Item 1. Financial Statements
ITEM
1. FINANCIAL STATEMENTS
LIPOCINE
INC. AND SUBSIDIARIES
Condensed
Consolidated Balance Sheets
(Unaudited)
March 31,
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$ 4,769,180
$ 3,148,496
Marketable investment securities
24,100,430
29,381,410
Accrued interest income
39,060
80,427
Contract asset - current portion
579,428
579,428
Prepaid and other current assets
1,126,731
945,319
Total current assets
30,614,829
34,135,080
Contract asset - non-current portion
3,252,500
3,252,500
Property and equipment, net of accumulated depreciation of $ 1,158,349 and $ 1,153,530 respectively
130,770
131,589
Other assets
23,753
23,753
Total assets
$ 34,021,852
$ 37,542,922
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 796,476
$ 600,388
Accrued expenses
1,133,626
1,077,738
Total current liabilities
1,930,102
1,678,126
Warrant liability
131,722
229,856
Total liabilities
2,061,824
1,907,982
Commitments and contingencies (notes 6, 8, 9 and 11)
-
-
Mezzanine equity:
Preferred stock, par value $ 0.0001 per share ($ 0.001 per share redemption value), 10,000,000 shares authorized; 88,511 and zero issued and outstanding at March 31, 2023 and December 31, 2022, respectively
9
-
Stockholders’ equity:
Common stock, par value $ 0.0001 per share, 200,000,000 shares authorized; 88,516,501 issued and 88,510,791 outstanding
8,852
8,852
Additional paid-in capital
219,284,000
219,112,164
Treasury stock at cost, 5,710 shares
( 40,712 )
( 40,712 )
Accumulated other comprehensive loss
3,241
( 20,321 )
Accumulated deficit
( 187,295,362 )
( 183,425,043 )
Total stockholders’ equity
31,960,028
35,634,940
Total liabilities and stockholders’ equity
$ 34,021,852
$ 37,542,922
See
accompanying notes to unaudited condensed consolidated financial statements
3
LIPOCINE
INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
2023
2022
Three Months Ended March 31,
2023
2022
Revenues:
$ 54,990
$ -
Operating expenses:
Research and development
3,106,310
1,887,953
General and administrative
1,287,313
1,243,687
Total operating expenses
4,393,623
3,131,640
Operating loss
( 4,338,633 )
( 3,131,640 )
Other income (expense):
Interest and investment income
370,469
41,576
Interest expense
-
( 19,529 )
Unrealized gain (loss) on warrant liability
98,134
( 377,988 )
Total other income (expense), net
468,603
( 355,941 )
Loss before income tax expense
( 3,870,030 )
( 3,487,581 )
Income tax expense
( 200 )
( 200 )
Net loss
( 3,870,230 )
( 3,487,781 )
Issuance of Series B preferred stock dividend
( 89 )
-
Net loss attributable to common shareholders
$ ( 3,870,319 )
$ ( 3,487,781 )
Basic loss per share attributable to common stock
$ ( 0.04 )
$ ( 0.04 )
Weighted average common shares outstanding, basic
88,510,791
88,309,628
Diluted loss per share attributable to common stock
$ ( 0.04 )
$ ( 0.04 )
Weighted average common shares outstanding, diluted
88,510,791
88,309,628
Comprehensive loss:
Net loss
$ ( 3,870,319 )
$ ( 3,487,781 )
Net unrealized gain (loss) on available-for-sale securities
23,562
( 49,400 )
Comprehensive loss
$ ( 3,846,757 )
$ ( 3,537,181 )
See
accompanying notes to unaudited condensed consolidated financial statements
4
LIPOCINE
INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Changes in Stockholders’ Equity
For
the Three Months Ended March 31, 2023 and 2022
(Unaudited)
Mezzanine Equity
Stockholder’s Equity
Series B Preferred Stock
Common Stock
Treasury Stock
Accumulated
Number of Shares
Amount
Number of Shares
Amount
Number of Shares
Amount
Additional Paid-In Capital
Other Comprehensive Loss
Accumulated Deficit
Total Stockholders’ Equity
Balances at December 31, 2021
-
$ -
88,290,650
$ 8,829
5,710
$ ( 40,712 )
$ 218,286,324
$ ( 18,016 )
$ ( 172,666,407 )
$ 45,570,018
Net loss
-
-
-
-
-
-
-
-
( 3,487,781 )
( 3,487,781 )
Unrealized net loss on marketable investment securities
-
-
-
-
-
-
-
( 49,400 )
-
( 49,400 )
Stock-based compensation
-
-
-
-
-
-
171,028
-
-
171,028
Option exercises
-
-
208,274
21
-
-
205,967
-
-
205,988
Balances at March 31, 2022
-
$ -
88,498,924
$ 8,850
5,710
$ ( 40,712 )
$ 218,663,319
$ ( 67,416 )
$ ( 176,154,188 )
$ 42,409,853
Balances
-
$ -
88,498,924
$ 8,850
5,710
$ ( 40,712 )
$ 218,663,319
$ ( 67,416 )
$ ( 176,154,188 )
$ 42,409,853
Series B Preferred Stock
Common Stock
Treasury Stock
Accumulated
Number of Shares
Amount
Number of Shares
Amount
Number of Shares
Amount
Additional Paid-In Capital
Other Comprehensive Gain (Loss)
Accumulated Deficit
Total Stockholders’ Equity
Balances at December 31, 2022
-
$ -
88,510,791
$ 8,852
5,710
$ ( 40,712 )
$ 219,112,164
$ ( 20,321 )
$ ( 183,425,043 )
$ 35,634,940
B alance
-
$ -
88,510,791
$ 8,852
5,710
$ ( 40,712 )
$ 219,112,164
$ ( 20,321 )
$ ( 183,425,043 )
$ 35,634,940
Net loss
-
-
-
-
-
-
-
-
( 3,870,230 )
( 3,870,230 )
Unrealized net gain on marketable investment
-
-
-
-
-
-
-
23,562
-
23,562
securities
Unrealized net gain loss on marketable investment securities
-
-
-
-
-
-
-
23,562
-
23,562
Stock-based compensation
-
-
-
-
-
-
177,772
-
-
177,772
Issuance of Series B referred stock dividend
88,511
9
-
-
-
-
80
-
( 89 )
-
Costs associated with ATM offering
-
-
-
-
-
-
( 6,016 )
-
-
( 6,016 )
Balances at March 31, 2023
88,511
$ 9
88,510,791
$ 8,852
5,710
$ ( 40,712 )
$ 219,284,000
$ 3,241
$ ( 187,295,362 )
$ 31,960,028
Balance
88,511
$ 9
88,510,791
$ 8,852
5,710
$ ( 40,712 )
$ 219,284,000
$ 3,241
$ ( 187,295,362 )
$ 31,960,028
See
accompanying notes to unaudited condensed consolidated financial statements
5
LIPOCINE
INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
Three Months Ended March 31, 2023
2023
2022
Cash flows from operating activities:
Net loss
$ ( 3,870,230 )
$ ( 3,487,781 )
Adjustments to reconcile net loss to cash used in operating activities:
Depreciation expense
4,819
1,719
Stock-based compensation expense
177,772
171,028
Non-cash interest expense
-
4,674
Non-cash (gain) loss on change in fair value of warrant liability
( 98,134 )
377,989
Amortization of premium (discounts) on marketable investment securities
( 254,215 )
51,282
Changes in operating assets and liabilities:
Accrued interest income
41,367
127,159
Prepaid and other current assets
( 181,412 )
136,540
Accounts payable
196,088
( 819,455 )
Accrued expenses
55,888
( 448,557 )
Cash used in operating activities
( 3,928,057 )
( 3,885,402 )
Cash flows from investing activities:
Purchase of property and equipment
( 4,000 )
( 26,797 )
Purchases of marketable investment securities
( 6,441,243 )
( 17,906,250 )
Maturities of marketable investment securities
12,000,000
25,228,474
Cash provided by investing activities
5,554,757
7,295,427
Cash flows from financing activities:
Debt repayments
-
( 833,334 )
Costs associated with At the Market Offering
( 6,016 )
-
Proceeds from stock option exercises
-
205,988
