SALT
LAKE CITY, March 7, 2024 /PRNewswire/ -- Lipocine
Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on
treating Central Nervous System ("CNS") disorders, today announced
financial results for the year ended December 31,
2023 and provided a corporate update.
Neuroactive Steroids
- Lipocine announced positive topline results from a
pharmacokinetics ("PK") pilot bridge study of LPCN 1154 (oral
brexanolone). Lipocine is developing LPCN 1154 for postpartum
depression ("PPD")
- The bridge study results demonstrated comparative
pharmacokinetics of LPCN 1154 to an approved IV infusion
brexanolone
- The study identified a dosing regimen of LPCN 1154 to be tested
in a single confirmatory pivotal PK study required for NDA
filing
- LPCN 1154 treatment was well-tolerated with no hypoxia or
sedation-related adverse events
- The Company completed a successful meeting with the U.S. Food
and Drug Administration ("FDA") during which it confirmed with the
FDA its 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. The use of exposure parameters and
criteria to assess comparable exposure to IV infusion brexanolone
was also agreed upon
- In January 2024, Lipocine
completed a single arm PK study (N=8) utilizing the "to be
marketed" LPCN 1154 formulation and target dosing regimen. PK
exposure results of the scaled-up formulation were consistent with
the PK performance of the formulation evaluated in the pilot study.
The study results confirm the 48-hour dosing regimen for the
planned pivotal PK study
- The company anticipates beginning the LPCN 1154 pivotal study
in Q1 '24. Top line results from the study are expected by the end
of Q2 '24. Assuming the study meets expectations, the company plans
to file an NDA at the end of Q4 '24
- Lipocine has identified a lead neuroactive steroid candidate
for the management of essential tremor and is planning to submit a
protocol for a proof-of-concept phase 2 study for Essential Tremor
("ET") in the first half of 2024
LPCN 1148
- Lipocine announced positive topline results from its Phase 2
proof-of-concept ("POC") study evaluating LPCN 1148 for the
management of decompensated cirrhosis
- The study met the 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 were
observed in the LPCN 1148 treatment arm relative to placebo (P <
0.05)
- More patients on LPCN 1148 reported symptom improvement
compared to those on placebo (P < 0.05)
- LPCN 1148 was well-tolerated, with AE rates and severities
similar to placebo
- Posters on LPCN 1148 and LPCN 1144 were presented
at the European Association for the Study of the Liver
(EASL) Congress 2023, in Vienna,
Austria, June 21 – 24,
2023
- Updated results from the Phase 2 POC study were presented at
The American Association for the Study of Liver Diseases (AASLD) –
The Liver Meeting® 2023, in Boston,
MA, November 2023
- After week 24, all patients in the study entered into a single
arm open-label extension ("OLE") stage and received LPCN 1148.
Patients converting from placebo to LPCN 1148 in this OLE
showed improvement in sarcopenia
- End of study results from the POC study are expected by the end
of Q2 '24
TLANDO™
- In January 2024, Lipocine and
Verity Pharma entered into an exclusive License Agreement under
which Verity Pharma will market TLANDO in the United States and, if approved, in
Canada
- Verity Pharma is responsible for regulatory and marketing
obligations in the U.S. and Canada, and for all further development of
TLANDO and TLANDO XR
- Verity Pharma agreed to pay Lipocine a license fee totaling
$11 million. Upon execution of the
agreement and upon transition of the commercialization of TLANDO to
Verity, Lipocine received initial payments of $2.5 million and $5
million. Further payments of $2.5
million and $1 million are due
from Verity Pharma no later than January 1,
2025, and January 1, 2026,
respectively
- Lipocine is entitled to receive up to $259 million in development and sales-based
commercial milestone payments, as well as tiered royalty payments
ranging from 12% up to 18% on net sales of TLANDO franchise
products
Year Ended December 31, 2023
Financial Results
Lipocine reported a net loss of $16.4 million,
or ($3.14) per diluted
share, for the year ended December 31, 2023, compared with a
net loss of $10.8 million, or ($2.15) per diluted share, for the year
ended December 31, 2022.
During 2023 Lipocine recognized a non-cash minimum guaranteed
royalties reversal of variable consideration revenue of
$2.9 million related to the
termination of the Antares License Agreement. The reversal of
revenue is due to the fact that, as a result of the termination of
the license agreement, the Company will not receive anticipated
minimum royalties that were previously recorded for the Antares
License Agreement. In 2022, the Company recorded revenue of
$500,000 related to a non-refundable
cash fee received from Antares.
Research and development expenses were $10.2 million and $8.6
million, respectively, for the years ended December 31, 2023 and 2022. The increase in
research and development expenses was primarily due to an increase
in contract research organization expense related to the LPCN 1154
clinical studies, an increase in TLANDO manufacturing related
costs, an increase related to the LPCN 1148 Phase 2 POC study in
male patients with cirrhosis, and an increase in personnel expense.
These increases were offset by a decrease related to expenses
incurred in 2022 for LPCN 1111 scale up costs, LPCN 1107 clinical
study costs, and other research and development activities.
General and administrative expenses were $4.9 million and $4.1
million, respectively, for the years ended December 31, 2023 and 2022. The increase in
general and administrative expenses was primarily due to an
increase in business development and strategic advisory services
expenses, an increase in legal fees, an increase in personnel
related costs, an increase in franchise taxes, an increase in
director fees, and an increase in other general and administrative
expenses. These increases were offset by a decrease in corporate
insurance expense, a decrease related to 2022 expenses for the
recruitment of two additional directors, and a decrease in various
consulting and professional fees.
As of December 31, 2023, Lipocine
had $22.0 million of unrestricted
cash, cash equivalents and marketable investment securities
compared to $32.5 million at
December 31, 2022.
