SALT LAKE CITY, Aug. 5, 2021 /PRNewswire/ -- Lipocine Inc.
(NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused
on metabolic and endocrine disorders, today announced financial
results for the second quarter ended June
30, 2021, and provided a corporate update.
Recent Corporate Highlights
- Announced positive topline results from the Phase
2 LiFT ("Liver Fat intervention with
oral Testosterone") clinical study, investigating LPCN 1144 in
biopsy-confirmed NASH male subjects
- 36-week biopsy data from the LiFT clinical
study are expected in August 2021
- Continued enrolling patients into an open label extension to
the LiFT clinical study in which all patients will
have access to LPCN 1144
- Clinical data from the LiFT clinical study were
presented at The International Liver Congress™ 2021, the annual
meeting of the European Association for the Study of the Liver
("EASL"), Digital Event, which took place June 23-26,
2021
-
- Results from the LiFT clinical study showed that LPCN
1144 treatment significantly reduced liver fat and key liver injury
markers in biopsy confirmed NASH subjects
- Data from the LiFT clinical study showed high
prevalence of low normal or overtly hypogonadal levels of
testosterone in histologically established NASH subjects
- LPCN 1144 was shown to improve body composition in
biopsy-confirmed NASH patients
- The U.S. Food and Drug Administration ("FDA") cleared the
Company's Investigational New Drug Application ("IND") to initiate
a Phase 2 study to evaluate the therapeutic potential of LPCN 1154,
an oral neuro-steroid product candidate, for the treatment of
postpartum depression ("PPD") in adults
-
- Top-line results from an ongoing pharmacokinetic ("PK") study
to assess dose proportionality are expected in the third quarter of
2021
- Following the PK study, a proof-of-concept study to evaluate
the safety, tolerability, and efficacy of LPCN 1154 in adult female
subjects diagnosed with PPD is expected to begin in the fourth
quarter of 2021
- Entered into a global settlement agreement with Clarus
Therapeutics Inc. ("Clarus") to resolve all outstanding claims in
the on-going intellectual property litigation between Lipocine and
Clarus, as well as the on-going interference proceeding between the
two companies
- Continued business development activities surrounding TLANDO
related to the commercialization of TLANDO upon approval by the
FDA
- Expect the first subject will be dosed in the proof-of-concept
Phase 2 study in male cirrhotic subjects to evaluate the
therapeutic potential of LPCN 1148 for the management of cirrhotic
subjects in the fourth quarter of 2021
Second Quarter Ended June 30,
2021 Financial Results
Lipocine reported a net loss
of $6.8 million, or ($0.08) per diluted share, for the second quarter
ended June 30, 2021, compared with a
net loss of $6.4 million, or
($0.13) per diluted share, for the
second quarter ended June 30,
2020.
Research and development expenses were $1.5 million for the second quarter ended
June 30 2021, compared with
$2.3 million for the second quarter
ended June 30, 2020. The decrease was
primarily due to a decrease in contract research organization
expense and outside consulting costs related to the LPCN 1144 Phase
2 LiFT clinical study in NASH subjects, a decrease in costs
associated with TLANDO and a decrease in personnel expense, which
was mainly due to a decrease in stock compensation and bonus
expense. These decreases were offset by an increase in costs
related to LPCN 1154 and LPCN 1107, as well as increases in other
R&D expenses.
General and administrative expenses were $1.5 million for the second quarter ended
June 30, 2021, compared with
$2.0 million for the second quarter
ended June 30, 2020. The decrease in
general and administrative was primarily related to a decrease in
personnel costs, which was mainly due to a decrease in stock
compensation and bonus expense, and a decrease in legal expenses.
These decreases were offset by increases in corporate insurance and
other general and administrative expenses.
As of June 30, 2021, the Company
had $46.6 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.
Six Months Ended June 30, 2021
Financial Results
Lipocine reported a net loss of
$10.2 million, or ($0.12) per diluted share, for the six months
ended June 30, 2021, compared with a
net loss of $12.1 million, or
($0.27) per diluted share, for the
six months ended June 30, 2020.
Research and development expenses were $3.0 million for the six months ended
June 30, 2021, compared with
$4.8 million for the six months ended
June 30, 2020. The decrease in
research and development expenses was primarily due to a decrease
in contract research organization expense and outside consulting
costs related to the LPCN 1144 Phase 2 LiFT clinical study
in NASH subjects, a decrease in costs associated with TLANDO and a
net decrease in personnel expense, which was mainly due to a
decrease in stock compensation expense offset by increases in
salaries. These decreases were offset by an increase in costs
related to LPCN 1154 and LPCN 1107, as well as increases in other
R&D expenses.
General and administrative expenses were $3.1 million for the six months ended
June 30, 2021, compared with
$4.0 million for the six months ended
June 30, 2020. The decrease in
general and administrative expenses was primarily due to a decrease
in legal costs and a decrease in personnel costs, mainly due a
reduction in stock compensation expense. These decreases were
offset by an increase in corporate insurance expenses and an
increase in other general and administrative expenses.