Cash provided used in financing activities
( 6,016 )
( 627,346 )
Net increase in cash and cash equivalents
1,620,684
2,782,679
Cash and cash equivalents at beginning of period
3,148,496
2,950,552
Cash and cash equivalents at end of period
$ 4,769,180
$ 5,733,231
Supplemental disclosure of cash flow information:
Interest paid
$ -
$ 14,855
Income taxes paid
$ 456
-
Supplemental disclosure of non-cash investing and financing activity:
Net unrealized gain (loss) on available-for-sale securities
$ 23,562
$ ( 49,400 )
Accrued final payment charge on debt
$ -
$ 4,674
Issuance of Series B preferred stock dividend
$ 89
$ -
See
accompanying notes to unaudited condensed consolidated financial statements
6
LIPOCINE
INC.
Notes
to Condensed Consolidated Financial Statements
(Unaudited)
(1)
Basis of Presentation
The
accompanying unaudited condensed consolidated financial statements included herein have been prepared by Lipocine Inc. (“Lipocine”
or the “Company”) in accordance with the rules and regulations of the United States Securities and Exchange Commission (“SEC”).
The unaudited condensed consolidated financial statements are comprised of the financial statements of Lipocine and its subsidiaries,
collectively referred to as the Company. In management’s opinion, the interim financial data presented includes all adjustments
(consisting solely of normal recurring items) necessary for fair presentation. All intercompany accounts and transactions have been eliminated.
Certain information required by U.S. generally accepted accounting principles (“U.S. GAAP”) has been condensed or omitted
in accordance with rules and regulations of the SEC. Operating results for the three months ended March 31, 2023 are not necessarily
indicative of the results that may be expected for any future period or for the year ending December 31, 2023.
These
unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial
statements and the notes thereto for the year ended December 31, 2022.
The
preparation of the unaudited condensed consolidated financial statements requires management to make estimates and assumptions relating
to reporting of the assets and liabilities and the disclosure of contingent assets and liabilities to prepare these condensed consolidated
financial statements and the reported amounts of revenues and expenses during the reporting period in conformity with U.S. GAAP. Actual
results could differ from these estimates.
The
Company believes that its existing capital resources, together with interest thereon, will be sufficient to meet its projected operating
requirements through at least May 11, 2024 which includes an on-going clinical study for LPCN 1148 in the management of decompensated
cirrhosis, a pilot pharmacokinetic (“PK”) bridge study for LPCN 1154 in Postpartum Depression (“PPD”), and compliance
with regulatory requirements. 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 if additional activities are performed by the Company including clinical
studies for LPCN 1148, LPCN 1154, LPCN 1144 for non-cirrhotic non-alcoholic steatohepatitis (“NASH”), LPCN 1111 an oral TRT
product with the potential for once daily dosing, LPCN 1107 for the prevention of recurrent preterm birth, and LPCN 2101 for epilepsy.
While the Company believes it has sufficient liquidity and capital resources to fund our projected operating requirements through at
least May 11, 2024, the Company will need to raise additional capital at some point 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 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 1148,
LPCN 1144, LPCN 1111, LPCN 1107, LPCN 1154 and LPCN 2101. 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 or suspends on-going clinical studies.
(2)
Revenue
The
Company generates most of its revenue from license and royalty arrangements. At inception of each contract, the Company identifies the
goods and services that have been promised to the customer and each of those that represent a distinct performance obligation, determines
the transaction price including any variable consideration, allocates the transaction price to the distinct performance obligations and
determines whether control transfers to the customer at a point in time or over time. Variable consideration is included in the transaction
price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when
the uncertainty associated with the variable consideration is subsequently resolved. The Company reassesses its reserves for variable
consideration at each reporting date and makes adjustments, if necessary, which may affect revenue and earnings in periods in which any
such changes become known.
See
Note 8 for a description of the license agreement with Antares Pharma, Inc. (“Antares”). See Note 12 for a description of
the agreement with Spriaso, a related party.
7
License
Fees . For distinct license performance obligations, upfront license fees are recognized when the Company satisfies the underlying
performance obligation. Performance obligations under these licenses, which consist of the right to use the Company’s proprietary
technology, are satisfied at a point in time corresponding with delivery of the underlying technology rights to the licensee, which is
generally upon transfer of the licensed technology/product to the customer. In addition, license arrangements may include contingent
milestone payments, which are due following achievement by our licensee of specified sales or regulatory milestones and the licensee
and/or Company will fulfill its performance obligation prior to achievement of these milestones. Because of the uncertainty of the milestone
achievement, and/or the dependence on sales of our licensee, variable consideration for contingent milestones is fully constrained and
is not recognized as revenue until the milestone is achieved by our licensee, to the extent collectability is reasonably certain.
Royalties.
Royalties revenue consists of sales-based and minimum royalties earned under license agreements for our products. Sales-based royalties
revenue represents variable consideration under the license agreements and is recognized in the period a customer sells products incorporating
the Company’s licensed technologies/products. The Company estimates sales-based royalties revenue earned but unpaid at each reporting
period using information provided by the licensee. The Company’s license arrangements may also provide for minimum royalties, which
the Company recognizes upon the satisfaction of the underlying performance obligation, which generally occurs with delivery of the underlying
technology rights to the licensee. Sales-based and minimum royalties are generally due within 45 days after the end of each quarter in
which they are earned.
