SALT LAKE CITY, March 9, 2022 /PRNewswire/ -- Lipocine Inc.
(NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused
on neuroendocrine and metabolic disorders, today announced
financial results for the fourth quarter and year ended
December 31, 2021 and provided a
corporate update.
Clinical Program Highlights
LPCN 1148
- Initiated a Phase 2 proof-of-concept clinical study evaluating
LCPN 1148 for the management of decompensated liver cirrhosis in
patients on the transplant waitlist
-
- We currently expect enrollment in the Phase 2 study to be
complete by the end of the second or third quarter of 2022 and
top-line 24-week results by the end of 2022 or during the first
quarter of 2023.
LPCN 1144
- In August 2021, Lipocine
announced positive topline 36-week results from its Phase 2 proof
of concept LiFT ("Liver Fat
intervention with oral Testosterone") clinical study
investigating LPCN 1144 in men with biopsy-confirmed NASH. Key
secondary endpoints post 36 weeks of treatment include assessment
of histological change for NASH resolution and/or fibrosis
improvement.
- Lipocine held a Type C meeting with the U.S. Food and Drug
Administration ("FDA") to discuss the clinical development path for
LPCN 1144 in non-cirrhotic non-alcoholic steatohepatitis ("NASH").
The FDA suggested a Phase 3 trial with a primary
multicomponent surrogate endpoint and indicated a study duration of
72 weeks would be adequate for seeking approval under an
accelerated pathway, if successful.
TLANDO®
- Lipocine entered into a license agreement with Antares Pharma
in 2021 to commercialize TLANDO in the U.S.
-
- The FDA accepted a New Drug Application ("NDA") resubmission
for TLANDO® (testosterone undecanoate) and designated the NDA as a
Class 1 resubmission with a two-month review goal period and set a
target action date of March 28, 2022,
under the Prescription Drug User Fee Act ("PDUFA").
Neuroactive Steroids
- The FDA has cleared an investigational new drug ("IND")
application to conduct a Phase 2 proof of concept study of LPCN
1154, an oral endogenous neuroactive steroid ("NAS") product
candidate, in postpartum depression.
- An IND application is planned to be filed with the FDA in the
second quarter of 2022 for LPCN 2101 to conduct and IND opening
proof-of-concept study in women with epilepsy of childbearing
age.
Year Ended December 31, 2021
Financial Results
Lipocine reported a net loss of
$634,399, or ($0.01) per diluted share, for the year ended
December 31, 2021, compared with a
net loss of $21 million, or
($0.38) per diluted share, in the
year ended December 31, 2020.
Lipocine recognized revenue of $16.1
million during the year ended December 31, 2021, compared to no revenue during
the year ended December 31,
2020. Revenue in 2021 primarily related to licensing fees,
minimum royalties and the sale of finished goods materials we
received in accordance with the Antares Licensing Agreement for
TLANDO which was signed on October
14, 2021.
Research and development expenses were $7.7 million for the year ended December 31, 2021, compared with $9.7 million for the year ended December 31, 2020. The decrease in research and
development expenses during the year ended December 31, 2021 was primarily due a decrease in
contract research organization expense and outside consulting costs
related to the LPCN 1144 LiFT Phase 2 clinical study in NASH
subjects, a decrease in costs associated with TLANDO and a net
decrease in personnel expense, as well as decreases in other
R&D expenses. These decreases were offset by increases in
costs related to LPCN 1154, LPCN 1148 and LPCN 1107.
General and administrative expenses were $5.3 million for the year ended December 31, 2021, compared with $8.2 million for the year ended December 31, 2020. The decrease in general and
administrative expenses during the year ended December 31, 2021 was primarily due to decreases
in legal costs and personnel costs, offset by an increase in
corporate insurance expenses and in other general and
administrative expenses.
Lipocine recorded an expense of $4.0
million on litigation settlement during 2021 related to the
Global Agreement with Clarus to resolve all outstanding claims in
the on-going intellectual property litigation between the two
companies as well as the on-going interference proceeding between
the two companies. There was no comparable litigation settlement
expense in 2020.
As of December 31, 2021, Lipocine had $44.6
million of unrestricted cash, cash equivalents, and marketable
investments, compared to $19.7 million of unrestricted
cash, cash equivalents and marketable investment securities as
of December 31, 2020.
About Lipocine
Lipocine Inc. is a clinical-stage
biopharmaceutical company focused on endocrine and metabolic
disorders using its proprietary drug delivery technologies.
Lipocine's clinical development pipeline includes: LPCN 1154, LPCN
2021, LPCN 1148, LPCN 1111, LPCN 1144, and LPCN 1107. LPCN 1154 is
an oral neuroactive steroid targeted for the treatment of
post-partum depression and LPCN 2101 is an oral neuroactive steroid
targeted for the treatment of women of childbearing age with
epilepsy. LPCN 1148 is an oral prodrug of bioidentical testosterone
targeted for the management of symptoms associated with liver
cirrhosis. TLANDO, a novel oral prodrug of testosterone
containing testosterone undecanoate, has received tentative
approval from the FDA for conditions associated with a deficiency
of endogenous testosterone, also known as hypogonadism, in adult
males and has been licensed for commercialization to Antares. 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
the typical primary and secondary endpoints. 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 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. 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 and studies,
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.
