Exhibit
99.1
Lipocine
Announces Financial Results for the Full Year Ended December 31, 2023
SALT
LAKE CITY, March 7, 2024 — 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 Stockholder’s 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 | ) |
SOURCE
Lipocine Inc.
For
further information:
Krista
Fogarty
Phone:
(801) 994-7383
kf@lipocine.com
Investors:
PJ
Kelleher
Phone:
(617) 430-7579
pkelleher@lifesciadvisors.com