Contract
Assets
Contract
assets consist of minimum royalty revenue earned in relation to the license agreement but not yet due based on the terms of the contract.
The contract asset as of March 31, 2023 is related to the Antares License Agreement. The contract asset was reduced by approximately
$ 218,000 for royalty payments received during 2022. These royalties were received from Antares under the terms of our license agreement
based on net sales of TLANDO. Based on the terms of the license agreement and sales estimates for the first quarter of 2023 provided
by Antares, the Company estimates that it will not receive a royalty payment on estimated first quarter 2023 net sales of TLANDO under
this agreement.
Revenue
Concentration
A
major partner is considered to be one that comprises more than 10 %
of the Company’s total revenues. The Company recognized revenue of approximately $ 55,000
and $ 0
for the three months ended March 31, 2023, and March 31, 2022, respectively. The revenue recognized in 2023 was 100 %
from one major related-party partner, Spriaso.
(3)
Earnings (Loss) per Share
Basic
earnings (loss) per share is calculated by dividing net income (loss) available to common shareholders by the weighted average number
of common shares outstanding during the period. Diluted earnings (loss) per share is based on the weighted average number of common shares
outstanding plus, where applicable, the additional potential common shares that would have been outstanding related to dilutive options,
warrants and, unvested restricted stock units to the extent such shares are dilutive.
8
The
following table sets forth the computation of basic and diluted earnings (loss) per share of common stock for the three months ended
March 31, 2023 and 2022:
Schedule
of Computation of Basic and Diluted Earnings (loss) Per Share of Common Stock
Three Months Ended March 31,
2023
2022
Basic loss per share attributable to common stock:
Numerator
Net loss
$ ( 3,870,230 )
$ ( 3,487,781 )
Denominator
Weighted avg. common shares outstanding
88,510,791
88,309,628
Basic loss per share attributable to common stock
$ ( 0.04 )
$ ( 0.04 )
Diluted loss per share attributable to common stock:
Numerator
Net loss
$ ( 3,870,230 )
$ ( 3,487,781 )
Effect of dilutive securities on net loss:
Common stock warrants
98,134
-
Total net loss for purpose of calculating diluted net loss per common share
$ ( 3,968,364 )
$ ( 3,487,781 )
Denominator
Weighted avg. common shares outstanding
88,510,791
88,309,628
Weighted average effect of dilutive securities:
Common stock warrants
-
-
Total shares for purpose of calculating diluted net loss per common share
88,510,791
88,309,628
Diluted loss per share attributable to common stock
$ ( 0.04 )
$ ( 0.04 )
The
computation of diluted loss per share for the three months ended March 31, 2023 and 2022 does not include the following stock options
and warrants to purchase shares of common stock 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
March 31,
2023
2022
Stock options
4,466,431
4,229,739
Warrants
840,336
1,934,366
(4)
Marketable Investment Securities
The
Company has classified its marketable investment securities as available-for-sale securities, all of which are debt securities. These
securities are carried at fair value with unrealized holding gains and losses, net of the related tax effect, included in accumulated
other comprehensive income (loss) in stockholders’ equity until realized. Gains and losses on investment security transactions
are reported on the specific-identification method. Dividend income is recognized on the ex-dividend date and interest income is recognized
on an accrual basis. 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, 2023, and December 31, 2022, were as follows:
Schedule
of Available for Sale Securities
March 31, 2023
Amortized Cost
Gross unrealized holding gains
Gross unrealized holding losses
Aggregate fair value
Government treasury bills
$ 1,995,817
$ -
$ ( 2,747 )
$ 1,993,070
Corporate bonds, notes and commercial paper
13,470,151
-
( 8,228 )
13,461,923
U.S. government agency securities
8,631,221
14,216
-
8,645,437
$ 24,097,189
$ 14,216
$ ( 10,975 )
$ 24,100,430
9
December 31, 2022
Amortized Cost
Gross unrealized holding gains
Gross unrealized holding losses
Aggregate fair value
Government treasury bills
$ 5,973,087
$ -
$ ( 14,087 )
$ 5,959,000
Commercial paper
20,052,505
-
( 10,885 )
20,041,620
U.S. government agency securities
3,376,139
4,651
-
3,380,790
$ 29,401,731
$ 4,651
$ ( 24,972 )
$ 29,381,410
Maturities
of debt securities classified as available-for-sale securities as of March 31, 2023, are as follows:
Schedule
of Maturities of Debt Securities Classified as Available-for-sale Securities
March 31, 2023
Amortized
Cost
Aggregate
fair value
Due within one year
$ 24,097,189
$ 24,100,430
$ 24,097,189
$ 24,100,430
There
were no sales of marketable investment securities during the three months ended March 31, 2023, and 2022 and therefore no realized gains
or losses. Additionally, $ 12.0 million and $ 25.2 million of marketable investment securities matured during the three months ended March
31, 2023 and March 31, 2022, respectively. The Company determined there were no other-than-temporary impairments for the three months
ended March 31, 2023, and March 31, 2022.
(5)
Fair Value
The
Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent
possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability
in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following
fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels:
●
Level 1 Inputs: Quoted
prices for identical instruments in active markets.
●
Level 2 Inputs: Quoted
prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active,
and model-derived valuation in which all significant inputs and significant value drivers are observable in active markets.
●
Level 3 Inputs: Valuations
derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.
10
All
of the Company’s financial instruments are valued using quoted prices in active markets or based on other observable inputs. For
accrued interest income, prepaid and other current assets, accounts payable, and accrued expenses, the carrying amounts approximate fair
value because of the short maturity of these instruments. 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, 2023 and December 31, 2022:
Schedule
of Fair Value, Assets Measured on Recurring Basis
Fair value measurements at reporting date using
March 31, 2023
Level 1 inputs
Level 2 inputs
Level 3 inputs
Assets:
Cash equivalents - money market funds
$ 4,353,929
$ 4,353,929
$ -
$ -
Government treasury bills
1,993,070
1,993,070
-
-
Commercial paper
11,129,370
-
11,129,370
-
Corporate bonds and notes
2,332,553
-
2,332,553
-
US. Government agency securities
8,645,437
-
8,645,437
-
$ 28,454,359
$ 6,346,999
$ 22,107,360
$ -
Liabilities:
Warrant liability
$ 131,722
$ -
$ -
$ 131,722
$ 28,586,081
$ 6,346,999
$ 22,107,360
$ 131,722
Fair value measurements at reporting date using
December 31, 2022
Level 1 inputs
Level 2 inputs
Level 3 inputs
Assets:
Cash equivalents - money market funds
$ 2,694,434
$ 2,694,434
$ -
$ -
Government treasury bills
5,959,000
5,959,000
-
-
Commercial paper
14,586,930
-
14,586,930
-
Corporate bonds and notes
5,454,690
-
5,454,690
-
U.S. government agency securities
3,380,790
-
3,380,790
-
$ 32,075,844
$ 8,653,434
$ 23,422,410
$ -
Liabilities:
Warrant liability
$ 229,856
$ -
$ -
$ 229,856
$ 32,305,700
$ 8,653,434
$ 23,422,410
$ 229,856
The
following methods and assumptions were used to determine the fair value of each class of assets and liabilities recorded at fair value
in the balance sheets:
Cash
equivalents: Cash equivalents primarily consist of highly-rated money market funds and treasury bills with original maturities to the
Company of three months or less and are purchased daily at par value with specified yield rates. Cash equivalents related to money market
funds and treasury bills are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices
or broker or dealer quotations for similar assets.
