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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
☒ |
Quarterly
Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For
Quarterly Period ended June 30, 2023
☐ |
Transition
Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For
the transition period from
to
.
Commission
File Number: 001-36357
LIPOCINE
INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
99-0370688 |
(State
or Other Jurisdiction of
Incorporation
or Organization) |
|
(IRS
Employer
Identification
No.) |
|
|
|
675
Arapeen Drive, Suite 202,
Salt
Lake City, Utah |
|
84108 |
(Address
of Principal Executive Offices) |
|
(Zip
Code) |
801-994-7383
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.0001 per share |
|
LPCN |
|
The
NASDAQ Stock Market LLC |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or such shorter period that the registrant was required to file such reports) and (2) has
been subject to such filing requirements for the past 90 days. Yes: ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act (Check one):
Large accelerated filer |
☐ |
Accelerated filer |
☐ |
Non-accelerated filer |
☒ |
Smaller reporting company |
☒ |
Emerging growth company |
☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
Outstanding
Shares
As
of August 8, 2023, the registrant had 5,315,830 shares of common stock outstanding.
TABLE
OF CONTENTS
PART
I—FINANCIAL INFORMATION
ITEM 1. |
FINANCIAL STATEMENTS |
LIPOCINE
INC. AND SUBSIDIARIES
Condensed
Consolidated Balance Sheets
(Unaudited)
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Assets | |
| | |
| |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 5,014,695 | | |
$ | 3,148,496 | |
Marketable investment securities | |
| 20,775,275 | | |
| 29,381,410 | |
Accrued interest income | |
| 24,230 | | |
| 80,427 | |
Contract asset - current portion | |
| 579,428 | | |
| 579,428 | |
Prepaid and other current assets | |
| 690,900 | | |
| 945,319 | |
| |
| | | |
| | |
Total current assets | |
| 27,084,528 | | |
| 34,135,080 | |
| |
| | | |
| | |
Contract asset - non-current portion | |
| 3,252,500 | | |
| 3,252,500 | |
Property and equipment, net of accumulated depreciation of $1,166,441 and $1,153,530 respectively | |
| 122,679 | | |
| 131,589 | |
Other assets | |
| 23,753 | | |
| 23,753 | |
| |
| | | |
| | |
Total assets | |
$ | 30,483,460 | | |
$ | 37,542,922 | |
Liabilities and Stockholders’ Equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 517,587 | | |
$ | 600,388 | |
Accrued expenses | |
| 1,309,595 | | |
| 1,077,738 | |
| |
| | | |
| | |
Total current liabilities | |
| 1,827,182 | | |
| 1,678,126 | |
| |
| | | |
| | |
Warrant liability | |
| 104,267 | | |
| 229,856 | |
| |
| | | |
| | |
Total liabilities | |
| 1,931,449 | | |
| 1,907,982 | |
| |
| | | |
| | |
Commitments and contingencies (notes 6, 8, 9 and 11) | |
| - | | |
| - | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Common stock, par value $0.0001 per share, 200,000,000 shares authorized; 5,235,166 issued and 5,234,830 outstanding | |
| 8,852 | | |
| 8,852 | |
Additional paid-in capital | |
| 219,443,674 | | |
| 219,112,164 | |
Treasury stock at cost, 336 shares | |
| (40,712 | ) | |
| (40,712 | ) |
Accumulated other comprehensive loss | |
| (15,812 | ) | |
| (20,321 | ) |
Accumulated deficit | |
| (190,843,991 | ) | |
| (183,425,043 | ) |
| |
| | | |
| | |
Total stockholders’ equity | |
| 28,552,011 | | |
| 35,634,940 | |
| |
| | | |
| | |
Total liabilities and stockholders’ equity | |
$ | 30,483,460 | | |
$ | 37,542,922 | |
See
accompanying notes to unaudited condensed consolidated financial statements
LIPOCINE
INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
| |
| | |
| | |
| | |
| |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Revenues: | |
$ | - | | |
$ | 500,000 | | |
$ | 54,990 | | |
$ | 500,000 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 2,515,211 | | |
| 2,898,012 | | |
| 5,621,521 | | |
| 4,785,965 | |
General and administrative | |
| 1,440,394 | | |
| 1,129,519 | | |
| 2,727,708 | | |
| 2,373,205 | |
Total operating expenses | |
| 3,955,605 | | |
| 4,027,531 | | |
| 8,349,229 | | |
| 7,159,170 | |
| |
| | | |
| | | |
| | | |
| | |
Operating loss | |
| (3,955,605 | ) | |
| (3,527,531 | ) | |
| (8,294,239 | ) | |
| (6,659,170 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Interest and investment income | |
| 379,521 | | |
| 69,877 | | |
| 749,991 | | |
| 111,453 | |
Interest expense | |
| - | | |
| (7,568 | ) | |
| - | | |
| (27,098 | ) |
Unrealized gain on warrant liability | |
| 27,455 | | |
| 583,445 | | |
| 125,589 | | |
| 205,457 | |
Gain on litigation settlement liability | |
| - | | |
| 250,000 | | |
| - | | |
| 250,000 | |
Total other income, net | |
| 406,976 | | |
| 895,754 | | |
| 875,580 | | |
| 539,812 | |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Income tax expense | |
| - | | |
| - | | |
| (200 | ) | |
| (200 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
| (3,548,629 | ) | |
| (2,631,777 | ) | |
| (7,418,859 | ) | |
| (6,119,558 | ) |
| |
| | | |
| | | |
| | | |
| | |
Issuance of Series B preferred stock dividend | |
| - | | |
| - | | |
| (89 | ) | |
| - | |
Net loss attributable to common shareholders | |
$ | (3,548,629 | ) | |
$ | (2,631,777 | ) | |
$ | (7,418,948 | ) | |
$ | (6,119,558 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic loss per share attributable to common stock | |
$ | (0.68 | ) | |
$ | (0.50 | ) | |
$ | (1.42 | ) | |
$ | (1.17 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding, basic | |
| 5,234,830 | | |
| 5,234,141 | | |
| 5,234,830 | | |
| 5,228,608 | |
| |
| | | |
| | | |
| | | |
| | |
Diluted loss per share attributable to common stock | |
$ | (0.68 | ) | |
$ | (0.61 | ) | |
$ | (1.44 | ) | |
$ | (1.20 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding, diluted | |
| 5,234,830 | | |
| 5,263,389 | | |
| 5,234,830 | | |
| 5,262,993 | |
| |
| | | |
| | | |
| | | |
| | |
Comprehensive loss: | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (3,548,629 | ) | |
$ | (2,631,777 | ) | |
$ | (7,418,859 | ) | |
$ | (6,119,558 | ) |
Net unrealized gain (loss) on available-for-sale securities | |
| (19,053 | ) | |
| (17,491 | ) | |
| 4,509 | | |
| (66,891 | ) |
| |
| | | |
| | | |
| | | |
| | |
Comprehensive loss | |
$ | (3,567,682 | ) | |
$ | (2,649,268 | ) | |
$ | (7,414,350 | ) | |
$ | (6,186,449 | ) |
See
accompanying notes to unaudited condensed consolidated financial statements
LIPOCINE
INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Changes in Stockholders’ Equity
For
the Three and Six Months Ended June 30, 2023 and 2022
(Unaudited)
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
| |
Mezzanine
Equity | | |
Stockholder’s
Equity | |
| |
Series
B Preferred Stock | | |
Common
Stock | | |
Treasury
Stock | | |
Additional | | |
Accumulated Other | | |
| | |
Total | |
| |
Number
of Shares | | |
Amount | | |
Number
of Shares | | |
Amount | | |
Number
of Shares | | |
Amount | | |
Paid-In
Capital | | |
Comprehensive
Loss | | |
Accumulated
Deficit | | |
Stockholders’
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balances at March 31, 2022 | |
| - | | |
$ | - | | |
| 5,234,132 | | |
$ | 8,850 | | |
| 336 | | |
$ | (40,712 | ) | |
$ | 218,663,319 | | |
$ | (67,416 | ) | |
$ | (176,154,188 | ) | |
$ | 42,409,853 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,631,777 | ) | |
| (2,631,777 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Unrealized net loss on marketable investment securities | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (17,491 | ) | |
| - | | |
| (17,491 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 139,569 | | |
| - | | |
| - | | |
| 139,569 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Option exercises | |
| - | | |
| - | | |
| 12 | | |
| - | | |
| - | | |
| - | | |
| 91 | | |
| - | | |
| - | | |
| 91 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Costs associated with ATM Offering | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (10,500 | ) | |
| - | | |
| - | | |
| (10,500 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balances at June 30, 2022 | |
| - | | |
$ | - | | |
| 5,234,144 | | |
$ | 8,850 | | |
| 336 | | |
$ | (40,712 | ) | |
$ | 218,792,479 | | |
$ | (84,907 | ) | |
$ | (178,785,965 | ) | |
$ | 39,889,745 | |
Balances | |
| - | | |
$ | - | | |
| 5,234,144 | | |
$ | 8,850 | | |
| 336 | | |
$ | (40,712 | ) | |
$ | 218,792,479 | | |
$ | (84,907 | ) | |
$ | (178,785,965 | ) | |
$ | 39,889,745 | |
| |
Mezzanine
Equity | | |
Stockholder’s
Equity | |
| |
Series
B Preferred Stock | | |
Common
Stock | | |
Treasury
Stock | | |
Additional | | |
Accumulated Other | | |
| | |
Total | |
| |
Number
of Shares | | |
Amount | | |
Number
of Shares | | |
Amount | | |
Number
of Shares | | |
Amount | | |
Paid-In
Capital | | |
Comprehensive
Loss | | |
Accumulated
Deficit | | |
Stockholders’
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balances at December 31, 2021 | |
| - | | |
$ | - | | |
| 5,221,883 | | |
$ | 8,829 | | |
| 336 | | |
$ | (40,712 | ) | |
$ | 218,286,324 | | |
$ | (18,016 | ) | |
$ | (172,666,407 | ) | |
$ | 45,570,018 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (6,119,558 | ) | |
| (6,119,558 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Unrealized net loss on marketable investment securities | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (66,891 | ) | |
| - | | |
| (66,891 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 310,597 | | |
| - | | |
| - | | |
| 310,597 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Option exercises | |
| - | | |
| - | | |
| 12,261 | | |
| 21 | | |
| - | | |
| - | | |
| 206,058 | | |
| - | | |
| - | | |
| 206,079 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Costs associated with ATM Offering | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (10,500 | ) | |
| - | | |
| - | | |
| (10,500 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balances at June 30, 2022 | |
| - | | |
$ | - | | |
| 5,234,144 | | |
$ | 8,850 | | |
| 336 | | |
$ | (40,712 | ) | |
$ | 218,792,479 | | |
$ | (84,907 | ) | |
$ | (178,785,965 | ) | |
$ | 39,889,745 | |
Balances | |
| - | | |
$ | - | | |
| 5,234,144 | | |
$ | 8,850 | | |
| 336 | | |
$ | (40,712 | ) | |
$ | 218,792,479 | | |
$ | (84,907 | ) | |
$ | (178,785,965 | ) | |
$ | 39,889,745 | |
| |
Mezzanine
Equity | | |
Stockholder’s
Equity | |
| |
Series
B Preferred Stock | | |
Common
Stock | | |
Treasury
Stock | | |
Additional | | |
Accumulated Other | | |
| | |
Total | |
| |
Number
of Shares | | |
Amount | | |
Number
of Shares | | |
Amount | | |
Number
of Shares | | |
Amount | | |
Paid-In
Capital | | |
Comprehensive
Gain (Loss) | | |
Accumulated
Deficit | | |
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 | |
Balances | |
| 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 | |
Balances | |
| - | | |
$ | - | | |
| 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 | | |
Additional | | |
Accumulated
Other | | |
| | |
Total | |
| |
Number
of Shares | | |
Amount | | |
Number
of Shares | | |
Amount | | |
Number
of Shares | | |
Amount | | |
Paid-In
Capital | | |
Comprehensive
Loss | | |
Accumulated
Deficit | | |
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 | |
Balances | |
| - | | |
$ | - | | |
| 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 dividend | |
| 88,511 | | |
| 9 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 80 | | |
| - | | |
| (89 | ) | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Redemption of Series B preferred stock | |
| (88,511 | ) | |
| (9 | ) | |
| - | | |
| - | | |
| - | | |
| - | | |
| 9 | | |
| - | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Costs associated with 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 | |
Balances | |
| - | | |
$ | - | | |
| 5,234,830 | | |
$ | 8,852 | | |
| 336 | | |
$ | (40,712 | ) | |
$ | 219,443,674 | | |
$ | (15,812 | ) | |
$ | (190,843,991 | ) | |
$ | 28,552,011 | |
See
accompanying notes to unaudited condensed consolidated financial statements
LIPOCINE INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
| |
| | |
| |
| |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Cash flows from operating activities: | |
| | | |
| | |
| |
| | | |
| | |
Net loss | |
$ | (7,418,859 | ) | |
$ | (6,119,558 | ) |
| |
| | | |
| | |
Adjustments to reconcile net loss to cash used in operating activities: | |
| | | |
| | |
Depreciation expense | |
| 12,910 | | |
| 4,297 | |
Stock-based compensation expense | |
| 342,637 | | |
| 310,597 | |
Non-cash interest expense | |
| - | | |
| 5,842 | |
Non-cash gain on change in fair value of warrant liability | |
| (125,589 | ) | |
| (205,457 | ) |
Amortization of premium (discounts) on marketable investment securities | |
| (508,425 | ) | |
| 87,282 | |
| |
| | | |
| | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accrued interest income | |
| 56,197 | | |
| 166,842 | |
Prepaid and other current assets | |
| 254,419 | | |
| 910,919 | |
Accounts payable | |
| (82,801 | ) | |
| (475,338 | ) |
Accrued expenses | |
| 231,857 | | |
| (117,157 | ) |
Litigation settlement liability | |
| - | | |
| (1,250,000 | ) |
Gain on extinguishment of litigation settlement liability | |
| - | | |
| (250,000 | ) |
| |
| | | |
| | |
Cash used in operating activities | |
| (7,237,654 | ) | |
| (6,931,731 | ) |
| |
| | | |
| | |
Cash flows from investing activities: | |
| | | |
| | |
Purchase of property and equipment | |
| (4,000 | ) | |
| (37,099 | ) |
Purchases of marketable investment securities | |
| (8,780,931 | ) | |
| (22,681,441 | ) |
Maturities of marketable investment securities | |
| 17,900,000 | | |
| 33,802,000 | |
| |
| | | |
| | |
Cash provided by investing activities | |
| 9,115,069 | | |
| 11,083,460 | |
| |
| | | |
| | |
Cash flows from financing activities: | |
| | | |
| | |
| |
| | | |
| | |
Debt repayments | |
| - | | |
| (1,666,667 | ) |
End of loan payment | |
| - | | |
| (650,000 | ) |
Costs associated with ATM Offering | |
| (11,216 | ) | |
| (10,500 | ) |
Proceeds from stock option exercises | |
| - | | |
| 206,079 | |
| |
| | | |
| | |
Cash used in financing activities | |
| (11,216 | ) | |
| (2,121,088 | ) |
| |
| | | |
| | |
Net increase in cash and cash equivalents | |
| 1,866,199 | | |
| 2,030,641 | |
| |
| | | |
| | |
Cash and cash equivalents at beginning of period | |
| 3,148,496 | | |
| 2,950,552 | |
| |
| | | |
| | |
Cash and cash equivalents at end of period | |
$ | 5,014,695 | | |
$ | 4,981,193 | |
| |
| | | |
| | |
Supplemental disclosure of cash flow information: | |
| | | |
| | |
Interest paid | |
$ | - | | |
$ | 21,256 | |
Income taxes paid | |
$ | 656 | | |
| 200 | |
| |
| | | |
| | |
Supplemental disclosure of non-cash investing and financing activity: | |
| | | |
| | |
Net unrealized gain (loss) on available-for-sale securities | |
$ | 4,509 | | |
$ | (66,891 | ) |
Accrued final payment charge on debt | |
$ | - | | |
$ | 5,842 | |
Issuance of Series B preferred stock dividend | |
$ | 89 | | |
$ | - | |
See
accompanying notes to unaudited condensed consolidated financial statements
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, 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 August 10, 2024 which includes an on-going clinical study for LPCN 1148 in the management of decompensated
cirrhosis, a confirmatory pivotal pharmacokinetic (“PK”) 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 August 10, 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.
On
May 10, 2023, at the 2023 annual meeting of the stockholders, the Company’s stockholders approved an amendment to the Company’s
Amended and Restated Certificate of Incorporation to effect a reverse stock split at a ratio not less than 1-for-5 and not more than
1-for-20, with the exact ratio to be set within that range at the discretion of the Company’s board of directors (the “Board”)
without further approval or authorization from our stockholders in order to achieve a minimum bid price of $1.00 per share for a minimum
of 10 consecutive trading days, as required for continuous listing of the common stock on the Nasdaq Capital Market pursuant to Nasdaq
Listing Rule 5550(a)(2).
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 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.
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 June 30, 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, the Company estimates that it will receive a royalty payment of
approximately $579,000 relating to the contract asset in the third quarter of 2023.
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 $0 and $500,000 for the three months ended June 30, 2023, and 2022, respectively. The Company recognized revenue of approximately
$55,000 and $500,000 for the six months ended June 30, 2023, and 2022, respectively. Revenue recognized in 2023 was 100% from a related-party,
Spriaso. Revenue recognized in 2022 was 100% from one major customer, Antares.
(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.
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, 2023 and 2022:
Schedule
of Computation of Basic and Diluted Earnings (loss) Per Share of Common Stock
| |
| | | |
| | | |
| | | |
| | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Basic loss per share attributable to common stock: | |
| | | |
| | | |
| | | |
| | |
Numerator | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (3,548,629 | ) | |
$ | (2,631,777 | ) | |
$ | (7,418,859 | ) | |
$ | (6,119,558 | ) |
| |
| | | |
| | | |
| | | |
| | |
Denominator | |
| | | |
| | | |
| | | |
| | |
Weighted avg. common shares outstanding | |
| 5,234,830 | | |
| 5,234,141 | | |
| 5,234,830 | | |
| 5,228,608 | |
| |
| | | |
| | | |
| | | |
| | |
Basic loss per share attributable to common stock | |
$ | (0.68 | ) | |
$ | (0.50 | ) | |
$ | (1.42 | ) | |
$ | (1.17 | ) |
| |
| | | |
| | | |
| | | |
| | |
Diluted loss per share attributable to common stock: | |
| | | |
| | | |
| | | |
| | |
Numerator | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (3,548,629 | ) | |
$ | (2,631,777 | ) | |
$ | (7,418,859 | ) | |
$ | (6,119,558 | ) |
Effect of dilutive securities on net loss: | |
| | | |
| | | |
| | | |
| | |
Common stock warrants | |
| 27,455 | | |
| 583,445 | | |
| 125,589 | | |
| 205,457 | |
Total net loss for purpose of calculating diluted net loss per common share | |
$ | (3,576,084 | ) | |
$ | (3,215,222 | ) | |
$ | (7,544,448 | ) | |
$ | (6,325,015 | ) |
Denominator | |
| | | |
| | | |
| | | |
| | |
Weighted avg. common shares outstanding | |
| 5,234,830 | | |
| 5,234,141 | | |
| 5,234,830 | | |
| 5,228,608 | |
Weighted average effect of dilutive securities: | |
| | | |
| | | |
| | | |
| | |
Common stock warrants | |
| - | | |
| 29,248 | | |
| - | | |
| 34,385 | |
Total shares for purpose of calculating diluted net loss per common share | |
| 5,234,830 | | |
| 5,263,389 | | |
| 5,234,830 | | |
| 5,262,993 | |
| |
| | | |
| | | |
| | | |
| | |
Diluted loss per share attributable to common stock | |
$ | (0.68 | ) | |
$ | (0.61 | ) | |
$ | (1.44 | ) | |
$ | (1.20 | ) |
The
computation of diluted loss per share for the three and six months ended June 30, 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
| |
June 30, | |
| |
2023 | | |
2022 | |
Stock options | |
| 264,150 | | |
| 236,822 | |
Warrants | |
| 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, 2023, and December 31, 2022, were as follows:
Schedule
of Available for Sale Securities
June 30, 2023 | |
Amortized
Cost | | |
Gross
unrealized
holding gains | | |
Gross
unrealized
holding
losses | | |
Aggregate
fair value | |
| |
| | |
| | |
| | |
| |
Government treasury bills | |
$ | 2,360,569 | | |
$ | - | | |
$ | (2,937 | ) | |
$ | 2,357,632 | |
Corporate bonds, notes and commercial paper | |
| 9,703,495 | | |
| - | | |
| (6,102 | ) | |
| 9,697,393 | |
U.S. government agency securities | |
| 8,727,023 | | |
| - | | |
| (6,773 | ) | |
| 8,720,250 | |
| |
| | | |
| | | |
| | | |
| | |
| |
$ | 20,791,087 | | |
$ | - | | |
$ | (15,812 | ) | |
$ | 20,775,275 | |
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 June 30, 2023, are as follows:
Schedule
of Maturities of Debt Securities Classified as Available-for-sale Securities
June 30, 2023 | |
Amortized
Cost | | |
Aggregate
fair value | |
Due within one year | |
$ | 20,791,087 | | |
$ | 20,775,275 | |
| |
$ | 20,791,087 | | |
$ | 20,775,275 | |
There
were no sales of marketable investment securities during the three and six months ended June 30, 2023, and 2022 and therefore no realized
gains or losses. Additionally, during the three months ended June 30, 2023 and 2022, $5.9 million and $8.6 million of marketable investment
securities matured, and during the six months ended June 30, 2023 and 2022, $17.9 million and $33.8 million of marketable investment
securities matured, respectively. The Company determined there were no other-than-temporary impairments for the three and six months
ended June 30, 2023, and 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. |
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, 2023 and December 31, 2022:
Schedule
of Fair Value, Assets Measured on Recurring Basis
| |
| | |
Fair value measurements at reporting date using | |
| |
June 30, 2023 | | |
Level 1 inputs | | |
Level 2 inputs | | |
Level 3 inputs | |
| |
| | |
| | |
| | |
| |
Assets: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents - money market funds | |
$ | 4,897,774 | | |
$ | 4,897,774 | | |
$ | - | | |
$ | - | |
Government treasury bills | |
| 2,357,632 | | |
| 2,357,632 | | |
| - | | |
| - | |
Commercial paper | |
| 7,339,702 | | |
| - | | |
| 7,339,702 | | |
| - | |
Corporate bonds and notes | |
| 2,357,691 | | |
| - | | |
| 2,357,691 | | |
| - | |
US. Government agency securities | |
| 8,720,250 | | |
| - | | |
| 8,720,250 | | |
| - | |
| |
| | | |
| | | |
| | | |
| | |
| |
$ | 25,673,049 | | |
$ | 7,255,406 | | |
$ | 18,417,643 | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Warrant liability | |
$ | 104,267 | | |
$ | - | | |
$ | - | | |
$ | 104,267 | |
| |
$ | 25,777,316 | | |
$ | 7,255,406 | | |
$ | 18,417,643 | | |
$ | 104,267 | |
| |
| | |
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.
