What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2026-08-04 compared with 2026-05-07 · 297 added, 1271 removed, 513 unchanged (75% of the section changed)

13 unchanged sentences

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

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

8,244,589 and 6,158,779 issued and 8,244,253 and 6,158,443 outstanding,

paid-in capital

8 unchanged sentences

Consolidated Statements of Operations and Comprehensive Loss

Months Ended March 31,

Royalty revenue

Total revenues

Months Ended June 30,

and development

and administrative

operating expenses

Research and development

General and administrative

Total operating expenses

Operating loss

( 2,842,246 )

( 2,404,353 )

Other income:

Interest and investment

Total other income

Loss before income tax

( 6,691,711 )

( 4,494,538 )

Income tax expense

Net loss attributable to

common shareholders

and investment income

before income tax expense

( 2,622,395 )

( 2,205,716 )

Basic loss per share attributable to common

Weighted average common shares outstanding, basic

Diluted loss per share attributable to common

Weighted average common shares outstanding, diluted

Comprehensive loss:

( 6,294,289 )

( 4,070,389 )

Net unrealized loss on

marketable investment securities

Comprehensive loss

loss attributable to common shareholders

$ ( 2,622,595 )

$ ( 2,205,716 )

$ ( 6,294,489 )

$ ( 4,070,589 )

loss per share attributable to common stock

average common shares outstanding, basic

loss per share attributable to common stock

average common shares outstanding, diluted

Comprehensive

$ ( 2,622,595 )

$ ( 2,205,716 )

$ ( 6,294,489 )

$ ( 4,070,589 )

unrealized loss on marketable investment securities

Comprehensive

$ ( 2,628,802 )

$ ( 2,212,480 )

$ ( 6,312,335 )

$ ( 4,080,970 )

accompanying notes to consolidated financial statements

1 unchanged sentence

Consolidated Statements of Changes in Stockholders’ Equity

the Three Months Ended March 31, 2026 and 2025

the Three and Six Months Ended June 30, 2026 and 2025

Number of Shares

Comprehensive

Income (Loss)

Stockholders’

Number of Shares

Comprehensive

Income (Loss)

Stockholders’

Balances at December 31, 2024

at March 31, 2025

$ 220,860,140

2 unchanged sentences

( 2,205,716 )

Unrealized net loss on marketable

investment securities

Unrealized net loss on marketable investment

Stock-based compensation

Vesting of restricted stock units

Balances at March 31, 2025

net loss on marketable investment securities

stock sold through ATM offering, net of costs

at June 30, 2025

$ 221,000,961

1 unchanged sentence

Stockholders’

Number of Shares

Comprehensive

Income (Loss)

Stockholders’

Balances at December 31, 2025

at December 31, 2024

$ 220,789,138

2 unchanged sentences

( 4,070,589 )

net loss on marketable investment securities

of restricted stock units

stock sold through ATM offering, net of costs

at June 30, 2025

$ 221,000,961

$ ( 203,839,451 )

Unrealized net loss on marketable investment

Stock-based compensation

Option exercises

Vesting of restricted stock units

Common stock sold through ATM offering, net

Balances at March 31,

Stockholders’

Number of Shares

Comprehensive

Stockholders’

at March 31, 2026

$ 235,937,414

2 unchanged sentences

( 2,622,595 )

accompanying notes to consolidated financial statements

net loss on marketable investment securities

of restricted stock units

stock sold through ATM offering, net of costs

at June 30, 2026

$ 237,503,220

$ ( 215,690,856 )

Stockholder’s

Number of Shares

Comprehensive

Stockholders’

at December 31, 2025

$ 223,901,106

$ ( 209,396,367 )

$ 223,901,106

$ ( 209,396,367 )

( 6,294,489 )

net loss on marketable investment securities

of restricted stock units

stock sold through ATM offering, net of costs

at June 30, 2026

$ 237,503,220

$ ( 215,690,856 )

$ 237,503,220

$ ( 215,690,856 )

accompanying notes to condensed consolidated financial statements

AND SUBSIDIARIES

Consolidated Statements of Cash Flows

Months Ended March 31,

Cash flows from operating activities:

$ ( 3,671,894 )

Months Ended June 30,

flows from operating activities:

$ ( 6,294,489 )

Adjustments to reconcile

net loss to cash used in

operating activities:

Depreciation expense

Stock-based compensation

Amortization of discounts

on marketable investment securities

Changes in operating assets

and liabilities:

Accrued interest income

License and royalties receivable

Prepaid and other current

Accounts payable

Accrued expenses

Cash used in operating

$ ( 4,070,589 )

to reconcile net loss to cash used in operating activities:

compensation expense

of discounts on marketable investment securities

in operating assets and liabilities:

interest income

and royalties receivable

and other current assets

used in operating activities

( 5,285,564 )

Cash flows from investing activities:

Purchases of marketable

investment securities

( 3,855,491 )

flows from investing activities:

of marketable investment securities

( 20,219,628 )

Maturities of marketable

investment securities

Net cash used in investing

( 5,082,073 )

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

of marketable investment securities

cash provided by (used in) investing activities

( 8,419,628 )

Cash and cash equivalents at beginning of period

Cash and cash equivalents at end of period

Supplemental disclosure

of non-cash investing and financing activity:

Net unrealized loss on

available-for-sale securities

flows from financing activities:

proceeds from sale of common stock through ATM

from stock option exercises

provided by financing activities

decrease in cash and cash equivalents

and cash equivalents at beginning of period

and cash equivalents at end of period

disclosure of non-cash investing and financing activity:

unrealized loss on available-for-sale securities

disclosure of cash flow information:

accompanying notes to consolidated financial statements

12 unchanged sentences

in accordance with rules and regulations of the SEC.

