Item 1. Financial Statements
ITEM
1. FINANCIAL STATEMENTS
LIPOCINE
INC. AND SUBSIDIARIES
Condensed
Consolidated Balance Sheets
(Unaudited)
June
30,
December
31,
2024
2023
Assets
Current assets:
Cash and cash
equivalents
$ 5,553,371
$ 4,771,758
Marketable investment securities
16,995,424
17,263,788
Accrued interest income
63,636
52,254
Prepaid
and other current assets
297,051
773,424
Total current assets
22,909,482
22,861,224
Property and equipment, net of accumulated depreciation of $ 1,199,215
and $ 1,182,191 respectively
99,071
116,095
Other assets
23,753
23,753
Total
assets
$ 23,032,306
$ 23,001,072
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 448,798
$ 1,395,977
Accrued expenses
1,233,477
1,218,486
Warrant
liability
141,668
17,166
Total
current liabilities
1,823,943
2,631,629
Total
liabilities
1,823,943
2,631,629
Commitments and contingencies (notes 7, 8,
9 and 10)
-
-
Stockholders’ equity:
Common stock, par value $ 0.0001 per share,
200,000,000 shares authorized; 5,348,276 and 5,316,166 issued, and 5,347,940 and 5,315,830 outstanding, respectively outstanding
8,863
8,860
Additional paid-in capital
220,582,158
220,171,250
Treasury stock at cost,
336 shares
( 40,712 )
( 40,712 )
Accumulated other comprehensive
gain (loss)
( 9,719 )
7,259
Accumulated
deficit
( 199,332,227 )
( 199,777,214 )
Total
stockholders’ equity
21,208,363
20,369,443
Total
liabilities and stockholders’ equity
$ 23,032,306
$ 23,001,072
See
accompanying notes to condensed consolidated financial statements
3
LIPOCINE
INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
Three
Months Ended June 30,
Six
Months Ended June 30,
2024
2023
2024
2023
Revenues:
License revenue
$ -
$ -
$ 7,500,000
$ 54,990
Royalty
revenue
89,565
-
206,738
-
Total
revenues
89,565
-
7,706,738
54,990
Operating expenses:
Research and development
1,874,721
2,515,211
4,693,646
5,621,521
General
and administrative
1,507,412
1,440,394
3,083,131
2,727,708
Total
operating expenses
3,382,133
3,955,605
7,776,777
8,349,229
Operating
loss
( 3,292,568 )
( 3,955,605 )
( 70,039 )
( 8,294,239 )
Other income (expense):
Interest and investment
income
308,845
379,521
640,209
749,991
Unrealized
gain (loss) on warrant liability
( 84,430 )
27,455
( 124,502 )
125,589
Total
other income, net
224,415
406,976
515,707
875,580
Income (loss) before income
tax expense
( 3,068,153 )
( 3,548,629 )
445,668
( 7,418,659 )
Income tax expense
( 481 )
-
( 681 )
( 200 )
Net income (loss)
( 3,068,634 )
( 3,548,629 )
444,987
( 7,418,859 )
Issuance
of Series B preferred stock dividend
-
-
-
( 89 )
Net
income (loss) attributable to common shareholders
$ ( 3,068,634 )
$ ( 3,548,629 )
$ 444,987
$ ( 7,418,948 )
Basic earnings (loss)
per share attributable to common stock
$ ( 0.57 )
$ ( 0.68 )
$ 0.08
$ ( 1.42 )
Weighted average common shares outstanding,
basic
5,343,922
5,234,830
5,329,876
5,234,830
Diluted earnings (loss)
per share attributable to common stock
$ ( 0.56 )
$ ( 0.68 )
$ 0.10
$ ( 1.44 )
Weighted average common shares outstanding,
diluted
5,343,922
5,234,830
5,459,204
5,234,830
Comprehensive income (loss):
Net income (loss)
$ ( 3,068,634 )
$ ( 3,548,629 )
$ 444,987
$ ( 7,418,859 )
Net
unrealized gain (loss) on marketable investment securities
885
( 19,053 )
( 16,978 )
4,509
Comprehensive
income (loss)
$ ( 3,067,749 )
$ ( 3,567,682 )
$ 428,009
$ ( 7,414,350 )
See
accompanying notes to condensed consolidated financial statements
4
LIPOCINE
INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Changes in Stockholders’ Equity
For
the Three and Six Months Ended June 30, 2024 and 2023
(Unaudited)
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
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
Gain (Loss)
Accumulated
Deficit
Total
Stockholders’
Equity
Balances
at March 31, 2023
88,511
9
5,234,830
8,852
336
( 40,712 )
219,284,000
3,241
( 187,295,362 )
31,960,028
Net
loss
-
-
-
-
-
-
-
-
( 3,548,629 )
( 3,548,629 )
Unrealized
net loss on marketable investment securities