11
Government
treasury bills: The Company uses a third-party pricing service to value these investments. United States treasury bills are classified
within Level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets for identical assets
and reportable trades.
Corporate
bonds, notes, commercial paper and U.S. government agency securities: The Company uses a third-party pricing service to value these investments.
Corporate bonds, notes commercial paper and U.S. government agency securities are classified within Level 2 of the fair value hierarchy
because they are valued using broker/dealer quotes, bids and offers, benchmark yields and credit spreads and other observable inputs.
Warrant
liability: The warrant liability (which relates to warrants to purchase shares of common stock)
is marked-to-market each reporting period with the change in fair value recorded to other income (expense) in the accompanying statements
of operations until the warrants are exercised, expire or other facts and circumstances lead the warrant liability to be reclassified
to stockholders’ equity. The fair value of the warrant liability is estimated using a Black-Scholes option-pricing model. The significant
assumptions used in preparing the option pricing model for valuing the warrant liability as of March 31, 2023, include (i) volatility
of 100 %, (ii) risk free interest rate of 4.34 %, (iii) strike price of $ 0.50 , (iv) fair value of common stock of $ 0.32 , and (v) expected
life of 1.6 years. The significant assumptions used in preparing the option pricing model for valuing the warrant liability as of December
31, 2022, include (i) volatility of 100 %, (ii) risk free interest rate of 4.41 %, (iii) strike price of $ 0.50 , (iv) fair value of common
stock of $ 0.40 , and (v) expected life of 1.9 years.
The
Company’s accounting policy is to recognize transfers between levels of the fair value hierarchy on the date of the event or change
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, 2023.
(6)
Loan and Security Agreements
Silicon
Valley Bank Loan
On
January 5, 2018, the Company entered into a Loan and Security Agreement (the “Loan and Security Agreement”) with Silicon
Valley Bank (“SVB”) pursuant to which SVB agreed to lend the Company $ 10.0 million. The principal borrowed under the Loan
and Security Agreement bore interest at a rate equal to the Prime Rate, as reported in the money rates section of The Wall Street Journal
or any successor publication representing the rate of interest per annum then in effect, plus one percent per annum, which interest was
payable monthly. Additionally on April 1, 2020, the Company entered into a Deferral Agreement with SVB. Under the Deferral Agreement,
principal repayments were deferred by six months and the Company was only required to make monthly interest payments. The loan matured
and was paid in full on June 1, 2022 . The Company made a final payment at maturity equal to $ 650,000 (the “Final Payment Charge”).
The expense of the final payment charge had been recognized over the term of the facility using the effective interest method.
(7)
Income Taxes
The
tax provision for interim periods is determined using an estimate of the Company’s effective tax rate for the full year adjusted
for discrete items, if any, that are taken into account in the relevant period. Each quarter the Company updates its estimate of the
annual effective tax rate, and if the estimated tax rate changes, the Company makes a cumulative adjustment.
At
March 31, 2023 and December 31, 2022, 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.
(8)
Contractual Agreements
(a)
Abbott Products, Inc.
On
March 29, 2012, the Company terminated its collaborative agreement with Solvay Pharmaceuticals, Inc. (later acquired by Abbott Products,
Inc.) for TLANDO. As part of the termination, the Company reacquired the rights to the intellectual property from Abbott. All obligations
under the prior license agreement have been completed except that Lipocine will owe Abbott a perpetual 1 % royalty on net sales. Such
royalties are limited to $ 1.0 million in the first two calendar years following product launch, after which period there is not a cap
on royalties and no maximum aggregate amount. If generic versions of any such product are introduced, then royalties are reduced by 50 %.
TLANDO was commercially launched on June 7, 2022. The Company incurred royalty expense of approximately $ 4,000 and $ 0 during the three
months ended March 31, 2023, and 2022, respectively.
12
(b)
Antares Pharma, Inc.
On
October 14, 2021, the Company entered into a license agreement (“License Agreement”) with Antares Pharma, Inc. (“Antares”)
pursuant to which the Company granted to Antares an exclusive, royalty-bearing, sublicensable right and license to develop and commercialize,
upon final approval of TLANDO® from the U.S. Food and Drug Administration (“FDA”), 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 New Drug Application (“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. TLANDO received FDA approval on March 29, 2022.
Upon
execution of the Antares License Agreement, Antares paid the Company an initial payment of $ 11.0 million. Antares will also make additional
payments of $ 5.0 million to the Company on each of January 1, 2025, and January 1, 2026, provided that certain conditions are satisfied.
The Company is also eligible to receive milestone payments of up to $ 160.0 million in the aggregate, depending on the achievement of
certain sales milestones in a single calendar year with respect to TLANDO, as licensed by Antares under the Antares License Agreement.
In addition, the Company will receive tiered royalty payments at rates ranging from percentages in the mid-teens to up to 20 % of net
sales of TLANDO in the United States, subject to certain minimum royalty obligations.
The
Company retains development and commercialization rights in the rest of the world, and with respect to applications outside of the Field
inside or outside the United States. Antares also purchased certain existing inventory of licensed products from the Company. Finally,
pursuant to the terms of the Antares License Agreement, Antares is generally responsible for expenses relating to the development (including
the conduct of any clinical trials) and commercialization of TLANDO in the Field in the United States, while the Company is generally
responsible for expenses relating to development activities outside of the Field and/or the United States. The Antares License Agreement
also provided Antares with an option, exercisable on or before March 31, 2022, to license TLANDO XR (LPCN 1111), the Company’s
potential once-daily oral product candidate for testosterone replacement therapy. On April 1, 2022, the Company entered into the First
Amendment to the License Agreement (the “Amendment”), pursuant to which the License Agreement was amended to extend the deadline
by which Antares was to exercise its option to license TLANDO XR to June 30, 2022. As consideration for the Company agreeing to enter
into the Amendment, in April 2022 Antares paid the Company a non-refundable cash fee of $ 500,000 . On June 30, 2022, Antares’ option
to license TLANDO XR expired and was not exercised. Lipocine retains all development and commercialization rights to TLANDO XR.
