SALT LAKE CITY, Nov. 7, 2018 /PRNewswire/ -- Lipocine
Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today
announced financial results for the three and nine months ended
September 30, 2018.
Third Quarter and Recent Corporate Highlights
- Completed enrollment of 138 subjects in the ongoing ambulatory
blood pressure ("ABPM") clinical study for TLANDO™, the Company's
oral testosterone product candidate for testosterone replacement
therapy ("TRT") in adult males for conditions associated with a
deficiency of endogenous testosterone, also known as hypogonadism.
The ABPM study is designed to address a deficiency identified in
the FDA's Complete Response Letter ("CRL") issued May 2018. Results from the study are expected in
the first quarter of 2019.
- Conducting a definitive phlebotomy study to evaluate the
extent, if any, of clinically meaningful ex vivo conversion of
testosterone undecanoate ("TU") to testosterone ("T") in serum
blood collection tubes to confirm the reliability of TLANDO data
results. Results are expected in the fourth quarter of 2018.
- Announced a late-breaking presentation highlighting LPCN 1144
data in potential non-alcoholic fatty liver disease ("NAFLD") /
non-alcoholic steatohepatitis ("NASH") patients, at The Liver
Meeting®, to take place in San
Francisco November 9-13, 2018.
The presentation will highlight data from multiple clinical trials
of LPCN 1144 in potential NAFLD/NASH patients.
- Conducting a Proof-Of-Concept ("POC") study with LPCN 1144 in a
biopsy-confirmed NASH in-vivo pre-clinical model. Results are
expected in the first quarter of 2019.
- Completed enrollment of 36 subjects in the LPCN 1144 POC
clinical study to assess liver fat changes in hypogonadal men at
risk of developing non-alcoholic steatohepatitis ("NASH") using
magnetic resonance imaging, proton density fat fraction
("MRI-PDFF") technique. Results are expected in the first quarter
of 2019.
"We continue to believe there is a path forward for TLANDO and
anticipate a resubmission of our NDA for TLANDO in the first half
of 2019 based on results from on-going clinical studies," said Dr.
Mahesh Patel, Chairman, President
and Chief Executive Officer of Lipocine. "We are also excited about
our new product candidate, LPCN 1144, for NASH and look forward to
receiving clinical trial results in the near term that will further
support the use of an oral androgen for this important
indication."
Three Months Ended September 30,
2018 Financial Results
Lipocine reported a net loss of $2.5
million, or ($0.12) per
diluted share, for the three months ended September 30, 2018, compared with a net loss of
$4.7 million, or ($0.22) per diluted share, for the three months
ended September 30, 2017.
Research and development expenses were $1.4 million for the three months ended
September 30, 2018, compared with
$2.0 million for the three months
ended September 30, 2017. The
decrease in research and development expenses year over year was
primarily due to reduced contract manufacturing organization costs
for TLANDO and LPCN 1107 and reduced personnel costs, offset by
increased contract research organization costs for TLANDO for the
ABPM study. We expect research and development costs to
increase through the first quarter of 2019 while we conduct the
ABPM study for TLANDO and complete the POC liver imaging study for
LPCN 1144.
General and administrative expenses were $930,000 for the three months ended September 30, 2018, compared with $2.7 million for the three months ended
September 30, 2017. The decrease in
general and administrative expenses year over year was primarily
due to lower professional fees related to legal, intellectual
property and commercial activities as well as decreased personnel
costs related to reduced headcount.
As of September 30, 2018, the
Company had unrestricted cash, cash equivalents, and marketable
securities of $16.9 million, compared
to cash, cash equivalents, and marketable securities of
$21.5 million at December 31, 2017.
Nine Months Ended September 30,
2018 Financial Results
Lipocine reported a net loss of $8.4
million, or ($0.40) per
diluted share, for the nine months ended September 30, 2018, compared with a net loss of
$15.7 million, or ($0.80) per diluted share, in the nine months
ended September 30, 2017.
Research and development expenses were $4.3 million for the nine months ended
September 30, 2018, compared with
$9.2 million for the nine months
ended September 30, 2017. The
decrease in research and development expenses year over year was
primarily due to reduced contract research organization costs for
TLANDO as the DV and DF studies were complete in 2017 while the
ABPM study was being initiated in 2018, lower personnel costs, and
lower contract manufacturing costs for LPCN 1107. This was offset
by increased outside service and other costs primarily related to
the Company's preparation for and participation in the meeting of
the Bone, Reproductive and Urologic Drugs Advisory Committee
("BRUDAC") of the FDA related to TLANDO that was held in
January 2018.
General and administrative expenses were $4.3 million for the nine months ended
September 30, 2018, compared with
$6.6 million for the nine months
ended September 30, 2017. The
decrease in general and administrative expenses year over year was
primarily due to decreased personnel costs related to reduced
headcount. Additionally, professional fees related to legal,
intellectual property and commercial activities also decreased in
2018.
