SALT
LAKE CITY, May 9, 2022 /PRNewswire/ -- Lipocine
Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on
developing innovative products for neuroendocrine and metabolic
disorders, today announced financial results for the quarter ended
March 31, 2022 and provided a
corporate update.
Program Highlights
- TLANDO™ was approved and granted Market Exclusivity by the U.S.
Food and Drug Administration ("FDA") for hypogonadism and our
licensee expects commercial launch in second quarter of 2022
- Lipocine is currently enrolling subjects in a Phase 2
proof-of-concept study to evaluate the therapeutic potential of
LPCN 1148 for the management of cirrhosis, with enrollment in the
study expected to be complete by the end of the third quarter of
2022
- Lipocine has requested an End of Phase 2 meeting to discuss the
Phase 3 study and confirmatory trial design for LPCN 1144 in
non-cirrhotic non-alcoholic steatohepatitis ("NASH")
- An open label extension ("OLE") study in non-cirrhotic NASH has
been completed and topline results are expected in May 2022
Board Appointments
The company appointed Jill M.
Jene, Ph.D. and Spyros Papapetropoulos, M.D., Ph.D. to its
board of directors in April 2022
First Quarter Ended March 31,
2022 Financial Results
Lipocine reported a net loss of $3.5
million or ($0.04 per diluted
share), for the quarter ended March 31,
2022, compared with a net loss of $3.4 million, or ($0.04) per diluted share, in the quarter ended
March 31, 2021.
Research and development expenses were $1.9 million for the quarter ended March 31, 2022, compared with $1.6 million for the quarter ended March 31, 2021. The increase in research and
development expenses for the quarter ended March 31, 2022, was a result of increases in
contract research organization expenses related to the ongoing
Phase 2 clinical study for LPCN 1148, PK and food effect studies
for LPCN 1107 and LPCN 1154, manufacturing scale up expenses for
LPCN 1111, and an increase in personnel and other R&D
expenses. These increases were offset by a decrease in
contract research organization expense and outside consulting costs
related to the LPCN 1144 LiFT Phase 2 clinical study and a decrease
in costs related to TLANDO.
General and administrative expenses were $1.2 million for the quarter ended March 31, 2022, compared with $1.5 million for the quarter ended March 31, 2021. The decrease in general and
administrative expenses for the quarter ended March 31, 2022, was primarily due to decreases in
legal costs, personnel costs and other general and administrative
costs. These decreases were offset by increases in professional
fees related to various consulting and proxy solicitation services
as well as an increase in corporate insurance expenses.
As of March 31, 2022, the company
had $42.0 million of unrestricted
cash, cash equivalents and marketable investment securities
compared to $46.6 million as of
December 31, 2021.
About Lipocine
Lipocine Inc. is a biopharmaceutical company focused on
neuroendocrine and metabolic disorders using its proprietary drug
delivery technologies. Lipocine's clinical development pipeline
includes: LPCN 1148, LPCN 1144, LPCN 1111, LPCN 1107 and oral
neuroactive steroids including LPCN 1154 and LPCN 2101. TLANDO, a
novel oral prodrug of testosterone containing testosterone
undecanoate, is approved by the FDA for conditions associated with
a deficiency of endogenous testosterone, also known as
hypogonadism, in adult males. LPCN 1148 is an oral prodrug of
bioidentical testosterone targeted for the management of symptoms
associated with liver cirrhosis. LPCN 1144, an oral prodrug
of bioidentical testosterone, recently completed a Phase 2 clinical
study demonstrating potential utility in the treatment of
non-cirrhotic NASH. LPCN 1111, 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 or twice daily, LPCN 1111 met primary and
secondary endpoints. LPCN 1107 is potentially the first oral
hydroxyprogesterone caproate product candidate indicated for the
prevention of recurrent preterm birth and has been granted orphan
drug designation by the FDA. Neuroactive steroids are
currently being evaluated including LPCN 1154 for the potential
treatment of postpartum depression and LPCN 2101 for the potential
treatment of epilepsy. 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 achievement of milestones within and
completion of clinical trials, the timing and completion of
regulatory reviews, outcomes of clinical trials of our product
candidates, 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.
*TLANDO® is a registered trademark assigned to Antares
Pharma.
