SALT
LAKE CITY, May 9, 2024 /PRNewswire/ -- Lipocine
Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced
financial results for the first quarter ended March 31,
2024 and provided a corporate update.
LPCN 1154 for Postpartum Depression
- In May 2024, dosing of subjects
was completed in the pivotal pharmacokinetic (PK) study designed to
support a New Drug Application (NDA) for LPCN 1154. LPCN 1154, oral
brexanolone, is being developed as a treatment for postpartum
depression
- The FDA has agreed with Lipocine's proposal for establishing
the efficacy of LPCN 1154 through the pivotal PK bridge to an
approved IV infusion of brexanolone via a 505(b)(2) NDA filing
- Topline results from the pivotal PK study are expected late in
2Q 2024. Positive results would support an NDA filing at the end of
Q4 2024
LPCN 1148 for Management of Cirrhosis
- In March 2024, Lipocine announced
positive Week 52 results from the LPCN 1148 Phase 2 study in
patients with cirrhosis. The study met primary and hepatic
encephalopathy endpoints
- Increase in Skeletal Muscle Index (SMI) observed at Week 24 was
maintained through 52 weeks
- Participants on placebo increased SMI when switched to LPCN
1148
- Patients on LPCN 1148 therapy had fewer overt hepatic
encephalopathy (OHE) events and longer time to first recurrent OHE
event, with no OHE background therapy restrictions
- LPCN 1148 was well-tolerated, with adverse events (AE) rates
and severities similar to placebo. Participants on LPCN 1148 were
hospitalized for fewer days
LPCN 2401 for Obesity Management
- In April 2024, Lipocine announced
positive clinical results from a multi-center prospective, blinded
Phase 2 study evaluating LPCN 2401 in participants with obesity
(BMI ≥30) and participants with BMI ≥27 with at least one
weight-related comorbidity
- Results showed treatment with LPCN 2401 resulted in
statistically significant body composition improvements
- Increased lean mass (LM) by 4.4% and decreased fat mass (FM) by
6.7%
- Reduced android fat (AF) by 4.1% and increased bone mineral
content (BMC) by 2.8%
- LPCN 2401 was well-tolerated; AEs were similar to placebo. A
replay of the webcast discussing the LPCN 2401 Phase 2 results can
be accessed on Lipocine's website here
- Potential for LPCN 2401 to be used in combination with incretin
mimetics (GLP-1 agonists and GLP/GIP dual agonists) for improved
body composition (ameliorate muscle loss with android fat loss) or
as a monotherapy post discontinuation
LPCN 2203 for Essential Tremor
- Oral GABA Positive Allosteric Modulator, targeting improved
efficacy with fewer side effects e.g. somnolence, dizziness
- Daytime efficacy and improved tolerability remains an unmet
need
- Achieved relevant target blood levels with good tolerability in
multiple Phase 1 studies with no incidence of somnolence, sedation
or dizziness
TRT Franchise - TLANDO™ and LPCN 1111 (TLANDO XR)
- 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. The terms of the license
agreement call for a license fee of $11
million and development and sales milestones of up to
$259 million in aggregate, dependent
on achievement of certain milestones. In addition, the Company is
eligible to receive tiered royalty payments ranging from 12% up to
18% on net sales in the U.S. and Canada.
First Quarter Ended March 31,
2024 Financial Results
Lipocine reported net income of $3.5 million,
or $0.66 per diluted share, for the first quarter
ended March 31, 2024, compared with a net loss of $3.9
million, or ($0.76) per
diluted share, for the quarter ended March 31, 2023.
Revenue in the first quarter of 2024 was $7.6 million, primarily consisting of licensing
revenue received from the Verity License Agreement. This
compares with revenue of $0.06
million in the comparable period in 2023.
Research and development expenses were $2.8 million and $3.1
million, respectively, for the quarters ended March 31, 2024 and 2023. The decrease in
research and development expenses was a result of a decrease in
contract research organization expense and outside consulting costs
related to the completion of our LPCN 1148 study late in 2023, a
decrease in personnel related costs, and a decrease in LPCN 1111
costs, offset by an increase in costs related to our LPCN 1154
clinical studies, and an increase in other R&D related
costs.
General and administrative expenses were $1.6 million and $1.3
million, respectively for the quarters ended March 31, 2024 and 2023. The increase in general
and administrative expenses was a result of an increase in business
development expenses and in other various general and
administrative expenses. These increases were offset by a decrease
in various administrative consulting fees, a decrease in corporate
insurance expense, a decrease in personnel salaries and benefits,
and a decrease in legal fees.
As of March 31, 2024, Lipocine had
$24.6 million of unrestricted cash,
cash equivalents and marketable investment securities compared to
$22.0 million at December 31,
2023.
