SALT
LAKE CITY, Aug. 10, 2023 /PRNewswire/ -- Lipocine
Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on
treating Central Nervous System (CNS) disorders, today announced
financial results for the second quarter and six months ended
June 30, 2023, and provided a
corporate update.
Clinical Program Highlights
Neuroactive Steroids
- Lipocine announced positive topline results from a pilot
pharmacokinetics ("PK") bridge study of LPCN 1154 (oral
brexanolone). Lipocine is developing LPCN 1154 for postpartum
depression ("PPD")
-
- The bridge study results demonstrated comparative
pharmacokinetics of LPCN 1154 to an approved
IV brexanolone
- The study identified a dosing regimen of LPCN 1154 to be
tested in a single confirmatory pivotal PK study required for
NDA filing
- LPCN 1154 treatment was well-tolerated with no hypoxia or
sedation-related adverse events
LPCN 1148 in liver cirrhosis
- Lipocine announced positive topline results from its Phase 2
proof-of-concept ("POC") study evaluating LPCN 1148
in cirrhosis
-
- Study met primary endpoint: treatment with LPCN 1148 increased
L3 skeletal muscle index (L3-SMI) relative to placebo (P
<0.01)
- Fewer hepatic encephalopathy (HE) events of grade >1 in the
LPCN 1148 treatment arm relative to placebo (P < 0.05)
- More patients on LPCN 1148 reported symptom improvement
compared to placebo (P < 0.05)
- LPCN 1148 was well-tolerated, with AE rates and severities
similar to placebo
- Lipocine plans to meet with the FDA to discuss
the development path to NDA filing
- Posters on LPCN 1148 and LPCN 1144 were presented at the
European Association for the Study of the Liver (EASL) Congress
2023, in Vienna, Austria,
June 21 – 24, 2023
Quarter Ended June 30, 2023
Financial Results
Lipocine reported a net loss of $3.6
million, or ($0.68) per
diluted share, for the three months ended June 30, 2023, compared with a net loss of
$2.6 million or ($0.61) per diluted share, in the three
months ended June 30, 2022.
Lipocine 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
$0.5 million received from Antares
for consideration of a 90-day extension for Antares to exercise its
option to license LPCN 1111.
Research and development expenses were $2.5 million and $2.9
million, respectively, for the three months ended
June 30, 2023, and 2022. The decrease
in research and development expenses year over year was a result of
a decrease in costs related to our LPCN 1154 clinical studies, a
decrease in lab supplies, small equipment and other research and
development costs, a decrease in contract research organization
expense and outside consulting costs related to the completion of
our LPCN 1144 LiFT study in 2022, a decrease related to our
completed PK and food effect studies for LPCN 1107, and a decrease
in LPCN 1111 scale up costs. These decreases were offset by an
increase in contract research organization expense related to the
LPCN 1148 Phase 2 POC study in male subjects with cirrhosis, an
increase in personnel related costs and an increase in TLANDO
related costs.
General and administrative expenses were $1.4 million and $1.1
million, respectively, for the three months ended
June 30, 2023, and 2022. The increase
in general and administrative expenses year over year was primarily
due to an increase in professional and legal fees related to our
reverse stock split and other general and administrative expenses,
an increase in estimated franchise taxes resulting from our reverse
stock split, as well as increases in business development fees,
personnel salaries and benefits, market research activities and
director fees. These increases were offset by a decrease resulting
from professional fees incurred in our recruitment of two
additional directors in 2022 and a decrease in corporate insurance
expense.
As of June 30, 2023, Lipocine had
$25.8 million of unrestricted cash,
cash equivalents and marketable investment securities compared to
$32.5 million at December 31,
2022.
Six Months Ended June 30, 2023
Financial Results
Lipocine reported a net loss of $7.4
million, or ($1.44) per
diluted share, for the six months ended June
30, 2023, compared with a net loss of $6.1 million or ($1.20) per diluted share, in the six months
ended June 30, 2022.
Lipocine recognized license revenue of approximately
$55,000 during the six months ended
June 30, 2023. We recognized revenue
related to a non-refundable cash fee of $0.5
million 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 were $5.6 million and $4.8
million, respectively, for the six months ended June 30, 2023, and 2022. The increase in research
and development expenses year over year resulted from an increase
in contract research organization expense related to the Phase 2
POC study of LPCN 1148, an increase in costs related to LPCN 1154
clinical studies, an increase in personnel salaries and benefits
resulting from the hiring of additional personnel, and an increase
in TLANDO related expenses. These increases were offset by a
decrease in contract research organization expense and outside
consulting costs related to the completion of our LPCN 1144 LiFT
study 2022, a decrease related to LPCN 1111 scale up costs in 2022,
a decrease related to the completion of our LPCN 1107 PK and food
effect studies in 2022 and a decrease in expenses for lab supplies,
small equipment and other research and development activities.
General and administrative expenses were $2.7 million and $2.4
million, respectively, for the six months ended June 30, 2023, and 2022. The increase in general
and administrative expenses year over year was primarily due to an
increase in professional and legal fees related to our reverse
stock split and other general and administrative expenses, an
increase in business development fees, an increase in estimated
franchise taxes, an increase in director fees, an increase in
personnel salaries and benefit costs, and an increase in market
research activities. These increases were offset by a
decrease resulting from professional fees incurred in our
recruitment of two additional directors in 2022 and a decrease in
corporate insurance expense.
For more information on Lipocine's financial results for the
three and six months ended June 30,
2023, refer to Form 10Q filed with the SEC.
About Lipocine
Lipocine is a biopharmaceutical company leveraging its
proprietary technology platform to augment therapeutics through
effective oral delivery to develop differentiated products for CNS
disorders. Lipocine has drug candidates in development as well as
drug candidates for which we are exploring partnering. Our drug
candidates represent enablement of differentiated, patient friendly
oral delivery options for favorable benefit to risk profile which
target large addressable markets with significant unmet medical
needs.
Lipocine's 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, a novel androgen receptor agonist prodrug for oral
administration 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, LPCN1154, for rapid relief of postpartum depression,
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, the
application of our proprietary platform in developing new
treatments for CNS disorders, our product candidates and related
clinical trials, our development of and filing of a NDA with the
FDA for LPCN 1148,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 have sufficient capital to complete the development
processes for our product candidates, 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 and our ability to utilize a streamlined
approval pathway for LPCN 1154, 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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
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
|
|
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 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)
|
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SOURCE Lipocine Inc.