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 and 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 June 30, 2023, include (i) volatility
of 100%, (ii) risk free interest rate of 5.25%, (iii) strike price of $8.50, (iv) fair value of common stock of $5.04, and (v) expected
life of 1.4 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 $8.50, (iv) fair value of common
stock of $6.77, 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 and six
months ended June 30, 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
June 30, 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
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 $9,000 and $17,000 during the
three months ended June 30, 2023 and 2022, respectively and royalty expense of approximately $13,000 and $17,000 during the six months
ended June 30, 2023 and 2022, respectively.
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 product 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 the three or six months ended June 30, 2023 or 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 $1.7 million and $2.1 million, respectively, for the three months ended
June 30, 2023 and 2022 and $3.8 million and $3.2 million, respectively, for the six months ended June 30, 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.
Future
minimum lease payments under the non-cancelable operating lease as of June 30, 2023 are:
Schedule
of Future Minimum Rental Payments for Operating Leases
| |
Operating | |
| |
leases | |
Year ending December 31: | |
| |
2023 | |
$ | 178,678 | |
2024 | |
| 59,559 | |
| |
| | |
Total minimum lease payments | |
$ | 238,237 | |
The
Company’s rent expense was $89,000 and $86,000 for the three months ended June 30, 2023 and 2022, respectively. The Company’s
rent expense was $176,000 and $170,000 for the six months ended June 30, 2023 and 2022, respectively.
(10) Stockholders’ Equity
On
May 10, 2023, at the 2023 annual meeting of the stockholders, the Company’s stockholders approved an amendment to the Company’s
Amended and Restated Certificate of Incorporation to effect a reverse stock split at a ratio not less than 1-for-5 and not more than
1-for-20, with the exact ratio to be set within that range at the discretion of the Board without further approval or authorization from
our stockholders.
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.
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 June 30, 2023, the Company had sold an aggregate of 883,711
shares at a weighted-average sales price of $37.23
per share under the At the Market Offering (the “ATM Offering”) 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 and six months ended
June 30, 2023, and 2022, the Company did not sell any shares of its common stock pursuant to the Sales Agreement. As of June 30,
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 the Company’s common stock pursuant to the
Sales Agreement having an aggregate offering price of up to $15.7
million.
| (b) | Series
B Preferred Stock |
On
March 7, 2023, the Board of the Company declared a dividend of one one-thousandth (1/1,000th) 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”). As of June 30, 2023, all shares of Series B Preferred Stock have been redeemed by the Company.
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 June 30, 2023, all shares of Series B Preferred
Stock have been redeemed by the Company.
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.
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.
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.
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 $165,000 and $ 140,000, for the three months ended June 30, 2023 and 2022, respectively,
and approximately $ and $311,000, for the six months ended June 30, 2023 and 2022, respectively, and is allocated as follows:
Schedule
of Employee Service Share-based Compensation, Allocation of Recognized Period Costs
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Research and development | |
$ | 83,229 | | |
$ | 63,021 | | |
$ | 178,742 | | |
$ | 142,673 | |
General and administrative | |
| 81,636 | | |
| 76,548 | | |
| 163,895 | | |
| 167,924 | |
| |
| | | |
| | | |
| | | |
| | |
Total | |
$ | 164,865 | | |
$ | 139,569 | | |
$ | 342,637 | | |
$ | 310,597 | |
The
Company issued 8,820 and 26,467 stock options, respectively, during the three and six months ended June 30, 2023, and issued 10,086 and
29,643 stock options during the three and six months ended June 30, 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 six months ended June 30, 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 | |
| 5.73 years | | |
| 5.77 years | |
Risk-free interest rate | |
| 3.73 | % | |
| 1.93 | % |
Expected dividend yield | |
| — | | |
| — | |
Expected volatility | |
| 98.97 | % | |
| 101.67 | % |
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 June 30, 2023, there was approximately $766,000
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 1.64
years and will be adjusted for subsequent changes in estimated forfeitures.
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. 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 189,522 to 336,582.
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 336,582 shares
of common stock are authorized for issuance under the 2014 Plan, with 46,519 shares remaining available for grant as of June 30, 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 | |
| 277,225 | | |
$ | 38.44 | |
Options granted | |
| 26,467 | | |
| 6.19 | |
Options exercised | |
| - | | |
| - | |
Options forfeited | |
| (7,352 | ) | |
| 6.91 | |
Options cancelled | |
| (32,190 | ) | |
| 47.77 | |
Balance at June 30, 2023 | |
| 264,150 | | |
| 34.95 | |
| |
| | | |
| | |
Options exercisable at June 30, 2023 | |
| 167,770 | | |
| 48.55 | |
The
following table summarizes information about stock options outstanding and exercisable at June 30, 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 | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
| 264,150 | | |
| 7.06 | | |
$ | 34.95 | | |
$ | 4,586 | | |
| 167,770 | | |
| 5.88 | | |
$ | 48.55 | | |
$ | - | |
The
intrinsic value for stock options is defined as the difference between the current market value and the exercise price. There were 0
and 12 stock options exercised during the three months ended June 30, 2023 and 2022, respectively. There were 0 and 12,261 stock options
exercised during the six months ended June 30, 2023 and 2022, respectively.
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, 2023, 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, 2023 and on December 31, 2022 was determined using the Black-Scholes
option pricing model with the following Level 3 inputs (as defined in the November 2019 Offering):
| |
June 30, 2023 | | |
December 31, 2022 | |
Expected life in years | |
| 1.38 | | |
| 1.88 | |
Risk-free interest rate | |
| 5.25 | % | |
| 4.41 | % |
Dividend yield | |
| — | | |
| — | |
Volatility | |
| 100.00 | % | |
| 100.00 | % |
Stock price | |
$ | 5.04 | | |
$ | 6.77 | |
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 of the November 2019 Offering warrants. During the three and six months ended June 30, 2022, the Company
recorded a non-cash gain of approximately $583,000 and $205,000, 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, 2022 | |
$ | 229,856 | |
Settlement of liability on warrant exercise | |
| - | |
Change in fair value of common stock warrants | |
| (125,589 | ) |
Balance at June 30, 2023 | |
$ | 104,267 | |
Additionally,
in the February 2020 Offering, 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, 2023, and 2022, there
were 49,433 warrants outstanding that were issued in the February 2020 Offering.
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 | |
| 113,795 | | |
$ | 8.72 | |
Issued | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | |
Expired | |
| - | | |
| - | |
Cancelled | |
| - | | |
| - | |
Forfeited | |
| - | | |
| - | |
Balance at June 30, 2023 | |
| 113,795 | | |
$ | 8.72 | |
There
were no common stock warrants exercised during either the three or six months ended June 30, 2023 and 2022.
The
following table summarizes information about common stock warrants outstanding at June 30, 2023:
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 | | |
| 1.51 | | |
$ | 8.72 | | |
$ | - | |
(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
(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 (the “Amendment
to 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.
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 and six months ended June 30, 2023, the Company received licensing revenue from Spriaso of
approximately $0
and $55,000,
respectively. During each of the three and six months ended June 30, 2022, the Company received licensing revenue of $0.
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.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion of our financial condition and results of operations should be read in conjunction with our unaudited condensed
consolidated financial statements and the related notes thereto and other financial information included elsewhere in this report. For
additional context with which to understand our financial condition and results of operations, see the management’s discussion
and analysis included in our Form 10-K, filed with the SEC on March 10, 2023, our first quarter Form 10-Q filed with the SEC on May 11,2023,
as well as the financial statements and related notes contained therein.
As
used in the discussion below, “we,” “our,” and “us” refers to Lipocine.
Forward-Looking
Statements
This
section and other parts of this report contain forward-looking statements within the meaning of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve risks and uncertainties. Forward-looking
statements provide current expectations of future events based on certain assumptions and include any statement that does not directly
relate to any historical or current fact. Forward-looking statements may refer to such matters as products, product benefits, pre-clinical
and clinical development timelines, clinical and regulatory expectations and plans, expected responses to regulatory actions, anticipated
financial performance, future revenues or earnings, business prospects, projected ventures, new products and services, anticipated market
performance, expected research and development and other expenses, future expectations for liquidity and capital resources needs and
similar matters. Such words as “may”, “will”, “expect”, “continue”, “estimate”,
“project”, and “intend” and similar terms and expressions are intended to identify forward looking statements.
Forward-looking statements are not guarantees of future performance and our actual results may differ significantly from the results
discussed in the forward-looking statements. Factors that might cause such differences include, but are not limited to, those discussed
in Part II, Item 1A (Risk Factors) of this Form 10-Q, or in Part II, Item 1A (Risk Factors) of our Form 10-Q for the quarter ended March
31, 2023 filed with the SEC on May 11, 2023, or in Part I, Item 1A (Risk Factors) of our Form 10-K filed with the SEC on March 10, 2023.
Except as required by applicable law, we assume no obligation to revise or update any forward-looking statements for any reason.
Overview
of Our Business
We
are a biopharmaceutical company focused on leveraging our proprietary Lip’ral platform to develop differentiated products through
the oral delivery of previously difficult to deliver molecules, focused on treating Central Nervous System (“CNS”) disorders.
Our proprietary delivery technologies are designed to improve patient compliance and safety through orally available treatment options.
Our primary development programs are based on oral delivery solutions for poorly bioavailable drugs. We have a portfolio of differentiated
innovative product candidates that target high unmet needs for neurological and psychiatric CNS disorders, liver diseases, and hormone
supplementation for men and women.
On
October 14, 2021, we entered into a license agreement (the “Antares License Agreement”) with Antares Pharma, Inc. (“Antares”
or our “Licensee”) for the development and commercialization of our product candidate, TLANDO®, an oral testosterone
replacement therapy (“TRT”) comprised of testosterone undecanoate (“TU”), pursuant to which we granted to Antares
an exclusive, royalty-bearing, sublicensable right and license to develop and commercialize the TLANDO product for TRT in the U.S. TLANDO
is a registered trademark assigned to Antares. Any FDA required post-marketing studies will also be the responsibility of our Licensee.
On March 28, 2022, Antares received approval from the FDA for TLANDO as a TRT in adult males for conditions associated with a deficiency
of endogenous testosterone, also known as hypogonadism. On May 24, 2022, Halozyme Therapeutics completed an acquisition of Antares Pharma
Inc. through a 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. On June 7, 2022, Halozyme announced the commercial launch of TLANDO, an oral treatment
indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone
(primary or hypogonadotropic hypogonadism).
Additional
clinical development pipeline candidates include: LPCN 1154 for postpartum depression (“PPD”); LPCN 2101 for epilepsy; and
LPCN 1148 comprising a novel prodrug of testosterone, testosterone laurate (“TL”), for the management of decompensated cirrhosis.
In addition to our CNS product candidates, we have assets for which we expect to seek partnerships to enable further development including
LPCN 1144, an oral prodrug of androgen receptor modulator for the treatment of non-cirrhotic non-alcoholic steatohepatitis (“NASH”)
which has completed Phase 2 testing; LPCN 1111, a next generation oral TRT product comprised of testosterone tridecanoate (“TT”)
with the potential for once daily dosing which has completed Phase 2 testing; and LPCN 1107, potentially the first oral hydroxy progesterone
caproate (“HPC”) product indicated for the prevention of recurrent preterm birth (“PTB”), which has completed
a dose finding clinical study in pregnant women and has been granted orphan drug designation by the FDA.
The
following charts summarize the status of our product candidate development and partnering programs:
Corporate
Strategy
Our
goal is to become a leading biopharmaceutical company focused on leveraging our proprietary Lip’ral drug delivery technology platform
to develop differentiated products through oral delivery of previously difficult to deliver molecules for CNS disorders. The key components
of our strategy are to:
Advance
LPCN 1154 and other CNS product candidates. We intend to focus on the development of endogenous neuroactive steroids (“NAS”)
which have broad applicability in treating various CNS conditions where we can leverage our technology platform to develop highly differentiated
oral therapeutics. Our priority is on the development of LPCN 1154, a fast-acting oral antidepressant for postpartum depression (“PPD”)
with potential for outpatient use.
Support
our licensee in commercialization of our licensed oral TRT option. We believe the TRT market needs a differentiated, convenient oral
option. We have exclusively licensed rights to TLANDO to Antares for commercialization of TLANDO in the US. We plan to support our Licensee’s
efforts to effectively enable the availability of TLANDO to patients in a timely manner, in addition to receiving milestone and royalty
payments associated with TLANDO commercialization as agreed to in the Antares License Agreement.
Develop
partnership(s) to continue the advancement of non-core pipeline assets. We continuously strive to prioritize our resources in seeking
partnerships for our pipeline assets. We are currently exploring partnering (i) LPCN 1144, our candidate for treatment of non-cirrhotic
NASH, (ii) LPCN 1148, for the management of decompensated cirrhosis, (iii) LPCN 1111, a once-a-day therapy candidate for TRT, and (iv)
LPCN 1107, our candidate for prevention of pre-term birth. We are also exploring the possibility of licensing LPCN 1021 (known as TLANDO
in the United States) to third parties outside the United States, although no licensing agreement has been entered into by the Company.
Our
Development Pipeline Product Candidates
Our
pipeline of clinical development candidates includes LPCN 1154 for PPD, LPCN 2101 for epilepsy, and LPCN 1148, an androgen therapy for
the management of cirrhosis. We will continue to explore other product development candidates targeting CNS indications with a significant
unmet need. We will also continue efforts to enter into partnership arrangements for the continued development and/or marketing of LPCN
1144, LPCN 1148, LPCN 1111, LPCN 1107 and TLANDO outside of the United States.
Our
products are based on our proprietary Lip’ral drug delivery technology platform. Lip’ral-based TLANDO was approved in March
2022. Lip’ral technology is a patented technology based on lipidic compositions which form an optimal dispersed phase in the gastrointestinal
environment for improved absorption of insoluble drugs. The drug loaded dispersed phase presents the solubilized drug efficiently at
the absorption site (gastrointestinal tract membrane) thus improving the absorption process and making the drug less dependent on physiological
variables such as dilution, gastro-intestinal pH and food effects for absorption. Lip’ral-based formulation enables improved solubilization
and higher drug-loading capacity, which can lead to improved bioavailability, reduced dose, faster and more consistent absorption, reduced
variability, reduced sensitivity to food effects, improved patient compliance, and targeted lymphatic delivery where appropriate.
Oral
Programs for CNS Disorders
Some
preferred endogenous or naturally occurring NAS present in central nervous system act as positive allosteric modulators (“PAM”)
of the GABAA receptor, the major biological target of the inhibitory neurotransmitter γ-aminobutyric acid (“GABAA”).
To improve oral delivery of these modulators, several synthetic NAS derivatives of endogenous GABAA receptor PAMs have been
developed for therapeutic use in the past few decades.
We
believe through utilization of our proprietary technology we may have the ability to enable effective oral delivery of endogenous GABAA
receptor PAMs which historically had been deemed to be not orally bioavailable. As a novel drug class, NAS have received considerable
attention because of their potential to treat various neuropsychiatric conditions including depression, movement disorders, epilepsy,
anxiety, and neurodegenerative diseases. We have conducted Phase 1 pharmacokinetic (“PK”) studies for each of our two lead
NAS candidates which have demonstrated promising PK results, safety, and tolerability and we are evaluating additional undisclosed CNS-focused
candidates.
LPCN
1154: Product Candidate for PPD
Our
most advanced NAS candidate is LPCN 1154, a rapid onset, oral formulation of the neuroactive steroid brexanolone which we are developing
for the treatment of PPD. The FDA recently agreed with our proposal for establishing the efficacy of LPCN 1154 through a pivotal PK bridge
to an approved IV infusion brexanolone via a 505(b)(2) NDA filing. Based on feedback from the FDA, the company conducted a pilot
PK bridge study of LPCN 1154, a prelude to a pivotal study required for NDA filing, and positive topline results from the pilot PK bridge
study were released in May of 2023. Results from the pilot PK study will enable identification of the dosing regimen to be used in a
single confirmatory pivotal PK study to establish efficacy for PPD and support NDA submission. We expect to dose the first patient in
the pivotal PK study in the fourth quarter of 2023. We have previously completed an oral PK study and a food effect study with LPCN 1154.
PPD
PPD,
a type of major depressive disorder with onset either during pregnancy or within four weeks of delivery, refers to depression persisting
up to 12 months after childbirth. PPD can be clinically segmented by the severity of symptoms and presence of a comorbidity, including
epilepsy. Approximately 1 in 8 mothers suffers from PPD in the United States alone; this equates to approximately 500,000 women being
affected by PPD annually.
Disease
Overview - PPD
|
● |
PPD
is distinct from the “baby blues,” a condition that up to 70% of all new mother’s experience; “baby blues”
tend to be short-lived emotional conditions that do not interfere with daily activities. |
|
|
|
|
● |
Symptoms
of PPD include hallmarks of major depression, including, but not limited to, sadness, depressed mood, loss of interest, change in
appetite, insomnia, sleeping too much, fatigue, difficulty thinking/concentrating, excessive crying, fear of harming the baby/oneself,
and/or thoughts of death or suicide. |
|
|
|
|
● |
During
pregnancy, levels of endogenous NAS increase considerably along with levels of progesterone; however, they drop sharply postpartum.
It has been hypothesized that the rapid perinatal decrease in circulating levels of endogenous NASs may be involved in the development
of PPD. The first approved treatment option for PPD is an injectable containing endogenous NAS. |
|
|
|
|
● |
Depression
may persist long after child delivery. Additionally, approximately 40% of women relapse in subsequent pregnancies or on other occasions. |
|
|
|
|
● |
Psychiatric
comorbidities are common in patients with epilepsy. Patients with epilepsy are at high risk for major depressive disorders and PPD.
Reported PPD rates are higher among women with epilepsy than the general population. |
Associated
Risk Factors
|
● |
Genetic:
family history and/or previous experience of depression or other mood disorders |
|
|
|
|
● |
Physiological:
rapid changes in sex hormones, stress hormones, and thyroid hormone levels during and after delivery |
|
|
|
|
● |
Environmental:
stressful life events, changes in relationships at home and at work, and/or lack of familial support |
Unmet
Medical Need
We
believe there is considerable unmet need within women with PPD due to lack of convenient and fast-acting oral therapies. Selective Serotonin
Reuptake Inhibitors (“SSRIs”) have been the traditional first-line therapy choice for women with severe PPD and require weeks
for onset of efficacy; therefore, a need for an oral treatment option with a faster onset of action remains a significant unmet need
in treating PPD, especially in women with epilepsy risk wherein psychiatric comorbidity is common and PPD rates are higher than the general
population.
Injectable
brexanolone (Zulresso™, Sage Therapeutics) became the first FDA-approved treatment for postpartum depression. However, numerous
factors limit the utilization of injectable brexanolone such as method of administration, cost, and safety concerns. Administration of
injectable brexanolone requires a 60-hour continuous infusion in a supervised medical setting, a demanding ask for a mother with a newborn.
Besides associated privacy concerns and social stigma, inpatient treatment may also require separation of the mother and child for a
few days, which may be difficult to the already strained mother-infant bond and may present breast feeding challenges. Moreover, the
pharmacotherapy costs coupled with inpatient treatment/childcare costs limits its accessibility and affordability to women most in need
of the therapy. Finally, due to concerns about the safety of injectable Zulresso including excessive sedation or loss of consciousness,
Zulresso has a Black Box Warning in its label and is only available through a restricted distribution program (“REMS”), and
sites need significant time to become treatment ready. Additionally, on August 4, 2023, Sage Therapeutics, Inc. and Biogen Inc. announced FDA approval of Zurzuvae™
(zuranolone), an oral treatment for women with postpartum depression and stated that Zurzuvae is expected to launch and be commercially
available in the fourth quarter of 2023 following scheduling as a controlled substance by the U.S. Drug Enforcement Administration, which
they expect within 90 days of FDA approval.
We
believe LPCN 1154 targets the current unmet need for a convenient oral treatment candidate with faster onset of action and rapid
relief.
LPCN
2101: NAS for Epilepsy
We
are currently evaluating an additional NAS candidate, LPCN 2101, for women with epilepsy (“WWE”). We have completed pre-clinical
and Phase 1 studies for LPCN 2101 which demonstrated promising PK results, safety and tolerability. In July 2022 our IND was accepted
by the FDA for LPCN 2101 for adults with epilepsy and we plan to initiate a Phase 2 IND opening proof-of-concept study to evaluate the
safety, tolerability, and efficacy of LPCN 2101, subject to the availability of additional resources.