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

Operating results for the three and six months ended June 30, 2026 are not necessarily

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

6 unchanged sentences

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

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.

requirements through at least August 4, 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 August 4, 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.

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 2203, LPCN 2101, LPCN

2401, 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.

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

26 unchanged sentences

States and Canada, and with respect to applications outside of the Field inside or outside the Licensed Verity Territory.

2026, Pharmalink received product marketing authorization approval for TESTYRA ® (TLANDO) in the UAE.

Company generates most of its revenue from license and royalty arrangements.

33 unchanged sentences

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

of June 30, 2026 and December 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

12 unchanged sentences

For the three months ended

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

June 30, 2026, the Company recognized royalty revenue of approximately $ 190,000 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

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:

months ended June 30, 2025, the Company recognized licensing revenue of $ 500,000 from one customer and royalty revenue of approximately

$ 123,000 relating to the Verity License Agreement.

For the six months ended June 30, 2026, the Company recognized royalty revenue of

$ 309,000 relating to the Verity License Agreement.

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

$ 500,000 from one customer and royalty revenue of approximately $ 217,000 relating to the Verity License Agreement.

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 six months ended June

30, 2026 and 2025:

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

Months Ended March 31,

Basic loss per share attributable

to common stock:

Months Ended June 30,

loss per share attributable to common stock:

$ ( 2,622,595 )

$ ( 2,205,716 )

Weighted avg.

shares outstanding

Basic loss per share attributable to common

Diluted loss per share attributable

to common stock:

$ ( 6,294,489 )

$ ( 4,070,589 )

Total net loss for purpose of calculating

diluted net loss per common share

common shares outstanding

loss per share attributable to common stock

loss per share attributable to common stock:

$ ( 2,622,595 )

$ ( 2,205,716 )

Weighted avg.

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:

$ ( 6,294,489 )

$ ( 4,070,589 )

net loss for purpose of calculating diluted net loss per common share Denominator

$ ( 2,622,595 )

$ ( 2,205,716 )

$ ( 6,294,489 )

$ ( 4,070,589 )

common shares outstanding

loss per share attributable to common stock

computation of diluted loss per share for the three and six months ended June 30, 2026 and 2025 does not include the following stock

options 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

Three Months Ended

Stock options

Unvested restricted stock units

Marketable Investment

Months Ended June 30,

restricted stock units

Investment Securities

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

6 unchanged sentences

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 March 31, 2026, and December 31, 2025, were as follows:

securities by major security type and class of security as of June 30, 2026, and December 31, 2025, were as follows:

Schedule of Available for Sale Securities

Holding Losses

Government treasury bills

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

Unrealized Holding Gains

Unrealized Holding Losses

treasury bills

Unrealized Holding Gains

Unrealized Holding Losses

treasury bills

of debt securities classified as available-for-sale securities as of June 30, 2026 are as follows:

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

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

within one year

were no sales of marketable investment securities during the three or six months ended June 30, 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.

Additionally, during the three months ended June 30, 2026 and 2025, $ 6.5 million and $ 4.5 million of marketable investment

securities matured, respectively and during the six months ended June 30, 2026 and 2025, $ 11.8 million and $ 8.7 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

As of June 30, 2026, the Company’s

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

2 unchanged sentences

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.

in earnings during the three or six months ended June 30, 2026 or 2025.

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

12 unchanged sentences

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 March 31, 2026 and December 31, 2025:

and liabilities that are measured at fair value on a recurring basis as of June 30, 2026 and December 31, 2025:

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

value measurements at reporting date using

Cash equivalents

- money market funds

equivalents - money market funds

treasury bills

value measurements at reporting date using

Cash equivalents

- money market funds

Government treasury bills

equivalents - money market funds

treasury bills

following methods and assumptions were used to determine the fair value of each class of assets and liabilities recorded at fair value

12 unchanged sentences

in circumstances that caused the transfer.

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

March 31, 2026.

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

ended June 30, 2026.

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

2 unchanged sentences

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

March 31, 2026 and December 31, 2025, the Company had a full valuation allowance against its deferred tax assets, net of expected reversals

June 30, 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.

3 unchanged sentences

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 (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.

