Full Press Release Details
SALT LAKE CITY,Nov. 6, 2025/PRNewswire/ -- 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 third quarter ended September 30, 2025 and provided a corporate update.
Neuroactive Steroids (NAS)
LPCN 1154 for Postpartum Depression (PPD)
LPCN 2101 for Epilepsy
LPCN 2401 for Obesity Management
TLANDO™
Third Quarter EndedSeptember 30, 2025,Financial Results
As of September 30, 2025, Lipocine had $15.1 million of unrestricted cash, cash equivalents and marketable investment securities compared to $21.6 million at December 31, 2024.
Lipocine reported a net loss of $3.2 million, or ($0.59) per diluted share, for the quarter ended September 30, 2025, compared with net loss of $2.2 million, or ($0.44) per diluted share, for the quarter ended September 30, 2024.
Royalty revenue from TLANDO sales was $115,000 during the quarter ended September 30, 2025. No royalty revenue was recorded during the comparable period in 2024.
Research and development expenses were $2.7 million and $1.6 million, respectively, for the quarters ended September 30, 2025 and 2024. The increase in research and development expenses was due to an increase in costs primarily related to the ongoing LPCN 1154 Phase 3 clinical trial in addition to other clinical trials, offset by a decrease in other research and development costs.
General and administrative expenses were $0.8 million and $1.1 million, respectively, for the quarters ended September 30, 2025 and 2024. The decrease in general and administrative expenses was primarily a result of a decrease in business development fees incurred in 2024, a decrease in Delaware franchise tax, and a decrease in other general and administrative costs, offset by an increase in legal fees.
Interest and investment income was $0.2 million and $0.3 million, respectively for the quarters ended September 30, 2025 and 2024. The decrease was due to lower interest rates and lower cash and marketable investment securities balances in 2025 as compared to 2024.
Nine Months Ended September 30, 2025, Financial Results
Lipocine reported a net loss of $7.3 million, or ($1.35) per diluted share, for the nine months ended September 30, 2025, compared with net loss of $1.8 million, or ($0.33) per diluted share, for the nine months ended September 30, 2024.
Lipocine recognized revenue of $831,000 and $7.7 million during the nine months ended September 30, 2025 and 2024, respectively. Revenue during the nine months ended September 30, 2025, consists of license revenue of $500,000 compared to license revenue of $7.5 million resulting from the Verity Licensing Agreement during the same period in 2024. During the nine months ended September 30, 2025, and 2024, the company recognized royalty revenue from TLANDO sales of $331,000 and $207,000, respectively.
Research and development expenses were $5.9 million and $6.3 million, respectively, for the nine month periods ended September 30 2025 and 2024. The decrease was a result of lower costs related to the LPCN 1154 Phase 3 clinical study in 2025 as compared to LPCN 1154 studies which occurred in 2024, and a decrease in other research and development related costs and supplies in 2025, offset by an increase in costs related to the initiation of the LPCN 2401 clinical study.
General and administrative expenses were $2.8 million and $4.1 million, respectively, for the nine-month period ended September 30 2025 and 2024. The decrease was a result of a decrease in business development fees, a decrease related to fees incurred in 2024 in conjunction with the Verity Pharmaceutical license agreement, a decrease in other general and administrative costs, a decrease in legal fees and a decrease in estimated Delaware franchises taxes.
Interest and investment income was $0.6 million and $0.9 million, respectively, for the nine months ended September 30 2025, and 2024. The decrease was due to lower interest rates and lower cash and marketable investment securities balances in 2025 as compared to 2024.
For further details on Lipocine's financial results from the three and nine months ended September 30, 2025, refer to Form 10Q filed with the SEC.
About Lipocine
Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery. 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.