Disease
Overview – Epilepsy
Epilepsy
is defined by the 1) occurrence of at least two unprovoked seizures more than 24 hours apart, 2) occurrence of one unprovoked seizure
and a probability of further seizures occurring over the next 10 years, and/or 3) diagnosis of an epilepsy syndrome. Patients with epilepsy
are more likely to be comorbid with other conditions, including depression and anxiety.
Patients
with epilepsy have increased risk of mortality due to direct effects of seizures (e.g., status epilepticus, car accidents) and indirect
effects of seizures (e.g., suicide, cardiovascular effects.)
Epilepsy
is a disorder of the brain that causes seizures, affecting the physical, mental, and social well-being of persons, and is associated
with a 2 to 3 times greater mortality rate compared with the general population. About 60-65% of epilepsy is idiopathic and about 30%
of patients are refractory (i.e., epilepsy not well managed with currently available Anti-Seizure Medications (“ASMs”). Epilepsy
is the most common neurological disorder during pregnancy.
It
is estimated that approximately 900,000 childbearing (“CB”) age women suffer from active epilepsy in the U.S. Women of CB
age with epilepsy face many additional challenges due to hormonal influences on seizure activity and endocrine function throughout the
different phases of their reproductive cycles. Elevated estrogen or decreased progesterone levels can exacerbate seizure frequency. Often,
these women experience hormonal and endogenous NAS imbalances, coupled with fluctuations in the blood levels of ASMs that impact control
of seizures, efficacy of oral contraceptives, any coexisting anxiety and/or depression and any associated sleep impairment. Epileptic
patients are 5-20 times more likely to develop depression.
Clinical
segmentation can be categorized by epilepsy type, comorbidities and patient subgroups. Categorization of focal epilepsy, generalized
epilepsy, combined focal and generalized epilepsy, and unknown epilepsy can guide the choice of ASM. Special patient subgroups, including
WWE of CB age and elderly patients, require special care and management of epilepsy. Comorbidities such as depression and anxiety may
be co-treated with therapies that do not aggravate seizures and have no drug interaction with the ASM used for epilepsy. While lowest
effective dose and monotherapy are preferred, management of patients with epilepsy is focused on controlling seizures, avoiding adverse
events, and maintaining quality of life. Despite a wide range of ASMs available, about 30% of all people with epilepsy still fail to
respond to treatment effectively. Women with epilepsy face specific challenges throughout their lifespan because of seizures, ASMs, and
hormonal fluctuations.
Women
with epilepsy were once counseled to avoid pregnancy, but epilepsy is no longer considered a contraindication to pregnancy. Caregivers
for WWE in the preconception phase either intending to start a family (planning pregnancy) or using contraception to prevent an unplanned
pregnancy face significant challenges to balance seizure control efficacy with the selection and dosage of ASMs and ASM-related risks
such as, among other risks, fetal-neonatal toxicity, contraception failure, and psychiatric side effects.
Several
ASMs are known to have teratogenic effects on the developing fetus (converging evidence from registry studies indicates that teratogenic
risks are highest with valproate, followed by carbamazepine and topiramate). Other commonly prescribed ASMs, including older generation
agents, such as phenobarbital and phenytoin, have been associated with higher risks as compared with lamotrigine, levetiracetam, clonazepam
and gabapentin (Vajda et al., 2014; Voinescu and Pennell, 2015). Moreover, risks associated with ASMs are considerable early in pregnancy;
therefore, it is necessary that WWE of CB age undergo counseling, monitoring, and adjustment to the most appropriate ASM prior to becoming
pregnant. It is preferable that WWE of CB age discuss seizure control with their doctor for at least 6 months before conception and,
if possible, cease ASM therapy or use the lowest effective dose of a single anticonvulsant according to the type of epilepsy and the
fetal toxicity of the ASM. Anxiety, depression, lack of adherence to ASM, and/or contraception failure may be experienced by women who
are worried about unplanned pregnancy or are late in confirming pregnancy, planned or unplanned. ASMs can reduce the efficacy of oral
contraceptives, compounding this problem.
Complex,
multidirectional interactions between female hormones, seizures, and ASMs exist. Most hormones act as NAS and can thus modulate brain
excitability. Any changes in endogenous or exogenous hormone levels can affect the occurrence of seizures, either directly or via PK
interactions that modify the plasma levels of ASMs (Harden, 2008). The PK interactions between oral contraceptives and ASMs are bidirectional
(Johnston and Crawford, 2014). The efficacy of hormonal contraception may be diminished for women taking CYP-P450 enzyme inducing ASMs.
Epilepsy is not a medical condition in which contraceptives are contraindicated. Contraceptive failure, possibly related to ASMs, may
be responsible for up to 1 in 4 unplanned pregnancies in WWE (~12.5% of all WWE pregnancies), versus a rate of 1% in healthy women.
Unmet
need to treat WWE in CB age
It
is estimated that approximately 900,000 CB age women suffer from active epilepsy in the U.S. Women of CB age with epilepsy face many
additional challenges such as hormonal influences on seizure activity and endocrine function throughout the different phases of their
reproductive cycles, and approximately 30% of patients with epilepsy cannot be efficiently controlled with available ASMs making consideration
of newer pharmacological treatment development options important.
Managing
uncontrolled seizures in WWE of CB age is the primary aim during preconception, pregnancy, and postpartum phases. Therefore, uncompromised
ASM efficacy with acceptable variability and less or no drug-drug interactions achieved with lowest possible monotherapy dose to address
fetal toxicity concerns remain highly unmet needs. Moreover, control of seizures including prevention of breakthrough seizures is critical
when planning for pregnancy and also during pregnancy, as it can also lead to undesired falls or auto-accidents and compromise freedom
to drive.
Select
ASMs have the potential to induce contraception failures, reproductive hormone imbalance, anxiety, and depression. There remains an unmet
need for an ASM without the aforementioned downsides, with no to low fetal-neonatal toxicity and without any breast-feeding concerns
as well as potential to treat associated comorbidities.
While
over 30 molecules have been approved for the treatment of epilepsy in the U.S., no epilepsy drug has been specifically approved for WWE
of CB age. We believe our endogenous NASs as GABAA PAMs, while targeting the goal of seizure control, also have the potential
for additional benefits in psychiatric disorders comorbidities (e.g., anxiety and/or depression) and sleep impairment. Moreover, these
oral endogenous NAS could potentially address some of the fetal toxicity concerns related to unplanned or planned pregnancy in WWE. (1)
|
(1) |
Ref:
S.Bangar et al. Functional Neurology 2016; 31(3): 127-134; Reimers et al. Seizure. 2015 May; 28: 66-70. |
LPCN
1148: Oral Product Candidate for the Management of Decompensated Cirrhosis
We
are currently evaluating LPCN 1148 comprising testosterone laurate (“TL”) for the management of decompensated cirrhosis.
We believe LPCN 1148 targets unmet needs for cirrhosis subjects including improvement in the quality of life of patients while on the
liver transplant waiting list, prevention or reduction in the occurrence of new decompensation events such as hepatic encephalopathy
(“HE”), and improvement in post liver transplant survival, including outcomes and costs.
We
are currently conducting a Phase 2 proof of concept (“POC”) study (NCT04874350) in male subjects with cirrhosis to
evaluate the therapeutic potential of LPCN 1148 for the management of sarcopenia. The ongoing Phase 2 POC study is a prospective,
multi-center, randomized, placebo-controlled study in male sarcopenic patients with cirrhosis. Subjects were initially randomized
1:1 to one of two arms. The treatment arm is an oral dose of LPCN 1148, and the second arm is a matching placebo. The primary
endpoint is change in skeletal muscle index at week 24 with key secondary endpoints including change in liver frailty index, rates
of breakthrough HE, and number of waitlist events, including all-cause mortality. The 24-week placebo-controlled treatment period of
the study is followed by a 28-week open-label extension (OLE) study where all subjects receive LPCN 1148 for the duration of the
study through week 52.
In
July 2023 we announced that the Phase 2 study met the study primary endpoint, increased skeletal muscle index (L3-SMI) relative to
placebo (P<.01), in patients with cirrhosis. The study also demonstrated improvements in clinical outcomes such as prevention of
new decompensation events including HE, rates of hospitalizations, and patient reported outcomes (“PROs”). LPCN 1148 was well-tolerated, with adverse event (AE) rates and severities similar to placebo and no mortality was
noted in the LPCN 1148 treatment group, nor were there any cases of drug-induced liver injury.
Disease
Overview – Cirrhosis
There
are over 2 million cases of cirrhosis worldwide, with over 500,000 people living with decompensated cirrhosis in the U.S. and nonalcoholic
fatty liver disease is the most rapidly increasing indication for liver transplant. 62% of those on the liver transplant (“LT”)
waitlist are male and the economic burden (approximately $812,500/transplant) is high and continues to increase. Each year about half
of the approximately 17,000 people in U.S. on the LT waitlist undergo transplant, while nearly 3,000 patients either die or are removed
from the list because they were “too sick to transplant.”
Liver
cirrhosis is defined as the histological development of regenerative nodules surrounded by fibrous bands. Patients with
cirrhosis typically have a years-long silent, asymptomatic phase (compensated cirrhosis) until decreasing liver function and
increasing portal pressure move the patient into the symptomatic phase (decompensated cirrhosis). Transition to decompensated
cirrhosis is marked by clinical events including ascites, encephalopathy, jaundice, and/or variceal hemorrhage. Decompensated
subjects survive on average less than 2 years. Common causes of liver cirrhosis include alcoholic liver disease, nonalcoholic fatty
liver disease (“NAFLD”), chronic hepatitis B and C, primary biliary cirrhosis (“PBC”), and primary
sclerosing cholangitis (“PSC”) and some patients have liver disease of unknown cause (cryptogenic).
Common
complications in patients with cirrhosis may include: compromised liver function, portal hypertension, varices in GI tract
with internal bleeding, edema, ascites, hepatic encephalopathy, compromised immunity with post-transplant acute rejection risk, high
sodium levels, increased bilirubin, low albumin level, insulin resistance with impaired peripheral uptake of glucose, depression,
accelerated muscle disorder in the form of sarcopenia, myosteatosis, and frailty with compromised energetics, bone diseases (e.g.,
osteoporosis), high alkaline phosphatase (“ALP”), cachexia, malnutrition, weight loss (>5%), symptoms of hypogonadism
such as abnormal hair distribution, anemia, sexual dysfunction, testicular atrophy, muscle wasting, fatigue, osteoporosis,
gynecomastia, inflammation with elevated cytokines, and infection risk leading to hospital admissions and possibly death.
HE,
a significant decompensation event in patients with cirrhosis, is a brain dysfunction caused by liver insufficiency and/or portal systemic
shunting. Because the damaged liver cannot function normally (as in cirrhosis), neurotoxins such as ammonia are inadequately removed
from systemic circulation and travel to the brain, where they affect neurotransmission. This can cause episodes of HE, which may present
as alterations in consciousness, cognition, and behavior that range from minimal to severe. Overt HE occurs in 30% to 40% of patients
with cirrhosis at some point during the clinical course of their disease. As the burden of chronic liver disease and cirrhosis is increasing,
the frequency of HE is also increasing.
Our
Partnership Pipeline Product Candidates
We
continue to pursue opportunities for partnering arrangements for the continued development and/or marketing of LPCN 1144, LPCN 1148,
LPCN 1111, LPCN 1107 and TLANDO outside of the U.S. We do not currently anticipate conducting any further significant development activities
with respect to these products and product candidates without the participation of a partner. There can be no guarantee that we will
be able to identify or enter into partnering arrangements on terms that are beneficial to us or at all. Even if we do enter into partnering
arrangements, such arrangements may not be sufficient to successfully develop and commercialize these products.
TLANDO:
An Oral Product for Testosterone Replacement Therapy
As
previously described, under the Antares License Agreement, we granted to Antares an exclusive, royalty-bearing, sublicensable right and
license to develop and commercialize TLANDO, our product for TRT in the U.S. TLANDO received FDA approval on March 28, 2022. Any FDA
requirement to conduct certain post-marketing studies will be the responsibility of our Licensee, Antares. On May 24, 2022, Halozyme
Therapeutics completed an acquisition of Antares Pharma Inc. through a 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.
Proof-of-concept
for TLANDO was initially established in 2006, and subsequently TLANDO was licensed in 2009 to Solvay Pharmaceuticals, Inc., which was
then acquired by Abbott Products, Inc. (“Abbott”). Following a portfolio review associated with the spin-off of AbbVie Inc.
by Abbott in 2011, the rights to TLANDO were reacquired by us. All obligations under the prior license agreement have been completed
except that Lipocine will owe Abbott a perpetual 1% royalty on net sales of TLANDO. Such royalties are limited to $1 million in the first
2 calendar years following product launch, after which period there is no 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. During
the three and six months ended June 30, 2023, we incurred royalty expense of approximately $9,000 and $13,000, respectively. During each
of the three and six months ended June 30, 2022 we incurred royalty expense of approximately $17,000.
Under
the Pediatric Research Equity Act (“PREA”), since TLANDO received full FDA approval under the Antares Licensing Agreement,
Antares will need to address the PREA requirement to assess the safety and effectiveness of TLANDO in pediatric patients. The FDA may
also require certain post-marketing studies to be conducted which will also be the responsibility of our licensee, Antares.
Upon
execution of the Antares License Agreement, Antares paid us an initial payment of $11.0 million. Antares will also make additional payments
of $5.0 million to us on each of January 1, 2025, and January 1, 2026, provided that certain conditions are satisfied. We are 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 products licensed by Antares under the Antares License Agreement. In addition, we 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. Further, on October 14, 2021, we assigned our Manufacturing Agreement, dated August 27, 2013,
by and between the Company and Encap Drug Delivery (the “Manufacturing Agreement”) to Antares as part of the Antares License
Agreement.
We
are exploring the possibility of licensing LPCN 1021 (known as TLANDO in the United States) to third parties outside the United States,
although no licensing agreement has been entered into by the Company. If and when an agreement is made with a partner, such arrangement
would likely be contingent upon obtaining acceptable cost of goods in addition to obtaining local regulatory approval. No assurance can
be given that any license agreement will be completed, or, if an agreement is completed, that such an agreement would be on terms favorable
to us.
LPCN
1144: An Oral Prodrug of Bioidentical Testosterone Product Candidate for the Treatment of NASH
We
are exploring the possibility of partnering LPCN 1144 to a third party, although no partnering agreement has been entered into by the
Company. No assurance can be given that any license agreement will be completed, or, if an agreement is completed, that such an agreement
would be on terms favorable to us.
Disease
Overview – NASH
NASH
is a more advanced state of non-alcoholic fatty liver disease (“NAFLD”) and can progress to a cirrhotic liver or liver failure,
require liver transplant, and can result in hepatocellular carcinoma/ liver cancer, and death. Progression of NASH to end stage liver
disease will soon surpass all other causes of liver failure requiring liver transplantation. Importantly, beyond these critical conditions,
NASH and NAFLD patients additionally suffer heightened cardiovascular risk and, in fact, die more frequently from cardiovascular events
than from liver disease. NAFLD/NASH is becoming more common due to its strong correlation with obesity and metabolic syndrome, including
components of metabolic syndrome such as diabetes, cardiovascular disease and high blood pressure. In the U.S., 20% to 30% of the population
is estimated to suffer from NAFLD and 15% to 20% of this group progress to NASH, which is a substantially large population that lacks
an effective therapy. NASH is a silent killer that affects millions in the U.S. Diagnoses have been on the rise and are expected to increase
dramatically in the next decade. Approximately 50% of NASH patients are adult males. In men, especially with comorbidities associated
with NAFLD/NASH, testosterone deficiency has been associated with an increased accumulation of visceral adipose tissue and insulin resistance,
which could be factors contributing to NAFLD/NASH. There is currently no approved therapy for the treatment of NASH although there are
several drug candidates currently under development with many having clinical failures to date.
The
critical pathophysiologic mechanisms underlying the development and progression of NASH include reduced ability to handle lipids, increased
insulin resistance, injury to hepatocytes and liver fibrosis in response to hepatocyte injury. NASH patients have an excessive accumulation
of fat in the liver resulting primarily from a caloric intake above and beyond energy needs. A healthy liver contains less than 5% fat,
but a liver in someone with NASH can contain more than 20% fat. This abnormal liver fat contributes to the progression to NASH, a liver
necro-inflammatory state that can lead to scarring, also known as fibrosis, and, for some, can progress to cirrhosis and liver failure.
Current
Status
We
have completed the LiFT Phase 2 clinical study in biopsy-confirmed non-cirrhotic NASH subjects. The LiFT clinical study
was a prospective, multi-center, randomized, double-blind, placebo-controlled multiple-arm study in biopsy-confirmed hypogonadal and
eugonadal male NASH subjects with grade F1-F3 fibrosis and a target NAFLD Activity Score ≥ 4 with a 36-week treatment period. The
LiFT clinical study enrolled 56 biopsy confirmed NASH male subjects. Subjects were randomized 1:1:1 to one of three arms (Treatment
A was a twice daily oral dose of 142 mg testosterone equivalent, Treatment B was a twice daily oral dose of 142 mg testosterone equivalent
formulated with 217 mg of d-alpha tocopherol equivalent, and the third arm was a twice daily matching placebo).
The
primary endpoint of the LiFT clinical study was change in hepatic fat fraction via MRI-PDFF and exploratory liver fat/marker end
points post 12 weeks of treatment. Additionally, key secondary endpoints post 36 weeks of treatment included assessment of histological
change for NASH resolution and/or fibrosis improvement (biopsy) as well as liver fat data (MRI-PDFF). The LiFT clinical study
was not powered to assess statistical significance of any of the secondary endpoints. Other important endpoints included the following:
change in liver injury markers, anthropomorphic measurements, lipids, insulin resistance and inflammatory/fibrosis markers; as well as
patient reported outcomes.
Treatments
with LPCN 1144 post 12 weeks of treatment in the LiFT study resulted in robust liver fat reduction, assessed by MRI-PDFF, and
showed improvement of liver injury markers with no observed tolerability issues.
Liver
biopsies were performed at baseline (“BL”) and after 36 weeks of treatment (“EOS”). Prespecified biopsy analyses
included NASH Clinical Research Network (“CRN”) scoring as well as a continuous paired (“Paired Technique”) and
digital technique (“Digital Technique-Fibronest”). All biopsy analyses were performed on the same slides and the reads for
the three techniques were done independently. Analysis sets included the NASH Resolution Set (all subjects that have BL and EOS biopsy
with NASH at BL [NAS ≥4 with lobular inflammation score ≥ 1 and hepatocyte ballooning score ≥1 at BL] (n=37)), the Biopsy Set
(all subjects with baseline and EOS biopsies (n=44)), and the Safety Set (all randomized subjects (n=56)).
Both
LPCN 1144 treatment arms met with statistical significance the pre-specified accelerated approval regulatory endpoint of NASH resolution
with no worsening of fibrosis based on NASH CRN scoring. Additionally, both treatment arms showed substantial improvement of the observed
NASH activity in steatosis, inflammation, and ballooning.
During
the 36 weeks of treatment, LPCN 1144 was well tolerated with an overall safety profile comparable to placebo. Additionally, subjects
were given the option to have access to LPCN 1144 through an open label extension (“OLE”) study. The extension study enabled
the collection of additional data on LPCN 1144 for up to a total of 72 weeks of therapy, as well as data for 36 weeks of therapy for
those subjects on placebo in the LiFT study. Key results from the OLE study are as follows:
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LPCN 1144 was well tolerated over 72-week exposure
with no observed safety signals; |
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Liver injury markers were reduced and maintained with
extended LPCN 1144 treatment; and |
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Observed liver histology improvements support further
development. |
In
November 2021, the FDA granted Fast Track Designation to LPCN 1144 as a treatment for non-cirrhotic NASH. The Fast Track program is designed
to accelerate the development and expedite the review of products, such as LPCN 1144, which are intended to treat serious diseases and
for which there is an unmet medical need.
We
had a written only response from FDA for a LPCN 1144 Type C meeting with the FDA in January 2022 to discuss the development path forward
with LPCN 1144. The FDA acknowledged that the NDA submission of LPCN 1144 would be via 505(b)2 regulatory pathway and agreed that no
additional non-clinical studies are needed to support an NDA submission. The FDA acknowledged that in the LiFT study subjects achieved
improvements in key components associated with NASH histopathology after 36-weeks of treatment with LPCN 1144 in adult males and agreed
that the proposed multicomponent primary surrogate endpoint is acceptable for seeking approval under the accelerated approval pathway.
The FDA agreed that the proposed primary multicomponent surrogate endpoint, NASH resolution with no worsening of fibrosis, is acceptable
for seeking approval under the accelerated approval pathway and the FDA recommended a Phase 3 trial with a study duration of 72 weeks.
In July 2022, Lipocine held an End of Phase 2 meeting with FDA for LPCN 1144 in NASH. The FDA recommended a Phase 2 dose ranging study
be conducted to identify the optimal dose prior to conducting a pivotal study. The FDA agreed to the proposed unique testosterone ester,
testosterone laurate, for future clinical studies.
LPCN
1111: A Next-Generation Long-Acting Oral Product Candidate for TRT
We
have commenced the process of scaling up the manufacturing process and generation of supplies of LPCN 1111 to enable potential
partners to conduct pivotal studies for registration. We are exploring the possibility of partnering LPCN 1111 with a third party,
although no partnering agreement has been entered into by the Company. No assurance can be given that any license agreement will be
completed, or, if an agreement is completed, that such an agreement would be on terms favorable to us.