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

15 unchanged sentences

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 March 31, 2026 and 2025, the Company recognized royalty

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

the Verity License Agreement with Verity Pharma, during the three months ended June 30, 2026 and 2025, the Company recognized royalty

revenue of approximately $ 190,000 and $ 123,000 , respectively and for the six months ended June 30, 2026 and 2025, the Company recognized

royalty revenue of approximately $ 309,000 and $ 217,000 , respectively.

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

7 unchanged sentences

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 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 .

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 Gulf Cooperation Council Countries (“GCC”),

including Saudi Arabia, Kuwait, the United Arab Emirates (“UAE”), Qatar, Bahrain, and Oman (the “GCC

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.

On July 8, 2026, Pharmalink received product marketing authorization approval for TESTYRA ® (TLANDO) in the

Laboratórios Farmacêuticos S.A .

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

3 unchanged sentences

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

Abbott Products, Inc.

Products, Inc.

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

10 unchanged sentences

The Company incurred royalty expense of approximately $ 16,000 and

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

Contract Research and

$ 10,000 during the three months ended June 30, 2026 and 2025, respectively and incurred royalty expense of approximately $ 26,000 and

$ 18,000 during the six months ended June 30, 2026 and 2025, respectively.

Research and Development

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 clinical researchers who serve

as advisors to the Company.

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.

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 $ 1.2 million and $ 1.3 million for the three months ended June 30, 2026 and 2025, respectively,

and incurred expenses of $ 3.0 million and $ 1.4 million for the six months ended June 30, 2026 and 2025, respectively, under these agreements

and has recorded these expenses in research and development expenses.

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

1 unchanged sentence

has been extended through February 28, 2027.

minimum lease payments under the non-cancelable operating lease as of March 31, 2026 are:

minimum lease payments under the non-cancelable operating lease as of June 30, 2026 are:

Schedule of Future Minimum Rental Payments for Operating Leases

Total minimum lease

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

minimum lease payments

Company’s rent expense was $ 97,000 and $ 94,000 for the three months ended June 30, 2026 and 2025, respectively.

The Company’s

rent expense was $ 192,000 and $ 187,000 for the six months ended June 30, 2026 and 2025, respectively.

(9) Stockholders’

9 unchanged sentences

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

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.

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

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 made.

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 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

as the Company’s sales agent.

may sell the Company’s

common stock by any method permitted by law deemed to be an “at the market offering” (“ATM”) 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.

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.

will pay A.G.P.

Company will pay A.G.P.

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

Sales Agreement.

In addition, the Company

has also provided A.G.P.

In addition, the Company has also

provided A.G.P.

with customary indemnification rights.

12 unchanged sentences

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

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

the three months ended June 30, 2026, the Company sold 769,138 shares of common stock at a weighted average price of $ 2.02 per share

under the A.G.P.

1 unchanged sentence

agent commissions, discounts and other offering costs.

Rights Agreement

During the six months ended June 30, 2026, the Company sold 2,083,276 shares of

common stock at a weighted average price of $ 6.67 per share under the A.G.P.

Sales Agreement, for aggregate gross proceeds of $ 13.9 million

and net proceeds of $ 13.5 million, after deducting sales agent commissions, discounts and other offering costs.

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

32 unchanged sentences

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

Share-Based Payments

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

20 unchanged sentences

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:

that has been expensed in the statements of operations amounted to approximately $ 58,000 and $ 65,000 , for the three months ended June

30, 2026 and 2025, respectively, and approximately $ 124,000 and $ 136,000 , for the six months ended June 30, 2026 and 2025, respectively.

The expense is allocated as follows:

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

Months Ended March 31,

Research and development

General and administrative

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.

Months Ended June 30,

and development

and administrative

Company issued 58,073

stock options during each of the three months ended June 30, 2026 and 2025, respectively, and 97,073

stock options during each of the six months ended June 30, 2026 and 2025.

The Company did not issue any restricted stock awards during the

three or six months ended June 30, 2026 or 2025.

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

16 unchanged sentences

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

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:

options granted during the six months ended June 30, 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

9 unchanged sentences

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

of June 30, 2026, there was approximately $ 687,000 of total unrecognized compensation cost related to unvested share-based compensation

arrangements granted under the Company’s stock plan, of which $ 628,000 relates to unvested stock options and $ 59,000 relates to

4 unchanged sentences

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.

granted during the six months ended June 30, 2026 and 2025 was approximately $ 3.39 and $ 3.32 per share, respectively.

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

15 unchanged sentences

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 109,133 shares

remaining available for grant as of March 31, 2026.

In June 2026, 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 600,000 to 1,000,000 .