On
May 24, 2022, Halozyme Therapeutics completed an acquisition of Antares Pharma Inc. through the merger of a wholly owned subsidiary of
Halozyme with and into Antares, with Antares continuing as the surviving corporation and becoming a wholly owned subsidiary of Halozyme.
The
Company did not recognize any revenue under the Antares Licensing Agreement during either the three months ended March 31, 2023, or March
31, 2022.
(c)
Contract Research and Development
The
Company has entered into agreements with various contract organizations that conduct pre-clinical, clinical, analytical and manufacturing
development work on behalf of the Company as well as a number of independent contractors and primarily clinical researchers who serve
as advisors to the Company. The Company incurred expenses of $ 2.1 and $ 1.0 million, respectively, for the three months ended March 31,
2023 and 2022 under these agreements and has recorded these expenses in research and development expenses.
(9)
Leases
The
Company has a non-cancelable operating lease for office space and laboratory facilities in Salt Lake City, Utah. The term of the lease
has been extended through February 28, 2024.
13
Future
minimum lease payments under the non-cancelable operating lease as of March 31, 2023 are:
Schedule
of Future Minimum Rental Payments for Operating Leases
Operating
leases
Year ending December 31:
2023
$ 268,017
2024
59,559
Total minimum lease payments
$ 327,576
The
Company’s rent expense was $ 87,000 and $ 84,000 for each of the three months ended March 31, 2023 and 2022, respectively.
(10)
Stockholders’ Equity
On
June 8, 2022, at the 2022 annual meeting of the stockholders, the Company’s stockholders approved an amendment to the Company’s
Amended and Restated Certificate of Incorporation to increase the number of authorized shares of the Company’s common stock, par
value $ 0.0001 , from 100,000,000 shares to 200,000,000 shares. The Company filed the amendment to the Restated Certificate with the Secretary
of State of the State of Delaware on June 28, 2022. The amendment to the Restated Certificate became effective upon filing with the Secretary
of State of the State of Delaware.
(a)
Issuance of Common Stock
On
March 6, 2017, the Company entered into the Sales Agreement with Cantor Fitzgerald & Co. (“Cantor”) 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. The Company currently has
registered up to $ 50.0 million for sale under the Sales Agreement, pursuant to the Registration Statement on Form S-3 (File No. 333-250072)
through Cantor as the Company’s sales agent. Cantor may sell the Company’s common stock by any method permitted by law deemed
to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act, including sales made directly on or
through the Nasdaq Capital Market or any other existing trade market for our common stock, in negotiated transactions at market prices
prevailing at the time of sale or at prices related to prevailing market prices, or any other method permitted by law. Cantor uses its
commercially reasonable efforts consistent with its normal trading and sales practices and applicable law and regulations to sell these
shares. The Company pays Cantor 3.0 % of the aggregate gross proceeds from each sale of shares under the Sales Agreement. In addition,
the Company has also provided Cantor with customary indemnification rights.
The
shares of the Company’s common stock sold under the Sales Agreement are sold and issued pursuant to the Registration Statement
on Form S-3 (File No. 333-250072) (the “Form S-3”), which was previously declared effective by the Securities and Exchange
Commission, and the related prospectus and one or more prospectus supplements.
The
Company is not obligated to make any sales of its common stock under the Sales Agreement. The offering of common stock pursuant to the
Sales Agreement will terminate upon the termination of the Sales Agreement as permitted therein. The Company and Cantor may each terminate
the Sales Agreement at any time upon ten days’ prior notice.
As
of March 31, 2023, the Company had sold an aggregate of 15,023,073 shares at a weighted-average sales price of $ 2.19 per share under
the ATM for aggregate gross proceeds of $ 32.9 million and net proceeds of $ 31.7 million, after deducting sales agent commission and discounts
and our other offering costs. During the three months ended March 31, 2023 and 2022, the Company did not sell any shares of its common
stock pursuant to the Sales Agreement. As of March 31, 2023, the Company had $ 41.2 million available for sale under the Sales Agreement.
However, as of April 3, 2023, the Company is now subject to General Instruction I.B.6 of Form S-3 which limits the amounts that we may
sell under the registration statement. As a result of such limitations, the Company has currently registered the offer and sale of shares
of our common stock pursuant to the Sales Agreement having an aggregate offering price of up to $ 15.7 million.
14
(b)
Series B Preferred Stock
On
March 7, 2023, the board of directors (the “Board”) of the Company declared a dividend of one one-thousandth (1/1,000 th )
of a share of Series B Preferred Stock, par value $ 0.0001 per share (“Series B Preferred Stock”), for each outstanding share
of common stock of the Company, to stockholders of record on March 24, 2023. The Certificate of Designation of Series B Preferred Stock
(the “Certificate of Designation”) was filed with the Delaware Secretary of State and became effective on March 10, 2023.
The
dividend was based on the number of shares of outstanding common stock on March 24, 2023, and resulted in 88,511 Series B Preferred shares
being issued. Each whole share of Series B Preferred Stock entitles the holder thereof to 1,000,000 votes per share, and each fraction
of a share of Series B Preferred Stock has a ratable number of votes. Thus, each one-thousandth of a share of Series B Preferred Stock
is entitled to 1,000 votes. The outstanding shares of Series B Preferred Stock are entitled to vote together with the outstanding shares
of common stock as a single class exclusively with respect to any proposal to adopt an amendment to the Company’s Amended and Restated
Certificate of Incorporation, as amended (the “Certificate of Incorporation”), to effect a reverse stock split of the outstanding
shares of Common Stock at a ratio determined in accordance with the terms of such amendment (the
“Reverse Stock Split”), and (ii) any proposal to adjourn any meeting of stockholders called for the purpose of voting on
the Reverse Stock Split (the “Adjournment Proposal”) in conjunction with the Company’s Annual Shareholder Meeting
(the “Meeting”).
All
shares of Series B Preferred Stock that are not present in person or by proxy at the Meeting as of immediately prior to the opening of
the polls (the “Initial Redemption Time”) w ill automatically be redeemed in whole,
but not in part, by the Company without further action on the part of the Company or the holder of shares of Series B Preferred Stock
(the “Initial Redemption”). Any outstanding shares of Series B Preferred Stock that have not been redeemed pursuant to an
Initial Redemption will be redeemed in whole, but not in part, (i) if such redemption is ordered by the Board in its sole discretion,
automatically and effective on such time and date specified by the Board in its sole discretion or (ii) automatically upon the effectiveness
of the amendment to the Certificate of Incorporation implementing the Reverse Stock Split (the “Subsequent Redemption”).