LPCN
1111 is a next-generation, novel ester prodrug of testosterone comprised of testosterone tridecanoate (“TT”) which uses our
proprietary delivery technology to enhance solubility and improve systemic absorption. We completed a Phase 2b dose finding study in
hypogonadal men in the third quarter of 2016. The primary objectives of the Phase 2b clinical study were to determine the starting Phase
3 dose of LPCN 1111 along with safety and tolerability of LPCN 1111 and its metabolites following oral administration of single and multiple
doses in hypogonadal men. Good dose-response relationship was observed over the tested dose range in the Phase 2b study. Additionally,
the target Phase 3 dose met primary and secondary end points. Overall, LPCN 1111 was well tolerated with no drug-related severe or serious
adverse events reported in the Phase 2b study.
In
February 2018 we had a meeting with the FDA to discuss these pre-clinical results and to discuss the Phase 3 clinical study and path
forward for LPCN 1111. Based on the results of the FDA meeting and additional pre-clinical studies conducted after the FDA meeting, we
have proposed a Phase 3 protocol for LPCN 1111 and have solicited FDA feedback. Based on initial FDA feedback, we expect the Phase 3
clinical trial design to follow the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(“ICH”) guidelines and we expect the trial will include at least a 3-month efficacy treatment period and a 1-year safety
component for approximately 100 subjects. We are currently seeking further clarification from FDA with respect to the total subject LPCN
1111 exposure information needed for an NDA filing. We continue to refine the Phase 3 protocol and plan to request FDA approval of the
protocol once it is finalized. Additionally, the FDA previously requested that a food effect and a phlebotomy study be completed, and
that ambulatory blood pressure monitoring (“ABPM”) be included as part of the Phase 3 clinical study. We are currently transferring
the manufacturing of LPCN 1111 to a third-party contract manufacturer and scaling up the formulation after which we anticipate the next
steps for a partner developing LPCN 1111 may be to conduct a food effect/phlebotomy study with LPCN 1111. Under the terms of the Antares
License Agreement, Antares had been granted an option to license LPCN 1111, exercisable on or before March 31, 2022, for further development
and, should LPCN 1111 receive FDA approval, commercialization. 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 LPCN 1111 to June 30, 2022. As consideration for the Company’s agreement to the Amendment,
Antares paid the Company a non-refundable cash fee of $500,000 in April 2022. On June 30, 2022, Antares’ option to license LPCN
1111 expired and was not exercised.
LPCN
1107: An Oral Product Candidate for the Prevention of Preterm Birth
We
are exploring the possibility of partnering LPCN 1107 to a third party, although no partnering agreement has been entered into by the
Company. No assurance can be given that any partnership agreement will be completed, or, if an agreement is completed, that such an agreement
would be on terms favorable to us.
We
believe LPCN 1107 has the potential to become the first oral hydroxyprogesterone caproate (“HPC”) product indicated for the
reduction of risk of PTB (delivery less than 37 weeks) in women with singleton pregnancy who have a history of singleton spontaneous
PTB. Prevention of PTB is a significant unmet need as approximately 11% of all U.S. pregnancies result in PTB, a leading cause of neonatal
mortality and morbidity.
Current
Status
We
have completed a multi-dose PK dose selection study in pregnant women. The objective of the multi-dose PK selection study was to assess
HPC blood levels in order to identify the appropriate LPCN 1107 Phase 3 dose. The multi-dose PK dose selection study was an open-label,
4-period, 4-treatment, randomized, single and multiple dose PK study in pregnant women with 3 dose levels of LPCN 1107 and the IM HPC
(Makena®). The study enrolled 12 healthy pregnant women (average age of 27 years) with a gestational age of approximately 16 to 19
weeks. Subjects received three dose levels of LPCN 1107 (400 mg BID, 600 mg BID, or 800 mg BID) in a randomized, crossover manner during
the first 3 treatment periods and then received 5 weekly injections of HPC during the fourth treatment period. During each of the LPCN
1107 treatment periods, subjects received a single dose of LPCN 1107 on Day 1 followed by twice daily administration from Day 2 to Day
8. Following completion of the 3 LPCN 1107 treatment periods and a washout period, all subjects received 5 weekly injections of HPC.
Results from this study demonstrated that average steady state HPC levels (Cavg0-24) were comparable or higher for all 3 LPCN 1107 doses
than for injectable HPC. Additionally, HPC levels as a function of daily dose were linear for the 3 LPCN 1107 doses. Also, unlike the
injectable HPC, steady state exposure was achieved for all 3 LPCN 1107 doses within 7 days.
A
traditional PK/PD based Phase 2 clinical study in the intended patient population is not expected to be required prior to entering into
Phase 3. Therefore, based on the results of our multi-dose PK study we had an End-of-Phase 2 meeting and subsequent guidance meetings
with the FDA to define a pivotal Phase 2b/3 development plan for LPCN 1107. However, these discussions may be updated based on recent
developments with Covis’ Makena® as described below. We have completed a food effect study to characterize the dosing regimen
for the pivotal study and we have submitted a pivotal clinical study protocol to the FDA.
The
FDA has granted orphan drug designation to LPCN 1107 based on a major contribution to patient care. Orphan designation qualifies Lipocine
for various development incentives, including tax credits for qualified clinical testing, and a waiver of the prescription drug user
fee when we file our NDA.
Recent
Competition Update
On
October 5, 2020, the FDA’s Center for Drug Evaluation and Research (“CDER”) proposed that Makena be withdrawn from
the market because the PROLONG trial failed to verify the clinical benefit of Makena and concluded that the available evidence does not
show Makena is effective for its approved use.
The
CDER issued AMAG Pharmaceuticals, the NDA holder at the time, a Notice of Opportunity for Hearing (“NOOH”) to withdraw approval
of Makena, for which AMAG Pharmaceuticals responded by requesting a hearing and providing detail on the company’s position, recognizing
clinicians’ decade-long use of treatment with Makena and the public health implications of withdrawing approval. The FDA Commissioner
held a public hearing with Covis from October 17 through 19, 2022, which resulted in a 14-1 vote recommending removal of the product
from the market. On October 31, 2022, Covis approached the CDER and outlined a plan of orderly withdrawal which would set a withdrawal
timeframe sufficient for current patients to complete their courses of treatment. The CDER declined this proposal. On March 6, 2023,
Covis announced its plan to voluntarily withdraw Makena from the market and submitted a request to the CDER for a minimum 21-week wind-down.
On April 6, 2023, the FDA withdrew its approval of Makena and ordered the immediate withdrawal of Makena and several approved generic
versions of the drug, making it unlawful for the drug to be distributed in the US. The FDA stated that in light of the unmet need for
a treatment for preventing preterm birth and improving neonatal outcomes, it is imperative that the medical and scientific communities
increase their efforts to find effective treatments and stated their hope that the decision to withdraw Makena will help galvanize further
research. The FDA further stated their commitment to working together with patients, researchers, and drug developers to advance the
development of safe and effective therapies that are urgently needed as a treatment for the prevention of preterm birth.
Financial
Operations Overview
Revenue
To
date, we have not generated any revenues from product sales and do not expect to generate revenue other than TLANDO royalties and licensing
fees until one of our product candidates receives approval from the FDA. Revenues to date have been generated substantially from license
fees, royalty and milestone payments and research support from our licensees. Since our inception through June 30, 2023, we have generated
$44.8 million in revenue under our various license and collaboration arrangements and from government grants. Based on the terms of the
Antares License Agreement, in the fourth quarter of 2021 we recorded $4.1 million in revenue and an associated contract asset for future
contractual minimum royalties. We reduced our contract asset by $218,000 in 2022 due to a royalty payment received from Antares under
the terms of our license agreement, based on net sales of TLANDO in 2022. We anticipate that we will receive a payment of $772,000 in
the third quarter of 2023 in accordance with the terms of the license agreement. We may never generate revenues from any of our clinical
or pre-clinical development programs other than TLANDO, and we may never succeed in obtaining regulatory approval or commercializing
any of these product candidates.
Research
and Development Expenses
Research
and development expenses consist primarily of salaries, benefits, stock-based compensation and related personnel costs, fees paid to
external service providers such as contract research organizations and contract manufacturing organizations, contractual obligations
for clinical development, clinical sites, manufacturing and scale-up for late stage clinical trials, formulation of clinical drug supplies,
and expenses associated with regulatory submissions. Research and development expenses also include an allocation of indirect costs,
such as those for facilities, office expense, and depreciation of equipment based on the ratio of direct labor hours for research and
development personnel to total direct labor hours for all personnel. We expense research and development expenses as incurred. Since
our inception, we have spent approximately $142.7 million in research and development expenses through June 30, 2023.
We
expect to continue to incur significant costs as we develop our other product candidates, including our CNS product candidates and the
ongoing Phase 2 POC study in male subjects with cirrhosis with LPCN 1148, as well as the development of any future pipeline product candidates.
In
general, the cost of clinical trials may vary significantly over the life of a project as a result of uncertainties in clinical development,
including, among others:
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the number of sites included in the trials; |
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the length of time required to enroll suitable subjects;
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the duration of subject follow-ups; |
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the length of time required to collect, analyze and
report trial results; |
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the cost, timing and outcome of regulatory review;
and |
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potential changes by the FDA in clinical trial and
NDA filing requirements. |
Future
research and development expenditures are subject to numerous uncertainties regarding timing and cost to completion, including, among
others:
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the timing and outcome of regulatory filings and FDA
reviews and actions for product candidates; |
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our dependence on third-party manufacturers for the
production of satisfactory finished product for registration and launch should regulatory approval be obtained on any of our product
candidates; |
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the potential for future license or co-promote arrangements
for our product candidates, when such arrangements will be secured, if at all, and to what degree such arrangements would affect
our future plans and capital requirements; and |
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the effect on our product development activities of
actions taken by the FDA or other regulatory authorities. |
A
change of outcome for any of these variables with respect to the development of our product development candidates could mean a substantial
change in the costs and timing associated with these efforts, could require us to raise additional capital, and may require us to reduce
operations.
Given
the stage of clinical development and the significant risks and uncertainties inherent in the clinical development, manufacturing, and
regulatory approval process, we are unable to estimate with any certainty the time or cost to complete the development of LPCN 1154,
LPCN 2101, LPCN 1148, LPCN 1144, LPCN 1111, LPCN 1107 and other product candidates. Clinical development timelines, the probability of
success and development costs can differ materially from expectations and results from our clinical trials may not be favorable. If we
are successful in progressing LPCN 1154, LPCN 2101, or other future product candidates into later stage development, we will require
additional capital. The amount and timing of our future research and development expenses for these product candidates will depend on
the pre-clinical and clinical success of both our current development activities and potential development of new product candidates,
as well as ongoing assessments of the commercial potential of such activities. We will continue efforts to enter into partnership arrangements
for the continued development and/or marketing of LPCN 1144, LPCN 1148, LPCN 1111, LPCN 1107 and TLANDO outside of the U.S.
We
will continue to incur significant research and development expenses as we are conducting on-going clinical studies, including the studies
for our CNS product candidates and the Phase 2 POC study in male subjects with cirrhosis with LPCN 1148, and as we conduct future clinical
studies, including when and if we conduct Phase 2 clinical studies with our development product candidates and when and if we conduct
Phase 3 clinical studies with LPCN 1144, LPCN 1148, LPCN 1111 and LPCN 1107. We are exploring the possibility of licensing LPCN 1144,
LPCN 1148, LPCN 1111 and LPCN 1107, although we have not entered into a licensing agreement and no assurance can be given that any license
agreement will be completed, or, if an agreement is completed, that such an agreement would be on terms favorable to us. If we are unable
to raise additional capital or obtain non-dilutive financing, we may need to reduce research and development expenses in order to extend
our ability to continue as a going concern.
General
and Administrative Expenses
General
and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation related to our executive,
finance, and administrative support functions. Other general and administrative expenses include rent and utilities, travel expenses,
and professional fees for auditing, tax, legal, business development and various other services.
General
and administrative expenses also include expenses for the cost of preparing, filling and prosecuting patent applications and maintaining,
enforcing and defending intellectual property-related claims.
We
expect that general and administrative expenses will increase in the future as we continue as a public company including legal and consulting
fees, accounting and audit fees, director fees, directors’ and officers’ insurance premiums, fees for investor relations
services and enhanced business and accounting systems, litigation costs, professional fees and other costs. However, if we are unable
to raise additional capital, we may need to reduce general and administrative expenses in order to extend our ability to continue as
a going concern.
Other
Income and Expense
Other
income and expense consists primarily of interest income earned on our cash, cash equivalents and marketable investment securities, imputed
interest on minimum royalties under the Antares Licensing Agreement, interest expense incurred on our Loan and Security Agreement, losses
(gains) on our warrant liability and gains on our litigation liability.
Results
of Operations
Comparison
of the Three Months Ended June 30, 2023 and 2022
The
following table summarizes our results of operations for the three months ended June 30, 2023 and 2022:
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Three Months Ended June 30, | | |
| |
| |
2023 | | |
2022 | | |
Variance | |
Revenue | |
$ | - | | |
$ | 500,000 | | |
$ | (500,000 | ) |
Research and development expenses | |
| 2,515,211 | | |
| 2,898,012 | | |
| (382,801 | ) |
General and administrative expenses | |
| 1,440,394 | | |
| 1,129,519 | | |
| 310,875 | |
Interest and investment income | |
| 379,521 | | |
| 69,877 | | |
| 309,644 | |
Interest expense | |
| - | | |
| (7,568 | ) | |
| 7,568 | |
Gain on litigation settlement | |
| - | | |
| 250,000 | | |
| (250,000 | ) |
Gain on warrant liability | |
| 27,455 | | |
| 583,445 | | |
| (555,990 | ) |
Revenue
We
did not recognize any revenue during the three months ended June 30, 2023. During the three months ended June 30, 2022, we recognized
revenue related to a non-refundable cash fee of $500,000 received from Antares for consideration of a 90-day extension for Antares to
exercise its option to license LPCN 1111.
Research
and Development Expenses
The
decrease in research and development expenses during the three months ended June 30, 2023, as compared to the three months ended
June 30, 2022 consists of a $229,000 decrease in costs related to our LPCN 1154 clinical studies, a $222,000 decrease in lab
supplies, small equipment and other research and development costs, a $146,000 decrease in contract research organization expense
and outside consulting costs related to the completion of our LPCN 1144 LiFT study in 2022,
an $82,000 decrease related to our completed PK and food effect studies for LPCN 1107, and a $32,000 decrease in LPCN 1111 scale up
costs. These decreases were offset by a $113,000 increase in contract research organization expense related to the Phase 2 POC study
in male subjects with cirrhosis with LPCN 1148, a $109,000 increase in personnel related costs and a $106,000 increase in TLANDO
related costs.
General
and Administrative Expenses
The
increase in general and administrative expenses during the three months ended June 30, 2023 as compared to the three months ended
June 30, 2022 was primarily due to a $120,000 increase in professional and legal fees related to our reverse stock split and other
general and administrative expenses, a $91,000 increase in estimated franchise taxes resulting from our reverse stock split, an
$82,000 increase in business development fees, a $58,000 increase in personnel salaries and benefits, a $42,000 increase in market
research activities, and a $36,000 increase in director fees. These increases were offset by an $82,000 decrease from professional
fees incurred in our recruitment of two additional directors in 2022 and a $36,000 decrease in corporate insurance
expense.
Interest
and Investment Income
The
increase in interest and investment income during the three months ended June 30, 2023 compared to interest and investment income during
the three months ended June 30, 2022 was due to higher interest rates despite declining cash and marketable investment securities balances,
in addition to imputed interest on the Antares License Agreement asset in 2023.
Interest
Expense
Our
Loan and Security Agreement with SVB was paid in full in June of 2022, thus the Company did not recognize any interest expense during
the three months ended June 30, 2023. Interest expense for the three months ended June 30, 2022, was entirely related to that Loan Agreement.
Gain
(Loss) on Warrant Liability
We recorded a gain of approximately $27,000 and $583,000 on warrant liability
during the three months ended June 30, 2023, and 2022, respectively, related to the change in the fair value of outstanding common stock
warrants issued in the November 2019 Offering. The gain in 2023 was mainly attributable to a decrease in the value of warrants outstanding
as of June 30, 2023 as compared to March 31, 2023, primarily due the decrease in our stock price at the end of the second quarter of 2023
as compared to the stock price at the end of the first quarter of 2023 in addition to higher interest rates, and the gain in 2022 was
mainly attributable to the decrease in the value of the warrants outstanding as of June 30, 2022 compared to March 31, 2022 due to the
lower stock price at the end of the second quarter of 2022 as compared to the stock price at the end of the first quarter of 2022. No
common stock warrants from the November 2019 Offering were exercised during either the three months ended June 30, 2023 or the three months
ended June 30, 2022. The warrants are classified as a liability due to a provision contained within the warrant agreement which allows
the warrant holder the option to elect to receive an amount of cash equal to the value of the warrants as determined in accordance with
the Black-Scholes option pricing model with certain defined assumptions upon a change of control. The warrant liability will continue
to fluctuate in the future based on inputs to the Black-Scholes model including our current stock price, the remaining life of the warrants,
the volatility of our stock price, the risk-free interest rate and the number of common stock warrants outstanding.
Litigation
Settlement
During
the three months ended June 30, 2022, we recorded a gain on the settlement of litigation liability of $250,000 as a result of the April
2022 Amendment to the Global Agreement with Clarus (the “Amended Settlement Agreement”). Under the terms of the original
Global Agreement, we had agreed to pay Clarus $4.0 million payable as follows: $2.5 million which was paid in July 2021, $1.0 million
which was to be paid on July 13, 2022, and $500,000 to be paid on July 13, 2023. The Amended Settlement Agreement settled the payments
due in July 2022 and 2023 for $1,250,000 rather than the $1,500,000 total future payments due under the terms of the original Global
Agreement agreed to in 2021. No future royalties are owing from either party under the Amendment to the Global Agreement.
Comparison
of the Six Months Ended June 30, 2023 and 2022
The
following table summarizes our results of operations for the six months ended June 30, 2023 and 2022:
| |
Six months ended June 30, | | |
| |
| |
2023 | | |
2022 | | |
Variance | |
Revenue | |
$ | 54,990 | | |
$ | 500,000 | | |
$ | (445,010 | ) |
Research and development expenses | |
| 5,621,521 | | |
| 4,785,965 | | |
| 835,556 | |
General and administrative expenses | |
| 2,727,708 | | |
| 2,373,205 | | |
| 354,503 | |
Interest and investment income | |
| 749,991 | | |
| 111,453 | | |
| 638,538 | |
Interest expense | |
| - | | |
| (27,098 | ) | |
| 27,098 | |
Gain on warrant liability | |
| 125,589 | | |
| 205,457 | | |
| (79,868 | ) |
Gain on litigation settlement | |
| - | | |
| 250,000 | | |
| (250,000 | ) |
Income tax expense | |
| (200 | ) | |
| (200 | ) | |
| - | |
Revenue
We
recognized license revenue of approximately $55,000 for payments receivable from Spriaso, a related party, under a licensing agreement
in the cough and cold field during the six months ended June 30, 2023. We recognized revenue related to a non-refundable cash fee of
$500,000 received from Antares for consideration of a 90-day extension for Antares to exercise its option to license LPCN 1111 during
the six months ended June 30, 2022.
Research
and Development Expenses
The
increase in research and development expenses during the six months ended June 30, 2023, as compared to the six months ended June
30, 2022 consisted of a $793,000 increase in contract research organization expense related to the Phase 2 POC study in male
subjects with cirrhosis with LPCN 1148, a $284,000 increase in costs related to our LPCN 1154 clinical studies, a $268,000 increase
in personnel salaries and benefits resulting primarily from the hiring of additional personnel, and a $99,000 increase in TLANDO.
These increases were offset by a $217,000 decrease in contract research organization expense and outside consulting costs related to
the completion of our LPCN 1144 LiFT study in 2022, a $203,000 decrease related to LPCN 1111 scale up costs in 2022, a
$120,000 decrease related to the completion of our LPCN 1107 PK and food effect studies in 2022 and a $68,000 decrease in lab
supplies, small equipment and other research and development activities.
General
and Administrative Expenses
The
increase in general and administrative expenses during the six months ended June 30, 2023 as compared to the six months ended June
30, 2022 was primarily due to a $185,000 increase in professional and legal fees related to our reverse stock split and other
general and administrative expenses, a $134,000 increase in business development fees, a $92,000 increase in estimated franchise
taxes, a $68,000 increase in director fees, a $49,000 increase in personnel salaries and benefit costs, and a $40,000 increase in
market research activities. These increases were offset by a $140,000 decrease resulting from professional fees incurred in our
recruitment of two additional directors in 2022 and a $73,000 decrease in corporate insurance expense.
Interest
and Investment Income
The
increase in interest and investment income during the six months ended June 30, 2023 compared to interest and investment income during
the six months ended June 30, 2022 was due to higher interest rates despite declining cash and marketable investment securities balances,
in addition to imputed interest on the Antares licensing contract asset in 2023.
Interest
Expense
Our
Loan and Security Agreement with SVB was paid in full in June of 2022, thus the Company did not recognize any interest expense during
the six months ended June 30, 2023. Interest expense for the six months ended June 30, 2022 was entirely related to that Loan and Security
Agreement.
(Gain)
Loss on Warrant Liability
We
recorded a gain of approximately $126,000 and $205,000 on warrant liability during the six months ended June 30, 2023,
and 2022, respectively, related to the change in the fair value of outstanding common stock warrants issued in the November 2019 Offering.
