulatory milestones, royalties on net sales and will supply TLANDO to Aché at

an agreed transfer price.

Products, Inc.

pursuant to which the Company granted to Aché an exclusive license to commercialize the Company’s TLANDO product with respect

to the Field, specific to Brazil (the “Aché Territory”).

Under the agreement, the Company is entitled to receive fees

upon the achievement of certain regulatory milestones, royalties on net sales and will supply TLANDO to Aché at an agreed transfer

Abbott Products, Inc.

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

(later acquired by Abbott

Products, Inc.

(later acquired by Abbott Products,

(“Abbott”) for TLANDO.

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 %.

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 Lipocine 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 %.

TLANDO was commercially launched on June 7, 2022.

The Company incurred royalty expense of approximately $ 10,000

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

The Company incurred royalty expense of approximately

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

Contract Research and Development

The Company incurred royalty expense of approximately $ 10,000 and

$ 8,000 during the three months ended March 31, 2026 and 2025, respectively.

Contract Research and

Company has entered into agreements with various contract organizations that conduct pre-clinical, clinical, analytical and manufacturing

development work on behalf of the Company as well as a number of independent contractors and primarily clinical researchers who serve

development work on behalf of the Company as well as a number of independent contractors and clinical researchers who serve

as advisors to the Company.

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,

The Company incurred expenses of $ 1.8 million and $ 109,000 for the three months ended March 31, 2026 and

2025, respectively, under these agreements and has recorded these expenses in research and development expenses.

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has been extended through February 28, 2027.

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

minimum lease payments under the non-cancelable operating lease as of March 31, 2026 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 September 30, 2025 and 2024, respectively.

The Company’s

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

(9) Stockholders’ Equity

Total minimum lease

Company’s rent expense was $ 94,000 and $ 93,000 for the three months ended March 31, 2026 and 2025, respectively.

(9) Stockholders’

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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the Secretary of State of the State of Delaware.

Company is authorized to issue up to 75,000,000 shares of its common stock, par value $ 0.0001 .

of Common Stock

April 26, 2024, the Company entered into a sales agreement with A.G.P./Alliance Global Partners (“A.G.P.”) (the “A.G.P.

April 26, 2024, the Company entered into a sales agreement with A.G.P.

/Alliance Global Partners (“A.G.P.”) (the “A.G.P.

Sales Agreement”) pursuant to which the Company may issue and sell, from time to time, shares of its common stock having an aggregate

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

The Company currently has registered $ 10,616,169 shares of common shares for sale under the A.G.P.

Sales Agreement, pursuant to

the Registration Statement on Form S-3, as amended (File No.

As of February 26, 2026, the Company has registered $ 50,000,000 of common shares for sale under the A.G.P.

Sales Agreement, pursuant

to the Registration Statement on Form S-3, as amended (File No.

333-275716) (the “Form S-3”), through A.G.P.

as the Company’s

may sell the Company’s common stock by any method permitted by law deemed to be an “at the market (“ATM”)

offering” as defined in Rule 415(a)(4) of the Securities Act, including sales made directly on or through the Nasdaq Capital Market

or any other existing trade market for our common stock, in negotiated transactions at market prices prevailing at the time of sale or

at prices related to prevailing market prices, or any other method permitted by law.

will use its commercially reasonable efforts

consistent with its normal trading and sales practices and applicable law and regulations to sell shares under the A.G.P.

may sell the Company’s common stock by any method permitted by law deemed to be an “at the market offering”

as defined in Rule 415(a)(4) of the Securities Act, including sales made directly on or through the Nasdaq Capital Market or any other

existing trade market for our common stock, in negotiated transactions at market prices prevailing at the time of sale or at prices related

to prevailing market prices, or any other method permitted by law.

will use its commercially reasonable efforts consistent with

its normal trading and sales practices and applicable law and regulations to sell shares under the A.G.P.

Sales Agreement.

The Company will pay A.G.P.

will pay A.G.P.

3.0 % of the aggregate gross proceeds from each sale of shares under the A.G.P.

Sales Agreement.

the Company has also provided A.G.P.

In addition, the Company

has also provided A.G.P.

with customary indemnification rights.

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

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.

on March 6, 2017, the Company entered into a sales agreement (the “Cantor Sales Agreement”) with Cantor Fitzgerald &

(“Cantor”) pursuant to which the Company could issue and sell, from time to time, shares of its common stock having an

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

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.

the three months ended March 31, 2026, the Company sold 1,314,138 shares of common stock at a weighted average price of $ 9.39 per share

under the A.G.P.

Sales Agreement, for aggregate gross proceeds of $ 12.3 million and net proceeds of $ 12.0 million, after deducting sales

agent commissions, discounts and other offering costs.

Rights Agreement

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of twice the Purchase Price.

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.

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.

Share-Based Payments

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periods if actual forfeitures differ from those estimates.

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

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

Stock-based compensation cost for stock option and restricted stock awards

that has been expensed in the statements of operations amounted to approximately $ 65,000 and $ 71,000 , respectively, for the three months

ended March 31, 2026 and 2025, and is allocated as follows:

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

Months Ended September 30,

Months Ended March 31,

Research and development

General and administrative

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.

Company issued 39,000 and 16,371 stock options during each of the three months ended March 31, 2026 and 2025.

The Company did not issue

any restricted stock options during either the three months ended March 31, 2026 or 2025.

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

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The expected term was estimated

using the average of the contractual term and the vesting period of the stock option.

For awards with performance conditions, and that

have the contractual term to satisfy the performance condition, the contractual term was used.

using the simplified method in accordance with the provisions of Staff Accounting Bulletin (“SAB”) No.

107, Share-Based

Payment , for awards with stated or implied service periods.

The simplified method defines the expected term as the average of the

contractual term and the vesting period of the stock option.

For awards with performance conditions, and that have the contractual term

to satisfy the performance condition, the contractual term was used.

Interest Rate:

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

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:

options granted during the three months ended March 31, 2026 and 2025, 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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Expected volatility

Company recognizes compensation expense for the portion of options that are expected to vest.

Therefore, the Company applied estimated

forfeiture rates that were derived from historical employee termination behavior.

If the actual number of forfeitures differs from those

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

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.

That cost is expected to be recognized over a weighted average period of 1.0 years

and will be adjusted for subsequent changes in estimated forfeitures.

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

in June 2014.

The 2014 Plan provides for the granting of nonqualified and incentive stock options, stock appreciation rights, restricted

stock units, restricted stock and dividend equivalents.

An aggregate of 58,823 shares were authorized for issuance under the 2014 Plan.

Additionally, 15,994 remaining authorized shares under the 2011 Equity Incentive Plan were issuable under the 2014 Plan at the time of

the 2014 Plan adoption.

Upon receiving shareholder approval in June 2016, the 2014 Plan was amended and restated to increase the authorized

Accounting Standards Codification (“ASC”) 718, Stock Compensation, requires the Company to recognize compensation

expense for the portion of options that are expected to vest.

Therefore, the Company applied estimated forfeiture rates that were derived

from historical employee termination behavior.

If the actual number of forfeitures differs from those estimated by management, additional

adjustments to compensation expense may be required in future periods.

of March 31, 2026, there was approximately $ 651,000 of total unrecognized compensation cost related to unvested share-based compensation

arrangements granted under the Company’s stock plan, of which $ 590,000 relates to unvested stock options and $ 61,000 relates to

unvested restricted stock units.

Share-based compensation related to options is expected to be recognized over a weighted average period

of 1.4 years.

