Full Press Release Details
Lipocine Announces Financial Results for the
Third Quarter Ended September 30, 2023
SALT LAKE CITY, November 8, 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 third quarter and nine months ended September 30,
2023, and provided a corporate update.
Clinical Program Highlights
Neuroactive Steroids
| Lipocine anticipates initiating the pivotal study program in Q1 2024 with the LPCN 1154 "to be marketed" formulation | ||
| Top line results from the study are expected by Q2 2024, with a goal of filing a New Drug Application (NDA) in 2024 | ||
| If approved, LPCN 1154, has the potential to be a differentiated preferred treatment option for PPD with rapid and high remission/response rates with short treatment duration |
LPCN 1148 in liver cirrhosis
| Study met 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 in the LPCN 1148 treatment arm relative to placebo (P < 0.05) | ||
| More patients on LPCN 1148 reported symptom improvement compared to placebo (P < 0.05) | ||
| LPCN 1148 was well-tolerated, with AE rates and severities similar to placebo | ||
| Lipocine plans to meet with the FDA to discuss the development path to NDA filing |
Quarter Ended September 30, 2023 Financial
Lipocine reported a net loss of $6.7 million,
or ($1.27) per diluted share, for the three months ended September 30, 2023, compared with a net loss of $2.4 million or ($0.52) per diluted
share, in the three months ended September 30, 2022.
During the three months ended September 30, 2023,
the Company recognized a non-cash minimum guaranteed royalties revenue reversal of variable consideration revenue of $3.1 million related
to the termination of the Antares License Agreement. The reversal of revenue is due to the fact that Lipoocine will not receive anticipated
royalties that were previously recorded for the Antares License Agreement due to the termination of the agreement.
Research and development expenses were $2.9 million
during the three months ended September 30, 2023, as compared with $2.1 million in the three months ended September 30, 2022. The increase
in research and development expenses was a result of an increase in costs related to the LPCN 1154 clinical studies, an increase in TLANDO
manufacturing related costs, and an increase in personnel related costs, offset by a decrease in LPCN 1111 scale up costs in 2022, a decrease
in contract research organization expense related to the LPCN 1148 Phase 2 POC study in male subjects with cirrhosis, a decrease in contract
research organization expense and outside consulting costs related to the completion of the LPCN 1144 LiFT study in 2022, and a decrease
in LPCN 1107 PK and food effect studies and other research and development costs in 2022.
General and administrative expenses were $1.0
million during the three months ended September 30, 2023, as compared to $0.8 million in the three months ended September 30, 2022. The
increase in expenses is mainly due to increases in business development expenses, and an increase in professional services and legal fees.
These increases were offset by a decrease in corporate insurance expense.
As of September 30, 2023, Lipocine had $23.8 million
of unrestricted cash, cash equivalents and marketable investment securities compared to $32.5 million at December 31, 2022.
Nine Months Ended September 30, 2023 Financial
Lipocine reported a net loss of $14.1 million,
or ($2.72) per diluted share, for the nine months ended September 30, 2023, compared with a net loss of $8.5 million or ($1.72) per diluted
share, in the nine months ended September 30, 2022.
The Company recognized a non-cash minimum guaranteed
royalties revenue reversal of variable consideration revenue of $3.1 million related to the termination of the Antares License Agreement
during the nine months ended September 30, 2023. The reversal of variable consideration revenue is offset by license revenue of approximately
$55,000 for payments received from Spriaso, a related party, under a licensing agreement for the cough and cold field during the nine
months ended September 30, 2023. The Company recognized revenue related to a non-refundable cash fee of $500,000 received from Antares
for consideration of a 90-day extension for Antares to exercise its option to license LPCN 1111 during the nine months ended September
Research and development expenses were $8.5 million
and $6.9 million, respectively, for the nine months ended September 30, 2023, and 2022. The increase was due to an increase in costs related
to the LPCN 1154 clinical studies, an increase in TLANDO manufacturing related costs, an increase in contract research organization expense
related to the LPCN 1148 Phase 2 POC study in male subjects with cirrhosis, and an increase in personnel salaries and benefits. These
increases were offset by a decrease related to LPCN 1111 scale up costs in 2022, a decrease in contract research organization expense
and outside consulting costs related to the completion of our LPCN 1144 LiFT study, a decrease related to the completion of our LPCN 1107
PK and food effect studies and a decrease in other research and development activities.
General and administrative expenses were $3.8
million and $3.2 million, respectively, for the nine months ended September 30, 2023, and 2022. The increase consisted of an increase
in business development expenses, an increase in professional and legal fees and an increase in other general and administrative expenses.
These increases were offset by decrease resulting from a decrease in corporate insurance expense and a decrease in various other consulting
For more information on Lipocine's financial
results for the three and nine months ended September 30, 2023, refer to Form 10Q filed with the SEC.
Lipocine is a biopharmaceutical
company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop 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.
