SALT
LAKE CITY, May 11, 2023 /PRNewswire/ -- Lipocine
Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on
treating Central Nervous System (CNS) disorders by leveraging its
proprietary platform to develop differentiated products, today
announced financial results for the first quarter ended
March 31, 2023, and provided a
corporate update.
First Quarter Highlights
Neuroactive Steroid for
Depression
Dosing was initiated in a pilot clinical bridge study of LPCN 1154
(oral brexanolone) a neuroactive steroid product candidate that
Lipocine is developing for postpartum depression ("PPD").
LPCN 1154 is targeted to be a differentiated oral treatment
option as a mono or add-on therapy for patients with unresolved
symptoms needing fast onset with high response in short treatment
duration.
- Results are expected in the second quarter of the year. The FDA
has agreed with Lipocine's proposal for establishing the efficacy
of LPCN 1154 via the 505(b)(2) pathway. The proof-of-concept study
is a prelude to a single confirmatory Pivotal PK study in place of
an efficacy study for NDA submission.
LPCN 1148 in liver cirrhosis
LPCN 1148 is being evaluated in an ongoing Phase 2 proof-of-concept
("POC") study for the management of decompensated cirrhosis of
various etiologies. Topline results are expected mid-2023.
Lipocine continues to explore partnering opportunities for LPCN
1107, our candidate for prevention of preterm birth, LPCN 1148, for
the management of decompensated cirrhosis, LPCN 1144, our candidate
for treatment of non-cirrhotic NASH, and LPCN 1111, a once-a-day
therapy candidate for testosterone replacement therapy (TRT).
Quarter Ended March 31, 2023
Financial Results
Lipocine reported a net loss of
$3.9 million, or ($0.04) per diluted share, for the three months
ended March 31, 2023, compared with a
net loss of $3.5 million
or ($0.04) per diluted
share, in the three months ended March 31,
2022.
Lipocine recognized license revenue for payments receivable from
Spriaso under a licensing agreement in the cough and cold field of
approximately $55,000 during the
three months ended March 31, 2023.
There was no revenue during the three months ended March 31, 2022.
Research and development expenses were $3.1 million and $1.9
million, respectively, for the three months ended
March 31, 2023, and 2022. The
increase in research and development expenses year-over-year was
the result of an increase in contract research organization expense
related to the Phase 2 POC study with LPCN 1148, an increase in
costs related to LPCN 1154 clinical studies, an increase in
personnel costs and expenses related to lab supplies, small
equipment and other research and development costs. These increases
were offset by a decrease in LPCN 1111 scale up costs, a decrease
in contract research organization expense and outside consulting
costs related to the completion of the LPCN 1144 LiFT Phase 2
clinical study, and a decrease in expenses as a result of
completing the PK and food effect studies for LPCN 1154 and LPCN
1107 in 2022.
General and administrative expenses were $1.3 million and $1.2
million, respectively, for the three months ended
March 31, 2023, and 2022. The
increase in general and administrative expenses year-over-year was
primarily due to increases in corporate legal fees, business
development consulting fees, director fees, and various
professional fees. These were offset by decreases in corporate
insurance expense and general and administrative expenses.
As of March 31, 2023, Lipocine had
$28.9 million of unrestricted cash,
cash equivalents and marketable investment securities compared to
$32.5 million at December 31,
2022.
About Lipocine
Lipocine is a biopharmaceutical company leveraging its proprietary
technology platform to augment therapeutics through effective oral
delivery to develop products for CNS disorders. Lipocine has
candidates in development as well as candidates for which we are
exploring partnering. Our candidates represent the enablement of
patient friendly oral delivery options for a favorable benefit to
risk profile which target large addressable markets with
significant unmet medical needs.
Lipocine clinical development candidates include: LPCN 1154,
oral brexanolone, for the potential treatment of postpartum
depression, LPCN 2101 for the potential treatment of epilepsy and
LPCN 1148, an oral prodrug of bioidentical testosterone targeted
for the management of symptoms associated with liver cirrhosis.
Lipocine is exploring partnering opportunities for LPCN 1107,
our candidate for prevention of preterm birth, LPCN 1148, for the
management of decompensated cirrhosis, LPCN 1144, our candidate for
treatment of non-cirrhotic NASH, and LPCN 1111, a once-a-day
therapy candidate for testosterone replacement therapy (TRT).