Each
share of Series B Preferred Stock redeemed in any redemption described above will be redeemed in consideration for the right to receive
an amount equal to $0.01 in cash for each ten whole shares of Series B Preferred Stock that are “beneficially owned” by the
“beneficial owner” (as such terms are defined in the Certificate of Designation with respect to the Series B Preferred Stock)
thereof as of immediately prior to the applicable redemption time and redeemed pursuant to such redemption, payable upon receipt by the
Company of a written request submitted by the applicable holder to the corporate secretary of the Company following the applicable redemption
time.
The
Series B Preferred Stock is not convertible into, or exchangeable for, shares of any other class or series of stock or other securities
of the Company. The Series B Preferred Stock has no stated maturity and is not subject to any sinking fund. The Series B Preferred Stock
is not subject to any restriction on the redemption or repurchase of shares by the Company while there is any arrearage in the payment
of dividends or sinking fund installments.
The
Company is not solely in control of the redemption of the shares of Series B Preferred Stock since the holders have the option of deciding
whether to vote in respect of the above described Reverse Stock Split, which determines whether a given holder’s shares of Series
B Preferred Stock are redeemed in the Initial Redemption or the Subsequent Redemption. Since the redemption of the Series B Preferred
Stock is not solely in the control of the Company, the shares of Series B Preferred Stock are classified within the mezzanine equity
in the Company’s audited consolidated statement of stockholder’s equity. The shares of Series B Preferred Stock will be measured
at redemption value. See Note 14. Subsequent Events, Redemption and Elimination of Series B Preferred Stock.
The
foregoing description of the Series B Preferred Stock does not purport to be complete and is qualified in its entirety by reference to
the Certificate of Designation, which is filed as Exhibit 3.2 to the Form 8-K filed with the SEC on March 10, 2023.
15
(c)
Rights Agreement
On
November 13, 2015, the Company and American Stock Transfer & Trust Company, LLC, as Rights Agent, entered into a Rights Agreement.
Also on November 12, 2015, the Board of the Company authorized and the Company declared a dividend of one preferred stock purchase right
(each a “Right” and collectively, the “Rights”) for each outstanding share of common stock of the Company. The
dividend was payable to stockholders of record as of the close of business on November 30, 2015 and entitles the registered holder to
purchase from the Company one one-thousandth of a fully paid non-assessable share of Series A Junior Participating Preferred Stock of
the Company at a price of $ 63.96 per one-thousandth share (the “Purchase Price”). The Rights will generally become exercisable
upon the earlier to occur of (i) 10 business days following a public announcement that a person or group of affiliated or associated
persons has become an Acquiring Person (as defined below) or (ii) 10 business days (or such later date as may be determined by action
of the Board prior to such time as any person or group of affiliated or associated persons becomes an Acquiring Person) following the
commencement of, or announcement of an intention to make, a tender offer or exchange offer the consummation of which would result in
the beneficial ownership by a person or group of 15% or more of the outstanding common stock of the Company. Except in certain situations,
a person or group of affiliated or associated persons becomes an “Acquiring Person” upon acquiring beneficial ownership of
15% or more of the outstanding shares of common stock of the Company.
In
general, in the event a person becomes an Acquiring Person, then each Right not owned by such Acquiring Person will entitle its holder
to purchase from the Company, at the Right’s then current exercise price, in lieu of shares of Series A Junior Participating Preferred
Stock, common stock of the Company with a market value of twice the Purchase Price. In addition, if after any person has become an Acquiring
Person, (a) the Company is acquired in a merger or other business combination, or (b) 50% or more of the Company’s assets, or assets
accounting for 50% or more of its earning power, are sold, leased, exchanged or otherwise transferred (in one or more transactions),
proper provision shall be made so that each holder of a Right (other than the Acquiring Person, its affiliates and associates and certain
transferees thereof, whose Rights became void) shall thereafter have the right to purchase from the acquiring corporation, for the Purchase
Price, that number of shares of common stock of the acquiring corporation which at the time of such transaction would have a market value
of twice the Purchase Price.
The
Company will be entitled to redeem the Rights at $ 0.001 per Right at any time prior to the time an Acquiring Person becomes such. The
terms of the Rights are set forth in the Rights Agreement, which is summarized in the Company’s Current Report on Form 8-K dated
November 13, 2015. The rights plan was originally set to expire on November 12, 2018; however, on November 5, 2018 our Board approved
an Amended and Restated Rights Agreement pursuant to which the expiration date was extended to November 5, 2021, and again on November
2, 2021, the Company adopted a Second Amended and Restated Rights Agreement pursuant to which the expiration date was extended to November
1, 2024, unless the rights are earlier redeemed or exchanged by the Company.
(d)
Share-Based Payments
The
Company recognizes stock-based compensation expense for grants of stock option awards, restricted stock units and restricted stock under
the Company’s Incentive Plan to employees, nonemployees and nonemployee members of the Company’s Board based on the grant-date
fair value of those awards. The grant-date fair value of an award is generally recognized as compensation expense over the award’s
requisite service period. In addition, the Company has granted performance-based stock option awards and restricted stock units, which
vest based upon the Company satisfying certain performance conditions. Potential compensation cost, measured on the grant date, related
to these performance options will be recognized only if, and when, the Company estimates that these options or units will vest, which
is based on whether the Company considers the performance conditions to be probable of attainment. The Company’s estimates of the
number of performance-based options or units that will vest will be revised, if necessary, in subsequent periods.
16
The
Company uses the Black-Scholes model to compute the estimated fair value of stock option awards. Using this model, fair value is calculated
based on assumptions with respect to (i) expected volatility of the Company’s common stock price, (ii) the periods of time over
which employees and members of the board of directors are expected to hold their options prior to exercise (expected term), (iii) expected
dividend yield on the Common Stock, and (iv) risk-free interest rates. Stock-based compensation expense also includes an estimate, which
is made at the time of grant, of the number of awards that are expected to be forfeited. This estimate is revised, if necessary, in subsequent
periods if actual forfeitures differ from those estimates. Stock-based compensation cost that has been expensed in the statements of
operations amounted to approximately $ 178,000 and $ 171,000 , respectively, for the three months ended March 31, 2023 and 2022 and
is allocated as follows:
Schedule
of Employee Service Share-based Compensation, Allocation of Recognized Period Costs
Three Months Ended
March 31,
2023
2022
Research and development
$ 95,513
$ 79,652
General and administrative
82,259
91,376
$ 177,772
$ 171,028
The
Company issued 300,000 and 332,500 stock options, respectively, during the three months ended March 31, 2023 and 2022.