The cost will be adjusted for subsequent changes in estimated forfeitures.

The weighted average fair value of stock options

granted during the quarters ended March 31, 2026 and 2025 was approximately $ 5.53 and $ 3.89 per share, respectively.

April 2014, the Board of Directors adopted the 2014 Stock and Incentive Plan (“2014 Plan”) subject to shareholder approval

which was received in June 2014.

The 2014 Plan provides for the granting of nonqualified and incentive stock options, stock appreciation

rights, restricted stock units, restricted stock and dividend equivalents.

An aggregate of 58,823 shares were authorized for issuance

under the 2014 Plan.

Additionally, 15,994 remaining authorized shares under the 2011 Equity Incentive Plan were issuable under the 2014

Plan at the time of the 2014 Plan adoption.

Upon receiving shareholder approval in June 2016, the 2014 Plan was amended and restated

to increase the authorized number of shares of common stock of the Company issuable under all awards granted under the 2014 Plan from

74,817 to 145,405 .

Additionally, upon receiving shareholder approval in June 2018, the 2014 Plan was further amended and restated to

increase the authorized number of shares of common stock of the Company issuable under all awards granted under the 2014 Plan from 145,405

Upon receiving shareholder approval in June 2020, the 2014 Plan was further amended and restated to increase the authorized

number of shares of common stock of the Company issuable under all awards granted under the 2014 Plan from 189,522 to 336,582 .

Additionally,

upon receiving shareholder approval in June 2018, the 2014 Plan was further amended and restated to increase the authorized number of

shares of common stock of the Company issuable under all awards granted under the 2014 Plan from 145,405 to 189,522 .

Upon receiving shareholder

approval in June 2020, the 2014 Plan was further amended and restated to increase the authorized number of shares of common stock of

the Company issuable under all awards granted under the 2014 Plan from 189,522 to 336,582 .

In June 2024, the 2014 Plan was further amended

and restated to increase the authorized number of shares of common stock of the Company issuable under all awards granted from 336,582

The Board, on an option-by-option basis, determines the number of shares, exercise price, term, and vesting period for options

2024, the 2014 Plan was further amended and restated to increase the authorized number of shares of common stock of the Company issuable

under all awards granted from 336,582 to 600,000 .

The Board, on an option-by-option basis, determines the number of shares, exercise

price, term, and vesting period for options granted.

Options granted generally have a ten-year contractual life.

The Company issues shares of common stock upon the exercise of options

with the source of those shares of common stock being either newly issued shares or shares held in treasury.

An aggregate of 600,000

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

The Company issues shares

of common stock upon the exercise of options with the source of those shares of common stock being either newly issued shares or shares

held in treasury.

An aggregate of 600,000 shares of common stock are authorized for issuance under the 2014 Plan, with 109,133 shares

remaining available for grant as of March 31, 2026.

summary of stock option activity is as follows:

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Options forfeited

Options cancelled

Balance at December 31, 2025

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Options forfeited

Balance at September 30, 2025

Options exercisable at September 30, 2025

Options cancelled

Balance at March 31, 2026

Options exercisable at March 31, 2026

following table summarizes information about stock options outstanding and exercisable:

of Share-based Compensation of Stock Options Outstanding and Exercisable

of September 30, 2025

average remaining contractual life (Years)

average exercise price

intrinsic value

of March 31, 2026

average remaining contractual life (Years)

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intrinsic value

of September 30, 2024

average remaining contractual life (Years)

average exercise price

intrinsic value

of March 31, 2025

average remaining contractual life (Years)

average exercise price

intrinsic value

average exercise

average remaining contractual

average exercise

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

(e) Restricted

summary of restricted stock unit activity is as follows:

Summary of Restricted Stock Unit Activity

of Unvested Restricted Stock Units

Balance at December 31, 2024

Balance at September 30, 2025

of Unvested Restricted Stock Units

of Unvested Restricted

Balance at December 31, 2025

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

Balance at March 31, 2026

Stock Warrants

Company accounts for its common stock warrants under ASC 480, Distinguishing Liabilities from Equity , which requires any financial

instrument, other than an outstanding share, that, at inception, embodies an obligation to repurchase the issuer’s equity shares,

or is indexed to such an obligation, and requires or may require the issuer to settle the obligation by transferring assets, to be classified

as a liability.

In accordance with ASC 480, the Company’s outstanding warrants from an offering conducted in 2019 (the “November

2019 Offering”) were classified as a liability.

The liability was adjusted to fair value at each reporting period, with the changes

in fair value recognized as gain (loss) on change in fair value of warrant liability in the Company’s consolidated statements of

The warrants issued in the November 2019 Offering allowed the warrant holder, if certain change in control events had occurred,

the option 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 fundamental transaction.

The warrants expired in November of 2024 and the related

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,

in an offering in February 2020, the Company issued 296,593 common stock warrants.

However, because these warrants did not provide the

warrant holder the option to put the warrant back to the Company, the warrants were classified as equity.

The common stock warrants from

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 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.

an offering in February 2020, the Company issued 296,593 common stock warrants to shareholders which allowed the shareholder the option

to purchase shares of common stock.

However, because these warrants did not provide the warrant holder the option to put the warrant

back to the Company, the warrants were classified as equity.

As of March 31, 2025, the warrants that had been outstanding from the offering

done in February 2020 to purchase an equal number of shares of common stock had expired.

No common stock warrants were exercised during

the three months ended March 31, 2025.

(10) Commitments

and Contingencies

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its directors and officers to the maximum extent permitted under the laws of the State of Delaware.

(11) Agreement

with Spriaso, LLC

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During the three

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.

months ended March 31, 2026 and 2025, 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

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

by the Chief Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance.

The Company operates as a single 1 reporting segment, focused on leveraging its proprietary technology platform to augment therapeutics

through effective oral delivery of products and product candidates.

The Company’s measure of segment profit or loss is net income

by the Chief Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing

The Company operates as a 1 single reporting segment, focused on leveraging its proprietary technology platform to

augment therapeutics through effective oral delivery of products and product candidates.

The Company’s measure of segment

profit or loss is net income (loss).

The CODM is the chief executive officer (“CEO”).

The CODM manages and allocates resources to the operations of the

Company on a total company basis.

Managing and allocating resources on a consolidated basis enables the CEO to assess the overall level

of resources available and how to best deploy these resources across functions, therapeutic target areas and research and development

projects that are in line with the Company’s long-term company-wide strategic goals.

Consistent with this decision-making process,

the CEO uses consolidated financial information for purposes of evaluating performance, forecasting future period financial results,

allocating resources and setting incentive targets.

Operating expenses are used to monitor budget versus actual results.

The review of

budgeted versus actual results is used in assessing performance of the segment.

All the Company’s long-lived assets are held in

the United States and all the Company’s revenues are primarily related to TLANDO.

The CODM manages and allocates

resources to the operations of the Company on a total company basis.

Managing and allocating resources on a consolidated basis

enables the CEO to assess the overall level of resources available and how to best deploy these resources across functions,

therapeutic target areas and research and development projects that are in line with the Company’s long-term company-wide

strategic goals.

Consistent with this decision-making process, the CEO uses consolidated financial information for purposes of

evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets.

expenses are used to monitor budget versus actual results.

The review of budgeted versus actual results is used in assessing

performance of the segment.

All the Company’s long-lived assets are held in the United States and all the Company’s

revenues are primarily related to TLANDO.

following table is representative of the significant expense categories regularly provided to the CODM when managing the Company’s

single reporting segment.