Subsequent to year end, Lipocine received payments of
$2.5 million and $5 million as part of the initial license fee
from Verity Pharma in connection with the agreement entered into in
January 2024 whereby Verity will take
over commercialization of TLANDO, as described above.
About Lipocine
Lipocine is a biopharmaceutical company leveraging its
proprietary technology platform to augment therapeutics through
effective oral delivery to develop differentiated 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, LPCN
2203 for the potential treatment of essential tremor 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, and LPCN 1144, our candidate
for treatment of non-cirrhotic NASH. 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, the
application of our proprietary platform in developing new
treatments for CNS disorders, our lead neuroactive steroid
candidate for the management of essential tremor, the timing of
studies and clinical trials, our product candidates and related
clinical trials, our development of and filing of a NDA with the
FDA for LPCN 1154, the receipt of license fees, milestone payments
and royalty payments under our license agreement with
Verity Pharma, 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 have sufficient capital to complete the development
processes for our product candidates, 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 and our ability to utilize a streamlined
approval pathway for LPCN 1154, 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,
|
|
December
31,
|
|
|
|
|
|
|
2023
|
|
2022
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
4,771,758
|
|
$
3,148,496
|
|
Marketable investment
securities
|
|
17,263,788
|
|
29,381,410
|
|
Accrued interest
income
|
|
52,254
|
|
80,427
|
|
Contract asset -
current portion
|
|
-
|
|
579,428
|
|
Prepaid and other
current assets
|
|
773,424
|
|
945,319
|
|
|
|
|
|
|
|
|
|
|
|
Total current
assets
|
|
22,861,224
|
|
34,135,080
|
|
|
|
|
|
|
|
|
|
Contract asset -
non-current portion
|
|
-
|
|
3,252,500
|
Property and equipment,
net of accumulated depreciation
|
|
|
|
|
of
$1,182,191 and $1,153,530 respectively
|
|
116,095
|
|
131,589
|
Other assets
|
|
23,753
|
|
23,753
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
23,001,072
|
|
$
37,542,922
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts
payable
|
|
$
1,395,977
|
|
$
600,388
|
|
Accrued
expenses
|
|
1,218,486
|
|
1,077,738
|
|
Warrant liability -
current portion
|
|
17,166
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
2,631,629
|
|
1,678,126
|
|
|
|
|
|
|
|
|
|
Warrant
liability
|
|
-
|
|
229,856
|
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
2,631,629
|
|
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
|
|
220,171,250
|
|
219,112,164
|
|
Treasury stock at cost,
336 shares
|
|
(40,712)
|
|
(40,712)
|
|
Accumulated other
comprehensive gain (loss)
|
|
7,259
|
|
(20,321)
|
|
Accumulated
deficit
|
|
(199,777,214)
|
|
(183,425,043)
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders'
equity
|
|
20,369,443
|
|
35,634,940
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
23,001,072
|
|
$
37,542,922
|
LIPOCINE INC. AND
SUBSIDIARIES
|
Consolidated Statements
of Operations and Comprehensive Loss
|
|
|
|
|
|
|
|
|
|
Years Ended December
31,
|
|
|
|
2023
|
|
2022
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
License
revenue
|
|
$
109,987
|
|
$
500,000
|
|
Minimum guaranteed
royalties revenue (reversal of
|
|
|
|
|
|
variable
consideration)
|
|
(2,960,805)
|
|
-
|
|
Total revenues
(reversal of variable consideration), net
|
|
(2,850,818)
|
|
500,000
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
Research and
development
|
|
10,175,251
|
|
8,556,888
|
|
General and
administrative
|
|
4,904,888
|
|
4,062,487
|
|
Total operating
expenses
|
|
15,080,139
|
|
12,619,375
|
|
|
|
|
|
|
|
Operating
loss
|
|
(17,930,957)
|
|
(12,119,375)
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
Interest and investment
income
|
|
1,366,940
|
|
572,578
|
|
Interest
expense
|
|
-
|
|
(27,098)
|
|
Unrealized gain on
warrant liability
|
|
212,690
|
|
565,940
|
|
Gain on litigation
settlement liability
|
|
-
|
|
250,000
|
|
Total other income,
net
|
|
1,579,630
|
|
1,361,420
|
|
|
|
|
|
|
|
Loss before income tax
expense
|
|
(16,351,327)
|
|
(10,757,955)
|
|
|
|
|
|
|
Income tax
expense
|
|
(755)
|
|
(681)
|
|
|
|
|
|
|
|
Net loss
|
|
(16,352,082)
|
|
(10,758,636)
|
|
|
|
|
|
|
|
Issuance of Series B
preferred stock dividend
|
|
(89)
|
|
-
|
|
Net loss attributable
to common shareholders
|
|
$
(16,352,171)
|
|
$
(10,758,636)
|
|
|
|
|
|
|
Basic loss per share
attributable to common stock
|
|
$
(3.10)
|
|
$
(2.06)
|
|
|
|
|
|
|
Weighted average common
shares outstanding, basic
|
|
5,269,671
|
|
5,231,681
|
|
|
|
|
|
|
Diluted loss per share
attributable to common stock
|
|
$
(3.14)
|
|
$
(2.15)
|
|
|
|
|
|
|
Weighted average common
shares outstanding, diluted
|
|
5,269,671
|
|
5,256,169
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
Net loss
|
|
$
(16,352,082)
|
|
$
(10,758,636)
|
|
Net unrealized gain
(loss) on available-for-sale securities
|
|
27,580
|
|
(2,305)
|
|
|
|
|
|
|
|
Comprehensive
loss
|
|
$
(16,324,502)
|
|
$
(10,760,941)
|
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SOURCE Lipocine Inc.