Full Press Release Details
Announces Financial Results for the Year Ended December 31, 2022
LAKE CITY, March 10, 2023 - 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 year ended December 31, 2022 and provided a corporate update.
2022, Lipocine announced a new strategic direction, focusing on the development of endogenous neuroactive steroids which have broad applicability
in treating various CNS conditions. The Company is currently exploring partnering non-core assets including LPCN 1107, for prevention
of pre-term birth, LPCN 1148, for the management of decompensated cirrhosis, LPCN 1144, for treatment of non-cirrhotic NASH, LPCN 1111,
a once-a-day therapy candidate for TRT and LPCN 1021 (TLANDO in the U.S.) outside of the U.S.
| The Company completed an oral PK study and a food effect study with LPCN 1154 demonstrating the first enablement of effective oral delivery of brexanalone, a bioidentical neuroactive steroid. | ||
| A pilot PK bridge study of LPCN 1154, an oral neuroactive steroid ("NAS") product candidate, in postpartum depression ("PPD") has been initiated. Results are expected in the first half of the year. The FDA has agreed with Lipocine's proposal for establishing the efficacy of LPCN 1154 via the 505(b)(2) pathway. The proof-of-concept study is a prelude to a pivotal study required for NDA filing. |
1148 in liver cirrhosis
Ended December 31, 2022 Financial Results
reported a net loss of $10.8 million, or ($0.13) per diluted share, for the year ended December 31, 2022, compared with a net loss of
$634,399, or ($0.01) per diluted share, for the year ended December 31, 2021.
recognized license revenue of $500,000 during the year ended December 31, 2022, compared to $16.1 million during the year ended December
31, 2021. License revenue in 2022 was related to a non-refundable cash fee of $500,000 received from Antares for consideration of a 90-day
extension to exercise its option to license LPCN 1111. License revenue in 2021 primarily related to the Antares Licensing Agreement for
TLANDO which was signed in October 2021 and was comprised of licensing fees, minimum royalties and the sale of finished goods inventory.
and development expenses were $8.6 million and $7.7 million, respectively, for the years ended December 31, 2022, and 2021. The increase
in research and development expenses during the year ended December 31, 2022 was primarily due to an increase in contract research organization
expense related to the Phase 2 POC study in male cirrhotic subjects with LPCN 1148, an increase in manufacturing scale up costs, an increase
in personnel expense primarily resulting from additional headcount, and an increase in other R&D expenses. These increases were offset
by decreases in costs related to LPCN 1144, LPCN 1107, and LPCN 1154.
and administrative expenses were $4.1 million and $5.3 million, respectively, for the years ended December 31, 2022, and 2021. The decrease
in general and administrative expenses during the year ended December 31, 2022 was primarily due to a decrease in legal fees, a decrease
in personnel related costs and a decrease in other general and administrative expenses. These decreases were offset by an increase in
costs related to the recruitment and compensation for two additional directors, an increase in other various professional fees, an increase
in strategic advisory services, an increase related to proxy solicitation services, and an increase in travel related costs.
of December 31, 2022, Lipocine had $32.5 million of unrestricted cash, cash equivalents and marketable investment securities compared
to $46.6 million at December 31, 2021.
is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery
to develop products for CNS disorders. Lipocine has candidates in development as well as candidates for which we are exploring partnering.
Our candidates represent enablement of patient friendly oral delivery options for favorable benefit to risk profile which target large
addressable markets with significant unmet medical needs.
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, an oral prodrug of bioidentical testosterone targeted for the management of symptoms
associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of pre-term
birth, 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.
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.
INC. AND SUBSIDIARIES
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 3,148,496 | $ | 2,950,552 | ||||
| Marketable investment securities | 29,381,410 | 41,667,405 | ||||||
| Accrued interest income | 80,427 | 247,253 | ||||||
| Contract asset - current | 579,428 | - | ||||||
| Prepaid and other current assets | 945,319 | 1,514,465 | ||||||
| Total current assets | 34,135,080 | 46,379,675 | ||||||
| Marketable investment securities | - | 2,021,800 | ||||||
| Contract asset - non-current | 3,252,500 | 4,050,000 | ||||||
| Property and equipment, net of accumulated depreciation of $1,153,530 and $1,144,077, respectively | 131,589 | 7,211 | ||||||
| Other assets | 23,753 | 23,753 | ||||||
| Total assets | $ | 37,542,922 | $ | 52,482,439 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 600,388 | $ | 1,289,342 | ||||
| Accrued expenses | 1,077,738 | 1,016,458 | ||||||
| Debt - current portion | - | 2,310,825 | ||||||
| Litigation settlement liability - current portion | - | 1,000,000 | ||||||
| Total current liabilities | 1,678,126 | 5,616,625 | ||||||
| Warrant liability | 229,856 | 795,796 | ||||||
| Litigation settlement liability - non-current portion | - | 500,000 | ||||||
| Total liabilities | 1,907,982 | 6,912,421 | ||||||
| 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, 200,000,000 and 100,000,000 shares authorized; 88,516,501 and 88,296,360 issued and 88,510,791 and 88,290,650 outstanding | 8,852 | 8,830 | ||||||
| Additional paid-in capital | 219,112,164 | 218,286,323 | ||||||
| Treasury stock at cost, 5,710 shares | (40,712 | ) | (40,712 | ) | ||||
| Accumulated other comprehensive loss | (20,321 | ) | (18,016 | ) | ||||
| Accumulated deficit | (183,425,043 | ) | (172,666,407 | ) | ||||
| Total stockholders' equity | 35,634,940 | 45,570,018 | ||||||
| Total liabilities and stockholders' equity | $ | 37,542,922 | $ | 52,482,439 |
INC. AND SUBSIDIARIES
Statements of Operations and Comprehensive Loss
Ended December 31, 2022 and 2021
| 2022 | 2021 | |||||||
| Revenues | $ | 500,000 | $ | 16,140,838 | ||||
| Operating expenses: | ||||||||
| Research and development | 8,556,888 | 7,665,559 | ||||||
| General and administrative | 4,062,487 | 5,329,776 | ||||||
| Total operating expenses | 12,619,375 | 12,995,335 | ||||||
| Operating income (loss) | (12,119,375 | ) | 3,145,503 | |||||
| Other income (expense) | ||||||||
| Interest and investment income | 572,578 | 67,700 | ||||||
| Interest expense | (27,098 | ) | (203,292 | ) | ||||
| Unrealized gain on warrant liability | 565,940 | 355,890 | ||||||
| Gain (loss) on litigation settlement liability | 250,000 | (4,000,000 | ) | |||||
| Total other income (expense), net | 1,361,420 | (3,779,702 | ) | |||||
| Loss before income tax expense | (10,757,955 | ) | (634,199 | ) | ||||
| Income tax expense | (681 | ) | (200 | ) | ||||
| Net loss | $ | (10,758,636 | ) | $ | (634,399 | ) | ||
| Basic loss per share attributable to common stock | $ | (0.12 | ) | $ | (0.01 | ) | ||
| Weighted average common shares outstanding, basic | 88,457,243 | 86,934,618 | ||||||
| Diluted loss per share attributable to common stock | $ | (0.13 | ) | $ | (0.01 | ) | ||
| Weighted average common shares outstanding, diluted | 88,875,946 | 87,623,452 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | (10,758,636 | ) | $ | (634,399 | ) | ||
| Unrealized net loss on available-for-sale securities | (2,305 | ) | (18,016 | ) | ||||
| Comprehensive loss | $ | (10,760,941 | ) | $ | (652,415 | ) |
further information: