SALT
LAKE CITY, Nov. 8, 2023 /PRNewswire/ -- Lipocine Inc.
(NASDAQ: LPCN), a biopharmaceutical company focused on treating
Central Nervous System (CNS) disorders by leveraging its
proprietary platform to develop differentiated products, today
announced financial results for the third quarter and nine months
ended September 30, 2023, and
provided a corporate update.
Clinical Program Highlights
Neuroactive Steroids
- On October 18, Lipocine completed
a successful meeting with the FDA on LPCN 1154, which is in
development for postpartum depression (PPD). The FDA agreed on
Lipocone's proposal for a 505(b)(2) NDA filing based on a single
pivotal study comparing exposure of LPCN 1154 with the approved IV
infusion of brexanolone
- Lipocine anticipates initiating the pivotal study program in Q1
2024 with the LPCN 1154 "to be marketed" formulation
- Top line results from the study are expected by Q2 2024, with a
goal of filing a New Drug Application (NDA) in 2024
- If approved, LPCN 1154, has the potential to be a
differentiated preferred treatment option for PPD with rapid and
high remission/response rates with short treatment duration
LPCN 1148 in liver cirrhosis
- In July, 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
Quarter Ended September 30,
2023 Financial Results
Lipocine reported a net loss of $6.7
million, or ($1.27) per
diluted share, for the three months ended September 30, 2023, compared with a net loss of
$2.4 million or ($0.52) per diluted share, in the three
months ended September 30, 2022.
During the three months ended September
30, 2023, the Company recognized a non-cash minimum
guaranteed royalties revenue reversal of variable consideration
revenue of $3.1 million related to
the termination of the Antares License Agreement. The
reversal of revenue is due to the fact that Lipoocine will not
receive anticipated royalties that were previously recorded for the
Antares License Agreement due to the termination of the
agreement.
Research and development expenses were $2.9 million during the three months ended
September 30, 2023, as compared with
$2.1 million in the three months
ended September 30, 2022. The
increase in research and development expenses was a result of an
increase in costs related to the LPCN 1154 clinical studies, an
increase in TLANDO manufacturing related costs, and an increase in
personnel related costs, offset by a decrease in LPCN 1111 scale up
costs in 2022, a decrease in contract research organization expense
related to the LPCN 1148 Phase 2 POC study in male subjects with
cirrhosis, a decrease in contract research organization expense and
outside consulting costs related to the completion of the LPCN 1144
LiFT study in 2022, and a decrease in LPCN 1107 PK and food effect
studies and other research and development costs in 2022.
General and administrative expenses were $1.0 million during the three months ended
September 30, 2023, as compared to
$0.8 million in the three months
ended September 30, 2022. The
increase in expenses is mainly due to increases in business
development expenses, and an increase in professional
services and legal fees. These increases were offset by a
decrease in corporate insurance expense.
As of September 30, 2023, Lipocine
had $23.8 million of unrestricted
cash, cash equivalents and marketable investment securities
compared to $32.5 million at
December 31, 2022.
Nine Months Ended September 30,
2023 Financial Results
Lipocine reported a net loss of $14.1
million, or ($2.72) per
diluted share, for the nine months ended September 30, 2023, compared with a net loss of
$8.5 million or ($1.72) per diluted share, in the nine months
ended September 30, 2022.
The Company recognized a non-cash minimum guaranteed royalties
revenue reversal of variable consideration revenue of $3.1 million related to the termination of the
Antares License Agreement during the nine months ended September 30, 2023. The reversal of
variable consideration revenue is offset by license revenue of
approximately $55,000 for payments
received from Spriaso, a related party, under a licensing agreement
for the cough and cold field during the nine months ended
September 30, 2023. The Company
recognized revenue related to a non-refundable cash fee of
$500,000 received from Antares for
consideration of a 90-day extension for Antares to exercise its
option to license LPCN 1111 during the nine months ended
September 30, 2022.
Research and development expenses were $8.5 million and $6.9
million, respectively, for the nine months ended
September 30, 2023, and 2022. The
increase was due to an increase in costs related to the LPCN 1154
clinical studies, an increase in TLANDO manufacturing related
costs, an increase in contract research organization expense
related to the LPCN 1148 Phase 2 POC study in male subjects with
cirrhosis, and an increase in personnel salaries and benefits.
These increases were offset by a decrease related to LPCN 1111
scale up costs in 2022, a decrease in contract research
organization expense and outside consulting costs related to the
completion of our LPCN 1144 LiFT study, a decrease related to the
completion of our LPCN 1107 PK and food effect studies and a
decrease in other research and development activities.
General and administrative expenses were $3.8 million and $3.2
million, respectively, for the nine months ended
September 30, 2023, and 2022. The
increase consisted of an increase in business development expenses,
an increase in professional and legal fees and an increase in other
general and administrative expenses. These increases were
offset by decrease resulting from a decrease in corporate insurance
expense and a decrease in various other consulting fees.