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 1,000,000 shares of common stock are authorized

for issuance under the 2014 Plan, with 466,200 shares remaining available for grant as of June 30, 2026.

summary of stock option activity is as follows:

3 unchanged sentences

Balance at December 31, 2024

Options granted

Options exercised

Options forfeited

Options cancelled

Balance at December 31, 2025

Options granted

Options exercised

Options forfeited

Options cancelled

Balance at March 31, 2026

Options exercisable at March 31, 2026

Balance at June 30, 2026

Options exercisable at June 30, 2026

following table summarizes information about stock options outstanding and exercisable:

of Share-based Compensation of Stock Options Outstanding and Exercisable

of March 31, 2026

of June 30, 2026

average remaining contractual life (Years)

3 unchanged sentences

average exercise price

of March 31, 2025

intrinsic value

of June 30, 2025

average remaining contractual life (Years)

average exercise

average remaining contractual

average exercise

average exercise price

intrinsic value

average remaining contractual life (Years)

average exercise price

intrinsic value

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

2 unchanged sentences

Summary of Restricted Stock Unit Activity

of Unvested Restricted

of Unvested Restricted Stock Units

Balance at December 31, 2025

Balance at March 31, 2026

Balance at June 30, 2026

Stock Warrants

36 unchanged sentences

During the three

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

and six months ended June 30, 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 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.

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

20 unchanged sentences

single reporting segment.

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

A reconciliation to the consolidated net loss for the three and six months ended June 30, 2026 and 2025 is

included at the bottom of the table below.

Schedule of Significant Expense Categories

Months Ended March 31,

Total revenues

Program expenses (1)

Lead clinical candidate (1)

Other research and development

Non-program expenses (2)

Personnel costs

Stock-based compensation

Total segment operating income (loss)

Months Ended June 30,

clinical candidate (1)

research and development programs (1)

segment operating income (loss)

( 2,842,246 )

( 2,404,353 )

Other income (loss) (3)

Net income (loss)

( 6,691,711 )

( 4,494,538 )

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

following discussion of our financial condition and results of operations should be read in conjunction with our unaudited condensed

consolidated financial statements and the related notes thereto and other financial information included elsewhere in this report.

additional context with which to understand our financial condition and results of operations, see management’s discussion and

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

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.

Forward-Looking

section and other parts of this report contain forward-looking statements within the meaning of Section 27A of the Securities Act of

1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange

Act”), that involve risks and uncertainties.

Forward-looking statements provide current expectations of future events based on

certain assumptions and include any statement that does not directly relate to any historical or current fact.

Forward-looking statements

may refer to such matters as products, product benefits, pre-clinical and clinical development timelines, clinical and regulatory expectations

and plans, expected responses to regulatory actions, anticipated financial performance, future revenues or earnings, business prospects,

projected ventures, new products and services, anticipated market performance, expected research and development and other expenses,

future expectations for liquidity and capital resources needs and similar matters.

Such words as “may,” “will,”

“expect,” “continue,” “estimate,” “project,” and “intend” and similar terms

and expressions are intended to identify forward looking statements.

Forward-looking statements are not guarantees of future performance

and our actual results may differ significantly from the results discussed in the forward-looking statements.

Factors that might cause

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 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 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 2201 for major depressive

disorder (“MDD”);

LPCN 2203 for essential tremor;

LPCN 2101 for epilepsy;

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”)

which have broad applicability in treating various CNS conditions where we can leverage our technology platform to develop highly differentiated

oral therapeutics.

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

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 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

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.

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

for TLANDO was initially established in 2006, and TLANDO was subsequently licensed in 2009 to Solvay Pharmaceuticals, Inc., which was

then acquired by Abbott Products, Inc.

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

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.

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

the License Agreement and $5 million which was received on February 1, 2024.

Verity Pharma also paid an additional payment of $2.5 million

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.

We also received additional payments including a non-refundable

payment in consideration for TLANDO product inventory, and we are eligible to receive additional payments for marketing authorization

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

In addition, we will receive royalties on net sales

in South Korea under the SPC License Agreement.

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.

Aché License Agreement, we may receive additional payments in regulatory authorization milestones, royalties on net sales and

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 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

preferred endogenous or naturally occurring NAS present in the central nervous system act as positive allosteric modulators (“PAMs”)

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

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:

● 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

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

receptor PAMs which historically had been deemed to be not orally bioavailable.

As a novel drug class, NASs have received considerable

attention because of their potential to treat various neuropsychiatric conditions including depression, movement disorders, epilepsy,

anxiety, and neurodegenerative diseases.

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

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

Product Candidate for PPD

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

first quarter of 2025.

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

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

Based on observed comparable exposure of LPCN 1154 and 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 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 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 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.

● 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.

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

● Environmental:

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

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

especially with respect to CNS depressant effects.

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

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

therefore, a need for an oral treatment option with

a faster onset of action, 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 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.

tolerability :

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 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

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

in the brain.

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

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

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

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

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

with a 2 to 3 times greater mortality rate compared with the general population.

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

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

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

Approximately 38% of adults with epilepsy report having

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

DRE is a significant clinical challenge in epilepsy

care, with high social and occupational limitations.

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

and DRE contributes heavily

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

medications, and need for early identification.

needs in DRE:

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

Seizures may cause physical injuries,

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

Rescue treatments (primarily benzodiazepines)

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

DRE patients are at high risk of seizure recurrence within hours

or days after a cluster.

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

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

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

There remains an

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

who experience recurrent seizure clusters or DRE.

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

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

the different phases of their reproductive cycles.