Key
assumptions used in the determination of the fair value of stock options granted are as follows:
Expected
Term : The expected term represents the period that the stock-based awards are expected to be outstanding. The expected term was estimated
using the simplified method in accordance with the provisions of Staff Accounting Bulletin (“SAB”) No. 107, Share-Based
Payment for awards with stated or implied service periods. The simplified method defines the expected term as the average of the
contractual term and the vesting period of the stock option. For awards with performance conditions, and that have the contractual term
to satisfy the performance condition, the contractual term was used.
Risk-Free
Interest Rate: The risk-free interest rate used was based on the implied yield currently available on U.S. Treasury issues with an
equivalent remaining term.
Expected
Dividend : The expected dividend assumption is based on management’s current expectation about the Company’s anticipated
dividend policy. The Company does not anticipate declaring dividends in the foreseeable future.
Expected
Volatility : The volatility factor is based solely on the Company’s trading history.
For
options granted during the three months ended March 31, 2023 and 2022, 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
2023
2022
Expected term
5.85 years
5.85 years
Risk-free interest rate
3.91 %
1.41 %
Expected dividend yield
—
—
Expected volatility
97.61 %
102.43 %
FASB
ASC 718, Stock Compensation, requires the Company to recognize compensation expense for the portion of options that are expected
to vest. Therefore, the Company applied estimated forfeiture rates that were derived from historical employee termination behavior. If
the actual number of forfeitures differs from those estimated by management, additional adjustments to compensation expense may be required
in future periods.
As
of March 31, 2023, there was $ 940,000 of total unrecognized compensation cost related to unvested share-based compensation arrangements
granted under the Company’s stock option plan. That cost is expected to be recognized over a weighted average period of 1.8 years
and will be adjusted for subsequent changes in estimated forfeitures.
17
(e)
Stock Option Plan
In
April 2014, the Board adopted the 2014 Stock and Incentive Plan (“2014 Plan”) subject to shareholder approval which was received
in June 2014. The 2014 Plan provides for the granting of nonqualified and incentive stock options, stock appreciation rights, restricted
stock units, restricted stock and dividend equivalents. An aggregate of 1,000,000 shares were authorized for issuance under the 2014
Plan. Additionally, 271,906 remaining authorized shares under the 2011 Equity Incentive Plan (“2011 Plan”) were issuable
under the 2014 Plan at the time of the 2014 Plan adoption. Upon receiving shareholder approval in June 2016, the 2014 Plan was amended
and restated to increase the authorized number of shares of common stock of the Company issuable under all awards granted under the 2014
Plan from 1,271,906 to 2,471,906 . Additionally, upon receiving shareholder approval in June 2018, the 2014 Plan was further amended and
restated to increase the authorized number of shares of common stock of the Company issuable under all awards granted under the 2014
Plan from 2,471,906 to 3,221,906 . Finally, upon receiving shareholder approval in June 2020, the 2014 Plan was further amended and restated
to increase the authorized number of shares of common stock of the Company issuable under all awards granted under the 2014 Plan from
3,221,906 to 5,721,906 . 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 5,721,906 shares of common stock are authorized for issuance under the 2014 Plan, with 814,092 shares remaining available for grant
as of March 31, 2023.
A
summary of stock option activity is as follows:
Schedule
of Stock Option Activity
Outstanding stock options
Number of shares
Weighted average exercise price
Balance at December 31, 2022
4,713,862
$ 2.29
Options granted
300,000
0.41
Options exercised
-
-
Options forfeited
( 547,431 )
2.81
Options cancelled
-
-
Balance at March 31, 2023
4,466,431
2.10
Options exercisable at March 31, 2023
2,599,610
3.08
The
following table summarizes information about stock options outstanding and exercisable at March 31, 2023:
Schedule
of Share-based Compensation of Stock Options Outstanding and Exercisable
Options outstanding
Options exercisable
Number outstanding
Weighted average remaining contractual life (Years)
Weighted average exercise price
Aggregate intrinsic value
Number exerciseable
Weighted average remaining contractual life (Years)
Weighted average exercise price
Aggregate intrinsic value
4,466,431
7.28
$ 2.10
$ -
2,599,610
5.88
$ 3.08
$ -
The
intrinsic value for stock options is defined as the difference between the current market value and the exercise price. There were 0
and 208,274 stock options exercised during the three months ended March 31, 2023 and March 31, 2022, respectively.
18
(f)
Common Stock Warrants
The
Company accounts for its common stock warrants under ASC 480, Distinguishing Liabilities from Equity , which requires any financial
instrument, other than an outstanding share, that, at inception, embodies an obligation to repurchase the issuer’s equity shares,
or is indexed to such an obligation, and requires or may require the issuer to settle the obligation by transferring assets, to be classified
as a liability. In accordance with ASC 480, the Company’s outstanding warrants from the November 2019 Offering are classified as
a liability. The liability is adjusted to fair value at each reporting period, with the changes in fair value recognized as gain (loss)
on change in fair value of warrant liability in the Company’s consolidated statements of operations. The warrants issued in the
November 2019 Offering allow the warrant holder, if certain change in control events occur, the option to receive an amount of cash equal
to the value of the warrants as determined in accordance with the Black-Scholes option pricing model with certain defined assumptions
upon a fundamental transaction.
As
of March 31, 2023, the Company had 1,094,030 common stock warrants outstanding from the November 2019 Offering to purchase an equal number
of shares of common stock. The fair value of these warrants on March 31, 2023 and on March 31, 2022 was determined using the Black-Scholes
option pricing model with the following Level 3 inputs (as defined in the November 2019 Offering):
March 31, 2023
March 31, 2022
Expected life in years
1.64
2.63
Risk-free interest rate
4.34 %
2.64 %
Dividend yield
—
—
Volatility
100.00 %
100.00 %
Stock price
$ 0.32
$ 1.38
During
the three months ended March 31, 2023, and March 31, 2022, the Company recorded a non-cash gain of approximately $ 98,000 and a non-cash
loss of $ 378,000 , respectively, from the change in fair value of the November 2019 Offering warrants. The following table is a reconciliation
of the warrant liability measured at fair value using level 3 inputs:
Schedule
of Reconciliation of Warrant Liability
Warrant Liability
Balance at December 31, 2022
$ 229,856
Settlement of liability on warrant exercise
-
Change in fair value of common stock warrants
( 98,134 )
Balance at March 31, 2023
$ 131,722
Additionally,
in the February 2020 Offering, the Company issued 5,042,017 common stock warrants, however, because these warrants do not provide the
warrant holder the option to put the warrant back to the Company, the warrants are classified as equity. As of March 31, 2023, and March
31, 2022, there were 840,336 warrants outstanding that were issued in conjunction with the February 2020 Offering.