-
-
-
-
-
-
-
( 19,053 )
-
( 19,053 )
Stock-based
compensation
-
-
-
-
-
-
164,865
-
-
164,865
Redemption
of Series B preferred stock
( 88,511 )
( 9 )
-
-
-
-
9
-
-
-
Costs
associated with ATM Offering
-
-
-
-
-
-
( 5,200 )
-
-
( 5,200 )
Balances
at June 30, 2023
-
$ -
5,234,830
$ 8,852
336
$ ( 40,712 )
$ 219,443,674
$ ( 15,812 )
$ ( 190,843,991 )
$ 28,552,011
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
-
$ -
5,234,830
$ 8,852
336
$ ( 40,712 )
$ 219,112,164
$ ( 20,321 )
$ ( 183,425,043 )
$ 35,634,940
Net
loss
-
-
-
-
-
-
-
-
( 7,418,859 )
( 7,418,859 )
Unrealized
net gain on marketable investment securities
-
-
-
-
-
-
-
4,509
-
4,509
Stock-based
compensation
-
-
-
-
-
-
342,637
-
-
342,637
Issuance
of Series B preferred stock
88,511
9
-
-
-
-
80
-
( 89 )
-
Redemption
of Series B preferred stock
( 88,511 )
( 9 )
-
-
-
-
9
-
-
-
Common
stock sold through ATM offering
-
-
-
-
-
-
( 11,216 )
-
-
( 11,216 )
Balances
at June 30, 2023
-
$ -
5,234,830
$ 8,852
336
$ ( 40,712 )
$ 219,443,674
$ ( 15,812 )
$ ( 190,843,991 )
$ 28,552,011
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
Gain (Loss)
Accumulated
Deficit
Total
Stockholders’
Equity
Balances
at March 31, 2024
-
-
5,315,830
8,860
336
( 40,712 )
220,262,456
( 10,604 )
( 196,263,593 )
23,956,407
Net
loss
-
-
-
-
-
-
-
-
( 3,068,634 )
( 3,068,634 )
Unrealized
net gain on marketable investment securities
-
-
-
-
-
-
-
885
-
885
Stock-based
compensation
-
-
-
-
-
-
102,265
-
-
102,265
Common
stock sold through ATM Offering
-
-
32,110
3
-
-
217,437
-
-
217,440
Balances
at June 30, 2024
-
$ -
5,347,940
$ 8,863
336
$ ( 40,712 )
$ 220,582,158
$ ( 9,719 )
$ ( 199,332,227 )
$ 21,208,363
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
Gain (Loss)
Accumulated
Deficit
Total
Stockholders’
Equity
Balances
at December 31, 2023
-
$ -
5,315,830
$ 8,860
336
$ ( 40,712 )
$ 220,171,250
$ 7,259
$ ( 199,777,214 )
$ 20,369,443
Balance
-
$ -
5,315,830
$ 8,860
336
$ ( 40,712 )
$ 220,171,250
$ 7,259
$ ( 199,777,214 )
$ 20,369,443
Net
income
-
-
-
-
-
-
-
-
444,987
444,987
Net
income (loss)
-
-
-
-
-
-
-
-
444,987
444,987
Unrealized
net loss on marketable investment securities
-
-
-
-
-
-
-
( 16,978 )
-
( 16,978 )
Stock-based
compensation
-
-
-
-
-
-
201,571
-
-
201,571
Common
stock sold through ATM offering
-
-
32,110
3
-
-
209,337
-
-
209,340
Balances
at June 30, 2024
-
$ -
5,347,940
$ 8,863
336
$ ( 40,712 )
$ 220,582,158
$ ( 9,719 )
$ ( 199,332,227 )
$ 21,208,363
Balance
-
$ -
5,347,940
$ 8,863
336
$ ( 40,712 )
$ 220,582,158
$ ( 9,719 )
$ ( 199,332,227 )
$ 21,208,363
See
accompanying notes to condensed consolidated financial statements
5
LIPOCINE
INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
Six
Months Ended June 30,
2024
2023
Cash flows from operating activities:
Net income
(loss)
$ 444,987
$ ( 7,418,859 )
Adjustments to reconcile
net income (loss) to cash used in operating activities:
Depreciation expense
17,024
12,910
Stock-based compensation
expense
201,571
342,637
Non-cash loss (gain) on
change in fair value of warrant liability
124,502
( 125,589 )
Amortization of discounts
on marketable investment securities
( 411,145 )
( 508,425 )
Changes in operating assets
and liabilities:
Accrued interest income
( 11,382 )
56,197
Prepaid and other current
assets
476,373
254,419
Accounts payable
( 947,179 )
( 82,801 )
Accrued expenses
14,991
231,857
Cash
used in operating activities
( 90,258 )
( 7,237,654 )
Cash flows from investing activities:
Purchase of property and
equipment
-
( 4,000 )
Purchases of marketable
investment securities
( 17,537,469 )
( 8,780,931 )
Maturities of marketable
investment securities
18,200,000
17,900,000
Net
cash provided by investing activities
662,531
9,115,069
Cash flows from financing activities:
Net
proceeds from sale of common stock through ATM
209,340
( 11,216 )
Cash
provided by (used in) financing activities
209,340
( 11,216 )
Net increase in cash and
cash equivalents
781,613
1,866,199