About Lipocine
Lipocine Inc. is a specialty
pharmaceutical company developing innovative pharmaceutical
products for use in men's and women's health using its proprietary
drug delivery technologies. Lipocine's clinical development
pipeline includes four development programs TLANDO, LPCN 1144, LPCN
1111 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone
containing testosterone undecanoate, is designed to help restore
normal testosterone levels in hypogonadal men. TLANDO received a
Complete Response Letter from the FDA on May
8, 2018. LPCN 1144, an oral prodrug of bioidentical
testosterone, is being developed as a treatment of non-alcoholic
steatohepatitis ("NASH") and is currently being studied in two
proof-of-concept clinical studies. 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 and is currently in Phase 2 testing. 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. An End of
Phase 2 meeting with the FDA has been completed. 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
and the FDA review process relating to its product candidates, the
timing of completion of clinical trials including the ABPM study
for TLANDO as well as ongoing LPCN 1144 clinical trials, the path
to approvability by the FDA of Lipocine's development programs, 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)
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
|
2018
|
|
2017
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
4,802,806
|
|
$
3,210,749
|
|
Restricted
cash
|
5,000,000
|
|
-
|
|
Marketable investment
securities
|
12,077,016
|
|
18,257,321
|
|
Accrued interest
income
|
29,892
|
|
23,067
|
|
Litigation insurance
recovery
|
-
|
|
3,319,927
|
|
Prepaid and other
current assets
|
728,482
|
|
408,227
|
|
|
|
|
|
|
|
|
Total current
assets
|
22,638,196
|
|
25,219,291
|
|
|
|
|
|
|
Property and
equipment, net of accumulated depreciation of $1,120,256 and
$1,121,080, respectively
|
23,442
|
|
75,070
|
Other
assets
|
23,753
|
|
30,753
|
|
|
|
|
|
|
|
|
Total
assets
|
$
22,685,391
|
|
$
25,325,114
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
$
239,922
|
|
$
598,070
|
|
Litigation settlement
payable
|
-
|
|
4,250,000
|
|
Accrued
expenses
|
488,632
|
|
1,497,056
|
|
Debt - current
portion
|
2,341,054
|
|
-
|
|
|
Total current
liabilities
|
3,069,608
|
|
6,345,126
|
|
|
|
|
|
|
Debt - non-current
portion
|
7,853,844
|
|
-
|
|
|
|
|
|
|
|
|
Total
liabilities
|
10,923,452
|
|
6,345,126
|
|
|
|
|
|
|
|
|
|
|
|
|
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; 21,340,017
and 21,270,249 issued and 21,334,307 and 21,264,539
outstanding
|
2,134
|
|
2,127
|
|
Additional paid-in
capital
|
146,638,736
|
|
145,423,012
|
|
Treasury stock at
cost, 5,710 shares
|
(40,712)
|
|
(40,712)
|
|
Accumulated other
comprehensive loss
|
(3,853)
|
|
(4,616)
|
|
Accumulated
deficit
|
(134,834,366)
|
|
(126,399,823)
|
|
|
|
|
|
|
|
|
Total stockholders'
equity
|
11,761,939
|
|
18,979,988
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
$
22,685,391
|
|
$
25,325,114
|
LIPOCINE INC. AND
SUBSIDIARIES
|
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months
Ended September 30,
|
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
License
revenue
|
$
-
|
|
$
-
|
|
$
428,031
|
|
$
-
|
|
|
Total
revenues
|
-
|
|
-
|
|
428,031
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
1,422,919
|
|
2,046,533
|
|
4,282,823
|
|
9,237,169
|
|
General and
administrative
|
930,137
|
|
2,719,526
|
|
4,299,659
|
|
6,578,423
|
|
|
Total operating
expenses
|
2,353,056
|
|
4,766,059
|
|
8,582,482
|
|
15,815,592
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
(2,353,056)
|
|
(4,766,059)
|
|
(8,154,451)
|
|
(15,815,592)
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest and
investment income
|
112,561
|
|
65,811
|
|
343,145
|
|
165,018
|
|
Interest
expense
|
(218,577)
|
|
-
|
|
(622,537)
|
|
-
|
|
|
Total other income
(expense), net
|
(106,016)
|
|
65,811
|
|
(279,392)
|
|
165,018
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income
tax expense
|
(2,459,072)
|
|
(4,700,248)
|
|
(8,433,843)
|
|
(15,650,574)
|
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
-
|
|
-
|
|
(700)
|
|
(700)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
$(2,459,072)
|
|
$(4,700,248)
|
|
$(8,434,543)
|
|
$
(15,651,274)
|
|
|
|
|
|
|
|
|
|
|
Basic loss per share
attributable to common stock
|
$
(0.12)
|
|
$
(0.22)
|
|
$
(0.40)
|
|
$
(0.80)
|
Weighted average
common shares outstanding, basic
|
21,266,639
|
|
20,890,580
|
|
21,265,247
|
|
19,666,131
|
|
Diluted loss per
share attributable to common stock
|
$
(0.12)
|
|
$
(0.22)
|
|
$
(0.40)
|
|
$
(0.80)
|
Weighted average
common shares outstanding, diluted
|
21,266,639
|
|
20,890,580
|
|
21,265,247
|
|
19,666,131
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
Net loss
|
$(2,459,072)
|
|
$(4,700,248)
|
|
$(8,434,543)
|
|
$
(15,651,274)
|
|
|
Net unrealized gain
on available-for-sale securities
|
7,756
|
|
79
|
|
763
|
|
7,960
|
|
|
Comprehensive
loss
|
$(2,451,316)
|
|
$(4,700,169)
|
|
$(8,433,780)
|
|
$
(15,643,314)
|
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SOURCE Lipocine Inc.