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 partnerships. 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 an oral candidate targeted for the management of essential
tremor, LPCN 2401 an oral proprietary combination of anabolic
androgen receptor agonist and α-tocopherol, an antioxidant, as an
adjunct therapy to incretin mimetics as an aid for improved body
composition in chronic weight management and LPCN 1148, a novel
androgen receptor agonist prodrug for oral administration targeted
for the management of symptoms associated with liver cirrhosis
including prevention of the recurrence of overt hepatic
encephalopathy. Lipocine is exploring partnership
opportunities for LPCN 1107, our candidate for prevention of
preterm birth, LPCN 1154, for rapid relief of postpartum
depression, LPCN 1148, for the management of decompensated
cirrhosis, LPCN 2401 for obesity management 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, our
strategic plans for developing products to treat CNS disorders, our
ability to monetize 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 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
|
Condensed
Consolidated Balance Sheets
|
|
|
|
|
|
|
|
March 31,
|
|
December 31,
|
|
|
2024
|
|
2023
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
3,081,337
|
|
$ 4,771,758
|
|
Marketable investment
securities
|
|
21,550,661
|
|
17,263,788
|
|
Accrued interest
income
|
|
100,134
|
|
52,254
|
|
Prepaid and other
current assets
|
|
583,087
|
|
773,424
|
|
|
Total current
assets
|
|
25,315,219
|
|
22,861,224
|
|
|
|
|
|
|
|
Property and equipment,
net of accumulated depreciation of $1,190,703 and $1,182,191
respectively
|
|
107,583
|
|
116,095
|
Other assets
|
|
23,753
|
|
23,753
|
|
|
Total assets
|
|
$
25,446,555
|
|
$
23,001,072
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts
payable
|
|
$
671,445
|
|
$ 1,395,977
|
|
Accrued
expenses
|
|
761,465
|
|
1,218,486
|
|
Warrant liability -
current portion
|
|
57,238
|
|
17,166
|
|
|
Total current
liabilities
|
|
1,490,148
|
|
2,631,629
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
1,490,148
|
|
2,631,629
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
Common stock, par value
$0.0001 per share, 200,000,000 shares authorized;
5,316,166 issued and
5,315,830
outstanding
|
|
8,860
|
|
8,860
|
|
Additional paid-in
capital
|
|
220,262,456
|
|
220,171,250
|
|
Treasury stock at cost,
336 shares
|
|
(40,712)
|
|
(40,712)
|
|
Accumulated other
comprehensive gain (loss)
|
|
(10,604)
|
|
7,259
|
|
Accumulated
deficit
|
|
(196,263,593)
|
|
(199,777,214)
|
|
|
Total stockholders'
equity
|
|
23,956,407
|
|
20,369,443
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
25,446,555
|
|
$
23,001,072
|
LIPOCINE INC. AND
SUBSIDIARIES
|
Condensed Consolidated
Statements of Operations and Comprehensive Income (Loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
|
|
|
2024
|
|
2023
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
License
revenue
|
|
$ 7,500,000
|
|
$ 54,990
|
|
|
|
Royalty
revenue
|
|
117,174
|
|
-
|
|
|
|
|
Total
revenues
|
|
7,617,174
|
|
54,990
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
|
2,818,926
|
|
3,106,310
|
|
|
|
General and
administrative
|
|
1,575,719
|
|
1,287,313
|
|
|
|
|
Total operating
expenses
|
|
4,394,645
|
|
4,393,623
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income
(loss)
|
|
3,222,529
|
|
(4,338,633)
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest and investment
income
|
|
331,364
|
|
370,469
|
|
|
|
Unrealized gain (loss)
on warrant liability
|
|
(40,072)
|
|
98,134
|
|
|
|
|
Total other income,
net
|
|
291,292
|
|
468,603
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before
income tax expense
|
|
3,513,821
|
|
(3,870,030)
|
|
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
(200)
|
|
(200)
|
|
|
|
|
Net income
(loss)
|
|
3,513,621
|
|
(3,870,230)
|
|
|
|
|
Issuance of Series B
preferred stock dividend
|
|
-
|
|
(89)
|
|
|
|
|
Net income (loss)
attributable to common shareholders
|
|
$ 3,513,621
|
|
$
(3,870,319)
|
|
|
|
|
|
|
|
|
|
|
|
Basic income (loss) per
share attributable to common stock
|
|
$
0.66
|
|
$
(0.74)
|
|
|
Weighted average common
shares outstanding, basic
|
|
5,315,830
|
|
5,234,830
|
|
|
|
|
|
|
|
|
|
|
|
Diluted income (loss)
per share attributable to common stock
|
|
$
0.66
|
|
$
(0.76)
|
|
|
Weighted average common
shares outstanding, diluted
|
|
5,357,530
|
|
5,234,830
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
|
|
Net income
(loss)
|
|
$ 3,513,621
|
|
$
(3,870,319)
|
|
|
|
|
Net unrealized gain
(loss) on available-for-sale securities
|
|
(17,863)
|
|
23,562
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income
(loss)
|
|
$ 3,495,758
|
|
$
(3,846,757)
|
|
|
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SOURCE Lipocine Inc.