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.

A reconciliation to the consolidated net income (loss) for the three months ended March 31, 2026 and 2025 is

included at the bottom of the table below.

Schedule of Significant Expense Categories

Months Ended September 30,

Months Ended March 31,

Total revenues

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Lead clinical candidate (1)

Other research and development programs

Other research and development

Non-program expenses (2)

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( 2,090,184 )

( 7,855,578 )

( 2,700,514 )

income (loss) (3)

Other income (loss) (3)

Net income (loss)

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$ ( 1,864,873 )

$ ( 7,257,421 )

$ ( 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

Pronouncements Issued Not Yet Adopted

November 2024, the FASB issued Accounting Standards Update (“ASU”) 2024-03, Income Statement – Reporting Comprehensive

Income – Expense Disaggregation Disclosures (Subtopic 220-40):

Disaggregation of Income Statement Expenses (“ASU 2024-03”).

This guidance requires the disaggregation of certain expense captions into specified categories in disclosures within the notes of the

financial statements to provide enhanced transparency into the expense captions presented on the statement of earnings.

It is effective

for annual reporting periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption

Adoption may be applied either prospectively to financial statements issued for reporting periods after the effective date

of ASU 2024-03 or retrospectively to any or all prior periods presented in financial statements.

Company is evaluating the impact of this guidance on the Company’s related disclosures.

Includes external research

and development expenses.

Includes general and administrative

expenses, information technology, infrastructure, facilities, intellectual property, and legal and professional fees.

Includes interest income

and income tax expense.

2.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

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analysis of financial condition and results of operations included in our annual report on Form 10-K for the year ended December 31,

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, 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.

2025, filed with the SEC on March 10, 2026 (the “2025 Form 10-K”), 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, 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.

such differences include, but are not limited to, those discussed in Part I, Item 1A (Risk Factors) of our 2025 Form 10-K.

required by applicable law, we assume no obligation to revise or update any forward-looking statements for any reason.

of Our Business

are a biopharmaceutical company focused on leveraging our proprietary Lip’ral platform to develop differentiated products through

the oral delivery of previously difficult to deliver molecules.

Our proprietary delivery technologies are designed to improve patient

compliance and safety through orally available treatment options.

Our primary development programs are based on oral delivery solutions

for poorly bioavailable drugs.

are a biopharmaceutical company focused on leveraging our proprietary technology platform to develop innovative products with effective

oral delivery of previously difficult to deliver molecules.

Our proprietary delivery technologies are designed to improve patient compliance

and safety through orally available treatment options.

Our primary development programs are based on oral delivery solutions for poorly

bioavailable drugs.

We have a portfolio of differentiated innovative product candidates that target high unmet needs for neurological

and psychiatric CNS disorders, liver diseases, and hormone supplementation for men and women.

entered into our first license agreement for the development and commercialization of our product, TLANDO®, an oral testosterone

replacement therapy comprised of testosterone undecanoate in October 2021.

On March 28, 2022, the FDA approved TLANDO as a testosterone

replacement therapy (“TRT”) in adult males for conditions associated with a deficiency of endogenous testosterone, also known

as hypogonadism and on June 7, 2022, our former commercial partner Antares (a wholly owned subsidiary of Halozyme) announced the commercial

launch of TLANDO.

January 12, 2024, we entered into the Verity License Agreement with Verity Pharma, pursuant to which we granted to Verity Pharma an exclusive,

royalty-bearing, sublicensable right and license to develop and commercialize the TLANDO product for TRT in the Licensed Verity Territory.

Any FDA post-marketing studies required will also be the responsibility of our licensee, Verity Pharma.

September 2024, we entered into the SPC License Agreement for the development and commercialization of TLANDO with SPC, pursuant to which

the Company granted to SPC a non-transferable, exclusive, royalty-bearing license to commercialize our TLANDO product for TRT in the

SPC Territory.

In October 2024, we entered into the Pharmalink Distribution Agreement with Pharmalink, granting a non-transferable, exclusive,

license to commercialize our TLANDO product specific to the GCC, including Saudi Arabia, Kuwait, UAE, Qatar, Bahrain, and Oman (the “Pharmalink

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

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

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

and psychiatric CNS disorders, liver disease, and hormone supplementation for men and women.

January 12, 2024, we entered into the Verity License Agreement with Verity, pursuant to which we granted to Verity an exclusive, royalty-bearing,

sublicensable right and license to develop and commercialize the TLANDO product for TRT in the Licensed Verity Territory.

Any FDA post-marketing

studies required will also be the responsibility of our licensee, Verity.

September 2024, we entered into the SPC License Agreement (the “SPC License Agreement”) for the development and commercialization

of TLANDO with SPC Korea Limited (“SPC”), pursuant to which the Company granted to SPC a non-transferable, exclusive, royalty-bearing

license to commercialize our TLANDO product for TRT in the SPC Territory.

In October 2024, we entered into the Pharmalink Distribution

Agreement with Pharmalink, granting a non-transferable, exclusive, license to commercialize our TLANDO product specific to the Gulf Cooperation

Council (“GCC”), including Saudi Arabia, Kuwait, UAE, Qatar, Bahrain, and Oman (the “Pharmalink Territory”).

In April 2025, we entered into a License and Supply Agreement (the “Aché License agreement”) with Aché Laboratórios

Farmacêuticos S.A.

(“Aché”) pursuant to which we granted to Aché an exclusive license to commercialize

our TLANDO product with respect to the Field, specific to Brazil (the “Aché Territory”).

Under the agreement, we are

entitled to receive fees upon the achievement of certain regulatory milestones, royalties on net sales and will supply TLANDO to Aché

at an agreed transfer price.

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 2201 for major depressive

disorder (“MDD”);

LPCN 2203 for essential tremor;

LPCN 2101 for epilepsy;

and LPCN 2203 for essential tremor.

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:

key components of our corporate strategy are to:

to leverage our drug delivery technology platform.

Our goal is to become a leading biopharmaceutical company focused on leveraging

our Lip’ral drug delivery technology platform to develop and register differentiated products to treat conditions with large unmet

medical need through effective oral drug delivery.

Our pipeline candidates are based on our Lip’ral drug delivery technology platform,

validated through TLANDO, an approved commercial product.

Lip’ral technology entails lipidic compositions which form an optimal

dispersed phase in the gastrointestinal environment for improved absorption of highly water insoluble drugs.

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, LPCN 2101 and other CNS product candidates.

LPCN 2401 for improved body composition in obesity

In 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, South Korea, the GCC and Brazil, LPCN 1148 comprising

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

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 programs:

goal is to become a leading biopharmaceutical company focused on leveraging our proprietary drug delivery technology platform to develop

differentiated products through oral delivery of previously difficult to deliver molecules.

The key components of our corporate strategy

LPCN 1154 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 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.

We believe the TRT market needs a differentiated, convenient oral option.

We have exclusively licensed rights to TLANDO to Verity

Pharma for commercialization of TLANDO in the Licensed Verity Territory, to SPC for commercialization in the SPC Territory, to Pharmalink

the Pharmalink Territory and to Aché in the Aché Territory.

We plan to support Verity Pharma’s, SPC’s, Pharmalink’s,

and Aché’s efforts to effectively enable the availability of TLANDO to patients in a timely manner, in addition to receiving

milestone and royalty payments associated with TLANDO commercialization as agreed to in the Verity License Agreement, the SPC License

Agreement, the Pharmalink Distribution Agreement and the Aché License Agreement.

