Full Press Release Details
Announces Financial Results for the Third Quarter Ended September 30, 2022
LAKE CITY, November 9, 2022 /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, 2022 and provided a corporate update.
the third quarter we announced a new strategic direction for Lipocine, which involves applying our validated technology to develop differentiated
treatments for CNS disorders. Our initial focus is on endogenous neuroactive steroids which have broad applicability in treating various
CNS conditions," said Dr. Mahesh Patel, President and CEO of Lipocine Inc. "Our most advanced neuroactive steroid ("NAS")
candidate is LPCN 1154, which we are developing for the treatment of postpartum depression. We recently initiated a pilot PK bridge study
(a prelude to a pivotal study required for NDA filing) and look forward to reporting results of the pilot study in the first half of
realignment and focus on CNS
quarter Ended September 30, 2022 Financial Results
reported a net loss of $2.4 million, or ($0.03) per diluted share for the quarter ended September 30, 2022, compared with a net loss
of $3.1 million, or ($0.04) per diluted share, in the quarter ended September 30, 2021.
were no revenues in the quarter ended September 30, 2022. There was $55,000 in license revenue recorded in the quarter ended September
30, 2021 related to payments received from Spriaso under a licensing agreement which did not recur in 2022.
and development expenses were $2.1 million for the quarter ended September 30, 2022, compared with $2.4 million for the quarter ended
September 30, 2021. The decrease in research and development expenses was primarily due to a decrease in expenses related to the LPCN
1154 clinical studies, a decrease in expenses and consulting costs related to the completion of the LPCN 1144 LiFT Phase 2 clinical study
in NASH subjects, and a decrease in costs associated with TLANDO. These decreases were offset by an increase in costs related to the
Phase 2 POC study in male cirrhotic subjects with LPCN 1148, an increase in LPCN 1111 manufacturing scale up, an increase in LPCN1107
clinical studies, and an increase in other research and development costs and personnel expenses.
and administrative expenses were $0.8 million for the quarter ended September 30, 2022, compared with $1.2 million for the quarter ended
September 30, 2021. The decrease in general and administrative expenses was primarily due to decreases in legal expenses, personnel costs,
corporate insurance expense and other G&A expenses. The decreases were offset by an increase in directors' fees resulting from
the addition of two new directors, increases in professional and consulting fees and increases in travel related expense.
of September 30, 2022, the company had $34.3 million of unrestricted cash, cash equivalents and marketable investment securities, compared
to $46.6 million at December 31, 2021.
Months Ended September 30, 2022 Financial Results
reported a net loss of $8.5 million, or ($0.10) per diluted share, for the nine months ended September 30, 2022, compared with a net
loss of $13.3 million, or ($0.16) per diluted share, in the nine months ended September 30, 2021.
in the nine months ended September 30, 2022 were $0.5 million, compared with revenues of $55,000 in the comparable period in 2021. The
increase in revenue was primarily related to a non-refundable cash fee received from Antares for consideration of a 90 day extension
to exercise its option to license LPCN 1111.
and development expenses for the nine months ended September 30, 2022, were $6.9 million compared to $5.4 million for the comparable
period in 2021. The increase in research and development expenses was due to an increase in expenses related to the Phase 2 POC study
in male cirrhotic subjects with LPCN 1148, an increase in costs related to LPCN 1154 clinical studies, an increase in expenses related
to LPCN 1111 scale up activities and a food effect study in LPCN 1107, an increase in personnel expense and other research and development
costs. These increases were offset by a decrease in expenses related to the completion of the LPCN 1144 LiFT Phase 2 clinical study in
NASH subjects, and a decrease in costs associated with TLANDO.
and administrative expenses for the nine months ended September 30, 2022 were $3.2 million compared to $4.3 million for the comparable
period in 2021. The decrease in general and administrative expenses was primarily due to a decrease in legal fees, a decrease in personnel
costs and a decrease in other general and administrative expenses. These decreases were offset by an increase in professional fees related
to the recruitment of additional directors to our Board and various other consulting services, an increase related to proxy solicitation
and distribution services, an increase in corporate insurance expenses and travel related expenses, as well as an increase in royalty
expense related to the net sales of TLANDO resulting from its commercial launch in June 2022.
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 and candidates for which we are exploring partnering which
target large addressable markets with significant unmet medical needs. Our candidates represent enablement of patient friendly oral delivery
options for favorable benefit to risk profile.
