LPCN

SALT LAKE CITY, Aug. 4, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company focused on the development of novel oral therapeutics, today announced financial results for the second quarter ended June 30, 2026 and provided a corporate update. Recent Developments and Corporate Update LPCN 1154 (BRLIZIO™) for Postpartum Depression (PPD) On April 2, 2026, Lipocine reported topline results from its Phase 3 placebo-controlled trial (N=90) evaluating oral LPCN 1154 (oral brexanolone) for the treatment of PPD. In the full analysis set, LPCN 1154 did not show a statistically significant reduction from baseline in HAM-D (Hamilton Depression Rating Scale) total score compared to placebo at hour 60, and the primary endpoint was not met. In a post hoc analysis, the Company identified anomalies at one high-enrolling site in the Phase 3 trial that raise substantive questions about the validity of that site's data. Excluding the outlier site, LPCN 1154 produced a rapid, sustained, and clinically meaningful improvement in depression symptoms. We believe that these results align with the established antidepressant profile of intravenous brexanolone and indicate a potential development path for LPCN 1154. We have requested a guidance meeting with the FDA and the meeting is scheduled for the third quarter of 2026. We have initiated a new placebo controlled clinical trial for PPD to complement the existing LPCN 1154 clinical database, and to further characterize the efficacy and safety of LPCN 1154. The LPCN 1154 Phase 3 data in PPD were featured in oral and poster presentations at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, on May 26, 2026, in Miami, FL. On June 12, 2026, Lipocine hosted a virtual key opinion leader (KOL) event for the investment community highlighting the unmet needs in PPD and the clinical profile of LPCN 1154. The event featured presentations by two leading physicians with deep expertise in PPD, Kristina M. Deligiannidis, MD, and Rakesh Jain, MD, MPH, as well as by company management. A replay of the event, with slides, can be accessed here. Lipocine continues to explore business partnerships around the development, approval and commercialization of Brlizio™ (LPCN 1154) for PPD. LPCN 2201 for Major Depressive Disorder In the aforementioned post hoc analysis of the Phase 3 PPD study, oral brexanolone also demonstrated that participants with a history of psychiatric conditions showed statistically significant and clinically meaningful reductions in HAM-D scores versus placebo, observed as early as hour 12 and sustained through day 30. We plan to submit a protocol for a Phase 2 study to the FDA, and we may initiate a study to evaluate LPCN 2201 for MDD. LPCN 2203 for Essential Tremor Literature reports of potential efficacy demonstrated with injectable brexanolone in treating essential tremor symptoms and with the observed low sedation, dizziness, and GI adverse events in oral brexanolone, we plan to submit a protocol for a Phase 2 study to the FDA and we may initiate a study to evaluate LPCN 2203 for essential tremor. 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, if approved. Lipocine has entered into additional license, supply and distribution agreements covering development and commercialization of TLANDO in other counties/ territories including Aché (Brazil), Pharmalink (GCC countries) and SPC (South Korea). On July 8, 2026, Pharmalink received product marketing authorization approval for TESTYRA® (TLANDO) in the UAE. Lipocine continues to explore partnering TLANDO in territories outside the U.S., Canada, South Korea, the GCC countries, and Brazil. Second Quarter Ended June 30, 2026 Financial Results As of June 30, 2026, Lipocine had $23.3 million of unrestricted cash, cash equivalents, and marketable investment securities, compared to $14.9 million at December 31, 2025. Lipocine reported a net loss of $2.6 million, or ($0.32) per diluted share, for the quarter ended June 30, 2026, compared to a net loss of $2.2 million, or ($0.41) per diluted share, for the quarter ended June 30, 2025. Royalty revenue from TLANDO sales were $190,000 during the three months ended June 30, 2026, compared to $123,000 during the three months ended June 30, 2025. In addition, license revenue of $500,000 was recognized in the three months ended June 30, 2025 and there was no license revenue in the comparable period of 2026. Research and development expenses were $2.0 million and $2.1 million, respectively, for the quarters ended June 30, 2026 and 2025. General and administrative expenses were $1.0 million and $0.9 million, respectively, for the quarters ended June 30, 2026 and 2025. Six Months Ended June 30, 2026 Financial Results Lipocine reported a net loss of $6.3 million, or ($0.84) per diluted share, for the six months ended June 30, 2026, compared to a net loss of $4.1 million, or ($0.76) per diluted share, for the six months ended June 30, 2025. Lipocine recognized revenue of $309,000 and $717,000 during the six months ended June 30, 2026 and 2025, respectively. Revenue during the six months ended June 30, 2026 consisted entirely of royalty revenue from TLANDO sales. There was $500,000 of license revenue and $217,000 in royalty revenue during the same period in 2025. Research and development expenses were $4.8 million and $3.2 million, respectively, for the six-month periods ended June 30, 2026 and 2025. The increase was driven primarily by costs related to the LPCN 1154 Phase 3 study and an increase in personnel expense, partially offset by a decrease in various research and development costs. General and administrative expenses were $2.2 million and $2.0 million, respectively, for the six-month periods ended June 30, 2026 and 2025. The increase was primarily a result of an increase in consulting and professional fees and an increase in various general and administrative fees. Interest and investment income was $0.4 million for each of the six-month periods ended June 30, 2026 and 2025. For further detail on Lipocine's financial results for the three and six months ended June 30, 2026, refer to the Company's Form 10-Q filed with the SEC. About LipocineLipocine 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 development pipeline includes: LPCN 1154 for the treatment of postpartum depression, LPCN 2201 for treatment of major depressive disorder, LPCN 2101 for the treatment of epilepsy, LPCN 2203 targeted for the management of essential tremor, LPCN 2401 as an aid for improved body composition in obesity management, LPCN 1148 targeted for the management of symptoms associated with liver cirrhosis, and LPCN 1107 our candidate for prevention of preterm birth. 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 StatementsThis 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 development of our products and product candidates and related efforts with the FDA, including the timing of clinical trials and regulatory submissions, the potential uses and benefits of our products and product candidates, the commercial potential for our product candidates, and potential strategic partnerships and other opportunities. 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, safety and efficacy 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, 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. View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocine-announces-financial-results-for-the-second-quarter-ended-june-30-2026-302841817.html