Our priority is on the development of LPCN 1154, a potential fast-acting oral antidepressant for PPD with potential

for outpatient use.

our Licensees, Verity, SPC, Pharmalink and Aché, in commercialization of our licensed oral TRT product.

We believe the TRT

market needs a differentiated, convenient oral option.

We have exclusively licensed rights to TLANDO to Verity for commercialization

of TLANDO in the U.S.

and Canada (the “Licensed Verity Territory”), to SPC for commercialization in South Korea (the “Licensed

SPC Territory”), to Pharmalink in the GCC (the “Licensed Pharmalink Territory”) and to Aché in Brazil (the “Licensed

Aché Territory”) (together, the “Currently Licensed TLANDO Territories”).

We plan to support Verity’s,

SPC’s, Pharmalink’s, and Aché’s efforts to effectively enable the availability of TLANDO to patients in a timely

manner, in addition to receiving milestone, royalty payments and/or payments for product sales associated with TLANDO commercialization

as agreed to in the Verity License Agreement, the SPC License Agreement, the Pharmalink Distribution Agreement and the Aché License

partnership(s) to continue the advancement of pipeline assets .

We continuously strive to prioritize our resources in seeking partnerships

for our pipeline assets.

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.

of our pipeline assets.

We are currently exploring partnerships for our liver program LPCN 1148 for the management of decompensated cirrhosis

including prevention of the recurrence of overt hepatic encephalopathy (“OHE”);

LPCN 2401 for improved body composition

as adjunct therapy to incretin mimetics use in obesity management;

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

are also exploring the possibility of licensing LPCN 1021 (known as TLANDO in the United States) to third parties outside of the Currently

Licensed TLANDO Territories although no additional licensing agreements have been entered into by the Company in any other territories.

Pipeline Product Candidates

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.

pipeline of clinical development candidates includes LPCN 1154 for PPD, LPCN 2201 for MDD, 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

We will also continue efforts to enter into partnership arrangements for the continued development and/or marketing of LPCN 1144,

LPCN 1148, LPCN 2401, and LPCN 1107 as well as for the TRT assets outside of the Currently Licensed TLANDO Territories.

We continually

evaluate our pipeline product candidates and all strategic options available to us, which options may include, but are not limited to,

continued development of LPCN 1154, including the potential submission of a validation study protocol, development of other product candidates,

strategic transactions, partnerships, and other opportunities.

products are based on our proprietary drug delivery technology platform.

TLANDO was approved by the FDA in March 2022.

Our patented technology

is based on lipidic compositions which form an optimal dispersed phase in the gastrointestinal environment for improved absorption of

insoluble drugs.

The drug loaded dispersed phase presents the solubilized drug efficiently at the absorption site (gastrointestinal tract

membrane) thus improving the absorption process and making the drug less dependent on physiological variables such as dilution, gastrointestinal

pH and food effects for absorption.

Our formulation enables improved solubilization and higher drug-loading capacity, which can lead

to improved bioavailability, reduced dose, faster and more consistent absorption, reduced variability, reduced sensitivity to food effects,

improved patient compliance, and targeted lymphatic delivery where appropriate.

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.

the Verity License Agreement, in January 2024, we granted to Verity 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, 2024.

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, 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.

TLANDO received FDA approval

on March 28, 2022.

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

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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Following a portfolio review associated with the spin-off of AbbVie Inc.

by Abbott in 2011, the rights to TLANDO were reacquired by us.

All obligations under the prior license agreement have been completed

except that Lipocine will owe Abbott a perpetual 1% royalty on net sales of TLANDO.

Such royalties are limited to $1 million in the first

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

by Abbott in 2011, we re-acquired the rights to TLANDO.

All obligations under the prior license agreement have been completed except

that Lipocine will owe Abbott a perpetual 1% royalty on net sales of TLANDO.

Such royalties are limited to $1 million in the first 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 will be reduced by 50%.

TLANDO was commercially launched on June 7, 2022.

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

effectiveness of TLANDO in pediatric patients, as required by the Pediatric Research Equity Act.

The FDA may also require certain post-marketing

studies to be conducted which will also be the responsibility of Verity Pharma.

Similarly, SPC, Pharmalink, and Aché are responsible

for obtaining any regulatory/marketing approvals for TLANDO required for the SPC Territory, the Pharmalink Territory, and the Aché

Territory, respectively.

the three months ended March 31, 2026 and 2025, we incurred royalty expense of approximately $10,000 and $8,000, respectively.

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

of TLANDO in pediatric patients, as required by the Pediatric Research Equity Act.

The FDA may also require certain post-marketing studies

to be conducted which will also be the responsibility of Verity.

Similarly, SPC, Pharmalink, and Aché are responsible for obtaining

any regulatory/marketing approvals for TLANDO required for the SPC Territory, the Pharmalink Territory, and the Aché Territory,

respectively.

execution of the Verity License Agreement, Verity Pharma paid us an initial payment of $2.5 million which was received on signing of

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Verity Pharma also paid an additional payment of $2.5 million

to us on December 30, 2024, and is required to make an additional payment of $1 million to us before January 1, 2026.

We are also eligible

to receive milestone payments of up to $259 million in the aggregate, depending on the achievement of certain sales milestones in a single

calendar year and/or development milestones with respect to products licensed by Verity Pharma under the Verity License Agreement.

addition, we will receive tiered royalty payments at rates ranging from 12% up to 18% of net sales of all products licensed under the

Verity License Agreement in the Licensed Verity Territory.

to us on December 30, 2024, and we received an additional payment of $1 million on January 5, 2026.

We are also eligible to receive milestone

payments of up to $259 million in the aggregate, depending on the achievement of certain sales milestones in a single calendar year and/or

development milestones with respect to products licensed by Verity Pharma under the Verity License Agreement.

In addition, we will receive

tiered royalty payments at rates ranging from 12% up to 18% of net sales of all products licensed under the Verity License Agreement

in the Licensed Verity Territory.

paid us a non-refundable, non-creditable upfront fee in October 2024.

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in South Korea under the SPC License Agreement.

execution of the Pharmalink Distribution Agreement, Pharmalink paid us a non-refundable, non-creditable upfront fee in October 2024.

Under the Pharmalink Distribution Agreement, we could receive additional payments in regulatory authorization milestones and we will

supply TLANDO to Pharmalink at an agreed transfer price.

execution of the Pharmalink License Agreement, Pharmalink paid us a non-refundable, non-creditable upfront fee in October 2024.

the Pharmalink License Agreement, we could receive additional payments in regulatory authorization milestones and we will supply TLANDO

to Pharmalink at an agreed transfer price.

execution of the Aché License Agreement, Aché paid us a non-refundable, non-creditable upfront fee in May 2025.

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will supply TLANDO to Aché at an agreed transfer price.

are exploring the possibility of licensing LPCN 1021 (known as TLANDO in the United States) to third parties outside the United States,

Canada, South Korea, the GCC countries and Brazil, although no licensing agreement has been entered into by the Company in any other

If and when an agreement is made with a partner, the success of any such arrangement would likely be partially contingent

upon obtaining local regulatory approval.

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.

are exploring the possibility of licensing LPCN 1021 (known as TLANDO in the United States) to third parties outside the Currently

Licensed TLANDO Territories, although no licensing agreement has been entered into by the Company in any other territories.

when an agreement is made with a partner, such arrangement would likely be partially contingent upon obtaining local regulatory

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.

