Full Press Release Details
Announces Financial Results for the Second Quarter Ended June 30, 2024
LAKE CITY, August 08, 2024 - Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform
to augment therapeutics through effective oral delivery, today announced financial results for the second quarter ended June 30, 2024
and provided a corporate update.
1154 for Postpartum Depression (PPD)
2401 for Chronic Weight Management
1148 for Management of Cirrhosis
continue to pursue opportunities for partnering and/or development arrangements for the continued development and/or marketing of our
pipeline candidates.
quarter Ended June 30, 2024 Financial Results
reported a net loss of $3.1 million, or ($0.56) per diluted share, for the second quarter ended June 30, 2024, compared with a net loss
of $3.6 million, or ($0.68) per diluted share, for the quarter ended June 30, 2023.
were approximately $90,000, consisting of royalty revenue from the Verity license agreement in the second quarter of 2024. No revenue
was recorded during the second quarter of 2023.
and development expenses were $1.9 million and $2.5 million, respectively, for the quarters ended June 30, 2024 and 2023. The decrease
was a result of a decrease in contract research organization expense and outside consulting costs related to the wind down of our LPCN
1148 study in 2024, a decrease in TLANDO related costs, and a decrease in personnel related costs, offset by an increase in costs related
to the LPCN 1154 clinical studies, and an increase in other R&D related costs.
and administrative expenses were $1.5 million and $1.4 million, respectively for the quarters ended June 30, 2024 and 2023.
of June 30, 2024, Lipocine had $22.5 million of unrestricted cash, cash equivalents and marketable investment securities compared to
$22.0 million at December 31, 2023.
Months Ended, June 30 2024 Financial Results
reported a net profit of $0.5 million, or $0.10 per diluted share, for the six months ended June 30, 2024, compared with a net loss of
$7.4 million, or ($1.42) per diluted share, for the six months ended June 30, 2023.
for the six-month period ended June 30, 2024 were $7.7 million, primarily consisting of licensing revenue from the Verity License Agreement.
This compares with licensing revenue of $55,000 during the six months ended June 30, 2023.
and development expenses were $4.7 million and $5.6 million, respectively, for the six months ended June 30, 2024 and 2023. The decrease
was a result of a decrease in contract research organization expense and outside consulting costs related to the wind down of our LPCN
1148 study in 2024, decrease in personnel related costs, and a decrease in LPCN 1111 and LPCN 1144 clinical study costs. These decreases
were offset by an increase in costs related to our LPCN 1154 clinical studies, an increase in TLANDO related costs, and an increase in
other research and development related costs.
administrative expenses were $3.1 million and $2.7 million, respectively, for the six months ended June 30, 2024 and 2023.
more information on Lipocine's financial results, refer to Form 10Q filed by the Company with the SEC.
is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery
to develop differentiated products. 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.
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 -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. Lipocine is exploring partnering opportunities
for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 2401 for chronic
weight management, 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.
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, our ability to monetize product candidates, including through entering into partnering arrangements, 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, 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.