19
The
following table summarizes the number of common stock warrants outstanding and the weighted average exercise price:
Schedule
of Number of Warrants Outstanding and the Weighted Average Exercise Price
Warrants
Weighted Average Exercise Price
Outstanding at December 31, 2022
1,934,366
$ 0.51
Issued
-
-
Exercised
-
-
Expired
-
-
Cancelled
-
-
Forfeited
-
-
Balance at March 31, 2023
1,934,366
$ 0.51
There
were no common stock warrants exercised during the three months ended March 31, 2023, or the three months ended March 31, 2022.
The
following table summarizes information about common stock warrants outstanding at March 31, 2023:
Schedule of Common Stock Warrants Outstanding
Warrants outstanding
Number exercisable
Weighted average remaining contractual life (Years)
Weighted average exercise price
Aggregate intrinsic value
1,934,366
1.76
$ 0.51
$ -
(11)
Commitments and Contingencies
Litigation
The
Company is involved in various lawsuits, claims and other legal matters from time to time that arise in the ordinary course of conducting
business. The Company records a liability when a particular contingency is probable and estimable.
On
April 2, 2019, the Company filed a lawsuit against Clarus in the United States District Court for the District of Delaware alleging that
Clarus’s JATENZO® product infringes six of Lipocine’s issued U.S. patents: 9,034,858; 9,205,057; 9,480,690; 9,757,390;
6,569,463; and 6,923,988. However, on February 11, 2020, the Company voluntarily dismissed allegations of patent infringement for expired
U.S. Patent Nos. 6,569,463 and 6,923,988 in an effort to streamline the issues and associated costs for dispute. Clarus answered the
complaint and asserted counterclaims of non-infringement and invalidity. The Company answered Clarus’s counterclaims on April 29,
2019. The Court held a scheduling conference on August 15, 2019, a claim construction hearing on February 11, 2020, and a summary judgment
hearing on January 15, 2021. In May 2021, the Court granted Clarus’ motion for Summary Judgment, finding the asserted claims of
Lipocine’s U.S. patents 9,034,858; 9,205,057; 9,480,690; and 9,757,390 invalid for failure to satisfy the written description requirement
of 35 U.S.C. § 112. Clarus still had remaining claims before the Court. On July 13, 2021, the Company entered into the Global Agreement
with Clarus which resolved all outstanding claims of this litigation as well as the on-going United States Patent and Trademark Office
(“USPTO”) Interference No. 106,128 between the parties. Under the terms of the Global Agreement, the Company agreed to pay
Clarus $ 4.0 million payable as follows: $ 2.5 million immediately, $ 1.0 million on July 13, 2022 and $ 500,000 on July 13, 2023. On April
29, 2022, the Company agreed to an amendment to Section 3.1 of the Global Agreement, pursuant to which the Company agreed to pay Clarus
$ 1,250,000 in May 2022, with no additional payments required thereafter. No future royalties are owing from either party.
20
On
November 14, 2019, the Company and certain of its officers were named as defendants in a purported shareholder class action lawsuit,
Solomon Abady v. Lipocine Inc. et al., 2:19-cv-00906-PMW, filed in the United District Court for the District of Utah. The complaint
alleges that the defendants made false and/or misleading statements and/or failed to disclose that the Company’s filing of the
NDA for TLANDO to the FDA contained deficiencies and as a result the defendants’ statements about our business and operations were
false and misleading and/or lacked a reasonable basis in violation of federal securities laws. The lawsuit sought certification as a
class action (for a purported class of purchasers of the Company’s securities from March 27, 2019 through November 8, 2019), compensatory
damages in an unspecified amount, and unspecified equitable or injunctive relief. The Company has insurance that covers claims of this
nature. The retention amount payable by the Company under its policy is $ 1.25 million. The Company filed a motion to dismiss the class
action lawsuit on July 24, 2020. In response, the plaintiffs filed their response to the motion to dismiss the class action lawsuit on
September 22, 2020 and the Company filed its reply to its motion to dismiss on October 22, 2020. A hearing on the motion to dismiss occurred
on January 12, 2022. On April 14, 2023, a judgment was issued ordering the case dismissed with prejudice and closure of the action.
Management
does not currently believe that any other matter, individually or in the aggregate, will have a material adverse effect on our financial
condition, liquidity or results of operations.
Guarantees
and Indemnifications
In
the ordinary course of business, the Company enters into agreements, such as lease agreements, licensing agreements, clinical trial agreements,
and certain services agreements, containing standard guarantee and / or indemnification provisions. Additionally, the Company has indemnified
its directors and officers to the maximum extent permitted under the laws of the State of Delaware.
(12)
Agreement with Spriaso, LLC
The
Company has a license and a services agreement with Spriaso, a related-party that is majority-owned by certain current and former directors
of Lipocine Inc. and their affiliates. Under the license agreement, the Company assigned and transferred to Spriaso all of the Company’s
rights, title and interest in its intellectual property to develop products for the cough and cold field. In addition, Spriaso received
all rights and obligations under the Company’s product development agreement with a third-party. In exchange, the Company will
receive a royalty of 20 percent of the net proceeds received by Spriaso, up to a maximum of $ 10.0 million. Spriaso also granted back
to the Company an exclusive license to such intellectual property to develop products outside of the cough and cold field. The Company
also agreed to continue providing up to 10 percent of the services of certain employees to Spriaso for a period of time. The agreement
to provide services expired in 2021 ; however, it may be extended upon written agreement of Spriaso and the Company. Additionally, during
the three months ended March 31, 2023 and 2022, the Company received licensing revenue from Spriaso of $ 55,000 and $ 0 , respectively.
Spriaso filed its first NDA and as an affiliated entity of the Company, it used 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.
(13)
Subsequent Events
Initial
Redemption of Series B Preferred Stock
All
shares of Series B Preferred Stock that were not present in person or by proxy at the Annual Shareholder Meeting as of immediately prior
to the opening of the polls on May 10, 2023 were automatically redeemed in whole, but not in part,
by the Company at the Initial Redemption Time. Any outstanding shares of Series B Preferred Stock that have not been redeemed pursuant
to the Initial Redemption will be redeemed in whole, but not in part, (i) if such redemption is ordered by the Board in its sole discretion,
automatically and effective on such time and date specified by the Board in its sole discretion or (ii) automatically upon the effectiveness
of the amendment to the Certificate of Incorporation implementing the Reverse Stock Split.
21
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.