Cash and cash equivalents
at beginning of period
4,771,758
3,148,496
Cash and cash equivalents
at end of period
$ 5,553,371
$ 5,014,695
Supplemental disclosure
of cash flow information:
Income taxes paid
$ 681
656
Supplemental disclosure
of non-cash investing and financing activities:
Net unrealized gain (loss)
on available-for-sale securities
$ ( 16,978 )
$ 4,509
Issuance of Series B preferred
stock
$ -
$ 89
See
accompanying notes to 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 and six months ended June 30, 2024 are not necessarily
indicative of the results that may be expected for any future period or for the year ending December 31, 2024.
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, 2023.
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 August 8, 2025. 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 8, 2025, 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 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 2101, LPCN 2203, LPCN 2401, LPCN
1148, LPCN 1144, and or LPCN 1107. Conversely, the Company’s capital resources could last longer if the Company reduces expenses,
reduces the number of activities currently contemplated under its operating plan, or terminates, modifies the design of or suspends on-going
clinical studies.
On
January 12, 2024, the Company entered into a License Agreement (the “Verity License Agreement”) with Gordon Silver
Limited (“GSL”) and Verity Pharmaceuticals, Inc. (“Verity Pharma”), pursuant to which the Company granted 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 a 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 and Canada.
The Verity License Agreement also provides GSL with a license to develop and commercialize TLANDO XR, the Company’s potential
once-daily oral product candidate for testosterone replacement therapy. The Company retains development and commercialization rights
for TLANDO and TLANDO XR (LPCN 1111) outside of the United States and Canada, and with respect to applications outside of the Field
inside or outside the United States and Canada.
Upon
execution of the Verity License Agreement, GSL agreed to pay the Company a license fee of $ 11.0
million with an initial payment of $ 2.5
million which was received on signing of the Verity License Agreement, $ 5.0
million which was received on February 1, 2024, $ 2.5
million to be paid no later than January 1, 2025, and $ 1.0
million to be paid no later than January 1, 2026. The Company is also eligible to receive development and sales milestone payments
of up to $ 259
million in the aggregate, depending primarily on the achievement of certain sales milestones in a single calendar year with respect
to all products licensed by GSL under the Verity License Agreement. In addition, the Company is eligible to receive tiered royalty
payments at rates ranging from 12 %
up to 18 %
of net sales of licensed products in the United States and Canada.
7
On
May 10, 2023, the Company’s Board approved a reverse stock split ratio of 1-for-17 . The Company
filed an Amendment to its Certificate of Incorporation with the Secretary of State of the State of Delaware on May 10, 2023, and the
Amendment became effective at 5:00 p.m. Eastern Time on Thursday, May 11, 2023. The Company’s shares began trading on a split-adjusted
basis on the Nasdaq Capital Market commencing upon market open on May 12, 2023.
The
accompanying consolidated financial statements and notes to consolidated financial statements give retroactive effect to the reverse
stock split for all periods presented. The reverse stock split did not change the number of authorized shares of common stock or its
par value.
(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 7 for a description of the Verity License Agreement.
See Note 11 for a description of the agreement with Spriaso, a related party.
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 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.