For more information on Lipocine's financial results for the
three and nine months ended September 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 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, our
strategic plans for developing products to treat CNS disorders, our
ability to monetize non-core product candidates, including through
entering into partnering arrangements, the application of our
proprietary platform in developing new treatments for CNS
disorders, our product candidates and related clinical trials, the
achievement of milestones within and completion of clinical trials,
the timing and completion of regulatory reviews, outcomes of
clinical trials of our product candidates, 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 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, 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,
|
|
|
|
|
|
|
2023
|
|
2022
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
4,072,706
|
|
$
3,148,496
|
|
Marketable investment
securities
|
|
19,775,290
|
|
29,381,410
|
|
Accrued interest
income
|
|
41,061
|
|
80,427
|
|
Contract asset -
current portion
|
|
130,505
|
|
579,428
|
|
Prepaid and other
current assets
|
|
594,097
|
|
945,319
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current
assets
|
|
24,613,659
|
|
34,135,080
|
|
|
|
|
|
|
|
|
|
Contract asset -
non-current portion
|
|
-
|
|
3,252,500
|
Property and equipment,
net of accumulated depreciation
|
|
|
|
|
of
$1,174,189 and $1,153,530 respectively
|
|
114,931
|
|
131,589
|
Other assets
|
|
23,753
|
|
23,753
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
24,752,343
|
|
$
37,542,922
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
1,101,068
|
|
$
600,388
|
|
|
Accrued
expenses
|
|
1,140,313
|
|
1,077,738
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
2,241,381
|
|
1,678,126
|
|
|
|
|
|
|
|
|
|
Warrant
liability
|
|
29,440
|
|
229,856
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
2,270,821
|
|
1,907,982
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
Common stock, par value
$0.0001 per share, 200,000,000
|
|
|
|
|
|
|
shares authorized;
5,316,166 and 5,235,166 issued and
|
|
|
|
|
|
|
5,315,830 and 5,234,830
outstanding
|
|
8,860
|
|
8,852
|
|
Additional paid-in
capital
|
|
220,022,838
|
|
219,112,164
|
|
Treasury stock at cost,
336 shares
|
|
(40,712)
|
|
(40,712)
|
|
Accumulated other
comprehensive loss
|
|
(14,503)
|
|
(20,321)
|
|
Accumulated
deficit
|
|
(197,494,961)
|
|
(183,425,043)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders'
equity
|
|
22,481,522
|
|
35,634,940
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
24,752,343
|
|
$
37,542,922
|
LIPOCINE INC. AND
SUBSIDIARIES
|
Condensed Consolidated
Statements of Operations and Comprehensive Loss
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
|
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
License
revenue
|
|
$
-
|
|
$
-
|
|
$
54,990
|
|
$
500,000
|
|
Minimum guaranteed
royalties revenue (reversal of
|
|
|
|
|
|
|
|
-
|
|
variable
consideration)
|
|
(3,121,996)
|
|
-
|
|
(3,121,996)
|
|
-
|
|
|
Total revenues
(reversal of variable consideration), net
|
|
(3,121,996)
|
|
-
|
|
(3,067,006)
|
|
500,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
2,878,798
|
|
2,100,432
|
|
8,500,319
|
|
6,886,398
|
|
General and
administrative
|
|
1,042,572
|
|
798,939
|
|
3,770,281
|
|
3,172,144
|
|
|
Total operating
expenses
|
|
3,921,370
|
|
2,899,371
|
|
12,270,600
|
|
10,058,542
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
(7,043,366)
|
|
(2,899,371)
|
|
(15,337,606)
|
|
(9,558,542)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
Interest and investment
income
|
|
317,569
|
|
163,966
|
|
1,067,561
|
|
275,420
|
|
Interest
expense
|
|
-
|
|
-
|
|
-
|
|
(27,098)
|
|
Unrealized gain on
warrant liability
|
|
74,827
|
|
326,240
|
|
200,416
|
|
531,697
|
|
Gain on litigation
settlement liability
|
|
-
|
|
-
|
|
-
|
|
250,000
|
|
|
Total other income,
net
|
|
392,396
|
|
490,206
|
|
1,267,977
|
|
1,030,019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income tax
expense
|
|
(6,650,970)
|
|
(2,409,165)
|
|
(14,069,629)
|
|
(8,528,523)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
-
|
|
-
|
|
(200)
|
|
(200)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
(6,650,970)
|
|
(2,409,165)
|
|
(14,069,829)
|
|
(8,528,723)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of Series B
preferred stock dividend
|
|
-
|
|
-
|
|
(89)
|
|
-
|
|
|
Net loss attributable
to common shareholders
|
|
$
(6,650,970)
|
|
$
(2,409,165)
|
|
$
(14,069,918)
|
|
$
(8,528,723)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic loss per share
attributable to common stock
|
|
$
(1.26)
|
|
$
(0.46)
|
|
$
(2.68)
|
|
$
(1.63)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding, basic
|
|
5,292,058
|
|
5,234,576
|
|
5,254,116
|
|
5,230,619
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted loss per share
attributable to common stock
|
|
$
(1.27)
|
|
$
(0.52)
|
|
$
(2.72)
|
|
$
(1.72)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding, diluted
|
|
5,292,058
|
|
5,250,179
|
|
5,254,116
|
|
5,260,530
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
(6,650,970)
|
|
$
(2,409,165)
|
|
$
(14,069,829)
|
|
$
(8,528,723)
|
|
|
Net unrealized gain
(loss) on available-for-sale securities
|
|
1,309
|
|
7,972
|
|
5,818
|
|
(58,919)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss
|
|
$
(6,649,661)
|
|
$
(2,401,193)
|
|
$
(14,064,011)
|
|
$
(8,587,642)
|
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SOURCE Lipocine Inc.