Elevated estrogen or decreased progesterone levels can exacerbate seizure frequency.

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

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

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

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

for WWE in the preconception phase either intending to start a family (planning pregnancy) or using contraception to prevent an unplanned

pregnancy face significant challenges to balance seizure control efficacy with the selection and dosage of ASMs and ASM-related risks

such as, among other risks, fetal-neonatal toxicity, contraception failure, and psychiatric side effects.

ASMs are known to have teratogenic effects on the developing fetus (converging evidence from registry studies indicates that teratogenic

risks are highest with valproate, followed by carbamazepine and topiramate).

Other commonly prescribed ASMs, including older generation

agents, such as phenobarbital and phenytoin, have been associated with higher risks as compared with lamotrigine, levetiracetam, clonazepam

and gabapentin (Vajda et al., 2014;

Voinescu and Pennell, 2015).

Moreover, risks associated with ASMs are considerable early in pregnancy;

therefore, it is necessary that WWE of CB age undergo counseling, monitoring, and adjustment to the most appropriate ASM prior to becoming

It is preferable that WWE of CB age discuss seizure control with their doctor for at least 6 months before conception and,

if possible, cease ASM therapy or use the lowest effective dose of a single anticonvulsant according to the type of epilepsy and the

fetal toxicity of the ASM.

Anxiety, depression, lack of adherence to ASM, and/or contraception failure may be experienced by women who

are worried about unplanned pregnancy or are late in confirming pregnancy, planned or unplanned.

ASMs can reduce the efficacy of oral

contraceptives, compounding this problem.

multidirectional interactions between female hormones, seizures, and ASMs exist.

Most hormones act as NASs and can thus modulate brain

excitability.

Any changes in endogenous or exogenous hormone levels can affect the occurrence of seizures, either directly or via PK

interactions that modify the plasma levels of ASMs (Harden, 2008).

The PK interactions between oral contraceptives and ASMs are bidirectional

(Johnston and Crawford, 2014).

The efficacy of hormonal contraception may be diminished for women taking CYP-P450 enzyme inducing ASMs.

Epilepsy is not a medical condition in which contraceptives are contraindicated.

Contraceptive failure, possibly related to ASMs, may

be responsible for up to 1 in 4 unplanned pregnancies in WWE (~12.5% of all WWE pregnancies), versus a rate of 1% in healthy women.

need to treat WWE in CB age

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.

There remains an unmet

need for an ASM without the aforementioned downsides, with no to low fetal-neonatal toxicity and without breast-feeding concerns, as

well as the potential to treat associated comorbidities.

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.

S.Bangar et al.

Functional Neurology 2016;

Reimers et al.

Oral Product for Management of Essential Tremor

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 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

necessitate a care partner.

Social anxiety and depressive symptoms can manifest in patients with ET as tremor severity increases and

may negatively impact a patient’s ability to work and engage in hobbies.

In an interview study of ET patients and care partners,

the most common impacts on activities of daily living are pouring liquids and writing/typing (100%) and grooming/hygiene, drinking, dressing,

eating, and reading (80-85%).

Overall, 90% of participants noted the emotional impact of ET, with 75% reporting tremor-related worry

only FDA approved pharmacological treatment for ET was approved more than 50 years ago, and the majority of patients with ET experience

a sub-optimal response with standard-of-care treatments, highlighting numerous and compelling unmet needs in care such as daytime efficacy

and improved tolerability, a PRN (pro re nata) or “as needed” option, and a superior benefit-to-risk profile.(1) (2)

Louis ED, Ottman R.

Tremor Other Kyperkinet Mov (NY).

Gerbasi et.al.

Patient experiences in essential tremor:

Mapping functional impacts to existing measures using qualitative research.

Pipeline Candidates

continue to pursue opportunities for partnering and/or development arrangements for the continued development 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.

LPCN 2401 is expected

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

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

maintenance with demonstrated benefits to the liver.

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

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

● Enhancement

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

in GLP-1 Receptor Expression in diabetics and non-diabetics

proliferation of β cells and improving insulin sensitivity

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

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.

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

expression activity of GLP1R and increased effectiveness of GIP1 therapies secondary to actions at GLP1R (glucose lowering).

could also be potentially used as monotherapy post discontinuation of GLP-1 agonist to manage weight/fat regain and durability of diabetes

from preclinical and clinical studies support the potential of LPCN 2401 and LPCN 2401+E in improving body composition.

In April 2024,

Lipocine announced results from a multi-center prospective, blinded Phase 2 study, which demonstrated increases in lean mass of 4.4%,

decreases in fat mass of 6.7%, reduction in android fat of 4.1% and increased bone mineral content of 2.8% in a population consistent

with GLP-1 use for weight management.

LPCN 2401 was well tolerated with minimal GI or androgenic adverse events and no reports of muscle

FDA Guidance (2025), for efficacy claims related to changes in body composition, trial design should include appropriate choice of population

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

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

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

No assurance can be given that

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

and Market Overview – Obesity Management

Approximately

adults aged 20 and older are either obese or overweight, and an estimated 30% of the U.S.

adult population has a BMI ≥

Elderly and sarcopenic GLP-1 agonist users are the population of GLP-1 users who are most vulnerable to accelerated

lean mass loss and functional decline.

