SALT LAKE CITY, Nov. 10, 2021 /PRNewswire/ -- Lipocine Inc.
(NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused
on metabolic and endocrine disorders, today announced financial
results for the third quarter and nine months ended September 30, 2021, and provided a corporate
update.
Third Quarter and Recent Corporate Highlights
- Entered into a license agreement with Antares Pharma to
commercialize TLANDO in the US
-
- Lipocine to receive up to $21.0
million in licensing fees, including $11.0 million payable immediately and
$10.0 million to be paid in the
future subject to certain conditions
- Lipocine is entitled to commercial sales milestone payments of
up to $160.0 million and tiered
royalties on net sales of TLANDO from mid-teens up to 20%
- Antares Pharma to undertake all commercialization,
post-marketing study obligations, and sourcing of TLANDO in the
U.S.
- Antares Pharma was also granted an option to license TLANDO XR
for development and commercialization in the U.S. for additional
licensing fees ($4.0 million),
clinical and regulatory milestone payments ($35.0 million), sales milestone payments and
royalties (mid-teens up to 20%)
- The U.S. Food and Drug Administration ("FDA") granted Fast
Track Designation to LPCN 1144 for the treatment of non-cirrhotic
non-alcoholic steatohepatitis ("NASH")
- The FDA has affirmed that the resubmission of the New Drug
Application ("NDA") for TLANDO will be a Class 1 resubmission, with
a two-month FDA review goal period
-
- The FDA previously granted tentative approval to TLANDO in
adult males indicated for conditions associated with a deficiency
or absence of endogenous testosterone: primary hypogonadism
(congenital or acquired) and hypogonadotropic hypogonadism
(congenital or acquired)
- The product is not eligible for final approval and marketing in
the U.S. until the expiration of the FDA's Orange Book listed
exclusivity period previously granted to Clarus Therapeutics, Inc.
with respect to Jatenzo®, which expires on March 27, 2022
- Announced positive topline 36-week results from its Phase 2
proof-of-concept Liver Fat intervention with oral
Testosterone ("LiFT") clinical study, NCT04134091,
investigating LPCN 1144 in men with biopsy-confirmed NASH
-
- Study met its primary endpoint. At 12 weeks, treatment with
LPCN 1144 resulted in statistically significant liver fat
reduction, assessed by MRI-PDFF
- Both LPCN 1144 treatment arms showed significant improvement in
NASH without worsening of fibrosis
- Efficacy and safety results from the LiFT study have
been accepted for late-breaking presentations at the American
Association for the Study of Liver Diseases ("AASLD") The Liver
Meeting® on November 12-15, 2021
- Company intends to meet with the FDA regarding the path forward
for an accelerated approval and to discuss Phase 3 study
requirements
Third Quarter Ended September 30,
2021 Financial Results
Lipocine reported a net loss of $3.1
million, or ($0.03) per
diluted share, for the third quarter ended September 30, 2021, compared with a net loss of
$4.3 million, or ($0.07) per diluted share, for the third quarter
ended September 30, 2020.
Research and development expenses were $2.4 million for the third quarter ended
September 30, 2021, compared with
$2.5 million for the third quarter
ended September 30, 2020. The
decrease for the third quarter of 2021 was primarily due to a
decrease in contract research organization expense and outside
consulting costs related to our LPCN 1144 LiFT clinical
study as well as decrease costs related to TLANDO. These
decreases were offset by increases in costs associated with our
LPCN 1154 and LPCN 1148 programs.
General and administrative expenses were $1.2 million for the third quarter ended
September 30, 2021, compared with
$1.9 million for the third quarter
ended September 30, 2020. The
decrease in general and administrative was primarily related to a
decrease in our legal costs in 2021 as well as decreased personnel
costs primarily related to reduced stock compensation
expense.
As of September 30, 2021, the
Company had $38.7 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.
Subsequent to the end of the third quarter, the Company received
an $11.0 million upfront license fee
as part of the licensing agreement with Antares Pharma to
commercialize TLANDO.
Nine Months Ended September 30,
2021 Financial Results
Lipocine reported a net loss of $13.3
million, or ($0.15) per
diluted share, for the nine months ended September 30, 2021, compared with a net loss of
$16.5 million, or ($0.32) per diluted share, for the nine months
ended September 30, 2020.
Research and development expenses were $5.4 million for the nine months ended
September 30, 2021, compared with
$7.3 million for the nine months
ended September 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 our LPCN 1144 LiFT clinical
study, a decrease in costs related to TLANDO and a decrease in
personnel costs primarily related to reduced stock compensation
expense. These decreases were offset by increases in costs
associated with our LPCN 1154 and LPCN 1148 programs.
General and administrative expenses were $4.3 million for the nine months ended
September 30, 2021, compared with
$5.9 million for the nine months
ended September 30, 2020. The
decrease in general and administrative expenses was primarily due
to a decrease in our legal costs in 2021 as well as decreased
personnel costs primarily related to reduced stock compensation
expense. These decreases were offset by an increase in
corporate insurance expense.