further information:
INC. AND SUBSIDIARIES
Consolidated Balance Sheets
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 5,553,371 | $ | 4,771,758 | ||||
| Marketable investment securities | 16,995,424 | 17,263,788 | ||||||
| Accrued interest income | 63,636 | 52,254 | ||||||
| Prepaid and other current assets | 297,051 | 773,424 | ||||||
| Total current assets | 22,909,482 | 22,861,224 | ||||||
| Property and equipment, net of accumulated depreciation of $1,199,215 and $1,182,191 respectively | 99,071 | 116,095 | ||||||
| Other assets | 23,753 | 23,753 | ||||||
| Total assets | $ | 23,032,306 | $ | 23,001,072 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 448,798 | $ | 1,395,977 | ||||
| Accrued expenses | 1,233,477 | 1,218,486 | ||||||
| Warrant liability | 141,668 | 17,166 | ||||||
| Total current liabilities | 1,823,943 | 2,631,629 | ||||||
| Total liabilities | 1,823,943 | 2,631,629 | ||||||
| Stockholders' equity: | ||||||||
| Common stock, par value $0.0001 per share, 200,000,000 shares authorized; 5,348,276 and 5,316,166 issued, and 5,347,940 and 5,315,830 outstanding, respectively outstanding | 8,863 | 8,860 | ||||||
| Additional paid-in capital | 220,582,158 | 220,171,250 | ||||||
| Treasury stock at cost, 336 shares | (40,712 | ) | (40,712 | ) | ||||
| Accumulated other comprehensive gain (loss) | (9,719 | ) | 7,259 | |||||
| Accumulated deficit | (199,332,227 | ) | (199,777,214 | ) | ||||
| Total stockholders' equity | 21,208,363 | 20,369,443 | ||||||
| Total liabilities and stockholders' equity | $ | 23,032,306 | $ | 23,001,072 |
INC. AND SUBSIDIARIES
Consolidated Statements of Operations and Comprehensive Loss
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenues: | ||||||||||||||||
| License revenue | $ | - | $ | - | $ | 7,500,000 | $ | 54,990 | ||||||||
| Royalty revenue | 89,565 | - | 206,738 | - | ||||||||||||
| Total revenues | 89,565 | - | 7,706,738 | 54,990 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,874,721 | 2,515,211 | 4,693,646 | 5,621,521 | ||||||||||||
| General and administrative | 1,507,412 | 1,440,394 | 3,083,131 | 2,727,708 | ||||||||||||
| Total operating expenses | 3,382,133 | 3,955,605 | 7,776,777 | 8,349,229 | ||||||||||||
| Operating loss | (3,292,568 | ) | (3,955,605 | ) | (70,039 | ) | (8,294,239 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and investment income | 308,845 | 379,521 | 640,209 | 749,991 | ||||||||||||
| Unrealized gain (loss) on warrant liability | (84,430 | ) | 27,455 | (124,502 | ) | 125,589 | ||||||||||
| Total other income, net | 224,415 | 406,976 | 515,707 | 875,580 | ||||||||||||
| Income (loss) before income tax expense | (3,068,153 | ) | (3,548,629 | ) | 445,668 | (7,418,659 | ) | |||||||||
| Income tax expense | (481 | ) | - | (681 | ) | (200 | ) | |||||||||
| Net income (loss) | (3,068,634 | ) | (3,548,629 | ) | 444,987 | (7,418,859 | ) | |||||||||
| Issuance of Series B preferred stock dividend | - | - | - | (89 | ) | |||||||||||
| Net loss attributable to common shareholders Net income (loss) attributable to common shareholders | $ | (3,068,634 | ) | $ | (3,548,629 | ) | $ | 444,987 | $ | (7,418,948 | ) | |||||
| Basic earnings (loss) per share attributable to common stock | $ | (0.57 | ) | $ | (0.68 | ) | $ | 0.08 | $ | (1.42 | ) | |||||
| Weighted average common shares outstanding, basic | 5,343,922 | 5,234,830 | 5,329,876 | 5,234,830 | ||||||||||||
| Diluted earnings (loss) per share attributable to common stock | $ | (0.56 | ) | $ | (0.68 | ) | $ | 0.10 | $ | (1.44 | ) | |||||
| Weighted average common shares outstanding, diluted | 5,343,922 | 5,234,830 | 5,459,204 | 5,234,830 | ||||||||||||
| Comprehensive income (loss): | ||||||||||||||||
| Net income (loss) | $ | (3,068,634 | ) | $ | (3,548,629 | ) | $ | 444,987 | $ | (7,418,859 | ) | |||||
| Net unrealized gain (loss) on marketable investment securities | 885 | (19,053 | ) | (16,978 | ) | 4,509 | ||||||||||
| Comprehensive income (loss) | $ | (3,067,749 | ) | $ | (3,567,682 | ) | $ | 428,009 | $ | (7,414,350 | ) |