Obesity is a chronic, relapsing health risk defined by excess body fat.

Excess body fat increases

the risk of death and major comorbidities such as type 2 diabetes, hypertension, dyslipidemia, cardiovascular disease, osteoarthritis

of the knee, sleep apnea, and some cancers 1 .

About 30% of overweight (BMI ≥ 25 kg/m 2 ) adults 2 have

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

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).

is estimated that the total GLP-1 users in the U.S.

may reach 30 million (around 9% of the overall population) by 2030 5 .

Reportedly, ~24M 6 obese elderly are most vulnerable to losing muscle mass.

The rapid weight loss observed with the currently

approved chronic weight management GLP-1 receptor agonist medications includes unwanted lean mass loss, up to 40% of the patient’s

total weight lost.

Moreover, discontinuation of these therapies frequently results in a rapid regain in weight.

Loss of lean mass has

multiple negative health implications including weakness/fatigue, lowered metabolism which can cause a regain in fat mass, declines in

neuromuscular function, potential effects on emotion and psychological states, and increased risk of injury.

recent studies showed that body composition, especially lean body mass (muscle) may play an independent role in survival of patients

with diseases such as cancer and cardiovascular diseases (DH Lee and EL Giovannucci, Exp Biol Med.

Therefore, a focus on body

composition in obesity management to sustainably lose fat mass while maintaining lean mass should be an essential goal.

is a significant unmet need for an oral, efficacious, muscle preserving/gaining option for chronic obesity/weight management that ameliorates

the loss of lean mass associated with GLP-1/GIP agonist treatment, resulting in a higher quality weight loss.

Moreover, there is a need

for a chronic long-term pharmacotherapy option to maintain weight upon cessation of incretin mimetic therapy, prevent fat/weight rebound

“overshoot” and minimize lag in muscle recovery to prevent collateral fattening as well as improve the durability of any

achieved diabetes remission while on GLP-1.

Caterson and Hubbard et al.

Calle and Thun et al.

(2) https://news.harvard.edu/gazette/story/2012/03/the-big-setup/

(3) https://www.ncbi.nlm.nih.gov/books/NBK305895/

(4) https://pmc.ncbi.nlm.nih.gov/articles/PMC6316192/#sec3-nutrients-10-01976

(5) https://www.jpmorgan.com/insights/global-research/current-events/obesity-drugs

Morgan Stanley, February 27, 2024

Oral Product Candidate for the Management of Decompensated Cirrhosis

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

potential of LPCN 1148 for the management of sarcopenia.

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

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.

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

including current standard of care, diet or exercise.

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

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

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

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

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

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

The study also demonstrated improvements in clinical outcomes such as prevention of new decompensation

events including OHE, rates of hospitalizations, and patient reported outcomes (“PROs”).

LPCN 1148 was well-tolerated, with

adverse event (“AE”) rates and severities similar to placebo and no mortality was noted in the LPCN 1148 treatment group,

nor were there any cases of drug-induced liver injury.

March 2024 we announced that 24-week L3-SMI increases were maintained through 52 weeks of LPCN 1148 intervention and that placebo patients

who switched to LPCN 1148 in the open label extension period of the study had increases in L3-SMI.

Furthermore, fewer OHE events were

observed in LPCN 1148 treated patients and time to first recurrent OHE event was longer for treated patients.

LPCN 1148 was well-tolerated,

with AE rates and severities similar to placebo and fewer participants experienced serious or severe adverse events when switched from

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

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, 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.

Patients with cirrhosis typically

have a year-long silent, asymptomatic phase (compensated cirrhosis) until decreasing liver function and increasing portal pressure move

the patient into the symptomatic phase (decompensated cirrhosis).

Transition to decompensated cirrhosis is marked by clinical events

including ascites, encephalopathy, jaundice, and/or variceal hemorrhage.

Decompensated subjects survive on average less than 2 years.

Common causes of liver cirrhosis include alcoholic liver disease, non-alcoholic fatty liver disease (“NAFLD”), chronic hepatitis

B and C, primary biliary cirrhosis, and primary sclerosing cholangitis and some patients have liver disease of unknown cause (cryptogenic).

complications in patients with cirrhosis may include:

compromised liver function, portal hypertension, varices in GI tract with internal

bleeding, edema, ascites, hepatic encephalopathy (“HE”), compromised immunity with post-transplant acute rejection risk,

high sodium levels, increased bilirubin, low albumin level, insulin resistance with impaired peripheral uptake of glucose, depression,

accelerated muscle disorder in the form of sarcopenia, myosteatosis, and frailty with compromised energetics, bone diseases (e.g., osteoporosis),

high alkaline phosphatase, cachexia, malnutrition, weight loss (>5%), symptoms of hypogonadism such as abnormal hair distribution,

anemia, sexual dysfunction, testicular atrophy, muscle wasting, fatigue, osteoporosis, gynecomastia, inflammation with elevated cytokines,

and infection risk leading to hospital admissions and possibly death.

a significant decompensation event in patients with cirrhosis, is a brain dysfunction caused by liver insufficiency and/or portal systemic

Because the damaged liver cannot function normally (as in cirrhosis), neurotoxins such as ammonia are inadequately removed

from systemic circulation and travel to the brain, where they affect neurotransmission.