TLANDO, a novel oral prodrug of testosterone containing
testosterone undecanoate developed by Lipocine, is approved by the
FDA for conditions associated with a deficiency of endogenous
testosterone, also known as hypogonadism, in adult males. 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 our product development efforts, our strategic plans for
developing products to treat CNS disorders, our ability to monetize
non-core product candidates, the application of our proprietary
platform in developing new treatments for CNS disorders, our
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, and the potential uses and benefits of our
product candidates. Investors are cautioned that all such
forward-looking statements involve risks and uncertainties,
including, without limitation, the risks that we may not be
successful in developing product candidates to treat CNS disorders,
we may not be able to enter into partnerships or other strategic
relationships to monetize our non-core assets, 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,
|
|
|
|
|
|
|
2023
|
|
2022
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash equivalents
|
|
$
4,769,180
|
|
$ 3,148,496
|
Marketable investment securities
|
|
24,100,430
|
|
29,381,410
|
Accrued interest income
|
|
39,060
|
|
80,427
|
Contract asset - current portion
|
|
579,428
|
|
579,428
|
Prepaid and other current assets
|
|
1,126,731
|
|
945,319
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
30,614,829
|
|
34,135,080
|
|
|
|
|
|
|
|
|
|
Contract asset -
non-current portion
|
|
3,252,500
|
|
3,252,500
|
Property and equipment,
net of accumulated depreciation
|
|
|
|
|
of $1,158,349 and
$1,153,530 respectively
|
|
130,770
|
|
131,589
|
Other assets
|
|
23,753
|
|
23,753
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$ 34,021,852
|
|
$
37,542,922
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
796,476
|
|
$
600,388
|
Accrued
expenses
|
|
1,133,626
|
|
1,077,738
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
1,930,102
|
|
1,678,126
|
|
|
|
|
|
|
|
|
|
Warrant
liability
|
|
131,722
|
|
229,856
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
2,061,824
|
|
1,907,982
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mezzanine
equity:
|
|
|
|
|
Preferred stock,
par value $0.0001 per share ($0.001 per
|
|
|
|
|
share redemption value), 10,000,000 shares
authorized;
|
|
|
|
88,511 and zero issued and outstanding at March
31, 2023
|
|
|
|
and December 31, 2022,
respectively
|
|
9
|
|
-
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
Common stock, par value $0.0001 per share,
200,000,000
|
|
|
|
shares authorized;
88,516,501 issued and
|
|
|
|
|
88,510,791
outstanding
|
|
8,852
|
|
8,852
|
Additional
paid-in capital
|
|
219,284,000
|
|
219,112,164
|
Treasury stock at
cost, 5,710 shares
|
|
(40,712)
|
|
(40,712)
|
Accumulated other comprehensive loss
|
|
3,241
|
|
(20,321)
|
Accumulated
deficit
|
|
(187,295,362)
|
|
(183,425,043)
|
|
|
|
|
|
|
|
|
|
Total stockholders' equity
|
|
31,960,028
|
|
35,634,940
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders'
equity
|
|
$ 34,021,852
|
|
$
37,542,922
|
LIPOCINE INC. AND
SUBSIDIARIES
|
Condensed Consolidated
Statements of Operations and Comprehensive Loss
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
|
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
$ 54,990
|
|
$
-
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
|
3,106,310
|
|
1,887,953
|
General and administrative
|
|
1,287,313
|
|
1,243,687
|
Total operating expenses
|
|
4,393,623
|
|
3,131,640
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
(4,338,633)
|
|
(3,131,640)
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
Interest and
investment income
|
|
370,469
|
|
41,576
|
Interest expense
|
|
-
|
|
(19,529)
|
Unrealized gain
(loss) on warrant liability
|
|
98,134
|
|
(377,988)
|
Total other income (expense),
net
|
|
468,603
|
|
(355,941)
|
|
|
|
|
|
|
|
|
|
Loss before income tax
expense
|
|
(3,870,030)
|
|
(3,487,581)
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
(200)
|
|
(200)
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
(3,870,230)
|
|
(3,487,781)
|
|
|
|
|
|
|
|
|
|
Issuance of Series B preferred stock dividend
|
|
(89)
|
|
-
|
Net loss attributable
to common shareholders
|
|
$(3,870,319)
|
|
$(3,487,781)
|
|
|
|
|
|
|
|
|
|
Basic loss per share
attributable to common stock
|
|
$
(0.04)
|
|
$
(0.04)
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding, basic
|
|
88,510,791
|
|
88,309,628
|
|
|
|
|
|
|
|
|
|
Diluted loss per share
attributable to common stock
|
|
$
(0.04)
|
|
$
(0.04)
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding, diluted
|
|
88,510,791
|
|
88,309,628
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
Net loss
|
|
$(3,870,319)
|
|
$(3,487,781)
|
Net unrealized gain (loss) on
available-for-sale securities
|
|
23,562
|
|
(49,400)
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
$(3,846,757)
|
|
$(3,537,181)
|
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SOURCE Lipocine Inc.