Revenue
Concentration
A
major partner is considered to be one that comprises more than 10 %
of the Company’s total revenues. For the three months ended June 30, 2024, the Company recognized royalty revenue of
approximately $ 90,000
relating to the Verity License Agreement. For the six months ended June 30, 2024, the Company recognized licensing revenue of $ 7.5
million and royalty revenue of approximately $ 140,000
relating to the Verity License Agreement. The revenue recognized in 2024 was 99 %
from one major customer, Verity Pharma. There was no
revenue recognized in the three months ended June 30, 2023. License revenue recognized in the six months ended June 30, 2023 of
$ 55,000
was 100 %
from a related-party, 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 and six months
ended June 30, 2024 and 2023:
Schedule of Computation of Basic and Diluted Earnings (Loss) Per Share of Common Stock
2024
2023
2024
2023
Three
Months Ended June 30,
Six
Months Ended June 30,
2024
2023
2024
2023
Basic earnings (loss) per
share attributable to common stock:
Numerator
Net
income (loss)
$ ( 3,068,634 )
$ ( 3,548,629 )
$ 444,987
$ ( 7,418,948 )
Denominator
Weighted avg. common
shares outstanding
5,343,922
5,234,830
5,329,876
5,234,830
Basic earnings (loss)
per share attributable to common stock
$ ( 0.57 )
$ ( 0.68 )
$ 0.08
$ ( 1.42 )
Diluted earnings (loss)
per share attributable to common stock:
Numerator
Net income (loss)
$ ( 3,068,634 )
$ ( 3,548,629 )
$ 444,987
$ ( 7,418,948 )
Effect of dilutive securities
on net income (loss):
Common
stock warrants
( 84,430 )
27,455
( 124,502 )
125,589
Total net earnings
(loss) for purpose of calculating diluted earnings (loss) per common share
$ ( 2,984,204 )
$ ( 3,576,084 )
$ 569,489
$ ( 7,544,537 )
Denominator
Weighted avg. common shares outstanding
5,343,922
5,234,830
5,329,876
5,234,830
Weighted average effect of dilutive securities:
Stock options
-
-
122,074
-
Restricted
stock units
-
-
7,254
-
Dilutive securities
-
-
7,254
-
Total
shares for purpose of calculating diluted net earnings (loss) per common share
5,343,922
5,234,830
5,459,204
5,234,830
Diluted
earnings (loss) per share attributable to common stock
$
( 0.56
)
$
( 0.68
)
$
0.10
$
( 1.44
)
The
computation of diluted loss per share for the six months ended June 30, 2024 and 2023 does not include the following stock options and
warrants to purchase shares of common stock or unvested restricted stock units in the computation of diluted loss per share because these
instruments were antidilutive:
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share
For
the Three Months Ended
June 30,
For
the Six Months Ended
June 30,
2024
2023
2024
2023
Stock options
295,517
264,150
173,443
264,150
Unvested restricted stock units
21,762
-
14,508
-
Warrants
49,333
49,433
49,433
49,433
(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 June 30, 2024, and December 31, 2023, were as follows:
9
Schedule
of Available for Sale Securities
June 30,
2024
Amortized
Cost
Gross
unrealized
holding
gains
Gross
unrealized
holding
losses
Aggregate
fair
value
Government treasury bills
$ 6,212,764
$ 98
$ -
$ 6,212,862
U.S. government agency securities
10,792,379
-
( 9,817 )
10,782,562
$ 17,005,143
$ 98
$ ( 9,817 )
$ 16,995,424
December
31, 2023
Amortized
Cost
Gross
unrealized
holding
gains
Gross
unrealized
holding
losses
Aggregate
fair
value
Government treasury bills
$ 14,272,530
$ 8,574
$ -
$ 14,281,104
U.S. government agency securities
2,983,999
-
( 1,315 )
2,982,684
$ 17,256,529
$ 8,574
$ ( 1,315 )
$ 17,263,788
Maturities
of debt securities classified as available-for-sale securities as of June 30, 2024 are as follows:
Schedule of Maturities of Debt Securities Classified as Available-for-Sale Securities
June 30,
2024
Amortized
Cost
Aggregate
fair
value
Due within
one year
$ 17,005,143
$ 16,995,424
$ 17,005,143
$ 16,995,424
There
were no sales of marketable investment securities during either the three or six months ended June 30, 2024 and 2023 and therefore no
realized gains or losses. Additionally, during the three months ended June 30, 2024 and 2023, $ 11.5 million and $ 5.9 million of marketable
investment securities matured, and during the six months ended June 30, 2024 and 2023, $ 18.2 million and $ 17.9 million of marketable
securities matured, respectively. The Company determined there were no other-than-temporary impairments for either the three or six months
ended June 30, 2024 and 2023.