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 LPCN 1144, our candidate for treatment of non-cirrhotic NASH, LPCN
1148, LPCN 1107, our candidate for prevention of pre-term birth, 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, the application of our Lip'ral
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.
further information:
INC. AND SUBSIDIARIES
Consolidated Balance Sheets
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 2,396,960 | $ | 2,950,552 | ||||
| Marketable investment securities | 31,858,842 | 41,667,405 | ||||||
| Accrued interest income | 40,774 | 247,253 | ||||||
| Contract asset - current portion | 579,428 | - | ||||||
| Prepaid and other current assets | 1,234,536 | 1,514,465 | ||||||
| Total current assets | 36,110,540 | 46,379,675 | ||||||
| Marketable investment securities | - | 2,021,800 | ||||||
| Contract asset - non-current portion | 3,252,500 | 4,050,000 | ||||||
| Property and equipment, net of accumulated depreciation of $1,150,952 and $1,144,077 | 37,435 | 7,211 | ||||||
| Other assets | 23,753 | 23,753 | ||||||
| Total assets | $ | 39,424,228 | $ | 52,482,439 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 630,456 | $ | 1,289,342 | ||||
| Accrued expenses | 880,850 | 1,016,458 | ||||||
| Debt - current portion | - | 2,310,825 | ||||||
| Litigation settlement liability - current portion | - | 1,000,000 | ||||||
| Total current liabilities | 1,511,306 | 5,616,625 | ||||||
| Warrant liability | 264,099 | 795,796 | ||||||
| Litigation settlement liability - non-current portion | - | 500,000 | ||||||
| Total liabilities | 1,775,405 | 6,912,421 | ||||||
| Commitments and contingencies | ||||||||
| 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 shares authorized; 88,516,501 and 88,296,360 issued and 88,510,791 and 88,290,650 outstanding | 8,851 | 8,829 | ||||||
| Additional paid-in capital | 218,952,749 | 218,286,324 | ||||||
| Treasury stock at cost, 5,710 shares | (40,712 | ) | (40,712 | ) | ||||
| Accumulated other comprehensive loss | (76,935 | ) | (18,016 | ) | ||||
| Accumulated deficit | (181,195,130 | ) | (172,666,407 | ) | ||||
| Total stockholders' equity | 37,648,823 | 45,570,018 | ||||||
| Total liabilities and stockholders' equity | $ | 39,424,228 | $ | 52,482,439 |
INC. AND SUBSIDIARIES
Consolidated Statements of Operations and Comprehensive Loss
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenues: | $ | - | $ | 54,994 | $ | 500,000 | $ | 54,994 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,100,432 | 2,366,521 | 6,886,398 | 5,411,748 | ||||||||||||
| General and administrative | 798,939 | 1,222,146 | 3,172,144 | 4,281,690 | ||||||||||||
| Total operating expenses | 2,899,371 | 3,588,667 | 10,058,542 | 9,693,438 | ||||||||||||
| Operating loss | (2,899,371 | ) | (3,533,673 | ) | (9,558,542 | ) | (9,638,444 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and investment income | 163,966 | 17,264 | 275,420 | 45,257 | ||||||||||||
| Interest expense | - | (44,839 | ) | (27,098 | ) | (171,241 | ) | |||||||||
| Unrealized gain on warrant liability | 326,240 | 479,951 | 531,697 | 506,208 | ||||||||||||
| Gain (loss) litigation settlement liability | - | - | 250,000 | (4,000,000 | ) | |||||||||||
| Total other income (expense), net | 490,206 | 452,376 | 1,030,019 | (3,619,776 | ) | |||||||||||
| Loss before income tax expense | (2,409,165 | ) | (3,081,297 | ) | (8,528,523 | ) | (13,258,220 | ) | ||||||||
| Income tax expense | - | - | (200 | ) | (200 | ) | ||||||||||
| Net loss | $ | (2,409,165 | ) | $ | (3,081,297 | ) | $ | (8,528,723 | ) | $ | (13,258,420 | ) | ||||
| Basic loss per share attributable to common stock | $ | (0.03 | ) | $ | (0.03 | ) | $ | (0.10 | ) | $ | (0.15 | ) | ||||
| Weighted average common shares outstanding, basic | 88,506,479 | 88,290,650 | 88,439,198 | 86,477,640 | ||||||||||||
| Diluted loss per share attributable to common stock | $ | (0.03 | ) | $ | (0.04 | ) | $ | (0.10 | ) | $ | (0.16 | ) | ||||
| Weighted average common shares outstanding, diluted | 88,771,698 | 88,963,899 | 88,945,040 | 87,197,002 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (2,409,165 | ) | $ | (3,081,297 | ) | $ | (8,528,723 | ) | $ | (13,258,420 | ) | ||||
| Net unrealized gain (loss) on available-for-sale securities | 7,972 | (3,234 | ) | (58,919 | ) | (3,420 | ) | |||||||||
| Comprehensive loss | $ | (2,401,193 | ) | $ | (3,084,531 | ) | $ | (8,587,642 | ) | $ | (13,261,840 | ) |