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 Phase 2 clinical study
demonstrating the potential utility in the treatment of
non-cirrhotic NASH. 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 the receipt of final FDA approval of
TLANDO, the timing and amount of sales and development milestone
payments and royalties under the License Agreement, the exercise of
Antares' option with respect to TLANDO XR, the costs and timing of
any post-marketing studies of TLANDO and clinical studies relating
to TLANDO XR, our ability to compete in the TRT market, the degree
to which TLANDO will gain market share in the TRT market, if at
all, Antares Pharma's ability to successfully commercialize TLANDO,
the benefits to Lipocine and Antares Pharma under the License
Agreement, the potential benefits of TLANDO to patients, Lipocine's
product candidates and related 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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
|
|
|
|
2021
|
|
2020
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
4,517,105
|
|
$
19,217,382
|
|
|
Restricted
cash
|
|
-
|
|
5,000,000
|
|
|
Marketable investment
securities
|
|
34,145,380
|
|
449,992
|
|
|
Accrued interest
income
|
|
159,230
|
|
391
|
|
|
Prepaid and other
current assets
|
|
1,543,641
|
|
661,258
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current
assets
|
|
40,365,356
|
|
25,329,023
|
|
|
|
|
|
|
|
|
|
Other
assets
|
|
23,753
|
|
23,753
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
40,389,109
|
|
$
25,352,776
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
725,552
|
|
$
1,597,220
|
|
|
Accrued
expenses
|
|
1,571,012
|
|
1,653,178
|
|
|
Debt - current
portion
|
|
3,135,979
|
|
3,333,333
|
|
|
Litigation settlement
liability - current portion
|
|
1,000,000
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
6,432,543
|
|
6,583,731
|
|
|
|
|
|
|
|
|
|
Debt - non-current
portion
|
|
-
|
|
2,257,075
|
Warrant
liability
|
|
645,478
|
|
1,170,051
|
Litigation settlement
liability - non-current portion
|
|
500,000
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
7,578,021
|
|
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
|
|
218,136,818
|
|
187,407,634
|
|
|
Treasury stock at
cost, 5,710 shares
|
|
(40,712)
|
|
(40,712)
|
|
|
Accumulated other
comprehensive loss
|
|
(3,420)
|
|
-
|
|
|
Accumulated
deficit
|
|
(185,290,428)
|
|
(172,032,008)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders'
equity
|
|
32,811,088
|
|
15,341,919
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
40,389,109
|
|
$
25,352,776
|
LIPOCINE INC. AND
SUBSIDIARIES
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
License
revenue
|
|
$
54,994
|
|
$
-
|
|
$
54,994
|
|
$
-
|
|
|
Total
revenues
|
|
54,994
|
|
-
|
|
54,994
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
2,366,521
|
|
$
2,487,861
|
|
$
5,411,748
|
|
$
7,268,599
|
|
General and
administrative
|
|
1,222,146
|
|
1,887,195
|
|
4,281,690
|
|
5,925,991
|
|
|
Total operating
expenses
|
|
3,588,667
|
|
4,375,056
|
|
9,693,438
|
|
13,194,590
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
(3,533,673)
|
|
(4,375,056)
|
|
(9,638,444)
|
|
(13,194,590)
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
Interest and
investment income
|
|
17,264
|
|
5,614
|
|
45,257
|
|
72,729
|
|
Interest
expense
|
|
(44,839)
|
|
(84,293)
|
|
(171,241)
|
|
(305,485)
|
|
Unrealized gain
(loss) on warrant liability
|
|
479,951
|
|
140,477
|
|
506,208
|
|
(3,025,997)
|
|
Litigation
settlement
|
|
-
|
|
-
|
|
(4,000,000)
|
|
-
|
|
|
Total other income
(expense), net
|
|
452,376
|
|
61,798
|
|
(3,619,776)
|
|
(3,258,753)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income
tax expense
|
|
(3,081,297)
|
|
(4,313,258)
|
|
(13,258,220)
|
|
(16,453,343)
|
|
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
-
|
|
-
|
|
(200)
|
|
(200)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
(3,081,297)
|
|
$
(4,313,258)
|
|
$
(13,258,420)
|
|
$
(16,453,543)
|
|
|
|
|
|
|
|
|
|
|
|
Basic loss per share
attributable to common stock
|
|
$
(0.03)
|
|
$
(0.07)
|
|
$
(0.15)
|
|
$
(0.32)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding, basic
|
|
88,290,650
|
|
64,833,714
|
|
86,477,640
|
|
52,030,431
|
Diluted loss per
share attributable to common stock
|
|
$
(0.03)
|
|
$
(0.07)
|
|
$
(0.15)
|
|
$
(0.32)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding, diluted
|
|
88,290,650
|
|
64,833,714
|
|
86,477,640
|
|
52,030,431
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
(3,081,297)
|
|
$
(4,313,258)
|
|
$
(13,258,420)
|
|
$
(16,453,543)
|
|
|
Net unrealized gain
(loss) on available-for-sale securities
|
|
(3,234)
|
|
579
|
|
(3,420)
|
|
513
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss
|
|
$
(3,084,531)
|
|
$
(4,312,679)
|
|
$
(13,261,840)
|
|
$
(16,453,030)
|
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SOURCE Lipocine Inc.