(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 June 30, 2024 and December 31, 2023:
Schedule
of Fair Value, Assets and Liabilities Measured on Recurring Basis
Fair
value measurements at reporting date using
June
30, 2024
Level
1 inputs
Level
2 inputs
Level
3 inputs
Assets:
Cash equivalents
- money market funds
$ 4,459,338
$ 4,459,338
$ -
$ -
Cash equivalents - treasury
bills
1,290,186
1,290,186
-
-
Government treasury bills
6,212,862
6,212,862
-
-
US.
Government agency securities
10,782,562
10,782,562
-
-
$ 22,744,948
$ 22,744,948
$ -
$ -
Liabilities:
Warrant
liability
$ 141,668
$ -
$ -
$ 141,668
$ 22,886,616
$ 22,744,948
$ -
$ 141,668
Fair
value measurements at reporting date using
December
31, 2023
Level
1 inputs
Level
2 inputs
Level
3 inputs
Assets:
Cash equivalents
- money market funds
$ 4,695,491
$ 4,695,491
$ -
$ -
Government treasury bills
14,281,104
14,281,104
-
-
U.S.
government agency securities
2,982,684
-
2,982,684
-
$ 21,959,279
$ 18,976,595
$ 2,982,684
$ -
Liabilities:
Warrant
liability
$ 17,166
$ -
$ -
$ 17,166
$ 21,976,445
$ 18,976,595
$ 2,982,684
$ 17,166
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.
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.
U.S.
government agency securities: The Company uses a third-party pricing service to value these investments. 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.
11
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 June 30, 2024, include (i) volatility
of 110.64 % , (ii) risk free interest rate of 5.45 % , (iii) strike price of $ 8.50 , (iv) fair value of common stock of $ 8.24 , and (v) expected
life of 0.4 years. The significant assumptions used in preparing the option pricing model for valuing the warrant liability as of December
31, 2023, include (i) volatility of 100 % , (ii) risk free interest rate of 4.79 % , (iii) strike price of $ 8.50 , (iv) fair value of common
stock of $ 2.79 , and (v) expected life of 0.9 years.
The
Company’s accounting policy is to recognize transfers between levels of the fair value hierarchy on the date of the event or changes
in circumstances that caused the transfer. There were no transfers into or out of Level 1, Level 2, or Level 3 for the three or six months
ended June 30, 2024.
(6) 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
June 30, 2024 and December 31, 2023, the Company had a full valuation allowance against its deferred tax assets, net of expected reversals
of existing deferred tax liabilities, as it believes it is more likely than not that these benefits will not be realized.
(7) Contractual Agreements
(a)
Verity
Pharmaceuticals, Inc.
On
January 12, 2024, the Company entered into the Verity License Agreement with GSL
and Verity Pharma, pursuant to which the Company granted 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 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. The Company retains rights to TLANDO and TLANDO XR in applications outside of the Field
and to development and commercialization rights in the field outside of the United States and Canada.
Upon
execution of the Verity License Agreement, GSL agreed to pay the Company a license fee of $ 11.0 million with an initial payment of $ 2.5
million which was received on signing of the Verity License Agreement, $ 5.0 million which was received on February 1, 2024, $ 2.5 million
to be paid no later than January 1, 2025, and $ 1.0 million to be paid no later than January 1, 2026. The Company is also eligible to
receive development and sales milestone payments of up to $ 259.0 million in the aggregate, depending primarily on the achievement of
certain sales milestones in a single calendar year with respect to all products licensed by GSL under the Verity License Agreement. GSL
is generally responsible for expenses relating to the development (including the conduct of any clinical trials) and commercialization
of licensed products in the Field in the United States and Canada, while the Company is generally responsible for expenses relating to
development activities outside of the Field and/or the United States and Canada.
The
Company concluded that licensing revenue recognized in conjunction with the Verity License Agreement met the requirements under ASC
606, Revenue from Contracts with Customers. The Company evaluates the measure of progress each reporting period and, if necessary,
adjusts 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.
12
Under
the Verity License Agreement with Verity Pharma, during the three months ended June 30, 2024, the Company recognized approximately
$ 90,000
in royalty revenue. During the six months ended June 30, 2024, the Company recognized $ 7.5
million in licensing revenue and approximately $ 140,000
in royalty revenue.
(b)
Antares
Pharma, Inc.