LIPOCINE INC. AND
SUBSIDIARIES
|
Condensed Consolidated
Balance Sheets
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March
31,
|
|
December
31,
|
|
|
|
|
|
|
2022
|
|
2021
|
|
|
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
5,733,231
|
|
$ 2,950,552
|
|
|
Marketable investment
securities
|
|
36,266,299
|
|
41,667,405
|
|
|
Accrued interest
income
|
|
120,094
|
|
247,253
|
|
|
Prepaid and other
current assets
|
|
1,377,925
|
|
1,514,465
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current
assets
|
|
43,497,549
|
|
46,379,675
|
|
|
|
|
|
|
|
|
|
Marketable investment
securities
|
|
-
|
|
2,021,800
|
Contract
asset
|
|
4,050,000
|
|
4,050,000
|
Property and equipment,
net of accumulated depreciation
|
|
|
|
|
|
|
of $1,145,796 and
$1,144,077, respectively
|
|
32,289
|
|
7,211
|
Other assets
|
|
23,753
|
|
23,753
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
47,603,591
|
|
$
52,482,439
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
469,887
|
|
$ 1,289,342
|
|
|
Accrued
expenses
|
|
567,901
|
|
1,016,458
|
|
|
Debt - current
portion
|
|
1,482,165
|
|
2,310,825
|
|
|
Litigation settlement
liability - current portion
|
|
1,000,000
|
|
1,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
3,519,953
|
|
5,616,625
|
|
|
|
|
|
|
|
|
|
Warrant
liability
|
|
1,173,785
|
|
795,796
|
Litigation settlement
liability - non-current portion
|
|
500,000
|
|
500,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
5,193,738
|
|
6,912,421
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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;
88,504,634 and 88,296,360 issued
|
|
|
|
|
|
|
|
and 88,498,924 and
88,290,650 outstanding
|
|
8,850
|
|
8,829
|
|
|
Additional paid-in
capital
|
|
218,663,319
|
|
218,286,324
|
|
|
Treasury stock at cost,
5,710 shares
|
|
(40,712)
|
|
(40,712)
|
|
|
Accumulated other
comprehensive loss
|
|
(67,416)
|
|
(18,016)
|
|
|
Accumulated
deficit
|
|
(176,154,188)
|
|
(172,666,407)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders'
equity
|
|
42,409,853
|
|
45,570,018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
47,603,591
|
|
$
52,482,439
|
|
|
|
|
|
|
|
|
|
|
LIPOCINE INC. AND
SUBSIDIARIES
|
|
Condensed Consolidated
Statements of Operations and Comprehensive Loss
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
|
|
|
|
2022
|
|
2021
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
$
-
|
|
$
-
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
1,887,953
|
|
1,580,540
|
|
|
General and
administrative
|
|
1,243,687
|
|
1,533,953
|
|
|
|
Total operating
expenses
|
|
3,131,640
|
|
3,114,493
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
(3,131,640)
|
|
(3,114,493)
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
Interest and investment
income
|
|
41,576
|
|
10,649
|
|
|
Interest
expense
|
|
(19,529)
|
|
(68,973)
|
|
|
Unrealized loss on
warrant liability
|
|
(377,988)
|
|
(195,065)
|
|
|
|
Total other expense,
net
|
|
(355,941)
|
|
(253,389)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income tax
expense
|
|
(3,487,581)
|
|
(3,367,882)
|
|
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
(200)
|
|
(200)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
(3,487,781)
|
|
$
(3,368,082)
|
|
|
|
|
|
|
|
|
|
|
|
Basic loss per share
attributable to common stock
|
|
$
(0.04)
|
|
$
(0.04)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding, basic
|
|
88,309,628
|
|
81,881,392
|
|
|
|
|
|
|
|
|
|
|
|
Diluted loss per share
attributable to common stock
|
|
$
(0.04)
|
|
$
(0.04)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding, diluted
|
|
88,309,628
|
|
81,881,392
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
|
Net loss
|
|
$
(3,487,781)
|
|
$
(3,368,082)
|
|
|
|
Net unrealized loss on
available-for-sale securities
|
|
(49,400)
|
|
(22,459)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss
|
|
$
(3,537,181)
|
|
$
(3,390,541)
|
|
|
|
|
|
|
|
|
|
|
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SOURCE Lipocine Inc.