The gain in 2023 was mainly attributable to a decrease in the value of warrants outstanding as of June 30, 2023 as compared to December
31, 2022, primarily due to the lower stock price at the end of the second quarter of 2023 compared to the stock price at
the end of 2022 and the gain in 2022 was mainly attributable to the decrease in the value of the warrants
outstanding as of June 30, 2022 compared to December 31, 2021 due to the lower stock price at the end of the second quarter of 2022 compared
to the stock price at the end of 2021. No common stock warrants from the November 2019 Offering were exercised during either of the six
months ended June 30, 2023, or June 30, 2022. The warrants are classified as a liability due to a provision contained within the warrant
agreement which allows the warrant holder the option to elect to receive an amount of cash equal to the value of the warrants as determined
in accordance with the Black-Scholes option pricing model with certain defined assumptions upon a change of control. The warrant liability
will continue to fluctuate in the future based on inputs to the Black-Scholes model including our current stock price, the remaining
life of the warrants, the volatility of our stock price, the risk-free interest rate and the number of common stock warrants outstanding.
Litigation
Settlement
During
the six months ended June 30, 2022, we recorded a gain on the settlement of litigation liability of $250,000 as a result of the April
2022 Amendment to the Global Agreement with Clarus (the “Amended Settlement Agreement”). Under the terms of the original
Global Agreement, we had agreed to pay Clarus $4.0 million payable as follows: $2.5 million which was paid in
July 2021, $1.0 million which was to be paid on July 13, 2022, and $500,000 to be paid on July 13, 2023. The Amended Settlement Agreement
settled the payments due in July 2022 and 2023 for $1,250,000 rather than the $1,500,000 total future payments due under the terms of
the original Global Agreement agreed to in 2021. No future royalties are owing from either party under the Amendment to the Global Agreement.
Liquidity
and Capital Resources
Since
our inception, our operations have been primarily financed through sales of our equity securities, debt and payments received under our
license and collaboration arrangements. We have devoted our resources to funding research and development programs, including discovery
research, pre-clinical and clinical development activities. We have incurred operating losses in most years since our inception and we
expect to continue to incur operating losses into the foreseeable future as we advance the clinical development of LPCN 1154, LPCN 2101,
LPCN 1148, and any other future product candidate, including continued research efforts.
As
of June 30, 2023, we had $25.8 million of unrestricted cash, cash equivalents and marketable investment securities compared to $32.5
million at December 31, 2022.
On
October 14, 2021, we entered into the Antares License Agreement with Antares, pursuant to which we granted to Antares an exclusive,
royalty-bearing, sublicensable right and license to develop and commercialize, upon final approval of TLANDO from the FDA, our
TLANDO product with respect to TRT in the U.S. Upon execution of the Antares License Agreement, Antares paid to us an initial
payment of $11.0 million. Antares has also agreed to make certain minimum royalty payments in the future and, since these future
minimum royalties are variable consideration deemed to be probable, approximately $4.0 million in revenue was recognized in 2021 for
the minimum royalties to be received in the future. In addition, Antares will also make additional payments of $5.0 million to us on
each of January 1, 2025 and January 1, 2026, provided that certain conditions are satisfied. We are 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 all products licensed by Antares under the Antares License Agreement. In addition, we 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. Our ability to realize benefits from the Antares License Agreement, including
milestone and royalty payments, is subject to a number of risks. We may not realize milestone or royalty payments in anticipated
amounts, or at all.
On
January 5, 2018, we entered into the Loan and Security Agreement with SVB pursuant to which SVB agreed to lend us $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 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, we entered into a Deferral Agreement with SVB.
Under the Deferral Agreement, principal repayments were deferred by six months and we were only required to make monthly interest payments
during the deferral period. The Loan matured and was paid in full on June 1, 2022. Additionally, we 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.
On
March 6, 2017, we entered into a sales agreement (“Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”)
pursuant to which we may issue and sell, from time to time, shares of our common stock having an aggregate offering price of up to the
amount we have registered on an effective registration statement pursuant to which the offering is being made. We currently have registered
up to $50.0 million for sale under the Sales Agreement, pursuant to our Registration Statement on Form S-3 (File No. 333-250072) (the
“Form S-3”), through Cantor as our sales agent. Cantor may sell our common stock by any method permitted by law deemed to
be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended, 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. We pay Cantor 3.0% of the aggregate gross proceeds from each sale of shares under the Sales Agreement. We have
also provided Cantor with customary indemnification rights.
The
shares of our common stock sold under the Sales Agreement are sold and issued pursuant to our Registration Statement on Form S-3, which
was previously declared effective by the Securities and Exchange Commission, and the related prospectus and one or more prospectus supplements.
We
are not obligated to make any sales of our common stock under the Sales Agreement. The offering of our common stock pursuant to the Sales
Agreement will terminate upon the termination of the Sales Agreement as permitted therein. We and Cantor may each terminate the Sales
Agreement at any time upon ten days’ prior notice.
During
the three and six months ended June 30, 2023, and 2022, we did not sell any shares of our common stock under the Sales Agreement. As
of June 30, 2023, we had sold shares of our common stock for $8,802,419 pursuant to the Sales Agreement and had approximately $41.2 million
available for sale under the Sales Agreement. However, as of April 3, 2023, we are 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, we have 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.
We
believe that our existing capital resources, together with interest thereon, will be sufficient to meet our projected operating requirements
through at least the next twelve months which include on-going clinical studies for LPCN 1154, an on-going study for LPCN 1148, and research
and development activities and compliance with regulatory requirements. We have based this estimate on assumptions that may prove to
be wrong, and we could utilize our available capital resources sooner than we currently expect if additional activities are performed
by us including new clinical studies for LPCN 1144, LPCN 1111, and LPCN 1107. While we believe we have sufficient liquidity and capital
resources to fund our projected operating requirements through at least the next twelve months, we will need to raise additional capital
at some point through the equity or debt markets or through additional out-licensing activities to support our operations. If we are
unsuccessful in raising additional capital as necessary, our ability to continue as a going concern will be limited. Further, our operating
plan may change, and we may need additional funds to meet operational needs and capital requirements for product development, regulatory
compliance and clinical trial activities sooner than planned. In addition, our capital resources may be consumed more rapidly if we pursue
additional clinical studies for LPCN 1154, LPCN 2101, LPCN 1148, LPCN 1144, LPCN 1111, and/or LPCN 1107. Conversely, our capital resources
could last longer if we reduce expenses, reduce the number of activities currently contemplated under our operating plan or if we terminate,
modify or suspend on-going clinical studies. We can raise capital pursuant to the Sales Agreement but may choose not to issue common
stock if our market price is too low to justify such sales in our discretion. There are numerous risks and uncertainties associated with
the development and, subject to approval by the FDA, commercialization of our product candidates. There are numerous risks and uncertainties
impacting our ability to enter into collaborations with third parties to participate in the development and potential commercialization
of our product candidates. We are unable to precisely estimate the amounts of increased capital outlays and operating expenditures associated
with our anticipated or unanticipated clinical studies and ongoing development efforts. All of these factors affect our need for additional
capital resources. To fund future operations, we will need to ultimately raise additional capital and our requirements will depend on
many factors, including the following:
|
● |
the scope, rate of progress, results and cost of our
clinical studies, pre-clinical testing and other related activities for all of our product candidates, including LPCN 1154 and LPCN
2101, LPCN 1148, LPCN 1111, LPCN 1144, LPCN 1107 and; |
|
|
|
|
● |
the cost of manufacturing clinical supplies and establishing
commercial supplies of our product candidates and any products that we may develop; |
|
|
|
|
● |
the cost and timing of establishing sales, marketing
and distribution capabilities, if any; |
|
|
|
|
● |
the terms and timing of any collaborative, licensing,
settlement and other arrangements that we may establish; |
|
|
|
|
● |
the number and characteristics of product candidates
that we pursue; |
|
|
|
|
● |
the cost, timing and outcomes of regulatory approvals;
|
|
|
|
|
● |
the timing, receipt and amount of sales, profit sharing,
milestones or royalties, if any, from our potential products; |
|
|
|
|
● |
the cost of preparing, filing, prosecuting, defending
and enforcing any patent claims and other intellectual property rights; |
|
|
|
|
● |
the extent to which we acquire or invest in businesses,
products or technologies, although we currently have no commitments or agreements relating to any of these types of transactions;
and |
|
|
|
|
● |
the extent to which we grow significantly in the number
of employees or the scope of our operations. |
Funding
may not be available to us on favorable terms, or at all. Also, market conditions may prevent us from accessing the debt and equity capital
markets, including sales of our common stock through the Sales Agreement. If we are unable to obtain adequate financing when needed,
we may have to delay, reduce the scope of or suspend one or more of our clinical studies, research and development programs or, if any
of our product candidates receive approval from the FDA, commercialization efforts. We may seek to raise any necessary additional capital
through a combination of public or private equity offerings, including the Sales Agreement, debt financings, collaborations, strategic
alliances, licensing arrangements and other marketing and distribution arrangements. These arrangements may not be available to us or
available on terms favorable to us. To the extent that we raise additional capital through marketing and distribution arrangements, other
collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our product
candidates, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us.
If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will
be diluted, and the terms of these securities may include liquidation or other preferences, warrants or other terms that adversely affect
our stockholders’ rights or further complicate raising additional capital in the future. If we raise additional capital through
debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional
debt, making capital expenditures or declaring dividends. If we are unable, for any reason, to raise needed capital, we will have to
reduce costs, delay research and development programs, liquidate assets, dispose of rights, commercialize products or product candidates
earlier than planned or on less favorable terms than desired or reduce or cease operations.
Sources
and Uses of Cash
The
following table provides a summary of our cash flows for the six months ended June 30, 2023, and 2022:
| |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
Cash used in operating activities | |
$ | (7,237,654 | ) | |
$ | (6,931,731 | ) |
Cash provided by investing activities | |
| 9,115,069 | | |
| 11,083,460 | |
Cash used in financing activities | |
| (11,216 | ) | |
| (2,121,088 | ) |
Net
Cash from Operating Activities
During
the six months ended June 30, 2023 and 2022, net cash used in operating activities was $7.2 million and $6.9 million, respectively.
Net
cash used in operating activities during the six months ended June 30, 2023, and June 30, 2022, was primarily attributable to cash outlays
to support ongoing operations, including research and development expenses and general and administrative expenses. During 2023, we performed
activities primarily related to our Phase 2 POC study in male subjects with cirrhosis with LPCN 1148 and clinical studies related to
LPCN 1154. During 2022, we performed activities related mainly to the Phase 2 POC study in male subjects with cirrhosis with LPCN 1148,
PK and food effect studies with LPCN 1154 and LPCN 1107, and manufacturing scale up with LPCN 1111.
Net
Cash from Investing Activities
During
the six months ended June 30, 2023 and 2022, net cash provided by investing activities was $9.1 million and $11.1 million, respectively.
Net
cash provided by investing activities during the six months ended June 30, 2023, and June 30, 2022, was primarily the result of
the maturity of marketable investment securities, net of $9.1 million and $11.1 million, respectively. There were approximately $4,000
and $37,000 in capital expenditures during the six months ended June 30, 2023, and 2022, respectively.
Net
Cash from Financing Activities
During
the six months ended June 30, 2023 and 2022, net cash used in financing activities was approximately $11,000 and $2.1 million, respectively.
Net
cash used in financing activities during the six months ended June 30, 2023, related to costs associated with our ATM registration. Net
cash used in financing activities during the six months ended June 30, 2022, was due to loan repayments of $1.7 million and payment of
the Final Payment Charge of $650,000 related to the SVB Loan and Security Agreement, offset by $206,000 cash provided by proceeds from
stock option exercises.
Contractual
Commitments and Contingencies
Long-Term
Debt Obligations and Interest on Debt
On
January 5, 2018, we entered into a Loan and Security Agreement with SVB pursuant to which SVB agreed to lend us $10.0 million. The principal
borrowed under the Loan and Security Agreement bore interest at a rate equal to the Prime Rate plus one percent per annum, which interest
was payable monthly. The loan matured on June 1, 2022 and the outstanding principal, interest and Final Payment Charge were paid in full.
Purchase
Obligations
We
enter into contracts and issue purchase orders in the normal course of business with clinical research organizations for clinical trials
and clinical and commercial supply manufacturing and with vendors for pre-clinical research studies, research supplies and other services
and products for operating purposes. These contracts generally provide for termination on notice and are cancellable obligations.
Operating
Leases
In
August 2004, we entered into an agreement to lease our facility in Salt Lake City, Utah consisting of office and laboratory space which
serves as our corporate headquarters. On January 16, 2023, we modified and extended the lease through February 28, 2024.
Critical
Accounting Policies and Significant Judgments and Estimates
Our
management’s discussion and analysis of our financial condition and results of operations is based on our financial statements
which we have prepared in accordance with U.S. generally accepted accounting principles. In preparing our financial statements, we are
required to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets
and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods.
Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances,
the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent
from other sources. Actual results may differ from these estimates under different assumptions or conditions. There have been no significant
and material changes in our critical accounting policies during the six months ended June 30, 2023, as compared to those disclosed in
“Management’s Discussion and Analysis of Financial Condition and Results of Operations-Critical Accounting Policies and Significant
Judgments and Estimates” in our Form 10-K filed March 10, 2023.
Off-Balance
Sheet Arrangements
None.
ITEM
3. | QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
We
are exposed to various market risks, which include potential losses arising from adverse changes in market rates and prices, such as
interest rates. We do not enter into derivatives or other financial instruments for trading or speculative purposes.
There
have been no material changes to the Company’s market risk during the first six months of 2023. For a discussion of the Company’s
exposure to market risk, refer to the Company’s market risk disclosures set forth in Part II, Item 7A, “Quantitative and
Qualitative Disclosures About Market Risk” of the 2022 Form 10-K.
ITEM
4. | CONTROLS
AND PROCEDURES |
Evaluation
of Disclosure Controls and Procedures
We
maintain “disclosure controls and procedures” within the meaning of Rule 13a-15(e) of the Securities Exchange Act of 1934,
as amended, or the Exchange Act. Our disclosure controls and procedures, or Disclosure Controls, are designed to ensure that information
required to be disclosed by us in the reports we file or submit under the Exchange Act, such as this Quarterly Report on Form 10-Q, is
recorded, processed, summarized and reported within the time periods specified in the U.S. Securities and Exchange Commission’s
rules and forms. Our Disclosure Controls include, without limitation, controls and procedures designed to ensure that such information
is accumulated and communicated to our management, including our Chief Executive Officer and Principal Financial Officer, as appropriate
to allow timely decisions regarding required disclosure.
As
of the end of the period covered by this Quarterly Report on Form 10-Q, we evaluated the effectiveness of the design and operation of
our Disclosure Controls, which was done under the supervision and with the participation of our management, including our Chief Executive
Officer and our Principal Financial Officer. Based on the controls evaluation, our Chief Executive Officer and Principal Financial Officer
have concluded that our Disclosure Controls were effective as of June 30, 2023.
Changes
in Internal Control over Financial Reporting
There
have been no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) during the
most recent fiscal quarter covered by this report, that have materially affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
PART
II—OTHER INFORMATION
The
Company is from time to time involved in various claims, legal proceedings and complaints arising in the ordinary course of business.
Please refer to Note 11 – Commitments and Contingences to the condensed consolidated financial statements contained in this
report for certain information regarding our legal proceedings.
In
addition to the other information set forth in this Report, consider the risk factors discussed in Part 1, “Item 1A. Risk Factors”
in the Company’s Annual Report filed on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 10, 2023, risk
factors discussed in Item 1A of the Form 10-Q for the quarter ended March 31, 2023 filed with the SEC on May 11, 2023, and the risk factors
discussed in Item 1A of this Form 10-Q, which could materially affect our business, financial condition or future results. The risks
described in the aforementioned report are not the only risks facing the Company. Additional risks and uncertainties not currently known
to the Company or that it currently deems to be not material also may materially adversely affect the Company’s business, financial
condition and or operating results.
The
following are the risk factors that have materially changed from our risk factors included in our Form 10-K for the year ended December
31, 2022, filed with the SEC on March 10, 2023:
Risks
Related to Ownership of Our Common Stock
The
value of our warrants outstanding from the November 2019 Offering is subject to potentially material increases and decreases based on
fluctuations in the price of our common stock, among other factors.
In
November 2019, we completed a public offering of common stock and warrants to purchase common stock (the “November 2019
Offering”). Gross proceeds from the November 2019 Offering were approximately $6.0 million. In the November 2019 Offering, the
Company sold (i) 614,706 Class A Units, with each Class A Unit consisting of one share of
common stock and a common stock warrant to purchase one share of common stock, and (ii) 91,177 Class B Units, with each Class B
Unit consisting of one pre-funded warrant to purchase one share of common stock and one common stock warrant to purchase one share
of common stock at a price of $8.50 per Class A Unit and $8.4998 per Class B Unit. The pre-funded warrants were issued in lieu of
common stock in order to ensure the purchaser did not exceed certain beneficial ownership limitations. The pre-funded warrants were
immediately exercisable at an exercise price of $0.0017 per share, subject to adjustment. Additionally, the common stock warrants
were immediately exercisable at an exercise price of $8.50 per share and expire on November 17, 2024. As of June 30,
2023, there were 64,362 common stock warrants outstanding.
We
account for the common stock warrants as a derivative instrument, and changes in the fair value of the warrants are included under other
income (expense) in the Company’s statements of operations for each reporting period. On June 30, 2023, the aggregate fair value
of the warrant liability included in the Company’s consolidated balance sheet was approximately $104,000. We use the Black-Scholes
option pricing model to determine the fair value of the warrants. As a result, the option-pricing model requires the input of several
assumptions, including the stock price volatility, share price and risk-free interest rate. Changes in these assumptions can materially
affect the fair value estimate. While the liability may only result from a change of control at that point in time, we ultimately may
incur amounts significantly different than the carrying value.
Our
management and directors will be able to exert influence over our affairs.
As
of June 30, 2023, our executive officers and directors beneficially owned approximately 5.6% of our common stock. These stockholders,
if they act together, may be able to influence our management and affairs and all matters requiring stockholder approval, including significant
corporate transactions. This concentration of ownership may have the effect of delaying or preventing a change in control and might affect
the market price of our common stock.
The
market price of our common stock has been volatile over the past year and may continue to be volatile.
The
market price and trading volume of our common stock has been volatile over the past year and it may continue to be volatile. Over the
past year, on a post-reverse stock split basis, our common stock has traded as low as $3.53 and as high as $13.99 per share. We cannot
predict the price at which our common stock will trade in the future and it may decline. The price at which our common stock trades may
fluctuate significantly and may be influenced by many factors, including our financial results; developments generally affecting our
industry; general economic, industry and market conditions; the depth and liquidity of the market for our common stock; investor perceptions
of our business; reports by industry analysts; announcements by other market participants, including, among others, investors, our competitors,
and our customers; regulatory action affecting our business; and the impact of other “Risk Factors” discussed herein and
in our Annual Report. In addition, changes in the trading price of our common stock may be inconsistent with our operating results and
outlook. The volatility of the market price of our common stock may adversely affect investors’ ability to purchase or sell shares
of our common stock.
Risks
Relating to Our Financial Position and Capital Requirements
We
have incurred significant operating losses in most years since our inception and anticipate that we will incur continued losses for the
foreseeable future.
We
have focused a significant portion of our efforts on developing TLANDO and more recently on LPCN 1154, LPCN 2101, LPCN 1148 and LPCN
1144. We have funded our operations to date through sales of our equity securities, debt and payments received under our license and
collaboration arrangements. We have incurred losses in most years since our inception. As of June 30, 2023, we had an accumulated deficit
of $190.8 million. Substantially all of our operating losses resulted from costs incurred in connection with our research and development
programs and from general and administrative costs associated with our operations. These losses, combined with expected future losses,
have had and will continue to have an adverse effect on our stockholders’ equity and working capital. We expect our research and
development expenses to continue to be significant in connection with clinical trials associated with LPCN 1154, LPCN 2101, LPCN 1148,
LPCN 1111, LPCN 1144, and LPCN 1107, and possibly increased research and development costs if further clinical trials are initiated.
As a result, we expect to continue to incur significant operating losses for the foreseeable future as we evaluate further clinical development
of LPCN 1154, LPCN 2101, LPCN 1148, LPCN 1111, LPCN 1144, and LPCN 1107, and our other programs and continued research efforts. Because
of the numerous risks and uncertainties associated with developing pharmaceutical products, we are unable to predict the extent of any
future losses or when we will become profitable, if at all.
We
may not be able to maintain our listing on the NASDAQ Capital Market, which would adversely affect the price and liquidity of our common
stock.
As
a small capitalization pharmaceutical company, the price of our common shares has been, and is likely to continue to be, highly volatile.
Any announcements concerning us or our competitors, clinical trial results, quarterly variations in operating results, introduction of
new products, delays in the introduction of new products or changes in product pricing policies by us or our competitors, acquisition
or loss of significant customers, partners and suppliers, changes in earnings estimates or our ratings by analysts, regulatory developments,
or fluctuations in the economy or general market conditions, among other factors, could cause the market price of our common shares to
fluctuate substantially. There can be no assurance that the market price of our common shares will not decline below its current price
or that it will not experience significant fluctuations in the future, including fluctuations that are unrelated to our performance.
Currently
our common stock is quoted on the NASDAQ Capital Market under the symbol “LPCN”. We must satisfy certain minimum listing
maintenance requirements to maintain the NASDAQ Capital Market quotation, including certain governance requirements and a series of financial
tests relating to stockholders’ equity or net income or market value, public float, number of market makers and stockholders, market
capitalization, and maintaining a minimum bid price of $1.00 per share. If we are not able to maintain compliance with the Nasdaq Listing
Rules, our securities may be subject to delisting.