On
October 14, 2021, the Company entered into the Antares License Agreement with 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 NDA No. 208088, treatment of Klinefelter syndrome, and pediatric indications relating to testosterone replacement therapy
in males for conditions associated with a deficiency or absence of endogenous testosterone, in each case within the 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 agreed to make additional payments of $ 5.0
million to the Company on each of January 1, 2025, and January 1, 2026, provided that certain conditions were satisfied. The Company
was 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 was to receive tiered royalty payments at rates
ranging from percentages in the mid-teens up to 20 %
of net sales of TLANDO in the United States, subject to certain minimum royalty obligations. On October 2, 2023, the Company
received notice from Antares of Antares’ termination of the Antares License Agreement. In accordance with the terms of the
Antares License Agreement, the Antares License Agreement terminated effective January 31, 2024. On January 12, 2024, the Company
entered into the Verity License Agreement with Verity Pharma. Upon termination of the Antares License Agreement, all rights and
licenses granted by the Company to Antares under the Antares License Agreement terminated and all rights in TLANDO were transferred
to the Company’s new licensing partner, Verity Pharma.
Under
the Antares License Agreement, the Company did not recognize revenue during either the three months ended June 30, 2024 or 2023, and
recognized revenue of approximately $ 67,000 and $ 0 for the six months ended June 30, 2024 and 2023, respectively. The Company does not
expect to receive any further royalties under the Antares License Agreement in the future.
(c)
Abbott
Products, Inc.
On
March 29, 2012, the Company terminated its collaborative agreement with Solvay Pharmaceuticals, Inc. (later acquired by Abbott
Products, Inc. (“Abbott”) for TLANDO. As part of the termination, the Company reacquired the rights to the intellectual property from Abbott.
All obligations under the prior license agreement have been completed except that 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 $ 7,000
and $ 9,000
during the three months ended June 30, 2024 and 2023, respectively, and approximately $ 16,000
and $ 13,000
during the six months ended June 30, 2024 and 2023, respectively.
(d)
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 $ 1.1 million and $ 1.7 million, respectively, for the three months ended
June 30, 2024 and 2023, respectively, and $ 2.9 million and $ 3.8 million for the six months ended June 30, 2024 and 2023, respectively,
under these agreements and has recorded these expenses in research and development expenses.
13
(8) 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, 2025.
Future
minimum lease payments under the non-cancelable operating lease as of June 30, 2024 are:
Schedule of Future Minimum Rental Payments for Operating Leases
Operating
leases
Year ending December 31:
2024
$ 184,038
2025
61,346
Total
minimum lease payments
$ 245,384
The
Company’s rent expense was $ 92,000 and $ 89,000 for the three months ended June 30, 2024 and 2023, respectively. The Company’s
rent expense was $ 182,000 and $ 176,000 , for the six months ended June 30, 2024, respectively.
(9) Stockholders’ Equity
On
May 10, 2023, the Company’s Board approved a reverse stock split ratio of 1-for-17 . The Company
filed the Amendment to its Certificate of Incorporation with the Secretary of State of the State of Delaware on May 10, 2023, and the
Amendment became effective at 5:00 p.m. Eastern Time on Thursday, May 11, 2023. The Company’s shares began trading on a split-adjusted
basis on the Nasdaq Capital Market commencing upon market open on May 12, 2023.
All
common stock share data and per share price data of the Company reflect the reverse stock split effective May 11, 2023.
The
Company is authorized to issue up to 200,000,000 shares of its common stock, par value $ 0.0001 .
(a)
Issuance
of Common Stock
On
April 26, 2024, the Company entered into a sales agreement with 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 made. The Company currently has registered
$ 10,616,169 shares of common shares for sale under the 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 sales agent. A.G.P. may sell the Company’s
common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the
Securities Act, including sales made directly on or through the Nasdaq Capital Market or any other existing trade market for our common
stock, in negotiated transactions at market prices prevailing at the time of sale or at prices related to prevailing market prices, or
any other method permitted by law. 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. The Company 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, the Company has also provided A.G.P. with customary
indemnification rights.
The
shares of the Company’s 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 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 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. The Company and
A.G.P. may each terminate the A.G.P. Sales Agreement at any time upon ten days’ prior notice.
As
of June 30, 2024, the Company had not sold any shares under the A.G.P. Sales Agreement.
14
Previously,
on March 6, 2017, the Company entered into a sales agreement (the “Cantor Sales Agreement”) with Cantor Fitzgerald &
Co. (“Cantor”) pursuant to which the Company could issue and sell, from time to time, shares of its common stock having
an aggregate offering price of up to the amount the Company registered on an effective registration statement pursuant to which the
offering is being made.
As
of June 30, 2024, the Company had sold an aggregate of 996,821
shares at a weighted-average sales price of $ 33.62
per share under the At the Market Offering ( the “ATM Offering”) Cantor Sales Agreement, for aggregate gross proceeds of
$ 33.5
million and net proceeds of $ 32.4
million, after deducting sales agent commission and discounts and other offering costs. During the three and six months ended June
30, 2024, the Company sold 32,110
shares of its common stock pursuant to the Cantor Sales Agreement. On April 24, 2024 the Cantor Sales Agreement was
terminated.