Programs for CNS Disorders

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of the GABA A receptor, the major biological target of the inhibitory neurotransmitter γ-aminobutyric acid (“GABA A ”).

To improve oral delivery of these modulators, several synthetic NAS derivatives of endogenous GABA A receptor PAMs have been

developed for therapeutic use in the past few decades.

October 2024, we announced positive data from our qEEG study of our oral brexanolone with results indicating robust central nervous system

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

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

confirmed GABA A modulation

● Quantitative

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 disorders

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

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 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 three lead

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

Product Candidate for PPD

most advanced NAS candidate is LPCN 1154, a non-invasive, rapid onset, oral formulation of the neuroactive steroid brexanolone which

we are developing for the treatment of PPD.

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.

most advanced NAS candidate is LPCN 1154, a rapid onset, oral formulation of the neuroactive steroid brexanolone which 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 pivotal 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”) filing.

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 Ctrough criteria.

LPCN 1154 treatment was well-tolerated with no sedation nor somnolence

events observed in the dosing regimen confirmation 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

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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

agreement has been entered into by the Company.

No assurance can be given that any partnering agreement will be completed, or, if an

agreement is completed, that such an agreement would be on terms favorable to us.

a type of major depressive disorder with onset either during pregnancy or within four weeks of delivery, refers to depression persisting

up to 12 months after childbirth.

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

Based on observed comparable exposure of LPCN 1154 and IV brexanolone in the dosing confirmation study, we have confirmed the target

dosing regimen and completed a Phase 3 safety and efficacy study.

April 2026, we released the topline results from our Phase 3 placebo-controlled trial for post-partum depression.

LPCN 1154 did not show

a statistically significant reduction from baseline in HAM-D total score compared to placebo at hour 60 in the full analysis set and

the primary endpoint was not met.

The results showed LPCN 1154 to be well tolerated and the treatment demonstrated a favorable safety

profile to support outpatient administration without the need for healthcare provider monitoring.

No treatment-related severe or serious

adverse events (SAEs) were reported;

no cases of excessive sedation or loss of consciousness were observed;

and no treatment-related

discontinuations were reported.

the primary endpoint in the study was not met, in a post hoc analysis of participants with a history of psychiatric conditions diagnosed

using Mini-International Neuropsychiatric Interview (MINI, a structured diagnostic interview used to screen for and diagnose psychiatric

disorders using DSM/ICD criteria), we identified signals that could indicate a potential development path for LPCN 1154.

on a post hoc analysis of participants with a history of psychiatric conditions identified using the MINI, we plan to further evaluate

these findings.

We have submitted requests for breakthrough therapy and fast track designations for LPCN 1154 in PPD;

however, the FDA

may not grant either designation.

We expect to submit a proposed validation study protocol and request a meeting with the FDA, and we

plan to present additional analyses as available.

continue to explore the possibility of partnering with a third party for the further development, marketing and commercialization of

LPCN 1154, although no partnering agreement has been entered into by the Company.

No assurance can be given that any partnering

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

a type of major depressive disorder with onset either during pregnancy or within four weeks of delivery, refers to depression

persisting up to 12 months after childbirth.

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

comorbidity, including epilepsy.

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.

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 are treated with prescription medication.

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 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.

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

“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.

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

It has been hypothesized that the rapid perinatal

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

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.

Additionally, approximately 40% of women relapse in

subsequent pregnancies or on other occasions.

● Psychiatric

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 delivery

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

● Environmental:

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

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 with good tolerability,

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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

However, numerous factors limited the utilization of injectable brexanolone such as method of administration, cost, and safety

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.

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.

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, 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 depression.

However, numerous factors limited the utilization of injectable brexanolone such as method of administration, cost, and safety concerns

and SAGE discontinued Zulresso in October 2024.

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 (“Supernus”) 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.

believe LPCN 1154 has the potential to target the current unmet need for robust, rapid relief of PPD symptoms with 48-hour dosing 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.

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.

fewer CNS depressant effects, better adherence to dosing regimen, more

quality time for baby care, and less dependence on caregiver support.

NAS for Major Depressive Disorders (“MDD”)

are currently advancing LPCN 2201, a unique oral brexanolone formulation, as a novel, rapid relief oral treatment option for MDD with

the goal of improving outcomes without the limitations of existing therapies.

LPCN 2201 is chemically identical to the endogenous human

hormone allopregnanolone, a positive allosteric modulator of y-aminobutyric acid (GABA A ) receptor.

Post planned clinical assessment of

unique formulations, we plan to submit a protocol for a Phase 2 study to the FDA, and we may initiate a study to evaluate LPCN 2201 for

MDD, subject to resource prioritization.

Overview – MDD

affects approximately 21 million adults in the U.S., representing 8.4% of the population.

While 12.8 million individuals receive treatment,

nearly 3.8 million patients continue to struggle with treatment-resistant depression (“TRD”), a condition where symptoms

persist despite multiple antidepressant therapies.

These patients experience persistent, debilitating symptoms, reduced quality of life,

higher comorbidities, and significant social and occupational impairment.

In 2018, the total annual burden of medication-treated MDD

was approximately $92.7 billion, with $43.8 billion (47%) attributable to TRD.

treatment options for MDD pose significant challenges.

Most available antidepressants such as SSRIs and SNRIs require 4-6 weeks to show

meaningful effects and often fail to deliver adequate relief.

Additionally, SSRIs and SNRIs can lead to metabolic issues, sexual dysfunction,

and heightened risk of cerebrovascular events in vulnerable populations.

Even newer therapies that can be used for fast depression symptom

relief like Spravato® (esketamine) come with serious safety concerns, including black box warnings for sedation, dissociation, cognitive

impairment, and increased blood pressure.

Beyond safety, access remains a major hurdle – esketamine, for example, requires intranasal

administration in a clinical setting under a restricted program, limiting convenience and scalability.

and providers urgently need a convenient, well-tolerated, at-home rapid relief option for MDD.

Ideal solutions should offer ease of use

without monitoring requirements, enabling treatment in outpatient or home settings.

Improved treatments should deliver effective antidepressant

action with high and sustained remission rates, while maintaining a wide therapeutic index for safety and tolerability.

Improved compliance,

better management of comorbid conditions such as anxiety, and enhanced patient experience are critical to addressing the gaps left by

current therapies.

believe LPCN 2201 has the potential to be a convenient, fastest time to action treatment through its fast-acting mechanism promoting

acute stabilization of symptoms with the freedom of at home dosing while presenting no significant risk of adverse reactions from exposure

to bioidentical brexanolone.

LPCN 2201 could be an appealing option for patients for whom rapid improvement is a priority for the treatment

of moderate or severe MDD with suicidal ideation.

NAS for Epilepsy

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.

are currently evaluating an additional NAS candidate, LPCN 2101, for Drug Resistant Epilepsy (“DRE”) and women with epilepsy

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

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

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

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

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

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need to treat WWE in CB age

is estimated that approximately 1,000,000 CB aged women suffer from active epilepsy in the U.S.

Women of CB age with epilepsy face many

additional challenges such as hormonal influences on seizure activity and endocrine function throughout the different phases of their

reproductive cycles, and approximately 30% of patients with epilepsy cannot be efficiently controlled with available ASMs making consideration

of newer pharmacological treatment development options important.

uncontrolled seizures in WWE of CB age is the primary aim during preconception, pregnancy, and postpartum phases.

Therefore, uncompromised

ASM efficacy with acceptable variability and less or no drug-drug interactions achieved with lowest possible monotherapy dose to address

fetal toxicity concerns remain highly unmet needs.

