Lipocine Regains Complinace With Nasdaq Minimum Bid Price Requirement
SALT LAKE CITY, July 13, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that it has received a letter from The Nasdaq Stock Market LLC ("Nasdaq") on July 9, 2020 indicating that Lipocine has regained compliance with Nasdaq's minimum bid price for continued listing on the Nasdaq Capital Market set forth in Nasdaq Listing Rule 5550(a)(2) ("Min Bid Price Listing Rule").
About Lipocine
Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and has a PDUFA date of August 28, 2020. LPCN 1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. LPCN 1144 is currently being studied in a Phase 2 clinical study. TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.
Forward-Looking Statements
This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's product candidates and related clinical trials, the timing of completion of clinical trials, the potential uses and benefits of our product candidates, and our product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.
LIPOCINE INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(Unaudited)
March 31,
December 31,
2020 2019
Current assets:
Cash and cash
equivalents $15,134,789 $9,728,523
Restricted cash 5,000,000 5,000,000
Marketable
investment
securities 448,077 4,340,041
Accrued
interest
income 9,212 16,522
Prepaid and
other current
assets 373,370 545,887
Total current
assets 20,965,448 19,630,973
Property and equipment, net of
accumulated depreciation of
$1,140,942 and $1,140,143, respectively 2,755 3,554
Other assets 23,753 23,753
Total assets $20,991,956 $19,658,280
Current liabilities:
Accounts
payable $1,654,909 $1,182,241
Accrued
expenses 738,280 449,303
Debt -current
portion 1,666,666 3,333,333
Total current
liabilities 4,059,855 4,964,877
Debt - non-current portion 4,688,136 3,814,407
Warrant liability 5,691,229 4,591,200
Total
liabilities 14,439,220 13,370,484
Commitments and contingencies
(notes 7, 8 and 10)
Stockholders' equity:
Preferred
stock, par
value $0.0001
per share,
10,000,000
shares authorized; zero issued
and outstanding
Common stock,
par value
$0.0001 per
share,
100,000,000
shares authorized; 47,860,209
and 37,655,175 issued
and 47,854,499 and 37,649,465
outstanding 4,786 3,766
Additional
paid-in
capital 163,426,502 157,391,969
Treasury stock
at cost, 5,710
shares -40,712 -40,712
Accumulated
other
comprehensive
loss -38
Accumulated
deficit -156,837,840 -151,067,189
Total
stockholders'
equity 6,552,736 6,287,796
Total
liabilities
and
stockholders'
equity $20,991,956 $19,658,280
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 March 31,
2020 2019
Operating expenses:
Research and
development 2,511,754 1,949,821
General and
administrative 2,085,261 1,175,927
Total operating expenses 4,597,015 3,125,748
Operating loss -4,597,015 -3,125,748
Other income (expense):
Interest and
investment income 59,938 125,265
Interest expense -133,345 -223,789
Total other expense, net -73,407 -98,524
Unrealized loss on warrant liability -1,100,029
Loss before income tax expense -5,770,451 -3,224,272
Income tax expense -200 -200
Net loss $(5,770,651) $(3,224,472)
Basic loss per share attributable to common stock ($0.14) ($0.14)
Weighted average common shares outstanding, basic 41,347,631 23,383,008
Diluted loss per share attributable to common stock ($0.14) ($0.14)
Weighted average common shares outstanding, diluted 41,347,631 23,383,008
Comprehensive loss:
Net loss $(5,770,651) $(3,224,472)
Net unrealized gain on available-for-
sale securities 38 2,352
Comprehensive loss $(5,770,613) $(3,222,120)
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SOURCE Lipocine Inc.