(b)
Series
B Preferred Stock
On
March 7, 2023, 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 entitled the holder thereof to 1,000,000 votes per share, and each fraction
of a share of Series B Preferred Stock had a ratable number of votes. Thus, each one-thousandth of a share of Series B Preferred Stock
was entitled to 1,000 votes. The outstanding shares of Series B Preferred Stock were 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 2023 annual meeting of
stockholders.
All
shares of Series B Preferred Stock that were not present in person or by proxy at the 2023 annual meeting as of immediately prior to
the opening of the polls (the “Initial Redemption Time”) were automatically redeemed
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”). The remaining shares of Series B Preferred Stock that were not redeemed pursuant to the Initial Redemption were redeemed
automatically upon the effectiveness of the amendment to the Certificate of Incorporation implementing the Reverse Stock Split (the “Subsequent
Redemption”).
Each
“beneficial owner” (as such terms are defined in the Certificate of Designation with respect to the Series B Preferred Stock)
of shares of Series B Preferred Stock redeemed in the redemptions described above has the right to receive an amount equal to $0.01 in
cash for each ten whole shares of Series B Preferred Stock that were “beneficially owned” by the beneficial owner 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 beneficial owner to the corporate secretary of the Company following the applicable redemption time.
The
Series B Preferred Stock was 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 had no stated maturity and was not subject to any sinking fund. The Series B Preferred Stock
was 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 was not solely in control of the redemption of the shares of Series B Preferred Stock prior to the annual meeting of stockholders
since the holders had the option of deciding whether to vote in respect of the above-described Reverse Stock Split, which determined
whether a given holder’s shares of Series B Preferred Stock was redeemed in the Initial Redemption or the Subsequent Redemption.
Since the redemption of the Series B Preferred Stock was not solely in the control of the Company, the shares of Series B Preferred Stock
were classified within the mezzanine equity in the Company’s unaudited consolidated statement of stockholder’s equity. Upon
issuance, the shares of Series B Preferred Stock were measured at redemption value. As of May 10, 2023, all shares of Series B Preferred
Stock had been redeemed by the Company.
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 $ 102,000 and $ 165,000 , respectively, for the three months ended June 30, 2024 and 2023, and approximately
$ 202,000 and $ 343,000 , respectively, for the six months ended June 30, 2024 and 2023, and is allocated as follows:
Schedule
of Employee Service Share-based Compensation, Allocation of Recognized Period Costs
2024
2023
2024
2023
Three
Months Ended June 30,
Six
Months Ended June 30,
2024
2023
2024
2023
Research and development
$ 57,786
$ 83,229
$ 112,866
$ 178,742
General and administrative
44,479
81,636
88,705
163,895
Total
$ 102,265
$ 164,865
$ 201,571
$ 342,637
The
Company issued 8,820 stock options, during each of the three months ended June 30, 2024 and 2023, and issued 34,446 and 10,086 stock
options, respectively, during the six months ended June 30, 2024 and 2023.
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 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 six months ended June 30, 2024 and 2023, 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
2024
2023
Expected term
5.76
years
5.73
years
Risk-free interest rate
4.32 %
3.73 %
Expected dividend yield
—
—
Expected volatility
97.78 %
98.97 %
The
Company recognizes compensation expense for the portion of options that are expected to vest. Therefore, the Company applied estimated
forfeiture rates that were derived from historical employee termination behavior. If the actual number of forfeitures differs from those
estimated by management, additional adjustments to compensation expense may be required in future periods.
As
of June 30, 2024, there was approximately $ 384,000 of total unrecognized compensation cost related to unvested stock option compensation
granted under the Company’s stock option plan. That cost is expected to be recognized over a weighted average period of 0.8 years
and will be adjusted for subsequent changes in estimated forfeitures. Additionally, as of June 30, 2024, there was $ 76,000 of total unrecognized
compensation costs related to unvested restricted stock units that have either time-based or performance vesting.
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 58,823 shares were authorized for issuance under the 2014 Plan.
Additionally, 15,994 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
74,817 to 145,405 . Additionally, upon receiving shareholder approval in June 2018, the 2014 Plan was further amended and restated to
increase the authorized number of shares of common stock of the Company issuable under all awards granted under the 2014 Plan from 145,405
to 189,522 . Upon receiving shareholder approval in June 2020, the 2014 Plan was further amended and restated to increase the authorized
number of shares of common stock of the Company issuable under all awards granted under the 2014 Plan from 189,522 to 336,582 . In June
2024, the 2014 Plan was further amended and restated to increase the authorized number of shares of common stock of the Company issuable
under all awards granted from 336,582 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 257,046 shares
remaining available for grant as of June 30, 2024.