If
Nasdaq delists our common stock from trading on its exchange and we are not able to list our securities on another national securities
exchange, we expect our securities could be quoted on an over-the-counter market. If this were to occur, we could face significant material
adverse consequences, including:
|
● |
a limited availability of market
quotations for our securities; |
|
● |
reduced liquidity for our securities; |
|
● |
a determination that our common stock is a “penny
stock” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced
level of trading activity in the secondary trading market for our securities; |
|
● |
a limited amount of news and analyst coverage; and |
|
● |
a decreased ability to issue additional securities
or obtain additional financing in the future. |
The
National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the
sale of certain securities, which are referred to as “covered securities.” If our common stock continues to be listed on
NASDAQ, our common stock will be a covered security. Although the states are preempted from regulating the sale of our securities, the
federal statute does allow the states to investigate companies if there is a suspicion of fraud, and, if there is a finding of fraudulent
activity, then the states can regulate or bar the sale of covered securities in a particular case.
ITEM
2. | UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
None.
ITEM
3. | DEFAULTS
UPON SENIOR SECURITIES |
None.
ITEM
4. | MINE
SAFETY DISCLOSURES |
None.
None.
INDEX
TO EXHIBITS
|
(1) |
This
certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and
is not to be incorporated by reference into any filing of the Registrant under the Securities Act, or the Exchange Act (whether made
before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing. |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
|
|
|
Lipocine
Inc. |
|
(Registrant) |
|
|
Dated:
August 10, 2023 |
/s/
Mahesh V. Patel |
|
Mahesh
V. Patel, President and Chief
Executive
Officer
(Principal
Executive Officer and Principal Financial Officer) |
|
|
Dated:
August 10, 2023 |
/s/
Krista Fogarty |
|
Krista
Fogarty, Corporate Controller
(Principal
Accounting Officer) |
EXHIBIT
31.1
CERTIFICATIONS
I,
Mahesh V. Patel, certify that:
1. |
I have reviewed this quarterly report on Form 10-Q
of Lipocine Inc.; |
|
|
2. |
Based on my knowledge, this report does not contain
any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by this report; |
|
|
3. |
Based on my knowledge, the financial statements, and
other financial information included in this report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this report; |
|
|
4. |
The registrant’s other certifying officer and
I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant
and have: |
|
a) |
designed such disclosure controls and procedures, or
caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating
to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during
the period in which this report is being prepared; |
|
|
|
|
b) |
designed such internal control over financial reporting,
or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding
the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally
accepted accounting principles; |
|
|
|
|
c) |
evaluated the effectiveness of the registrant’s
disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls
and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
|
|
|
d) |
disclosed in this report any change in the registrant’s
internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s
fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect,
the registrant’s internal control over financial reporting; and |
5. |
The registrant’s other certifying officer and
I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors
and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
|
a) |
all significant deficiencies and material weaknesses
in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s
ability to record, process, summarize and report financial information; and |
|
|
|
|
b) |
any fraud, whether or not material, that involves management
or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Dated:
August 10, 2023 |
/s/
Mahesh V. Patel |
|
Mahesh V. Patel, President
and Chief Executive Officer |
|
(Principal Executive
Officer) |
EXHIBIT
31.2
CERTIFICATIONS
I,
Mahesh V. Patel, certify that:
1. |
I have reviewed this quarterly report on Form 10-Q
of Lipocine Inc.; |
|
|
2. |
Based on my knowledge, this report does not contain
any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by this report; |
|
|
3. |
Based on my knowledge, the financial statements, and
other financial information included in this report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this report; |
|
|
4. |
The registrant’s other certifying officer and
I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant
and have: |
|
a) |
designed such disclosure controls and procedures, or
caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating
to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during
the period in which this report is being prepared; |
|
|
|
|
b) |
designed such internal control over financial reporting,
or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding
the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally
accepted accounting principles; |
|
|
|
|
c) |
evaluated the effectiveness of the registrant’s
disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls
and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
|
|
|
d) |
disclosed in this report any change in the registrant’s
internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s
fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect,
the registrant’s internal control over financial reporting; and |
5. |
The registrant’s other certifying officer and
I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors
and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
|
a) |
all significant deficiencies and material weaknesses
in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s
ability to record, process, summarize and report financial information; and |
|
|
|
|
b) |
any fraud, whether or not material, that involves management
or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Dated:
August 10, 2023 |
/s/
Mahesh V. Patel |
|
Mahesh
V. Patel
(Principal
Financial Officer) |
EXHIBIT
32.1
CERTIFICATION
In
connection with the Quarterly Report on Form 10-Q of Lipocine Inc. (the “Corporation”) for the quarter ended June 30, 2023
as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, Mahesh V. Patel,
President and Chief Executive Officer of the Corporation, hereby certifies, pursuant to Rule 13a-14(b) or Rule 15d-14(b) and 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:
(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Corporation.
Dated:
August 10, 2023 |
/s/
Mahesh V. Patel |
|
Mahesh
V. Patel, President and Chief Executive Officer
(Principal
Executive Officer) |
EXHIBIT
32.2
CERTIFICATION
In
connection with the Quarterly Report on Form 10-Q of Lipocine Inc. (the “Corporation”) for the quarter ended June 30, 2023
as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, Mahesh V. Patel,
Principal Financial Officer of the Corporation, hereby certifies, pursuant to Rule 13a-14(b) or Rule 15d-14(b) and 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:
(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Corporation.
Dated:
August 10, 2023 |
/s/
Mahesh V. Patel |
|
Mahesh
V. Patel
(Principal
Financial Officer) |
v3.23.2
Cover - shares
|
6 Months Ended |
|
Jun. 30, 2023 |
Aug. 08, 2023 |
Cover [Abstract] |
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|
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|
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Entity File Number |
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|
|
Entity Registrant Name |
LIPOCINE
INC.
|
|
Entity Central Index Key |
0001535955
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v3.23.2
Condensed Consolidated Balance Sheets (Unaudited) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash and cash equivalents |
$ 5,014,695
|
$ 3,148,496
|
Marketable investment securities |
20,775,275
|
29,381,410
|
Accrued interest income |
24,230
|
80,427
|
Contract asset - current portion |
579,428
|
579,428
|
Prepaid and other current assets |
690,900
|
945,319
|
Total current assets |
27,084,528
|
34,135,080
|
Contract asset - non-current portion |
3,252,500
|
3,252,500
|
Property and equipment, net of accumulated depreciation of $1,166,441 and $1,153,530 respectively |
122,679
|
131,589
|
Other assets |
23,753
|
23,753
|
Total assets |
30,483,460
|
37,542,922
|
Current liabilities: |
|
|
Accounts payable |
517,587
|
600,388
|
Accrued expenses |
1,309,595
|
1,077,738
|
Total current liabilities |
1,827,182
|
1,678,126
|
Warrant liability |
104,267
|
229,856
|
Total liabilities |
1,931,449
|
1,907,982
|
Commitments and contingencies (notes 6, 8, 9 and 11) |
|
|
Stockholders’ equity: |
|
|
Common stock, par value $0.0001 per share, 200,000,000 shares authorized; 5,235,166 issued and 5,234,830 outstanding |
8,852
|
8,852
|
Additional paid-in capital |
219,443,674
|
219,112,164
|
Treasury stock at cost, 336 shares |
(40,712)
|
(40,712)
|
Accumulated other comprehensive loss |
(15,812)
|
(20,321)
|
Accumulated deficit |
(190,843,991)
|
(183,425,043)
|
Total stockholders’ equity |
28,552,011
|
35,634,940
|
Total liabilities and stockholders’ equity |
$ 30,483,460
|
$ 37,542,922
|
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v3.23.2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Accumulated depreciation |
$ 1,166,441
|
$ 1,153,530
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
200,000,000
|
200,000,000
|
Common stock, shares issued |
5,235,166
|
5,235,166
|
Common stock, shares outstanding |
5,234,830
|
5,234,830
|
Treasury stock, shares |
336
|
336
|
X |
- DefinitionAmount of accumulated depreciation, depletion and amortization for physical assets used in the normal conduct of business to produce goods and services.
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v3.23.2
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Revenues: |
|
$ 500,000
|
$ 54,990
|
$ 500,000
|
Operating expenses: |
|
|
|
|
Research and development |
2,515,211
|
2,898,012
|
5,621,521
|
4,785,965
|
General and administrative |
1,440,394
|
1,129,519
|
2,727,708
|
2,373,205
|
Total operating expenses |
3,955,605
|
4,027,531
|
8,349,229
|
7,159,170
|
Operating loss |
(3,955,605)
|
(3,527,531)
|
(8,294,239)
|
(6,659,170)
|
Other income (expense): |
|
|
|
|
Interest and investment income |
379,521
|
69,877
|
749,991
|
111,453
|
Interest expense |
|
(7,568)
|
|
(27,098)
|
Unrealized gain on warrant liability |
27,455
|
583,445
|
125,589
|
205,457
|
Gain on litigation settlement liability |
|
250,000
|
|
250,000
|
Total other income, net |
406,976
|
895,754
|
875,580
|
539,812
|
Loss before income tax expense |
(3,548,629)
|
(2,631,777)
|
(7,418,659)
|
(6,119,358)
|
Income tax expense |
|
|
(200)
|
(200)
|
Net loss |
(3,548,629)
|
(2,631,777)
|
(7,418,859)
|
(6,119,558)
|
Issuance of Series B preferred stock dividend |
|
|
(89)
|
|
Net loss attributable to common shareholders |
$ (3,548,629)
|
$ (2,631,777)
|
$ (7,418,948)
|
$ (6,119,558)
|
Basic loss per share attributable to common stock |
$ (0.68)
|
$ (0.50)
|
$ (1.42)
|
$ (1.17)
|
Weighted average common shares outstanding, basic |
5,234,830
|
5,234,141
|
5,234,830
|
5,228,608
|
Diluted loss per share attributable to common stock |
$ (0.68)
|
$ (0.61)
|
$ (1.44)
|
$ (1.20)
|
Weighted average common shares outstanding, diluted |
5,234,830
|
5,263,389
|
5,234,830
|
5,262,993
|
Comprehensive loss: |
|
|
|
|
Net unrealized gain (loss) on available-for-sale securities |
$ (19,053)
|
$ (17,491)
|
$ 4,509
|
$ (66,891)
|
Comprehensive loss |
$ (3,567,682)
|
$ (2,649,268)
|
$ (7,414,350)
|
$ (6,186,449)
|
X |
- DefinitionAmount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners.
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v3.23.2
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($)
|
Preferred Stock [Member]
Series B Preferred Stock [Member]
|
Common Stock [Member] |
Treasury Stock, Common [Member] |
Additional Paid-in Capital [Member] |
AOCI Attributable to Parent [Member] |
Retained Earnings [Member] |
Total |
Balances at Dec. 31, 2021 |
|
$ 8,829
|
$ (40,712)
|
$ 218,286,324
|
$ (18,016)
|
$ (172,666,407)
|
$ 45,570,018
|
Balances, shares at Dec. 31, 2021 |
|
5,221,883
|
336
|
|
|
|
|
Net loss |
|
|
|
|
|
(6,119,558)
|
(6,119,558)
|
Unrealized net gain on marketable investment securities |
|
|
|
|
(66,891)
|
|
(66,891)
|
Stock-based compensation |
|
|
|
310,597
|
|
|
310,597
|
Option exercises |
|
$ 21
|
|
206,058
|
|
|
206,079
|
Option exercises, shares |
|
12,261
|
|
|
|
|
|
Costs associated with ATM Offering |
|
|
|
(10,500)
|
|
|
(10,500)
|
Balances at Jun. 30, 2022 |
|
$ 8,850
|
$ (40,712)
|
218,792,479
|
(84,907)
|
(178,785,965)
|
39,889,745
|
Balances, shares at Jun. 30, 2022 |
|
5,234,144
|
336
|
|
|
|
|
Balances at Mar. 31, 2022 |
|
$ 8,850
|
$ (40,712)
|
218,663,319
|
(67,416)
|
(176,154,188)
|
42,409,853
|
Balances, shares at Mar. 31, 2022 |
|
5,234,132
|
336
|
|
|
|
|
Net loss |
|
|
|
|
|
(2,631,777)
|
(2,631,777)
|
Unrealized net gain on marketable investment securities |
|
|
|
|
(17,491)
|
|
(17,491)
|
Stock-based compensation |
|
|
|
139,569
|
|
|
139,569
|
Option exercises |
|
|
|
91
|
|
|
91
|
Option exercises, shares |
|
12
|
|
|
|
|
|
Costs associated with ATM Offering |
|
|
|
(10,500)
|
|
|
(10,500)
|
Balances at Jun. 30, 2022 |
|
$ 8,850
|
$ (40,712)
|
218,792,479
|
(84,907)
|
(178,785,965)
|
39,889,745
|
Balances, shares at Jun. 30, 2022 |
|
5,234,144
|
336
|
|
|
|
|
Balances at Dec. 31, 2022 |
|
$ 8,852
|
$ (40,712)
|
219,112,164
|
(20,321)
|
(183,425,043)
|
35,634,940
|
Balances, shares at Dec. 31, 2022 |
|
5,234,830
|
336
|
|
|
|
|
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
|
Costs associated with ATM Offering |
|
|
|
(11,216)
|
|
|
(11,216)
|
Redemption of Series B preferred stock |
$ (9)
|
|
|
9
|
|
|
|
Redemption of Series B preferred stock, shares |
(88,511)
|
|
|
|
|
|
|
Issuance of Series B preferred stock dividend |
$ 9
|
|
|
80
|
|
(89)
|
|
Issuance of Series B preferred stock dividend, shares |
88,511
|
|
|
|
|
|
|
Balances at Jun. 30, 2023 |
|
$ 8,852
|
$ (40,712)
|
219,443,674
|
(15,812)
|
(190,843,991)
|
28,552,011
|
Balances, shares at Jun. 30, 2023 |
|
5,234,830
|
336
|
|
|
|
|
Balances at Mar. 31, 2023 |
$ 9
|
$ 8,852
|
$ (40,712)
|
219,284,000
|
3,241
|
(187,295,362)
|
31,960,028
|
Balances, shares at Mar. 31, 2023 |
88,511
|
5,234,830
|
336
|
|
|
|
|
Net loss |
|
|
|
|
|
(3,548,629)
|
(3,548,629)
|
Unrealized net gain on marketable investment securities |
|
|
|
|
(19,053)
|
|
(19,053)
|
Stock-based compensation |
|
|
|
164,865
|
|
|
164,865
|
Costs associated with ATM Offering |
|
|
|
(5,200)
|
|
|
(5,200)
|
Redemption of Series B preferred stock |
$ (9)
|
|
|
9
|
|
|
|
Redemption of Series B preferred stock, shares |
(88,511)
|
|
|
|
|
|
|
Balances at Jun. 30, 2023 |
|
$ 8,852
|
$ (40,712)
|
$ 219,443,674
|
$ (15,812)
|
$ (190,843,991)
|
$ 28,552,011
|
Balances, shares at Jun. 30, 2023 |
|
5,234,830
|
336
|
|
|
|
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement.
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v3.23.2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Cash flows from operating activities: |
|
|
Net loss |
$ (7,418,859)
|
$ (6,119,558)
|
Adjustments to reconcile net loss to cash used in operating activities: |
|
|
Depreciation expense |
12,910
|
4,297
|
Stock-based compensation expense |
342,637
|
310,597
|
Non-cash interest expense |
|
5,842
|
Non-cash gain on change in fair value of warrant liability |
(125,589)
|
(205,457)
|
Amortization of premium (discounts) on marketable investment securities |
(508,425)
|
87,282
|
Changes in operating assets and liabilities: |
|
|
Accrued interest income |
56,197
|
166,842
|
Prepaid and other current assets |
254,419
|
910,919
|
Accounts payable |
(82,801)
|
(475,338)
|
Accrued expenses |
231,857
|
(117,157)
|
Litigation settlement liability |
|
(1,250,000)
|
Gain on extinguishment of litigation settlement liability |
|
(250,000)
|
Cash used in operating activities |
(7,237,654)
|
(6,931,731)
|
Cash flows from investing activities: |
|
|
Purchase of property and equipment |
(4,000)
|
(37,099)
|
Purchases of marketable investment securities |
(8,780,931)
|
(22,681,441)
|
Maturities of marketable investment securities |
17,900,000
|
33,802,000
|
Cash provided by investing activities |
9,115,069
|
11,083,460
|
Cash flows from financing activities: |
|
|
Debt repayments |
|
(1,666,667)
|
End of loan payment |
|
(650,000)
|
Costs associated with ATM Offering |
(11,216)
|
(10,500)
|
Proceeds from stock option exercises |
|
206,079
|
Cash used in financing activities |
(11,216)
|
(2,121,088)
|
Net increase in cash and cash equivalents |
1,866,199
|
2,030,641
|
Cash and cash equivalents at beginning of period |
3,148,496
|
2,950,552
|
Cash and cash equivalents at end of period |
5,014,695
|
4,981,193
|
Supplemental disclosure of cash flow information: |
|
|
Interest paid |
|
21,256
|
Income taxes paid |
656
|
200
|
Supplemental disclosure of non-cash investing and financing activity: |
|
|
Net unrealized gain (loss) on available-for-sale securities |
4,509
|
(66,891)
|
Accrued final payment charge on debt |
|
5,842
|
Issuance of Series B preferred stock dividend |
$ 89
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v3.23.2
Basis of Presentation
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
(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, 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 August 10, 2024 which includes an on-going clinical study for LPCN 1148 in the management of decompensated
cirrhosis, a confirmatory pivotal pharmacokinetic (“PK”) 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 August 10, 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.
On
May 10, 2023, at the 2023 annual meeting of the stockholders, the Company’s stockholders approved an amendment to the Company’s
Amended and Restated Certificate of Incorporation to effect a reverse stock split at a ratio not less than 1-for-5 and not more than
1-for-20, with the exact ratio to be set within that range at the discretion of the Company’s board of directors (the “Board”)
without further approval or authorization from our stockholders in order to achieve a minimum bid price of $1.00 per share for a minimum
of 10 consecutive trading days, as required for continuous listing of the common stock on the Nasdaq Capital Market pursuant to Nasdaq
Listing Rule 5550(a)(2).
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.
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- DefinitionThe entire disclosure for the business description and basis of presentation concepts. Business description describes the nature and type of organization including but not limited to organizational structure as may be applicable to holding companies, parent and subsidiary relationships, business divisions, business units, business segments, affiliates and information about significant ownership of the reporting entity. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
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v3.23.2
Revenue
|
6 Months Ended |
Jun. 30, 2023 |
Revenue from Contract with Customer [Abstract] |
|
Revenue |
(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.
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 June 30, 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, the Company estimates that it will receive a royalty payment of
approximately $579,000 relating to the contract asset in the third quarter of 2023.
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 $0 and $500,000 for the three months ended June 30, 2023, and 2022, respectively. The Company recognized revenue of approximately
$55,000 and $500,000 for the six months ended June 30, 2023, and 2022, respectively. Revenue recognized in 2023 was 100% from a related-party,
Spriaso. Revenue recognized in 2022 was 100% from one major customer, Antares.
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v3.23.2
Earnings (Loss) per Share
|
6 Months Ended |
Jun. 30, 2023 |
Earnings Per Share [Abstract] |
|
Earnings (Loss) per Share |
(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.
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, 2023 and 2022:
Schedule
of Computation of Basic and Diluted Earnings (loss) Per Share of Common Stock
| |
| | | |
| | | |
| | | |
| | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Basic loss per share attributable to common stock: | |
| | | |
| | | |
| | | |
| | |
Numerator | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (3,548,629 | ) | |
$ | (2,631,777 | ) | |
$ | (7,418,859 | ) | |
$ | (6,119,558 | ) |
| |
| | | |
| | | |
| | | |
| | |
Denominator | |
| | | |
| | | |
| | | |
| | |
Weighted avg. common shares outstanding | |
| 5,234,830 | | |
| 5,234,141 | | |
| 5,234,830 | | |
| 5,228,608 | |
| |
| | | |
| | | |
| | | |
| | |
Basic loss per share attributable to common stock | |
$ | (0.68 | ) | |
$ | (0.50 | ) | |
$ | (1.42 | ) | |
$ | (1.17 | ) |
| |
| | | |
| | | |
| | | |
| | |
Diluted loss per share attributable to common stock: | |
| | | |
| | | |
| | | |
| | |
Numerator | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (3,548,629 | ) | |
$ | (2,631,777 | ) | |
$ | (7,418,859 | ) | |
$ | (6,119,558 | ) |
Effect of dilutive securities on net loss: | |
| | | |
| | | |
| | | |
| | |
Common stock warrants | |
| 27,455 | | |
| 583,445 | | |
| 125,589 | | |
| 205,457 | |
Total net loss for purpose of calculating diluted net loss per common share | |
$ | (3,576,084 | ) | |
$ | (3,215,222 | ) | |
$ | (7,544,448 | ) | |
$ | (6,325,015 | ) |
Denominator | |
| | | |
| | | |
| | | |
| | |
Weighted avg. common shares outstanding | |
| 5,234,830 | | |
| 5,234,141 | | |
| 5,234,830 | | |
| 5,228,608 | |
Weighted average effect of dilutive securities: | |
| | | |
| | | |
| | | |
| | |
Common stock warrants | |
| - | | |
| 29,248 | | |
| - | | |
| 34,385 | |
Total shares for purpose of calculating diluted net loss per common share | |
| 5,234,830 | | |
| 5,263,389 | | |
| 5,234,830 | | |
| 5,262,993 | |
| |
| | | |
| | | |
| | | |
| | |
Diluted loss per share attributable to common stock | |
$ | (0.68 | ) | |
$ | (0.61 | ) | |
$ | (1.44 | ) | |
$ | (1.20 | ) |
The
computation of diluted loss per share for the three and six months ended June 30, 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
| |
June 30, | |
| |
2023 | | |
2022 | |
Stock options | |
| 264,150 | | |
| 236,822 | |
Warrants | |
| 49,433 | | |
| 49,433 | |
|
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v3.23.2
Marketable Investment Securities
|
6 Months Ended |
Jun. 30, 2023 |
Investments, Debt and Equity Securities [Abstract] |
|
Marketable Investment Securities |
(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, 2023, and December 31, 2022, were as follows:
Schedule
of Available for Sale Securities
June 30, 2023 | |
Amortized
Cost | | |
Gross
unrealized
holding gains | | |
Gross
unrealized
holding
losses | | |
Aggregate
fair value | |
| |
| | |
| | |
| | |
| |
Government treasury bills | |
$ | 2,360,569 | | |
$ | - | | |
$ | (2,937 | ) | |
$ | 2,357,632 | |
Corporate bonds, notes and commercial paper | |
| 9,703,495 | | |
| - | | |
| (6,102 | ) | |
| 9,697,393 | |
U.S. government agency securities | |
| 8,727,023 | | |
| - | | |
| (6,773 | ) | |
| 8,720,250 | |
| |
| | | |
| | | |
| | | |
| | |
| |
$ | 20,791,087 | | |
$ | - | | |
$ | (15,812 | ) | |
$ | 20,775,275 | |
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 June 30, 2023, are as follows:
Schedule
of Maturities of Debt Securities Classified as Available-for-sale Securities
June 30, 2023 | |
Amortized
Cost | | |
Aggregate
fair value | |
Due within one year | |
$ | 20,791,087 | | |
$ | 20,775,275 | |
| |
$ | 20,791,087 | | |
$ | 20,775,275 | |
There
were no sales of marketable investment securities during the three and six months ended June 30, 2023, and 2022 and therefore no realized
gains or losses. Additionally, during the three months ended June 30, 2023 and 2022, $5.9 million and $8.6 million of marketable investment
securities matured, and during the six months ended June 30, 2023 and 2022, $17.9 million and $33.8 million of marketable investment
securities matured, respectively. The Company determined there were no other-than-temporary impairments for the three and six months
ended June 30, 2023, and 2022.