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, 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, 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.
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 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.
For further information:
Phone: (801) 994-7383
Phone: (617) 430-7579
LIPOCINE INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
| September 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Asset | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 4,072,706 | $ | 3,148,496 | ||||
| Marketable investment securities | 19,775,290 | 29,381,410 | ||||||
| Accrued interest income | 41,061 | 80,427 | ||||||
| Contract asset - current portion | 130,505 | 579,428 | ||||||
| Prepaid and other current assets | 594,097 | 945,319 | ||||||
| Total current assets | 24,613,659 | 34,135,080 | ||||||
| Contract asset - non-current portion | - | 3,252,500 | ||||||
| Property and equipment, net of accumulated depreciation of $1,174,189 and $1,153,530 respectively | 114,931 | 131,589 | ||||||
| Other assets | 23,753 | 23,753 | ||||||
| Total assets | $ | 24,752,343 | $ | 37,542,922 | ||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,101,068 | $ | 600,388 | ||||
| Accrued expenses | 1,140,313 | 1,077,738 | ||||||
| Total current liabilities | 2,241,381 | 1,678,126 | ||||||
| Warrant liability | 29,440 | 229,856 | ||||||
| Total liabilities | 2,270,821 | 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 | 220,022,838 | 219,112,164 | ||||||
| Treasury stock at cost, 336 shares | (40,712 | ) | (40,712 | ) | ||||
| Accumulated other comprehensive loss | (14,503 | ) | (20,321 | ) | ||||
| Accumulated deficit | (197,494,961 | ) | (183,425,043 | ) | ||||
| Total stockholders' equity | 22,481,522 | 35,634,940 | ||||||
| Total liabilities and stockholders' equity | $ | 24,752,343 | $ | 37,542,922 |
LIPOCINE INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
and Comprehensive Loss
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenues: | ||||||||||||||||
| License revenue | $ | - | $ | - | $ | 54,990 | $ | 500,000 | ||||||||
| Minimum guaranteed royalties revenue (reversal of variable consideration) | (3,121,996 | ) | - | (3,121,996 | ) | - | ||||||||||
| Total revenues (reversal of variable consideration), net | (3,121,996 | ) | - | (3,067,006 | ) | 500,000 | ||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,878,798 | 2,100,432 | 8,500,319 | 6,886,398 | ||||||||||||
| General and administrative | 1,042,572 | 798,939 | 3,770,281 | 3,172,144 | ||||||||||||
| Total operating expenses | 3,921,370 | 2,899,371 | 12,270,600 | 10,058,542 | ||||||||||||
| Operating loss | (7,043,366 | ) | (2,899,371 | ) | (15,337,606 | ) | (9,558,542 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and investment income | 317,569 | 163,966 | 1,067,561 | 275,420 | ||||||||||||
| Interest expense | - | - | - | (27,098 | ) | |||||||||||
| Unrealized gain on warrant liability | 74,827 | 326,240 | 200,416 | 531,697 | ||||||||||||
| Gain on litigation settlement liability | - | - | - | 250,000 | ||||||||||||
| Total other income, net | 392,396 | 490,206 | 1,267,977 | 1,030,019 | ||||||||||||
| Loss before income tax expense | (6,650,970 | ) | (2,409,165 | ) | (14,069,629 | ) | (8,528,523 | ) | ||||||||
| Income tax expense | - | - | (200 | ) | (200 | ) | ||||||||||
| Net loss | (6,650,970 | ) | (2,409,165 | ) | (14,069,829 | ) | (8,528,723 | ) | ||||||||
| Issuance of Series B preferred stock dividend | - | - | (89 | ) | - | |||||||||||
| Net loss attributable to common shareholders | $ | (6,650,970 | ) | $ | (2,409,165 | ) | $ | (14,069,918 | ) | $ | (8,528,723 | ) | ||||
| Basic loss per share attributable to common stock | $ | (1.26 | ) | $ | (0.46 | ) | $ | (2.68 | ) | $ | (1.63 | ) | ||||
| Weighted average common shares outstanding, basic | 5,292,058 | 5,234,576 | 5,254,116 | 5,230,619 | ||||||||||||
| Diluted loss per share attributable to common stock | $ | (1.27 | ) | $ | (0.52 | ) | $ | (2.72 | ) | $ | (1.72 | ) | ||||
| Weighted average common shares outstanding, diluted | 5,292,058 | 5,250,179 | 5,254,116 | 5,260,530 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (6,650,970 | ) | $ | (2,409,165 | ) | $ | (14,069,829 | ) | $ | (8,528,723 | ) | ||||
| Net unrealized gain (loss) on available-for-sale securities | 1,309 | 7,972 | 5,818 | (58,919 | ) | |||||||||||
| Comprehensive loss | $ | (6,649,661 | ) | $ | (2,401,193 | ) | $ | (14,064,011 | ) | $ | (8,587,642 | ) |