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, 2023
262,247
$ 34.21
Options granted
34,446
4.77
Options exercised
-
-
Options forfeited
-
-
Options
cancelled
( 1,176 )
140.25
Balance at June 30, 2024
295,517
30.36
Options exercisable at June 30, 2024
224,887
37.54
The
following table summarizes information about stock options outstanding and exercisable at June 30, 2024:
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
295,517
6.55
$ 30.36
$ 230,307
224,887
5.79
$ 37.54
$ 77,671
The
intrinsic value for stock options is defined as the difference between the current market value and the exercise price. There were 0
stock options exercised during either the three or six months ended June 30, 2024 or 2023.
18
(f) Restricted
Stock Units
A
summary of restricted stock unit activity is as follows:
Summary
of Restricted Stock Unit Activity
Number
of unvested restricted stock units
Balance at December 31, 2023
-
Granted
21,762
Vested
-
Cancelled
-
Balance at June 30, 2024
21,762
There
were no restricted stock units awarded during either the three months ended June 30, 2024 or 2023 . There were 21,762 and 0 restricted
stock units awarded during the six months ended June 30, 2024 and 2023, respectively. The weighted average grant date fair value of restricted
stock units awarded during the six months ended June 30, 2024 was $ 3.61 per share.
(g) 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 June 30, 2024, the Company had 64,362 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 June 30, 2024 and on December 31, 2023 was determined using the Black-Scholes
option pricing model with the following Level 3 inputs (as defined in the November 2019 Offering):
Schedule of Fair Value of Warrants
June
30, 2024
December
31, 2023
Expected life in years
0.39
0.88
Risk-free interest rate
5.45 %
4.79 %
Dividend yield
—
—
Volatility
110.64 %
100.00 %
Stock price
$ 8.24
$ 2.79
During
the three and six months ended June 30, 2024, the Company recorded a non-cash loss of approximately $ 84,000 and $ 125,000 , respectively,
from the change in fair value of the November 2019 Offering warrants. During the three and six months ended June 30, 2023, the Company
recorded non-cash gains of approximately $ 27,000 and $ 126,000 , respectively, from the change in fair value on 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, 2023
$ 17,166
Change
in fair value of common stock warrants
124,502
Balance at June 30, 2024
$ 141,668
19
Additionally,
in an offering in February 2020, the Company issued 296,593 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 June 30, 2024, and 2023, there
were 49,433 warrants outstanding that were issued in February 2020.
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, 2023
113,795
$ 8.72
Issued
-
-
Exercised
-
-
Expired
-
-
Cancelled
-
-
Forfeited
-
-
Balance at June 30, 2024
113,795
$ 8.72
There
were no common stock warrants exercised during either the three or six months ended June 30, 2024 or 2023.
The
following table summarizes information about common stock warrants outstanding at June 30, 2024:
Schedule
of Common Stock Warrants Outstanding
Warrants
outstanding
Number
exercisable
Weighted
average remaining contractual life (Years)
Weighted
average exercise price
Aggregate
intrinsic value
113,795
0.50
$ 8.72
$ -
(10) 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
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.
20
The
Company is not currently aware of any matter, individually or in the aggregate, that could 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.
(11) 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.
During the three and six months ended June 30, 2024, the Company did not receive any revenue from Spriaso. During the three and six
months ended June 30, 2023, the Company received licensing revenue from Spriaso of $ 0
and approximately $ 55,000 ,
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.
(12) Recent Accounting Pronouncements
Accounting
Pronouncements Issued Not Yet Adopted
In
November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2023-07, Segment Reporting (Topic
280): Improvements to Reportable Segment Disclosures, which enhances reporting requirements under Topic 280. The enhanced disclosure
requirements include: title and position of the Chief Operating Decision Maker (CODM), significant segment expenses provided to the CODM,
extending certain annual disclosures to interim periods, clarifying single reportable segment entities must apply ASC 280 in its entirety,
and permitting more than one measure of segment profit or loss to be reported under certain circumstances. This change is effective for
fiscal years beginning after December 15, 2023 and interim periods beginning after December 15, 2024. This change will apply retrospectively
to all periods presented. Management is currently assessing the impact of the adoption of this ASU on the financials statements of the
Company.
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.