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- DefinitionThe entire disclosure for investments in certain debt and equity securities.
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v3.23.2
Fair Value
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Fair Value |
(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. |
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, 2023 and December 31, 2022:
Schedule
of Fair Value, Assets Measured on Recurring Basis
| |
| | |
Fair value measurements at reporting date using | |
| |
June 30, 2023 | | |
Level 1 inputs | | |
Level 2 inputs | | |
Level 3 inputs | |
| |
| | |
| | |
| | |
| |
Assets: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents - money market funds | |
$ | 4,897,774 | | |
$ | 4,897,774 | | |
$ | - | | |
$ | - | |
Government treasury bills | |
| 2,357,632 | | |
| 2,357,632 | | |
| - | | |
| - | |
Commercial paper | |
| 7,339,702 | | |
| - | | |
| 7,339,702 | | |
| - | |
Corporate bonds and notes | |
| 2,357,691 | | |
| - | | |
| 2,357,691 | | |
| - | |
US. Government agency securities | |
| 8,720,250 | | |
| - | | |
| 8,720,250 | | |
| - | |
| |
| | | |
| | | |
| | | |
| | |
| |
$ | 25,673,049 | | |
$ | 7,255,406 | | |
$ | 18,417,643 | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Warrant liability | |
$ | 104,267 | | |
$ | - | | |
$ | - | | |
$ | 104,267 | |
| |
$ | 25,777,316 | | |
$ | 7,255,406 | | |
$ | 18,417,643 | | |
$ | 104,267 | |
| |
| | |
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.
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 and 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 June 30, 2023, include (i) volatility
of 100%, (ii) risk free interest rate of 5.25%, (iii) strike price of $8.50, (iv) fair value of common stock of $5.04, and (v) expected
life of 1.4 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 $8.50, (iv) fair value of common
stock of $6.77, 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 and six
months ended June 30, 2023.
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- DefinitionThe entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.
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v3.23.2
Loan and Security Agreements
|
6 Months Ended |
Jun. 30, 2023 |
Debt Disclosure [Abstract] |
|
Loan and Security Agreements |
(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.
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.23.2
Income Taxes
|
6 Months Ended |
Jun. 30, 2023 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
(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
June 30, 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.
|
X |
- DefinitionThe entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.
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v3.23.2
Contractual Agreements
|
6 Months Ended |
Jun. 30, 2023 |
Health Care Organizations [Abstract] |
|
Contractual Agreements |
(8) Contractual Agreements
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 $9,000 and $17,000 during the
three months ended June 30, 2023 and 2022, respectively and royalty expense of approximately $13,000 and $17,000 during the six months
ended June 30, 2023 and 2022, respectively.
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 product 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 the three or six months ended June 30, 2023 or 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 $1.7 million and $2.1 million, respectively, for the three months ended
June 30, 2023 and 2022 and $3.8 million and $3.2 million, respectively, for the six months ended June 30, 2023 and 2022 under these agreements
and has recorded these expenses in research and development expenses.
|
X |
- DefinitionThe entire disclosure for prepaid health care service provider's significant business and contractual arrangements with hospitals, physicians, or other associated entities.
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v3.23.2
Leases
|
6 Months Ended |
Jun. 30, 2023 |
Leases [Abstract] |
|
Leases |
(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.
Future
minimum lease payments under the non-cancelable operating lease as of June 30, 2023 are:
Schedule
of Future Minimum Rental Payments for Operating Leases
| |
Operating | |
| |
leases | |
Year ending December 31: | |
| |
2023 | |
$ | 178,678 | |
2024 | |
| 59,559 | |
| |
| | |
Total minimum lease payments | |
$ | 238,237 | |
The
Company’s rent expense was $89,000 and $86,000 for the three months ended June 30, 2023 and 2022, respectively. The Company’s
rent expense was $176,000 and $170,000 for the six months ended June 30, 2023 and 2022, respectively.
|
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- DefinitionThe entire disclosure for operating leases of lessee. Includes, but is not limited to, description of operating lease and maturity analysis of operating lease liability.
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v3.23.2
Stockholders’ Equity
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
Stockholders’ Equity |
(10) Stockholders’ Equity
On
May 10, 2023, at the 2023 annual meeting of the stockholders, the Company’s stockholders approved an amendment to the Company’s
Amended and Restated Certificate of Incorporation to effect a reverse stock split at a ratio not less than 1-for-5 and not more than
1-for-20, with the exact ratio to be set within that range at the discretion of the Board without further approval or authorization from
our stockholders.
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.
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 June 30, 2023, the Company had sold an aggregate of 883,711
shares at a weighted-average sales price of $37.23
per share under the At the Market Offering (the “ATM Offering”) 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 and six months ended
June 30, 2023, and 2022, the Company did not sell any shares of its common stock pursuant to the Sales Agreement. As of June 30,
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 the Company’s common stock pursuant to the
Sales Agreement having an aggregate offering price of up to $15.7
million.
| (b) | Series
B Preferred Stock |
On
March 7, 2023, the Board of the Company declared a dividend of one one-thousandth (1/1,000th) 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”). As of June 30, 2023, all shares of Series B Preferred Stock have been redeemed by the Company.
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 June 30, 2023, all shares of Series B Preferred
Stock have been redeemed by the Company.
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.
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.
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.
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 $165,000 and $ 140,000, for the three months ended June 30, 2023 and 2022, respectively,
and approximately $ and $311,000, for the six months ended June 30, 2023 and 2022, respectively, and is allocated as follows:
Schedule
of Employee Service Share-based Compensation, Allocation of Recognized Period Costs
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Research and development | |
$ | 83,229 | | |
$ | 63,021 | | |
$ | 178,742 | | |
$ | 142,673 | |
General and administrative | |
| 81,636 | | |
| 76,548 | | |
| 163,895 | | |
| 167,924 | |
| |
| | | |
| | | |
| | | |
| | |
Total | |
$ | 164,865 | | |
$ | 139,569 | | |
$ | 342,637 | | |
$ | 310,597 | |
The
Company issued 8,820 and 26,467 stock options, respectively, during the three and six months ended June 30, 2023, and issued 10,086 and
29,643 stock options during the three and six months ended June 30, 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 six months ended June 30, 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 | |
| 5.73 years | | |
| 5.77 years | |
Risk-free interest rate | |
| 3.73 | % | |
| 1.93 | % |
Expected dividend yield | |
| — | | |
| — | |
Expected volatility | |
| 98.97 | % | |
| 101.67 | % |
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 June 30, 2023, there was approximately $766,000
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 1.64
years and will be adjusted for subsequent changes in estimated forfeitures.
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. 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 189,522 to 336,582.
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 336,582 shares
of common stock are authorized for issuance under the 2014 Plan, with 46,519 shares remaining available for grant as of June 30, 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 | |
| 277,225 | | |
$ | 38.44 | |
Options granted | |
| 26,467 | | |
| 6.19 | |
Options exercised | |
| - | | |
| - | |
Options forfeited | |
| (7,352 | ) | |
| 6.91 | |
Options cancelled | |
| (32,190 | ) | |
| 47.77 | |
Balance at June 30, 2023 | |
| 264,150 | | |
| 34.95 | |
| |
| | | |
| | |
Options exercisable at June 30, 2023 | |
| 167,770 | | |
| 48.55 | |
The
following table summarizes information about stock options outstanding and exercisable at June 30, 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 | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
| 264,150 | | |
| 7.06 | | |
$ | 34.95 | | |
$ | 4,586 | | |
| 167,770 | | |
| 5.88 | | |
$ | 48.55 | | |
$ | - | |
The
intrinsic value for stock options is defined as the difference between the current market value and the exercise price. There were 0
and 12 stock options exercised during the three months ended June 30, 2023 and 2022, respectively. There were 0 and 12,261 stock options
exercised during the six months ended June 30, 2023 and 2022, respectively.
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, 2023, 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, 2023 and on December 31, 2022 was determined using the Black-Scholes
option pricing model with the following Level 3 inputs (as defined in the November 2019 Offering):
| |
June 30, 2023 | | |
December 31, 2022 | |
Expected life in years | |
| 1.38 | | |
| 1.88 | |
Risk-free interest rate | |
| 5.25 | % | |
| 4.41 | % |
Dividend yield | |
| — | | |
| — | |
Volatility | |
| 100.00 | % | |
| 100.00 | % |
Stock price | |
$ | 5.04 | | |
$ | 6.77 | |
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 of the November 2019 Offering warrants. During the three and six months ended June 30, 2022, the Company
recorded a non-cash gain of approximately $583,000 and $205,000, 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, 2022 | |
$ | 229,856 | |
Settlement of liability on warrant exercise | |
| - | |
Change in fair value of common stock warrants | |
| (125,589 | ) |
Balance at June 30, 2023 | |
$ | 104,267 | |
Additionally,
in the February 2020 Offering, 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, 2023, and 2022, there
were 49,433 warrants outstanding that were issued in the February 2020 Offering.
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 | |
| 113,795 | | |
$ | 8.72 | |
Issued | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | |
Expired | |
| - | | |
| - | |
Cancelled | |
| - | | |
| - | |
Forfeited | |
| - | | |
| - | |
Balance at June 30, 2023 | |
| 113,795 | | |
$ | 8.72 | |
There
were no common stock warrants exercised during either the three or six months ended June 30, 2023 and 2022.
The
following table summarizes information about common stock warrants outstanding at June 30, 2023:
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 | | |
| 1.51 | | |
$ | 8.72 | | |
$ | - | |
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v3.23.2
Commitments and Contingencies
|
6 Months Ended |
Jun. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
(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
(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 (the “Amendment
to 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.
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.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.23.2
Agreement with Spriaso, LLC
|
6 Months Ended |
Jun. 30, 2023 |
Related Party Transactions [Abstract] |
|
Agreement with Spriaso, LLC |
(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 and six months ended June 30, 2023, the Company received licensing revenue from Spriaso of
approximately $0
and $55,000,
respectively. During each of the three and six months ended June 30, 2022, the Company received licensing revenue of $0.
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.
|
X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.23.2
Earnings (Loss) per Share (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Earnings Per Share [Abstract] |
|
Schedule of Computation of Basic and Diluted Earnings (loss) Per Share of Common Stock |
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, 2023 and 2022:
Schedule
of Computation of Basic and Diluted Earnings (loss) Per Share of Common Stock
| |
| | | |
| | | |
| | | |
| | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Basic loss per share attributable to common stock: | |
| | | |
| | | |
| | | |
| | |
Numerator | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (3,548,629 | ) | |
$ | (2,631,777 | ) | |
$ | (7,418,859 | ) | |
$ | (6,119,558 | ) |
| |
| | | |
| | | |
| | | |
| | |
Denominator | |
| | | |
| | | |
| | | |
| | |
Weighted avg. common shares outstanding | |
| 5,234,830 | | |
| 5,234,141 | | |
| 5,234,830 | | |
| 5,228,608 | |
| |
| | | |
| | | |
| | | |
| | |
Basic loss per share attributable to common stock | |
$ | (0.68 | ) | |
$ | (0.50 | ) | |
$ | (1.42 | ) | |
$ | (1.17 | ) |
| |
| | | |
| | | |
| | | |
| | |
Diluted loss per share attributable to common stock: | |
| | | |
| | | |
| | | |
| | |
Numerator | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (3,548,629 | ) | |
$ | (2,631,777 | ) | |
$ | (7,418,859 | ) | |
$ | (6,119,558 | ) |
Effect of dilutive securities on net loss: | |
| | | |
| | | |
| | | |
| | |
Common stock warrants | |
| 27,455 | | |
| 583,445 | | |
| 125,589 | | |
| 205,457 | |
Total net loss for purpose of calculating diluted net loss per common share | |
$ | (3,576,084 | ) | |
$ | (3,215,222 | ) | |
$ | (7,544,448 | ) | |
$ | (6,325,015 | ) |
Denominator | |
| | | |
| | | |
| | | |
| | |
Weighted avg. common shares outstanding | |
| 5,234,830 | | |
| 5,234,141 | | |
| 5,234,830 | | |
| 5,228,608 | |
Weighted average effect of dilutive securities: | |
| | | |
| | | |
| | | |
| | |
Common stock warrants | |
| - | | |
| 29,248 | | |
| - | | |
| 34,385 | |
Total shares for purpose of calculating diluted net loss per common share | |
| 5,234,830 | | |
| 5,263,389 | | |
| 5,234,830 | | |
| 5,262,993 | |
| |
| | | |
| | | |
| | | |
| | |
Diluted loss per share attributable to common stock | |
$ | (0.68 | ) | |
$ | (0.61 | ) | |
$ | (1.44 | ) | |
$ | (1.20 | ) |
|
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share |
The
computation of diluted loss per share for the three and six months ended June 30, 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
| |
June 30, | |
| |
2023 | | |
2022 | |
Stock options | |
| 264,150 | | |
| 236,822 | |
Warrants | |
| 49,433 | | |
| 49,433 | |
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v3.23.2
Marketable Investment Securities (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Investments, Debt and Equity Securities [Abstract] |
|
Schedule of Available for Sale Securities |
Schedule
of Available for Sale Securities
June 30, 2023 | |
Amortized
Cost | | |
Gross
unrealized
holding gains | | |
Gross
unrealized
holding
losses | | |
Aggregate
fair value | |
| |
| | |
| | |
| | |
| |
Government treasury bills | |
$ | 2,360,569 | | |
$ | - | | |
$ | (2,937 | ) | |
$ | 2,357,632 | |
Corporate bonds, notes and commercial paper | |
| 9,703,495 | | |
| - | | |
| (6,102 | ) | |
| 9,697,393 | |
U.S. government agency securities | |
| 8,727,023 | | |
| - | | |
| (6,773 | ) | |
| 8,720,250 | |
| |
| | | |
| | | |
| | | |
| | |
| |
$ | 20,791,087 | | |
$ | - | | |
$ | (15,812 | ) | |
$ | 20,775,275 | |
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 | |
|
Schedule of Maturities of Debt Securities Classified as Available-for-sale Securities |
Maturities
of debt securities classified as available-for-sale securities as of June 30, 2023, are as follows:
Schedule
of Maturities of Debt Securities Classified as Available-for-sale Securities
June 30, 2023 | |
Amortized
Cost | | |
Aggregate
fair value | |
Due within one year | |
$ | 20,791,087 | | |
$ | 20,775,275 | |
| |
$ | 20,791,087 | | |
$ | 20,775,275 | |
|
X |
- DefinitionTabular disclosure of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale).
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v3.23.2
Fair Value (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Schedule of Fair Value, Assets Measured on Recurring Basis |
Schedule
of Fair Value, Assets Measured on Recurring Basis
| |
| | |
Fair value measurements at reporting date using | |
| |
June 30, 2023 | | |
Level 1 inputs | | |
Level 2 inputs | | |
Level 3 inputs | |
| |
| | |
| | |
| | |
| |
Assets: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents - money market funds | |
$ | 4,897,774 | | |
$ | 4,897,774 | | |
$ | - | | |
$ | - | |
Government treasury bills | |
| 2,357,632 | | |
| 2,357,632 | | |
| - | | |
| - | |
Commercial paper | |
| 7,339,702 | | |
| - | | |
| 7,339,702 | | |
| - | |
Corporate bonds and notes | |
| 2,357,691 | | |
| - | | |
| 2,357,691 | | |
| - | |
US. Government agency securities | |
| 8,720,250 | | |
| - | | |
| 8,720,250 | | |
| - | |
| |
| | | |
| | | |
| | | |
| | |
| |
$ | 25,673,049 | | |
$ | 7,255,406 | | |
$ | 18,417,643 | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Warrant liability | |
$ | 104,267 | | |
$ | - | | |
$ | - | | |
$ | 104,267 | |
| |
$ | 25,777,316 | | |
$ | 7,255,406 | | |
$ | 18,417,643 | | |
$ | 104,267 | |
| |
| | |
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 | |
|
X |
- DefinitionTabular disclosure of assets, including [financial] instruments measured at fair value that are classified in stockholders' equity, if any, by class that are measured at fair value on a recurring basis. The disclosures contemplated herein include the fair value measurements at the reporting date by the level within the fair value hierarchy in which the fair value measurements in their entirety fall, segregating fair value measurements using quoted prices in active markets for identical assets (Level 1), significant other observable inputs (Level 2), and significant unobservable inputs (Level 3).
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X |
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v3.23.2
Stockholders’ Equity (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs |
Schedule
of Employee Service Share-based Compensation, Allocation of Recognized Period Costs
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Research and development | |
$ | 83,229 | | |
$ | 63,021 | | |
$ | 178,742 | | |
$ | 142,673 | |
General and administrative | |
| 81,636 | | |
| 76,548 | | |
| 163,895 | | |
| 167,924 | |
| |
| | | |
| | | |
| | | |
| | |
Total | |
$ | 164,865 | | |
$ | 139,569 | | |
$ | 342,637 | | |
$ | 310,597 | |
|
Schedule of Key Assumption of Fair Value of Stock Options Granted |
For
options granted during the six months ended June 30, 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 | |
| 5.73 years | | |
| 5.77 years | |
Risk-free interest rate | |
| 3.73 | % | |
| 1.93 | % |
Expected dividend yield | |
| — | | |
| — | |
Expected volatility | |
| 98.97 | % | |
| 101.67 | % |
| |
June 30, 2023 | | |
December 31, 2022 | |
Expected life in years | |
| 1.38 | | |
| 1.88 | |
Risk-free interest rate | |
| 5.25 | % | |
| 4.41 | % |
Dividend yield | |
| — | | |
| — | |
Volatility | |
| 100.00 | % | |
| 100.00 | % |
Stock price | |
$ | 5.04 | | |
$ | 6.77 | |
|
Schedule of Stock Option Activity |
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 | |
| 277,225 | | |
$ | 38.44 | |
Options granted | |
| 26,467 | | |
| 6.19 | |
Options exercised | |
| - | | |
| - | |
Options forfeited | |
| (7,352 | ) | |
| 6.91 | |
Options cancelled | |
| (32,190 | ) | |
| 47.77 | |
Balance at June 30, 2023 | |
| 264,150 | | |
| 34.95 | |
| |
| | | |
| | |
Options exercisable at June 30, 2023 | |
| 167,770 | | |
| 48.55 | |
|
Schedule of Share-based Compensation of Stock Options Outstanding and Exercisable |
The
following table summarizes information about stock options outstanding and exercisable at June 30, 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 | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
| 264,150 | | |
| 7.06 | | |
$ | 34.95 | | |
$ | 4,586 | | |
| 167,770 | | |
| 5.88 | | |
$ | 48.55 | | |
$ | - | |
|
Schedule of Reconciliation of Warrant Liability |
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 | |
| (125,589 | ) |
Balance at June 30, 2023 | |
$ | 104,267 | |
|
Schedule of Number of Warrants Outstanding and the Weighted Average Exercise Price |
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 | |
| 113,795 | | |
$ | 8.72 | |
Issued | |
| - | | |
| - | |
Exercised | |
| - | | |
| - | |
Expired | |
| - | | |
| - | |
Cancelled | |
| - | | |
| - | |
Forfeited | |
| - | | |
| - | |
Balance at June 30, 2023 | |
| 113,795 | | |
$ | 8.72 | |
|
Schedule of Common Stock Warrants Outstanding |
The
following table summarizes information about common stock warrants outstanding at June 30, 2023:
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 | | |
| 1.51 | | |
$ | 8.72 | | |
$ | - | |
|
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v3.23.2
Revenue (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
Revenue |
|
|
$ 500,000
|
$ 54,990
|
$ 500,000
|
|
Major Customer [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] |
|
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
Concentration Risk, Percentage |
|
|
|
10.00%
|
|
|
Spriaso [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] |
|
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
Concentration Risk, Percentage |
|
|
|
100.00%
|
|
|
Antares [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] |
|
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
Concentration Risk, Percentage |
|
|
|
|
100.00%
|
|
License Agreement [Member] |
|
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
Payments for royalty |
|
|
|
|
|
$ 218,000
|
License Agreement [Member] | Forecast [Member] |
|
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
Payments for royalty |
$ 579,000
|
|
|
|
|
|
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v3.23.2
Schedule of Computation of Basic and Diluted Earnings (loss) Per Share of Common Stock (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Earnings Per Share [Abstract] |
|
|
|
|
Net loss |
$ (3,548,629)
|
$ (2,631,777)
|
$ (7,418,859)
|
$ (6,119,558)
|
Weighted avg. common shares outstanding |
5,234,830
|
5,234,141
|
5,234,830
|
5,228,608
|
Basic loss per share attributable to common stock |
$ (0.68)
|
$ (0.50)
|
$ (1.42)
|
$ (1.17)
|
Effect of dilutive securities on net loss: |
|
|
|
|
Common stock warrants |
$ 27,455
|
$ 583,445
|
$ 125,589
|
$ 205,457
|
Total net loss for purpose of calculating diluted net loss per common share |
$ (3,576,084)
|
$ (3,215,222)
|
$ (7,544,448)
|
$ (6,325,015)
|
Weighted average effect of dilutive securities: |
|
|
|
|
Common stock warrants |
|
29,248
|
|
34,385
|
Total shares for purpose of calculating diluted net loss per common share |
5,234,830
|
5,263,389
|
5,234,830
|
5,262,993
|
Diluted loss per share attributable to common stock |
$ (0.68)
|
$ (0.61)
|
$ (1.44)
|
$ (1.20)
|
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v3.23.2
Schedule of Available for Sale Securities (Details) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Marketable Securities [Line Items] |
|
|
Amortized Cost |
$ 20,791,087
|
$ 29,401,731
|
Gross unrealized holding gains |
|
4,651
|
Gross unrealized holding losses |
(15,812)
|
(24,972)
|
Aggregate fair value |
20,775,275
|
29,381,410
|
US Treasury Securities [Member] |
|
|
Marketable Securities [Line Items] |
|
|
Amortized Cost |
2,360,569
|
5,973,087
|
Gross unrealized holding gains |
|
|
Gross unrealized holding losses |
(2,937)
|
(14,087)
|
Aggregate fair value |
2,357,632
|
5,959,000
|
Corporate Bonds Notes and Commercial Paper [Member] |
|
|
Marketable Securities [Line Items] |
|
|
Amortized Cost |
9,703,495
|
20,052,505
|
Gross unrealized holding gains |
|
|
Gross unrealized holding losses |
(6,102)
|
(10,885)
|
Aggregate fair value |
9,697,393
|
20,041,620
|
U S Government Agency Securities [Member] |
|
|
Marketable Securities [Line Items] |
|
|
Amortized Cost |
8,727,023
|
3,376,139
|
Gross unrealized holding gains |
|
4,651
|
Gross unrealized holding losses |
(6,773)
|
|
Aggregate fair value |
$ 8,720,250
|
$ 3,380,790
|
X |
- DefinitionAmount, before tax, of unrealized gain in accumulated other comprehensive income (AOCI) on investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale).