LIPOCINE INC. AND
SUBSIDIARIES
|
Consolidated Balance
Sheets
|
December 31, 2021 and
2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2021
|
|
2020
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
2,950,552
|
|
$
19,217,382
|
|
|
Restricted
cash
|
|
-
|
|
5,000,000
|
|
|
Marketable investment
securities
|
|
41,667,405
|
|
449,992
|
|
|
Accrued interest
income
|
|
247,253
|
|
391
|
|
|
Prepaid and other
current assets
|
|
1,514,465
|
|
661,258
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current
assets
|
|
46,379,675
|
|
25,329,023
|
|
|
|
|
|
|
|
|
|
Marketable investment
securities
|
|
2,021,800
|
|
-
|
Contract
asset
|
|
4,050,000
|
|
-
|
Property and
equipment, net of accumulated depreciation
|
|
|
|
|
of
$1,144,077 and $1,143,697 respectively
|
|
7,211
|
|
-
|
Other
assets
|
|
23,753
|
|
23,753
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
52,482,439
|
|
$
25,352,776
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
1,289,342
|
|
$
1,597,220
|
|
|
Accrued
expenses
|
|
1,016,458
|
|
1,653,178
|
|
|
Debt - current
portion
|
|
2,310,825
|
|
3,333,333
|
|
|
Litigation settlement
liability - current portion
|
|
1,000,000
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
5,616,625
|
|
6,583,731
|
|
|
|
|
|
|
|
|
|
|
|
Debt - non-current
portion
|
|
-
|
|
2,257,075
|
|
|
Warrant
liability
|
|
795,796
|
|
1,170,051
|
|
|
Litigation settlement
liability - non-current portion
|
|
500,000
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
6,912,421
|
|
10,010,857
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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;
88,296,360 and 70,041,967
|
|
|
|
|
|
|
|
issued and 88,290,650
and 70,036,257 outstanding
|
|
8,830
|
|
7,005
|
|
|
Additional paid-in
capital
|
|
218,286,323
|
|
187,407,634
|
|
|
Treasury stock at
cost, 5,710 shares
|
|
(40,712)
|
|
(40,712)
|
|
|
Accumulated other
comprehensive loss
|
|
(18,016)
|
|
-
|
|
|
Accumulated
deficit
|
|
(172,666,407)
|
|
(172,032,008)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders'
equity
|
|
45,570,018
|
|
15,341,919
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
52,482,439
|
|
$
25,352,776
|
LIPOCINE INC. AND
SUBSIDIARIES
|
Consolidated
Statements of Operations and Comprehensive Loss
|
Years Ended December
31, 2021 and 2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2021
|
|
2020
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
$
16,140,838
|
|
$
-
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
|
7,665,559
|
|
9,748,469
|
|
General and
administrative
|
|
|
5,329,776
|
|
8,247,795
|
|
|
Total operating
expenses
|
|
|
12,995,335
|
|
17,996,264
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income
(loss)
|
|
|
3,145,503
|
|
(17,996,264)
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense)
|
|
|
|
|
|
|
Interest and
investment income
|
|
|
67,700
|
|
75,650
|
|
Interest
expense
|
|
|
(203,292)
|
|
(386,618)
|
|
Gain on
extinguishment of debt
|
|
|
-
|
|
234,802
|
|
Unrealized gain
(loss) on warrant liability
|
|
|
355,890
|
|
(2,892,189)
|
|
Litigation
settlement
|
|
|
(4,000,000)
|
|
-
|
|
|
Total other expense,
net
|
|
|
(3,779,702)
|
|
(2,968,355)
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income
tax expense
|
|
|
(634,199)
|
|
(20,964,619)
|
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
|
(200)
|
|
(200)
|
|
|
Net loss
|
|
|
$
(634,399)
|
|
$
(20,964,819)
|
|
|
|
|
|
|
|
|
|
|
Basic loss per share
attributable to common stock
|
|
|
$
(0.01)
|
|
$
(0.38)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding,
|
|
|
86,934,618
|
|
55,688,085
|
basic
|
|
|
|
|
|
Diluted loss per
share attributable to common stock
|
|
|
$
(0.01)
|
|
$
(0.38)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding, diluted
|
|
|
86,934,618
|
|
55,688,085
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
|
Net loss
|
|
|
$
(634,399)
|
|
$
(20,964,819)
|
|
|
Unrealized net gain
(loss) on available-for-sale securities
|
|
(18,016)
|
|
38
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss
|
|
|
$
(652,415)
|
|
$
(20,964,781)
|
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SOURCE Lipocine Inc.