This can cause episodes of HE, which may present

as alterations in consciousness, cognition, and behavior that range from minimal to severe.

Overt HE occurs in 30% to 40% of patients

with cirrhosis at some point during the clinical course of their disease.

As the burden of chronic liver disease and cirrhosis is increasing,

the frequency of HE is also increasing.

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

are exploring the possibility of partnering with a third party for the development and/or marketing of LPCN 1107, although no partnering

agreement has been entered into by us.

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.

believe LPCN 1107 has the potential to become the first oral hydroxyprogesterone caproate (“HPC”) product indicated for the

reduction of risk of PTB (delivery less than 37 weeks) in women with singleton pregnancy who have a history of singleton spontaneous

Prevention of PTB is a significant unmet need as approximately 11% of all U.S.

pregnancies result in PTB, a leading cause of neonatal

mortality and morbidity.

have completed a multi-dose PK dose selection study in pregnant women.

The objective of the multi-dose PK selection study was to assess

HPC blood levels in order to identify the appropriate LPCN 1107 Phase 3 dose.

The multi-dose PK dose selection study was an open-label,

4-period, 4-treatment, randomized, single and multiple dose PK study in pregnant women with 3 dose levels of LPCN 1107 and the IM HPC

The study enrolled 12 healthy pregnant women (average age of 27 years) with a gestational age of approximately 16 to 19

Subjects received three dose levels of LPCN 1107 (400 mg BID, 600 mg BID, or 800 mg BID) in a randomized, crossover manner during

the first 3 treatment periods and then received 5 weekly injections of HPC during the fourth treatment period.

During each of the LPCN

1107 treatment periods, subjects received a single dose of LPCN 1107 on Day 1 followed by twice daily administration from Day 2 to Day

Following completion of the 3 LPCN 1107 treatment periods and a washout period, all subjects received 5 weekly injections of HPC.

Results from this study demonstrated that average steady state HPC levels (Cavg0-24) were comparable or higher for all 3 LPCN 1107 doses

than for injectable HPC.

Additionally, HPC levels as a function of daily dose were linear for the 3 LPCN 1107 doses.

Also, unlike the

injectable HPC, steady state exposure was achieved for all 3 LPCN 1107 doses within 7 days.

traditional PK/PD based Phase 2 clinical study in the intended patient population is not expected to be required prior to entering into

Therefore, based on the results of our multi-dose PK study we had an End-of-Phase 2 meeting and subsequent guidance meetings

with the FDA to define a pivotal Phase 2b/3 development plan for LPCN 1107.

We have completed a food effect study to characterize the

dosing regimen for the pivotal study and we have submitted a pivotal clinical study protocol to the FDA.

FDA has granted orphan drug designation to LPCN 1107 based on a major contribution to patient care.

Orphan designation qualifies Lipocine

for various development incentives, including tax credits for qualified clinical testing, and a waiver of the prescription drug user

fee when we file our NDA.

Operations Overview

date, we have not generated any revenues from product sales and do not expect to do so until our FDA approved product receives regulatory

approval outside the U.S.

and Canada or until one of our product candidates receives approval from the FDA.

Revenues to date have been

generated substantially from license fees, royalty and milestone payments and research support from our licensees.

Since our inception

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

government grants.

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

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

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

obtaining regulatory approval or commercializing any of these product candidates.

and Development Expenses

and development expenses consist primarily of salaries, benefits, stock-based compensation and related personnel costs, fees paid to

external service providers such as contract research organizations and contract manufacturing organizations, contractual obligations

for clinical development, clinical sites, manufacturing and scale-up for late stage clinical trials, formulation of clinical drug supplies,

and expenses associated with regulatory submissions.

Research and development expenses also include an allocation of indirect costs,

such as those for facilities, office expense, and depreciation of equipment based on the ratio of direct labor hours for research and

development personnel to total direct labor hours for all personnel.

We expense research and development expenses as incurred.

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

as the development of any future pipeline product candidates.

general, the cost of clinical trials may vary significantly over the life of a project as a result of uncertainties in clinical development,

including, among others:

number of sites included in the trials;

length of time required to enroll suitable subjects;

duration of subject follow-ups;

length of time required to collect, analyze and report trial results;

cost, timing and outcome of regulatory review;

changes by the FDA in clinical trial and NDA filing requirements.

research and development expenditures are subject to numerous uncertainties regarding timing and cost to completion, including, among

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

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

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

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

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

affect our future plans and capital requirements;

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

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

change in the costs and timing associated with these efforts, could require us to raise additional capital, and may require us to reduce

the stage of clinical development and the significant risks and uncertainties inherent in the clinical development, manufacturing, and

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

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.

