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Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2025

1. LPCN 1154 Phase 3 trial for PPD continues, data due Q2 2026. 2. LPCN 2101 planned Phase 2 trial, posters at AES meeting in December. 3. LPCN 2401 for obesity may enter Phase 2; seeking partnerships. 4. Royalty revenue from TLANDO increased. Net loss widened in Q3 2025. 5. Cash reserves decreased significantly by over 30% since December 2024.

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Why Bullish?

The promising developments in clinical trials suggest potential for future revenue growth, particularly with LPCN 1154, which targets a significant unmet medical need in postpartum depression. Successful outcomes could lead to increased investor confidence and higher stock valuations, as seen historically with biotech firms during successful trial announcements.

How important is it?

The piece outlines critical developments in LPCN's pipeline and financial health, which are pivotal for investors. Insights into clinical trials and potential market introductions significantly enhance its significance for stakeholders.

Why Long Term?

The importance of LPCN 1154's Phase 3 data expected in 2026 may lead to longer-term stock price appreciation if results are favorable. Historical precedence shows that drugs reaching final phases often see considerable upticks in stock before and after NDA submissions.

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TLANDONDAQLPCN 2101LPCN 2401
, /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 1154 (oral brexanolone) is a non-invasive, rapid onset, oral formulation of the neuroactive steroid brexanolone that Lipocine is developing for the treatment of PPD. A Phase 3 safety and efficacy study evaluating LPCN 1154 as a treatment for PPD continues to enroll patients and top-line data is expected in the second quarter of 2026. A meeting of the independent Data Safety Monitoring Board (DSMB) overseeing this trial will take place to review safety data from the first one-third of participants who were randomized and completed the day seven follow up visit, and the Company plans to provide a safety update in November 2025 following the DSMB review. Lipocine believes data from the Phase 3 study will be beneficial for potential inclusion in product labeling and for eligibility for clinical investigation exclusivity for a 48-hour, oral treatment option. The Phase 3 trial is expected to support a global registration package for LPCN 1154 in PPD, including a 505(b)(2) New Drug Application (NDA) submission in the U.S. which is expected in 2026. On July 9, 2025, Lipocine hosted a virtual R&D investor event to discuss the current treatment landscape and unmet needs in PPD. The event featured presentations by Kristina M. Deligiannidis, MD (Zucker Hillside Hospital, Northwell Health, New York) and by company management. A replay of the webinar can be accessed here. Lipocine is exploring the possibility of partnering LPCN 1154 with a third party for commercialization. LPCN 2101 for Epilepsy Lipocine is evaluating LPCN 2101, a neuroactive steroid GABA positive allosteric modulator for epilepsy including drug resistant epilepsy (DRE) and women with epilepsy (WWE), both of which pose significant treatment challenges under current standard of care. The Company may initiate a Phase 2 proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 2101, subject to resource prioritization. Pre-clinical and Phase 1 studies have demonstrated promising PK results, safety and tolerability. Two abstracts related to LPCN 2101 have been accepted for poster presentation at the 2025 American Epilepsy Society (AES) annual meeting to be held December 5-9 in Atlanta, Georgia. Oral Toxicokinetics of a Bioidentical GABAA Receptor Modulating Neuroactive Steroid (NAS) Anti-seizure Medication (ASM) Candidate for Women with Epilepsy (WWE) Clinical Pharmacokinetics (PK) and Tolerability of a Novel Oral GABAA Receptor Positive Allosteric Modulating (PAM) Candidate for Epilepsy LPCN 2401 for Obesity Management LPCN 2401 is targeted to be a once daily oral formulation comprising a proprietary anabolic androgen receptor agonist. It is expected to have a favorable benefit to risk profile as a non-invasive option for use as an adjunct to GLP-1 receptor agonist chronic weight management therapies and/or as a monotherapy post cessation of GLP-1 receptor agonist chronic weight management therapies with demonstrated benefits to the liver. Pending further regulatory guidance, Lipocine may conduct a proof-of-concept Phase 2 study for LPCN 2401 in elderly obese and overweight GLP-1 eligible patients, with possible appropriate body composition and functional end points such as stair climb performance measure. Lipocine may explore the possibility of partnering LPCN 2401 with a third party. TLANDO™ Lipocine has an exclusive License Agreement with Verity Pharma, entered into in 2024, under which Verity Pharma has the rights to market TLANDO, its oral testosterone replacement therapy, in the United States and Canada.  Rights to TLANDO have also been licensed to companies in South Korea, the GCC countries, and Brazil. Third Quarter Ended  September 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 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 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 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. 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) SOURCE Lipocine Inc.

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