Moreover, control of seizures including prevention of breakthrough seizures is critical

when planning for pregnancy and also during pregnancy, as it can also lead to undesired falls or auto-accidents and compromise freedom

Approximately

30% of patients with epilepsy cannot efficiently control their condition with available ASMs, making consideration of newer pharmacological

treatment development options important, and managing uncontrolled seizures in WWE of CB age is the primary aim during preconception,

pregnancy, and postpartum phases.

Therefore, uncompromised ASM efficacy with acceptable variability and less or no drug-drug interactions

achieved with lowest possible monotherapy dose to address fetal toxicity concerns remain highly unmet needs.

Moreover, control of seizures

including prevention of breakthrough seizures is critical when planning for pregnancy and also during pregnancy, as it can also lead

to undesired falls or auto-accidents and compromise freedom to drive.

ASMs have the potential to induce contraception failures, reproductive hormone imbalance, anxiety, and depression.

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over 30 molecules have been approved for the treatment of epilepsy in the U.S., no epilepsy drug has been specifically approved for WWE

We believe our endogenous NASs as GABA A PAMs, while targeting the goal of seizure control, also have the potential

for additional benefits in psychiatric disorders comorbidities (e.g., anxiety and/or depression) and sleep impairment.

Moreover, these

oral endogenous NASs could potentially address some of the fetal toxicity concerns related to unplanned or planned pregnancy in WWE.

We believe our endogenous NASs as GABA A PAMs, while targeting the goal of seizure control, also have the potential for additional

benefits in psychiatric disorders comorbidities (e.g., anxiety and/or depression) and sleep impairment.

Moreover, these oral endogenous

NASs could potentially address some of the fetal toxicity concerns related to unplanned or planned pregnancy in WWE.

S.Bangar et al.

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Oral Product for Management of Essential Tremor

2203 is an oral candidate for management of essential tremor comprising a bioidentical GABA modulating NAS.

We have successfully completed

oral pharmacokinetics with bioidentical GABA Modulating NAS and are planning to submit a protocol for a proof-of-concept Phase 2 study

for ET to the FDA.

2203 is an oral candidate for management of essential tremor (“ET”) comprising a bioidentical GABA A modulating NAS.

successfully completed oral pharmacokinetics with bioidentical GABA A and are planning to submit a protocol for a proof-of-concept Phase

2 study for ET to the FDA.

Overview - Essential Tremor

Tremor (“ET”) is one of the most common movement disorders in the United States, affecting an estimated 7 million in the

For ET patients, uncontrollable shaking of the hands, head, voice, or legs creates difficulty eating, dressing, writing, and pursuing

other day-to-day tasks.

The etiology of ET is largely unknown, but reduced GABA A receptor levels and decreased GABAergic activity

have been observed in ET.

Tremor is one of the most common movement disorders in the United States, affecting an estimated 7 million in the U.S.

For ET patients,

uncontrollable shaking of the hands, head, voice, or legs creates difficulty eating, dressing, writing, and pursuing other day-to-day

The etiology of ET is largely unknown, but reduced GABA A receptor levels and decreased GABAergic activity have been observed in

ET is often associated with aging populations, ET can begin much earlier in life, with a progressive disease course that can eventually

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Pipeline Candidates

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

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

continue to pursue opportunities for partnering and/or development arrangements for the continued development of LPCN 2401, LPCN 1148,

and LPCN 1107.

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.

Obesity Management

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

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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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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.

of daily life 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 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.

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.

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 initiate

a proof-of-concept study evaluating LPCN 2401 as an adjunct to GLP-1 agonist after we obtain regulatory clarity with respect to development

path and acceptable end points for improved body composition in obesity management pending available resources.

We may explore the possibility

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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

and Market Overview – Obesity Management

Approximately

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type 2 diabetes, 50% 3 have dyslipidemia, and 67% 4 have hypertension.

In the US alone, ~34M older adults aged 60+

alone, ~34M older adults aged

60+ years are obese (BMI at or above 30.0) and ~31M older adults aged 60+ years are overweight (BMI between 25.0 to 30).

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Oral Product Candidate for the Management of Decompensated Cirrhosis

studied LPCN 1148 comprising testosterone laurate (“TL”) for the management of decompensated cirrhosis.

We believe LPCN 1148

targets unmet needs for cirrhosis subjects including improvement in the quality of life of patients while on the liver transplant waiting

list, prevention or reduction in the occurrence of new decompensation events such as OHE, and improvement in post liver transplant survival,

including outcomes and costs.

We are exploring the possibility of partnering with a third party for the development and/or marketing

of LPCN 1148, although no partnering agreement has been entered into by the Company.

No assurance can be given that any partnering agreement

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

are currently evaluating LPCN 1148 comprising testosterone laurate (“TL”) for the management of decompensated cirrhosis.

We believe LPCN 1148 targets unmet needs for patients with cirrhosis, including improvement in the quality of life of patients while

on the liver transplant waiting list, prevention or reduction in the occurrence of new decompensation events such as OHE, and improvement

in post liver transplant survival, including outcomes and costs.

We are exploring the possibility of partnering with a third party for

the development and/or marketing of LPCN 1148, although no partnering agreement has been entered into by the Company.

No assurance can

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

favorable to us.

conducted a Phase 2 proof of concept (“POC”) study (NCT04874350) in male subjects with cirrhosis to evaluate the therapeutic

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The Phase 2 POC study was a prospective, multi-center, randomized, placebo-controlled

study in male sarcopenic cirrhotic patients.

study in male sarcopenic patients with cirrhosis.

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

The treatment arm was an oral dose

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

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,

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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

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

(P<.01), in patients with cirrhosis.

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placebo to LPCN 1148 and patients on therapy were hospitalized for fewer days.

We plan to request a Type C meeting with the FDA to discuss

the clinical development plan for LPCN 1148.

We had a Type D meeting with the FDA to discuss the clinical

development plan for LPCN 1148 for OHE, and we plan to continue discussions with the FDA seeking clarity on the Phase 3 study design

and endpoint.

Overview – Cirrhosis

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

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 increase.

Each year about half

of the approximately 17,000 people in the 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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fee when we file our NDA.

Competition Update

October 5, 2020, the FDA’s Center for Drug Evaluation and Research (“CDER”) proposed that Makena be withdrawn from

the market because the PROLONG trial failed to verify the clinical benefit of Makena and concluded that the available evidence does not

show Makena is effective for its approved use and on April 6, 2023, the FDA withdrew its approval of Makena and ordered the immediate

withdrawal of Makena and several approved generic versions of the drug, making it unlawful for the drug to be distributed in the U.S.

The FDA stated that in light of the unmet need for a treatment for preventing preterm birth and improving neonatal outcomes, it is imperative

that the medical and scientific communities increase their efforts to find effective treatments and stated their hope that the decision

to withdraw Makena will help galvanize further research.

The FDA further stated their commitment to working together with patients, researchers,

and drug developers to advance the development of safe and effective therapies that are urgently needed as a treatment for the prevention

of preterm birth.

Operations Overview

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Since our inception

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

through March 31, 2026, we have generated $55.2 million in revenue under our various license and collaboration arrangements and from

government grants.

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We expense research and development expenses as incurred.

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

our inception, we have spent approximately $165.9 million in research and development expenses through March 31, 2026.

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 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.

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

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 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,

LPCN 2201, LPCN 2101, LPCN 2203, LPCN 2401, 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.