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 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral proprietary anabolic androgen receptor agonist, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in obesity 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 obesity management, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of metabolic dysfunction-associated steatohepatitis (MASH). 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 visitwww.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 candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1154, LPCN 2101, and LPCN 2401, our Phase 3 safety and efficacy study relating to LPCN 1154, the timing and potential results of the safety and efficacy study relating to LPCN 1154, the potential Phase 2 proof-of-concept studies for LPCN 2101 and LPCN 2401, potential partnering of our product candidates with third parties, 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 or we may decide to allocate our available capital to other product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our assets, clinical and other studies, including those relating to LPCN 1154, may not be successful or may not provide results that would support the submission of a NDA, the FDA may 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 and our other product candidates, 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 atwww.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 | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (Unaudited) | ||||||||
| September 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ 3,901,040 | $ 6,205,926 | ||||||
| Marketable investment securities | 11,230,031 | 15,427,385 | ||||||
| Accrued interest income | 115,272 | 120,447 | ||||||
| Prepaid and other current assets | 683,797 | 567,915 | ||||||
| Total current assets | 15,930,140 | 22,321,673 | ||||||
| Property and equipment, net of accumulated depreciation | ||||||||
| of$1,269,098 and $1,223,297 respectively | 119,274 | 165,075 | ||||||
| Other assets | 23,753 | 23,753 | ||||||
| Total assets | $ 16,073,167 | $ 22,510,501 | ||||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ 861,452 | $ 271,696 | ||||||
| Accrued expenses | 749,667 | 921,240 | ||||||
| Deferred revenue | 320,000 | 320,000 | ||||||
| Total current liabilities | 1,931,119 | 1,512,936 | ||||||
| Total liabilities | 1,931,119 | 1,512,936 | ||||||
| Stockholders' equity: | ||||||||
| Common stock, par value $0.0001 per share, 75,000,000 | ||||||||
| shares authorized; 5,420,592 and 5,348,276 issued and | ||||||||
| 5,420,256 and 5,347,940 outstanding, respectively | 8,870 | 8,863 | ||||||
| Additional paid-in capital | 221,195,546 | 220,789,138 | ||||||
| Treasury stock at cost, 336 shares | (40,712) | (40,712) | ||||||
| Accumulated other comprehensive income | 4,627 | 9,138 | ||||||
| Accumulated deficit | (207,026,283) | (199,768,862) | ||||||
| Total stockholders' equity | 14,142,048 | 20,997,565 | ||||||
| Total liabilities and stockholders' equity | $ 16,073,167 | $ 22,510,501 |
| LIPOCINE INC. AND SUBSIDIARIES | |||||||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) | |||||||||||||
| (Unaudited) | |||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||
| Revenues: | |||||||||||||
| License revenue | $ - | $ - | $ 500,000 | $ 7,500,000 | |||||||||
| Royalty revenue | 114,574 | - | 331,287 | 206,738 | |||||||||
| Total revenues | 114,574 | - | 831,287 | 7,706,738 | |||||||||
| Operating expenses: | |||||||||||||
| Research and development | 2,707,777 | 1,585,233 | 5,906,118 | 6,278,881 | |||||||||
| General and administrative | 767,837 | 1,045,240 | 2,780,747 | 4,128,371 | |||||||||
| Total operating expenses | 3,475,614 | 2,630,473 | 8,686,865 | 10,407,252 | |||||||||
| Operating loss | (3,361,040) | (2,630,473) | (7,855,578) | (2,700,514) | |||||||||
| Other income: | |||||||||||||
| Interest and investment income | 174,208 | 273,574 | 598,357 | 913,784 | |||||||||
| Unrealized gain on warrant liability | - | 138,081 | - | 13,580 | |||||||||
| Total other income | 174,208 | 411,655 | 598,357 | 927,364 | |||||||||
| Loss before income tax expense | (3,186,832) | (2,218,818) | (7,257,221) | (1,773,150) | |||||||||
| Income tax expense | - | - | (200) | (681) | |||||||||
| Net loss attributable to common shareholders | $ (3,186,832) | $ (2,218,818) | $ (7,257,421) | $ (1,773,831) | |||||||||
| Basic loss per share attributable to common stock | $ (0.59) | $ (0.41) | $ (1.35) | $ (0.33) | |||||||||
| Weighted average common shares outstanding, basic | 5,413,149 | 5,347,940 | 5,371,458 | 5,335,941 | |||||||||
| Diluted loss per share attributable to common stock | $ (0.59) | $ (0.44) | $ (1.35) | $ (0.33) | |||||||||
| Weighted average common shares outstanding, diluted | 5,413,149 | 5,347,940 | 5,371,458 | 5,335,941 | |||||||||
| Comprehensive income (loss): | |||||||||||||
| Net loss | $ (3,186,832) | $ (2,218,818) | $ (7,257,421) | $ (1,773,831) | |||||||||
| Net unrealized income (loss) on marketable investment securities | 5,870 | 19,661 | (4,511) | 2,683 | |||||||||
| Comprehensive loss | $ (3,180,962) | $ (2,199,157) | $ (7,261,932) | $ (1,771,148) |