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v3.23.2
Schedule of Maturities of Debt Securities Classified as Available-for-sale Securities (Details)
|
Jun. 30, 2023
USD ($)
|
Investments, Debt and Equity Securities [Abstract] |
|
Due within one year, Amortized Cost |
$ 20,791,087
|
Due within one year, Aggregate fair value |
20,775,275
|
Total maturities of debt securities classified as available-for-sale securities, Amortized Cost |
20,791,087
|
Total maturities of debt securities classified as available-for-sale securities, Aggregate fair value |
$ 20,775,275
|
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v3.23.2
Marketable Investment Securities (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Investments, Debt and Equity Securities [Abstract] |
|
|
|
|
Sales of marketable investment securities |
|
|
$ 0
|
$ 0
|
Realized gains or losses |
|
|
0
|
0
|
Matured marketable investment securities |
$ 5,900,000
|
$ 8,600,000
|
17,900,000
|
33,800,000
|
Other-than-temporary impairments |
$ 0
|
$ 0
|
$ 0
|
$ 0
|
X |
- DefinitionAmount of realized gain (loss) on investment in debt and equity securities.
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v3.23.2
Schedule of Fair Value, Assets Measured on Recurring Basis (Details) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
$ 25,673,049
|
$ 32,075,844
|
Fair value net asset liability |
25,777,316
|
32,305,700
|
Corporate Bonds and Notes [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
2,357,691
|
5,454,690
|
Warrant [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Liabilities, fair value |
104,267
|
229,856
|
Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
7,255,406
|
8,653,434
|
Fair value net asset liability |
7,255,406
|
8,653,434
|
Fair Value, Inputs, Level 1 [Member] | Corporate Bonds and Notes [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
|
|
Fair Value, Inputs, Level 1 [Member] | Warrant [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Liabilities, fair value |
|
|
Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
18,417,643
|
23,422,410
|
Fair value net asset liability |
18,417,643
|
23,422,410
|
Fair Value, Inputs, Level 2 [Member] | Corporate Bonds and Notes [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
2,357,691
|
5,454,690
|
Fair Value, Inputs, Level 2 [Member] | Warrant [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Liabilities, fair value |
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
|
|
Fair value net asset liability |
104,267
|
229,856
|
Fair Value, Inputs, Level 3 [Member] | Corporate Bonds and Notes [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
|
|
Fair Value, Inputs, Level 3 [Member] | Warrant [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Liabilities, fair value |
104,267
|
229,856
|
Money Market Funds [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
4,897,774
|
2,694,434
|
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
4,897,774
|
2,694,434
|
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
|
|
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
|
|
US Treasury Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
2,357,632
|
5,959,000
|
US Treasury Securities [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
2,357,632
|
5,959,000
|
US Treasury Securities [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
|
|
US Treasury Securities [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
|
|
Commercial Paper [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
7,339,702
|
14,586,930
|
Commercial Paper [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
|
|
Commercial Paper [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
7,339,702
|
14,586,930
|
Commercial Paper [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
|
|
US Government Corporations and Agencies Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
8,720,250
|
3,380,790
|
US Government Corporations and Agencies Securities [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
|
|
US Government Corporations and Agencies Securities [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
8,720,250
|
3,380,790
|
US Government Corporations and Agencies Securities [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Assets, fair value |
|
|
X |
- DefinitionFair value portion of probable future economic benefits obtained or controlled by an entity as a result of past transactions or events.
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Fair Value (Details Narrative) - Warrant [Member]
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023
$ / shares
|
Dec. 31, 2022
$ / shares
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Fair value of common stock |
$ 5.04
|
$ 6.77
|
Measurement Input, Price Volatility [Member] |
|
|
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|
|
Derivative liability, measurement input |
100
|
100
|
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|
|
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|
|
Derivative liability, measurement input |
5.25
|
4.41
|
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|
|
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|
|
Derivative liability, measurement input |
8.50
|
8.50
|
Measurement Input, Expected Term [Member] |
|
|
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|
|
Derivative liability, measurement input, term |
1 year 4 months 24 days
|
1 year 10 months 24 days
|
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v3.23.2
Loan and Security Agreements (Details Narrative) - Loan and Security Agreement [Member] - Silicon Valley Bank [Member]
|
Jan. 05, 2018
USD ($)
|
Line of Credit Facility [Line Items] |
|
Aggregate amount |
$ 10,000,000.0
|
Debt instrument description |
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.
|
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Jun. 01, 2022
|
Debt instrument, balloon payment to be paid |
$ 650,000
|
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- DefinitionFace (par) amount of debt instrument at time of issuance.
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v3.23.2
Contractual Agreements (Details Narrative) - USD ($)
|
|
|
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
Jan. 01, 2026 |
Jan. 01, 2025 |
Oct. 14, 2021 |
Mar. 29, 2012 |
Apr. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] |
|
|
|
|
|
|
|
|
|
Contract research and development expenses |
|
|
|
|
|
$ 1,700,000
|
$ 2,100,000
|
$ 3,800,000
|
$ 3,200,000
|
Collaborative Agreement [Member] | Abbott Products, Inc. [Member] |
|
|
|
|
|
|
|
|
|
Research and Development Arrangement, Contract to Perform for Others [Line Items] |
|
|
|
|
|
|
|
|
|
Percentage of net sales |
|
|
|
1.00%
|
|
|
|
|
|
Royalties, commitment amount |
|
|
|
$ 1,000,000.0
|
|
|
|
|
|
Percentage of royalties reduction based upon product launch |
|
|
|
50.00%
|
|
|
|
|
|
Royalty expense |
|
|
|
|
|
$ 9,000
|
$ 17,000
|
$ 13,000
|
$ 17,000
|
License Agreement [Member] |
|
|
|
|
|
|
|
|
|
Research and Development Arrangement, Contract to Perform for Others [Line Items] |
|
|
|
|
|
|
|
|
|
License fee |
|
|
$ 11,000,000.0
|
|
|
|
|
|
|
Royalty payments rates |
|
|
20.00%
|
|
|
|
|
|
|
Non-refundable cash fee |
|
|
|
|
$ 500,000
|
|
|
|
|
License Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
Research and Development Arrangement, Contract to Perform for Others [Line Items] |
|
|
|
|
|
|
|
|
|
Milestone revenue to be received |
|
|
$ 160,000,000.0
|
|
|
|
|
|
|
License Agreement [Member] | Forecast [Member] |
|
|
|
|
|
|
|
|
|
Research and Development Arrangement, Contract to Perform for Others [Line Items] |
|
|
|
|
|
|
|
|
|
Payments to be made for license fees |
$ 5,000,000.0
|
$ 5,000,000.0
|
|
|
|
|
|
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v3.23.2
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v3.23.2
Leases (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Leases [Abstract] |
|
|
|
|
Rent expense |
$ 89,000
|
$ 86,000
|
$ 176,000
|
$ 170,000
|
X |
- References
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v3.23.2
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Total |
$ 164,865
|
$ 139,569
|
$ 342,637
|
$ 310,597
|
Research and Development Expense [Member] |
|
|
|
|
Total |
83,229
|
63,021
|
178,742
|
142,673
|
General and Administrative Expense [Member] |
|
|
|
|
Total |
$ 81,636
|
$ 76,548
|
$ 163,895
|
$ 167,924
|
X |
- DefinitionAmount of noncash expense for share-based payment arrangement.
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v3.23.2
Schedule of Key Assumption of Fair Value of Stock Options Granted (Details)
|
6 Months Ended |
|
Jun. 30, 2023
$ / shares
|
Jun. 30, 2022 |
Dec. 31, 2022
$ / shares
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
Expected term |
5 years 8 months 23 days
|
5 years 9 months 7 days
|
|
Risk-free interest rate |
3.73%
|
1.93%
|
|
Expected dividend yield |
|
|
|
Expected volatility |
98.97%
|
101.67%
|
|
November 2019 Offering [Member] | Fair Value, Inputs, Level 3 [Member] | Measurement Input, Expected Term [Member] |
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
Expected life in years |
1 year 4 months 17 days
|
|
1 year 10 months 17 days
|
November 2019 Offering [Member] | Fair Value, Inputs, Level 3 [Member] | Measurement Input, Risk Free Interest Rate [Member] |
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
Warrants measurement input |
5.25
|
|
4.41
|
November 2019 Offering [Member] | Fair Value, Inputs, Level 3 [Member] | Measurement Input, Expected Dividend Rate [Member] |
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
Warrants measurement input |
|
|
|
November 2019 Offering [Member] | Fair Value, Inputs, Level 3 [Member] | Measurement Input, Option Volatility [Member] |
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
Warrants measurement input |
100.00
|
|
100.00
|
November 2019 Offering [Member] | Fair Value, Inputs, Level 3 [Member] | Measurement Input, Share Price [Member] |
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
Stock price |
$ 5.04
|
|
$ 6.77
|
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v3.23.2
Schedule of Stock Option Activity (Details) - $ / shares
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Option Indexed to Issuer's Equity [Line Items] |
|
|
|
|
Number of shares, ending balance |
264,150
|
|
264,150
|
|
Weighted average exercise price, Balance |
$ 34.95
|
|
$ 34.95
|
|
Number of shares, options exercisable |
167,770
|
|
167,770
|
|
Weighted average exercise price, options exercisable |
$ 48.55
|
|
$ 48.55
|
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
Option Indexed to Issuer's Equity [Line Items] |
|
|
|
|
Number of shares, beginning balance |
|
|
277,225
|
|
Weighted average exercise price, ending balance |
|
|
$ 38.44
|
|
Number of shares, Options granted |
8,820
|
10,086
|
26,467
|
29,643
|
Weighted average exercise price, Options granted |
|
|
$ 6.19
|
|
Number of shares, Options exercised |
0
|
(12)
|
|
(12,261)
|
Weighted average exercise price, Options exercised |
|
|
|
|
Number of shares, Options forfeited |
|
|
(7,352)
|
|
Weighted average exercise price, Options forfeited |
|
|
$ 6.91
|
|
Number of shares, Options cancelled |
|
|
(32,190)
|
|
Weighted average exercise price, Options cancelled |
|
|
$ 47.77
|
|
Number of shares, ending balance |
264,150
|
|
264,150
|
|
Weighted average exercise price, Balance |
$ 34.95
|
|
$ 34.95
|
|
Number of shares, options exercisable |
167,770
|
|
167,770
|
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v3.23.2
Schedule of Share-based Compensation of Stock Options Outstanding and Exercisable (Details)
|
6 Months Ended |
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Equity [Abstract] |
|
Number of options outstanding | shares |
264,150
|
Options outstanding, Weighted average remaining contractual life (Years) |
7 years 21 days
|
Options outstanding, Weighted average exercise price | $ / shares |
$ 34.95
|
Options outstanding, Aggregate intrinsic value | $ |
$ 4,586
|
Number of options exercisable | shares |
167,770
|
Options exercisable, Weighted average remaining contractual life (Years) |
5 years 10 months 17 days
|
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$ 48.55
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Schedule of Number of Warrants Outstanding and the Weighted Average Exercise Price (Details) - Warrant [Member]
|
6 Months Ended |
Jun. 30, 2023
$ / shares
shares
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
Warrants Outstanding, Beginning | shares |
113,795
|
Weighted Average Exercise Price, Outstanding, Beginning | $ / shares |
$ 8.72
|
Warrants, Issued | shares |
|
Weighted Average Exercise Price, Issued | $ / shares |
|
Warrants, Exercised | shares |
|
Weighted Average Exercise Price, Exercised | $ / shares |
|
Warrants, Expired | shares |
|
Weighted Average Exercise Price, Expired | $ / shares |
|
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|
Weighted Average Exercise Price, Cancelled | $ / shares |
|
Warrants, Forfeited | shares |
|
Weighted Average Exercise Price, Forfeited | $ / shares |
|
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113,795
|
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$ 8.72
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v3.23.2
Stockholders’ Equity (Details Narrative) - USD ($)
|
|
|
|
|
3 Months Ended |
6 Months Ended |
|
|
|
|
|
|
|
|
|
Jun. 30, 2023 |
May 10, 2023 |
Mar. 24, 2023 |
Mar. 06, 2017 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Mar. 07, 2023 |
Dec. 31, 2022 |
Jun. 08, 2022 |
Jun. 07, 2022 |
Jun. 30, 2020 |
Jun. 30, 2018 |
Jun. 30, 2016 |
Nov. 13, 2015 |
Apr. 30, 2014 |
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reverse stock split, description |
|
reverse stock split ratio of 1-for-17
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, par value |
$ 0.0001
|
|
|
|
$ 0.0001
|
|
$ 0.0001
|
|
|
$ 0.0001
|
|
|
|
|
|
|
|
Common stock, shares authorized |
200,000,000
|
|
|
|
200,000,000
|
|
200,000,000
|
|
|
200,000,000
|
|
|
|
|
|
|
|
Preferred stock redemption price |
$ 0.001
|
|
|
|
$ 0.001
|
|
$ 0.001
|
|
|
|
|
|
|
|
|
$ 63.96
|
|
Stock-based compensation expense |
|
|
|
|
$ 164,865
|
$ 139,569
|
$ 342,637
|
$ 310,597
|
|
|
|
|
|
|
|
|
|
Unrecognized compensation cost |
$ 766,000
|
|
|
|
$ 766,000
|
|
$ 766,000
|
|
|
|
|
|
|
|
|
|
|
Share based payment arrangement, nonvested award, cost not yet recognized, period for recognition |
|
|
|
|
|
|
1 year 7 months 20 days
|
|
|
|
|
|
|
|
|
|
|
Non-cash loss on change in fair value of warrant liability |
|
|
|
|
|
|
$ (125,589)
|
(205,457)
|
|
|
|
|
|
|
|
|
|
November 2019 Offering [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants outstanding |
64,362
|
|
|
|
64,362
|
|
64,362
|
|
|
|
|
|
|
|
|
|
|
Non-cash loss on change in fair value of warrant liability |
|
|
|
|
$ 27,000
|
$ 583,000
|
$ 126,000
|
$ 205,000
|
|
|
|
|
|
|
|
|
|
February 2020 Offering [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants outstanding |
49,433
|
|
|
|
49,433
|
49,433
|
49,433
|
49,433
|
|
|
|
|
|
|
|
|
|
Warrants, Issued |
|
|
|
|
|
|
296,593
|
|
|
|
|
|
|
|
|
|
|
Common stock warrants exercised |
|
|
|
|
0
|
0
|
|
0
|
|
|
|
|
|
|
|
|
|
Stock Incentive Plan 2014 [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation arrangement by share-based payment award, number of shares authorized |
336,582
|
|
|
|
336,582
|
|
336,582
|
|
|
|
|
|
|
|
|
|
58,823
|
Share-based compensation arrangement by share-based payment award, number of shares available for grant |
46,519
|
|
|
|
46,519
|
|
46,519
|
|
|
|
|
|
|
|
|
|
|
Contractual life |
|
|
|
|
|
|
10 years
|
|
|
|
|
|
|
|
|
|
|
2011 Equity Incentive Plan [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation arrangement by share-based payment award, number of shares available for grant |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,994
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares, Options granted (in shares) |
|
|
|
|
8,820
|
10,086
|
26,467
|
29,643
|
|
|
|
|
|
|
|
|
|
Option exercises, shares |
|
|
|
|
0
|
12
|
|
12,261
|
|
|
|
|
|
|
|
|
|
Series B Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, stated par value |
|
|
|
|
|
|
|
|
$ 0.0001
|
|
|
|
|
|
|
|
|
Preferred stock, shares issued |
|
|
88,511
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock voting rights, description |
|
|
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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock redemption terms |
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
|
|
Maximum [Member] | Stock Incentive Plan 2014 [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation arrangement by share-based payment award, number of shares authorized |
|
|
|
|
|
|
|
|
|
|
|
|
336,582
|
189,522
|
145,405
|
|
|
Minimum [Member] | Stock Incentive Plan 2014 [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation arrangement by share-based payment award, number of shares authorized |
|
|
|
|
|
|
|
|
|
|
|
|
189,522
|
145,405
|
74,817
|
|
|
Sales Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of gross proceeds on sale of shares |
|
|
|
3.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares, new issues |
883,711
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares issued, price per share |
$ 37.23
|
|
|
|
$ 37.23
|
|
$ 37.23
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock, gross |
$ 32,900,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from common stock offering |
31,700,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from available for sale |
41,200,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from available for sale |
$ 15,700,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales Agreement [Member] | Cantor Fitzgerald & Co. [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value of shares issued during the period |
|
|
|
$ 50,000,000.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revision of Prior Period, Adjustment [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, par value |
|
|
|
|
|
|
|
|
|
|
$ 0.0001
|
|
|
|
|
|
|
Common stock, shares authorized |
|
|
|
|
|
|
|
|
|
|
200,000,000
|
100,000,000
|
|
|
|
|
|
X |
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v3.23.2
Commitments and Contingencies (Details Narrative) - USD ($)
|
|
|
|
|
|
6 Months Ended |
Jul. 13, 2023 |
Jul. 13, 2022 |
Apr. 29, 2022 |
Nov. 14, 2019 |
Apr. 02, 2019 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Litigation settlement |
|
|
|
|
|
|
$ 250,000
|
Payments for legal settlements |
|
|
|
$ 1,250,000
|
|
|
|
Global Agreement [Member] | May 2022 [Member] |
|
|
|
|
|
|
|
Litigation settlement |
|
|
$ 1,250,000
|
|
|
|
|
Global Agreement [Member] | Clarus Therapeutics, Inc [Member] |
|
|
|
|
|
|
|
Litigation settlement |
|
$ 1,000,000.0
|
|
|
$ 4,000,000.0
|
|
|
Global Agreement [Member] | Clarus Therapeutics, Inc [Member] | Forecast [Member] |
|
|
|
|
|
|
|
Litigation settlement |
$ 500,000
|
|
|
|
|
|
|
Global Agreement [Member] | Clarus Therapeutics, Inc [Member] | Immediately [Member] |
|
|
|
|
|
|
|
Litigation settlement |
|
|
|
|
$ 2,500,000
|
|
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v3.23.2
Agreement with Spriaso, LLC (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Licensing revenue |
|
$ 500,000
|
$ 54,990
|
$ 500,000
|
License and Service Agreement [Member] | Spriaso LLC [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Percentage of royalty |
|
|
20.00%
|
|
Proceeds from contributions from affiliates |
|
|
$ 10,000,000.0
|
|
Agreement description |
|
|
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;
|
|
Service Agreement [Member] | Spriaso LLC [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Licensing revenue |
$ 0
|
$ 0
|
$ 55,000
|
$ 0
|
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