If we are successful in progressing LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203, or other future product candidates into later stage development,

we will require additional capital.

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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 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.

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

when and if we conduct Phase 2 clinical studies with LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203, LPCN 2401, and/or development product

candidates and when and if we conduct 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 to us.

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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expenses include rent and utilities, travel expenses, and professional fees for auditing, tax, legal, and various other services.

and administrative expenses also include expenses for the cost of preparing, filling and prosecuting patent applications and maintaining,

and administrative expenses also include expenses for the cost of preparing, filing and prosecuting patent applications and maintaining,

enforcing and defending intellectual property-related claims.

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Income and Expense

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

gains on our warrant liability in 2024.

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

of Operations

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 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 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 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

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 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 )

of the Three Months Ended March 31, 2026 and 2025

following table summarizes our results of operations for the three months ended March 31, 2026 and 2025:

Months Ended March 31,

Research and development expenses

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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.

recognized royalty revenue from TLANDO sales of $119,000 during the three months ended March 31, 2026, compared to royalty revenue of

$94,000 during the three months ended March 31, 2025.

and Development Expenses

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.

increase in research and development expenses during the three months ended March 31, 2026, as compared to the three months ended March

31, 2025 consists of an approximately $1.7 million increase in costs related to our LPCN 1154 clinical study in 2026 which had not yet

started in 2025 and a $28,000 increase in personnel related costs, offset by a $54,000 decrease in other research and development related

costs and supplies from 2025.

and Administrative Expenses

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

increase in general and administrative expenses during the three months ended March 31, 2026 as compared to the three months ended March

31, 2025 primarily consists of a $43,000 increase in personnel related costs and a $39,000 increase in various professional and consulting

and Investment Income

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 was extinguished when the November

2019 warrants expired in November 2024.

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.

decrease in interest and investment income during the three months ended March 31, 2026 compared to interest and investment income during

the three months ended March 31, 2025 was due to lower cash and marketable investment securities balances in the first quarter of 2026

as compared to the first quarter of 2025.

and Capital Resources

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LPCN 2201, LPCN 2101, LPCN 2203, and any other future product candidates, including continued research efforts.

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.

of March 31, 2026, we had $24.7 million of unrestricted cash, cash equivalents and marketable investment securities compared to $14.9

million at December 31, 2025.

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

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Aché at an agreed transfer price.

Our ability to realize benefits from the Aché License Agreement, including milestone,

product sale and royalty payments, is subject to a number of risks.

We may not realize milestone, product sale, or royalty payments in

anticipated amounts, or at all.

October 2024, we entered into the Pharmalink Distribution Agreement with Pharmalink, pursuant to which we granted to Pharmalink a non-transferable,

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at a specified transfer price.

September 2024, we entered into the SPC License Agreement with SPC, pursuant to which we granted to SPC a non-transferable, exclusive,

royalty-bearing license to develop and commercialize our TLANDO product with respect to TRT in South Korea.

Under the terms of the SPC

License Agreement, SPC paid us a non-refundable, non-creditable upfront fee in October 2024.

We also received a non-refundable payment

in consideration for certain TLANDO product inventory, and are eligible to receive additional payments upon the receipt of marketing

authorization and achievement of sales milestones, and we will supply TLANDO to SPC and receive a supply price.

In addition, we will

receive royalties on net sales in the SPC Territory under the SPC License Agreement.

Our ability to realize benefits from the SPC License

Agreement, including milestone, product sale and royalty payments, is subject to a number of risks.

We may not realize milestone, product

sale or royalty payments in anticipated amounts, or at all.

Our ability to realize benefits from the Pharmalink Distribution Agreement, including milestone, product

sale and royalty payments, is subject to a number of risks.

We may not realize milestone, product sale, or royalty payments in anticipated

amounts, or at all.

September 2024, we entered into the SPC License Agreement with SPC, pursuant to which we granted to SPC a non-transferable, royalty-bearing

license to develop and commercialize our TLANDO product with respect to TRT in South Korea.

Under the terms of the SPC License Agreement,

SPC paid us a non-refundable, non-creditable upfront fee in October 2024.

We also received a non-refundable payment in consideration

for certain TLANDO product inventory, and are eligible to receive additional payments upon the receipt of marketing authorization and

achievement of sales milestones, and we will supply TLANDO to SPC at a specified supply price.

In addition, we will receive royalties

on net sales in the SPC Territory under the SPC License Agreement.

Our ability to realize benefits from the SPC License Agreement, including

milestone, product sale and royalty payments, is subject to a number of risks.

We may not realize milestone, product sale, or royalty

payments in anticipated amounts, or at all.

January 12, 2024, we entered into the Verity License Agreement with Verity Pharma, pursuant to which we granted to Verity Pharma an exclusive,

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from Antares to Verity Pharma in February 2024, Verity Pharma paid us initial payments of $2.5 million and $5 million, respectively.

Verity Pharma also paid us of $2.5 million on December 30, 2024, has agreed to make additional payments to us of $1 million before January

The Verity License Agreement also provides Verity Pharma with a license to develop and commercialize TLANDO XR (LPCN 1111),

our potential next generation, once daily oral product candidate for testosterone replacement therapy comprised of TT in the U.S.

We are eligible to receive milestone payments of up to $259 million in the aggregate, depending on the achievement of certain

development milestones and sales milestones in a single calendar year with respect to all products licensed by Verity Pharma under the

Verity License Agreement.

In addition, we receive tiered royalty payments at rates ranging from 12% up to 18% of net sales of all products

licensed to Verity Pharma in the Licensed Verity Territory.

Our ability to realize benefits from the Verity License Agreement, including

milestone and royalty payments, is subject to a number of risks.

We may not realize milestone or royalty payments in anticipated amounts,

on March 6, 2017, we entered into the Cantor Sales Agreement with Cantor under which we agreed to sell shares of our common stock, having

registered up to $50.0 million for sale under the Cantor Sales Agreement.

During the year ended December 31, 2024, we sold 32,110 shares

of our common stock under the Cantor Sales Agreement at a weighted-average sales price of $6.77 per share, resulting in net proceeds

of approximately $209,000, which is net of approximately $8,000 in expenses.

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

From the inception to the termination of the Cantor Sales Agreement, we sold, in aggregate, 996,821 shares of our common stock for $33.5

April 26, 2024, we entered into the A.G.P.

Sales Agreement with A.G.P.

pursuant to which we may issue and sell, from time to time, shares

of our common stock having an aggregate offering price of up to the amount we registered on an effective registration statement pursuant

to which the offering is being made.

We currently have registered up to $10,616,169 of shares of common stock for sale under the A.G.P.

Sales Agreement, pursuant to the Form S-3, through A.G.P.

Verity Pharma also paid us $2.5 million on December 30, 2024, and we received payment for the final portion of the initial license of

$1.0 million on January 5, 2026.

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

TLANDO XR (LPCN 1111), our potential next generation, once daily oral product candidate for testosterone replacement therapy comprised

of TT in the U.S.

Under the Verity License Agreement, we are eligible to receive milestone payments of up to $259 million

in the aggregate, depending on the achievement of certain development milestones and sales milestones in a single calendar year with

respect to all products licensed by Verity Pharma under the Verity License Agreement.

In addition, we receive tiered royalty payments

at rates ranging from 12% up to 18% of net sales of all products licensed to Verity Pharma in the Licensed Verity Territory.

to realize benefits from the Verity License Agreement, including milestone and royalty payments, is subject to a number of risks.

may not realize milestone or royalty payments in anticipated amounts, or at all.