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

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

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

We will continue efforts to enter into partnership

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

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

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

studies for our CNS product candidates, including a 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

and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation, and outside consulting

services related to our executive, finance, business development and administrative support functions.

Other general and administrative

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, filing and prosecuting patent applications and maintaining,

enforcing and defending intellectual property-related claims.

expect that general and administrative expenses will increase in the future as we continue as a public company.

These fees include legal

and consulting fees, accounting and audit fees, director fees, directors’ and officers’ insurance premiums, fees for investor

relations services and enhanced business and accounting systems, litigation costs, professional fees and other costs.

However, if we

are unable to raise additional capital, we may need to reduce general and administrative expenses in order to extend our ability to continue

as a going concern.

Income and Expense

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 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

General and administrative expenses

Interest and investment income

Income tax expense

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

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

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 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

our inception, our operations have been primarily financed through sales of our equity securities, issuances of debt and payments received

under our license and collaboration arrangements.

We have devoted our resources to funding research and development programs, including

discovery research, and preclinical and clinical development activities.

We have incurred operating losses in most years since our inception

and we expect to continue to incur operating losses into the foreseeable future as we advance the clinical development of LPCN 1154,

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

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

an exclusive license to commercialize our TLANDO® product with respect to the Field, specific to Brazil.

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.

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,

exclusive, license to commercialize our TLANDO product in the Pharmalink Territory.

Pharmalink paid us a one-time non-refundable, non-creditable

We are eligible to receive additional payments in regulatory authorization milestones related to the marketing approval

in countries in the Pharmalink Territory under the Pharmalink Distribution Agreement and we have agreed to supply TLANDO to Pharmalink

at a specified transfer price.

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,

royalty-bearing, sublicensable right and license to develop and commercialize our TLANDO product with respect to TRT in the Licensed

Verity Territory.

Upon execution of the Verity License Agreement in January 2024 and upon transition of the commercialization of TLANDO

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 $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 “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.

Sales Agreement.

In addition, we have also provided A.G.P.

with customary indemnification rights.

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 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.

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 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.

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.

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;

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;

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

may not be available to us on favorable terms, or at all.

Also, market conditions may prevent us from accessing the debt and equity capital

markets, including sales of our common stock through the A.G.P.

Sales Agreement.

If we are unable to obtain adequate financing when needed,

we may have to delay, reduce the scope of or suspend one or more of our clinical studies, research and development programs or, if any

of our product candidates receive approval from the FDA, commercialization efforts.

We may seek to raise any necessary additional capital

through a combination of public or private equity offerings, including the Sales Agreement, debt financings, collaborations, strategic

alliances, licensing arrangements and other marketing and distribution arrangements.

These arrangements may not be available to us or

available on terms favorable to us.

To the extent that we raise additional capital through marketing and distribution arrangements, other

collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our product

candidates, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us.

If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will

be diluted, and the terms of these securities may include liquidation or other preferences, warrants or other terms that adversely affect

our stockholders’ rights or further complicate raising additional capital in the future.

If we raise additional capital through

debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional

debt, making capital expenditures or declaring dividends.

If we are unable, for any reason, to raise needed capital, we will have to

reduce costs, delay research and development programs, liquidate assets, dispose of rights, commercialize products or product candidates

earlier than planned or on less favorable terms than desired or reduce or cease operations.

and Uses of Cash

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

income (loss) (3)

income (loss)

$ ( 2,622,595 )

$ ( 2,205,716 )

Cash used in investing activities

Cash provided by financing activities

Cash from Operating Activities

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 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.

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

Cash from Financing Activities

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.

No cash was provided by financing activities

during the three months ended March 31, 2025.

Commitments and Contingencies

enter into contracts and issue purchase orders in the normal course of business with clinical research organizations for clinical trials

and clinical and commercial supply manufacturing and with vendors for pre-clinical research studies, research supplies and other services

and products for operating purposes.

These contracts generally provide for termination on notice and are cancellable obligations.

August 2004, we entered into an agreement to lease our facility in Salt Lake City, Utah consisting of office and laboratory space which

serves as our corporate headquarters.

On December 12, 2025, we modified and extended the lease through February 28, 2027.

Accounting Policies and Significant Judgments and Estimates

management’s discussion and analysis of our financial condition and results of operations is based on our financial statements

which we have prepared in accordance with U.S.

In preparing our financial statements, we are required to make estimates and assumptions

that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial

statements and the reported amounts of revenues and expenses during the reporting periods.

Our estimates are based on our historical

experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for

making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.

Actual results

may differ from these estimates under different assumptions or conditions.

We concluded that licensing revenue recognized in conjunction

with the Verity License Agreement met the requirements under ASC 606, Revenue from Contracts with Customers.

We evaluate the measure

of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.

License revenue

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, 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.

$ ( 6,294,489 )

$ ( 4,070,589 )

external research and development expenses.

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

interest income and income tax expense.

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