About Lipocine Inc.
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, LPCN 1154, and
LPCN 1107. 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. LPCN
1144, an oral prodrug 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 1154 is an oral neuro-steroid targeted
for the treatment of post-partum depression. 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, 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)
|
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
2021
|
|
2020
|
Assets
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
10,967,713
|
|
$
19,217,382
|
|
|
Restricted
cash
|
|
-
|
|
5,000,000
|
|
|
Marketable investment
securities
|
|
35,672,059
|
|
449,992
|
|
|
Accrued interest
income
|
|
232,568
|
|
391
|
|
|
Prepaid and other
current assets
|
|
283,180
|
|
661,258
|
|
|
|
|
|
|
|
|
Total current
assets
|
47,155,520
|
|
25,329,023
|
|
|
|
|
|
|
|
Other
assets
|
|
23,753
|
|
23,753
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
$
47,179,273
|
|
$
25,352,776
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
906,476
|
|
$
1,597,220
|
|
|
Accrued
expenses
|
|
1,444,188
|
|
1,653,178
|
|
|
Debt - current
portion
|
|
3,957,627
|
|
3,333,333
|
|
|
Litigation settlement
liability - current portion
|
|
2,500,000
|
|
-
|
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
8,808,291
|
|
6,583,731
|
|
|
|
|
|
|
|
|
Debt - non-current
portion
|
|
-
|
|
2,257,075
|
|
Warrant
liability
|
|
1,125,429
|
|
1,170,051
|
|
Litigation settlement
liability - non-current portion
|
|
1,500,000
|
|
-
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
11,433,720
|
|
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
|
|
217,986,752
|
|
187,407,634
|
|
|
Treasury stock at
cost, 5,710 shares
|
|
(40,712)
|
|
(40,712)
|
|
|
Accumulated other
comprehensive loss
|
|
(186)
|
|
-
|
|
|
Accumulated
deficit
|
|
(182,209,131)
|
|
(172,032,008)
|
|
|
|
|
|
|
|
|
|
Total stockholders'
equity
|
|
35,745,553
|
|
15,341,919
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
47,179,273
|
|
$
25,352,776
|
LIPOCINE INC. AND
SUBSIDIARIES
|
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months
Ended June 30,
|
|
|
|
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
1,464,687
|
|
$
2,268,984
|
|
$
3,045,228
|
|
$
4,780,739
|
|
General and
administrative
|
|
1,525,592
|
|
1,953,535
|
|
3,059,544
|
|
4,038,795
|
|
|
Total operating
expenses
|
|
2,990,279
|
|
4,222,519
|
|
6,104,772
|
|
8,819,534
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
(2,990,279)
|
|
(4,222,519)
|
|
(6,104,772)
|
|
(8,819,534)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
Interest and
investment income
|
|
17,344
|
|
7,177
|
|
27,993
|
|
67,115
|
|
Interest
expense
|
|
(57,428)
|
|
(87,847)
|
|
(126,401)
|
|
(221,192)
|
|
Unrealized gain
(loss) on warrant liability
|
|
221,322
|
|
(2,066,445)
|
|
26,257
|
|
(3,166,474)
|
|
Litigation
settlement
|
|
(4,000,000)
|
|
-
|
|
(4,000,000)
|
|
-
|
|
|
Total other expense,
net
|
|
(3,818,762)
|
|
(2,147,115)
|
|
(4,072,151)
|
|
(3,320,551)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income
tax expense
|
|
(6,809,041)
|
|
(6,369,634)
|
|
(10,176,923)
|
|
(12,140,085)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
-
|
|
-
|
|
(200)
|
|
(200)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
(6,809,041)
|
|
$
(6,369,634)
|
|
$
(10,177,123)
|
|
$
(12,140,285)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic loss per share
attributable to common stock
|
|
$
(0.08)
|
|
$
(0.13)
|
|
$
(0.12)
|
|
$
(0.27)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding, basic
|
|
88,290,650
|
|
49,769,253
|
|
85,556,110
|
|
45,558,442
|
Diluted loss per
share attributable to common stock
|
|
$
(0.08)
|
|
$
(0.13)
|
|
$
(0.12)
|
|
$
(0.27)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding, diluted
|
|
88,290,650
|
|
49,769,253
|
|
85,556,110
|
|
45,558,442
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
(6,809,041)
|
|
$
(6,369,634)
|
|
$
(10,177,123)
|
|
$
(12,140,285)
|
|
|
Net unrealized gain
(loss) on available-for-sale securities
|
|
22,273
|
|
(104)
|
|
(186)
|
|
(66)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss
|
|
$
(6,786,768)
|
|
$
(6,369,738)
|
|
$
(10,177,309)
|
|
$
(12,140,351)
|
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SOURCE Lipocine Inc.