April 26, 2024, we entered into a sales agreement (the “A.G.P.

Sales Agreement”) with A.G.P./Alliance Global Partners (“A.G.P.”)

pursuant to which we can issue and sell, from time to time, shares of our common stock having an aggregate offering price of up to the

amount we registered on an effective registration statement pursuant to which the offering is being made.

As of February 26, 2026, we

have registered up to $50,000,000 of common shares for sale under the A.G.P.

Sales Agreement, pursuant to the Registration Statement

on Form S-3, as amended (File No.

333-275716) (the “Form S-3”), through A.G.P.

as sales agent.

may sell our common stock by any method permitted by

law deemed to be an ATM offering as defined in Rule 415(a)(4) of the Securities Act, including sales made directly on or through the

Nasdaq Capital Market or any other existing trade market for our common stock, in negotiated transactions at market prices prevailing

at the time of sale or at prices related to prevailing market prices, or any other method permitted by law.

will use its commercially

reasonable efforts consistent with its normal trading and sales practices and applicable law and regulations to sell shares under the

may sell our common

stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities

Act, including sales made directly on or through the Nasdaq Capital Market or any other existing trade market for our common stock, in

negotiated transactions at market prices prevailing at the time of sale or at prices related to prevailing market prices, or any other

method permitted by law.

will use its commercially reasonable efforts consistent with its normal trading and sales practices and

applicable law and regulations to sell shares under the A.G.P.

Sales Agreement.

We will pay A.G.P.

3.0% of the aggregate gross proceeds from each sale of shares under the A.G.P.

3.0% of the aggregate gross proceeds

from each sale of shares under the A.G.P.

Sales Agreement.

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with customary indemnification rights.

shares of common stock to be sold under the A.G.P.

Sales Agreement will be sold and issued pursuant to the Form S-3, as amended, which

was previously declared effective by the SEC, and the related prospectus and one or more prospectus supplements.

are not obligated to make any sales of our common stock under the A.G.P.

Our shares of common stock to be sold under the A.G.P.

Sales Agreement will be sold and issued pursuant to the Form S-3, as amended,

which was previously declared effective by the SEC, and the related prospectus and one or more prospectus supplements.

We are not obligated

to make any sales of our common stock under the A.G.P.

Sales Agreement.

The offering of common stock pursuant to the

Sales Agreement will terminate upon the termination of the A.G.P.

The offering of common stock pursuant to the A.G.P.

Sales Agreement

will terminate upon the termination of the A.G.P.

Sales Agreement as permitted therein.

We and A.G.P.

terminate the A.G.P.

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

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 $217,000, after paying commissions of approximately $7,000

to A.G.P, as sales agent.

may each terminate the A.G.P.

Agreement at any time upon ten days’ prior notice.

During the three months ended March 31, 2026, we sold 1,314,138 shares of our

common stock for gross proceeds of approximately $12.3 million and net proceeds of $12.0 million under the A.G.P.

Sales Agreement.

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

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 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

through at least May 7, 2027, which include research and development activities and compliance with regulatory requirements.

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 1154, LPCN 2201, LPCN 2101, LPCN 2203, LPCN

2401, LPCN 1148, and/or LPCN 1107.

Conversely, our capital resources could last longer if we reduce expenses, reduce the number of activities

currently contemplated under our operating plan or if we terminate, modify or suspend on-going clinical studies.

We can raise capital

pursuant to the A.G.P.

Sales Agreement but may choose not to issue common stock if our market price is too low to justify such sales

in our discretion.

There are numerous risks and uncertainties associated with the development and, subject to approval by the FDA, commercialization

While we believe we have sufficient liquidity and capital resources to fund our projected operating

requirements through at least May 7, 2027, 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 May 7, 2027, 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 2201, LPCN 2101, LPCN 2203, LPCN 2401, LPCN 1148, and/or LPCN 1107.

Conversely, our capital resources

could last longer if we reduce expenses, reduce the number of activities currently contemplated under our operating plan or if we terminate,

modify or suspend on-going clinical studies.

We can raise capital pursuant to the A.G.P.

Sales Agreement but may choose not to issue

common stock if our market price is too low to justify such sales in our discretion.

There are numerous risks and uncertainties associated

with the development and, subject to approval by the FDA, commercialization of our product candidates.

There are numerous risks and uncertainties

impacting our ability to enter into collaborations with third parties to participate in the development and potential commercialization

of our product candidates.

There are numerous risks and uncertainties impacting our ability to enter into collaborations with third parties

to participate in the development and potential commercialization of our product candidates.

We are unable to precisely estimate the

amounts of increased capital outlays and operating expenditures associated with our anticipated or unanticipated clinical studies and

ongoing development efforts.

All of these factors affect our need for additional capital resources.

To fund future operations, we will

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 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

We are unable to precisely estimate the amounts of increased capital outlays and operating expenditures associated

with our anticipated or unanticipated clinical studies and ongoing development efforts.

All of these factors affect our need for additional

capital resources.

To fund future operations, we will 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 2201,

LPCN 2101, LPCN 2203, LPCN 2401, LPCN 1148, and LPCN 1107;

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

candidates and any products that we may develop;

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 nine months ended September 30, 2025 and 2024:

Months Ended September 30,

following table provides a summary of our cash flows for the three months ended March 31, 2026 and 2025:

Months Ended March 31,

Cash used in operating activities

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$ (1,969,257 )

Cash provided by investing activities

Cash used in investing activities

Cash provided by financing activities

Cash from Operating Activities

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.

the three months ended March 31, 2026 and 2025, net cash used in operating activities was $2.3 million and $2.0 million, respectively.

cash used in operating activities during the three months ended March 31, 2026, was primarily attributable to cash required to support

our LPCN 1154 clinical trial activities and our ongoing operations.

Net cash used in operating activities during the three months ended

March 31, 2025, was primarily attributable to cash required to support ongoing operations.

Cash from Investing Activities

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

the three months ended March 31, 2026 and 2025, net cash used in investing activities was $9.9 million and $0.9 million, respectively.

cash used in investing activities during the three months ended both March 31, 2026 and 2025, was primarily the result of the purchases

of marketable investments securities, net.

Capital expenditures during the nine months ended September 30, 2025 and 2024, were $0 and

80,000 respectively.

There were no capital expenditures during either the three months ended March 31, 2026 or

Cash from Financing Activities

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.

the three months ended March 31, 2026 and 2025, net cash provided by financing activities was approximately $12.0 million and $0, respectively.

cash provided by financing activities during the three months ended March 31, 2026 was related to the sale of 1,314,138 shares of common

stock for net proceeds of approximately $12.0 million under the A.G.P.

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.

No cash was provided by financing activities

during the three months ended March 31, 2025.

Commitments and Contingencies

23 unchanged sentences

from payments to be received in the future will be recognized when it is probable that we will receive license payments under the terms

of the Verity License Agreement, the SPC License Agreement or the Pharmalink Distribution Agreement (see Footnote 7 – Contractual

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 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.

of the Verity License Agreement, the SPC License Agreement, the Pharmalink Distribution Agreement and the Aché License Agreement

(see Footnote 7 – Contractual Agreements for disclosure regarding the SPC License Agreement, the Pharmalink Distribution Agreement,

and the Aché License Agreement).

have been no significant and material changes in our critical accounting policies during the three months ended March 31, 2026, 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 2025 Form 10-K.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

a “smaller reporting company,” this item is not required.

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