SALT LAKE CITY, May 7, 2026 /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 first quarter ended March 31, 2026 and provided a corporate update. Neuroactive Steroids (NAS) LPCN 1154 for Postpartum Depression ("PPD") In April 2026, Lipocine announced topline results from its Phase 3 placebo-controlled trial (N=90) evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression. LPCN 1154 did not show a statistically significant reduction from baseline in HAM-D (Hamilton Depression Rating Scale) total score compared to placebo at hour 60 in the full analysis set and the primary endpoint was not met. The Phase 3 results showed LPCN 1154 to be well tolerated, demonstrating a differentiated safety profile supportive of outpatient, at-home use, with no treatment-related serious adverse events, no cases of excessive sedation or loss of consciousness, and no treatment-related discontinuations. In a post hoc analysis of participants with a history of psychiatric conditions (n=54), LPCN 1154 showed statistically significant and clinically meaningful reductions in HAM-D scores versus placebo, observed as early as hour 12 and sustained through day 30. Based on these findings, Lipocine has applied for breakthrough therapy and fast track designations for LPCN 1154 in PPD and is awaiting FDA feedback. The Company intends to complete its full analysis of the Phase 3 trial data and plans to present results at upcoming medical conferences. For more information on the Phase 3 trial, refer to clinicaltrials.gov: NCT06979544. The Company is evaluating all options regarding the potential path forward for LPCN 1154. Such options may include, but are not limited to, continued development of LPCN 1154, including the potential submission of a validation study protocol in patients with a history of psychiatric conditions, development of other product candidates, strategic transactions, partnerships, and other opportunities. TLANDOﾮ 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, if approved. Lipocine has entered into additional license, supply and distribution agreements covering development and commercialization of TLANDO in other counties/ territories including Ach￩ (Brazil), Pharmalink (GCC countries) and SPC (South Korea). Lipocine continues to explore partnering TLANDO in territories outside the U.S., Canada, South Korea, the GCC countries, and Brazil. First Quarter Ended March 31, 2026, Financial Results As of March 31, 2026, Lipocine had $24.7 million of unrestricted cash, cash equivalents and marketable investment securities compared to $14.9 million at December 31, 2025. Lipocine reported a net loss of $3.7 million, or ($0.52) per diluted share, for the quarter ended March 31, 2026, compared with a net loss of $1.9 million, or ($0.35) per diluted share, for the quarter ended March 31, 2025. The company recognized royalty revenue from TLANDO sales of $119,000 during the quarter ended March 31, 2026, compared to royalty revenue of $94,000 during the quarter ended March 31, 2025. Research and development expenses were $2.8 million and $1.1 million, respectively, for the quarters ended March 31, 2026 and 2025. The increase in research and development expenses was mainly the result of an increase in costs related to our LPCN 1154 clinical study in 2026. General and administrative expenses were $1.2 million and $1.1 million, respectively, for the quarters ended March 31, 2026 and 2025. The increase in general and administrative expenses was primarily a result of an increase in various professional and consulting fees. For further details on Lipocine's financial results for the quarter ended March 31, 2026, refer to Form 10-Q 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 development pipeline includes: LPCN 1154 for the treatment of postpartum depression, LPCN 2201 for treatment of major depressive disorder, LPCN 2101 for the treatment of epilepsy, LPCN 2203 targeted for the management of essential tremor, LPCN 2401 as an aid for improved body composition in obesity management, LPCN 1148 targeted for the management of symptoms associated with liver cirrhosis, and LPCN 1107 our candidate for prevention of preterm birth. 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 the potential uses and benefits of products and product candidates, the commercial potential for product candidates, the timing of regulatory reviews and approvals and related procedures, and potential strategic opportunities. 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, safety and efficacy 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, 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. View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocine-announces-financial-results-for-the-first-quarter-ended-march-31-2026-302766140.html

In the Phase 3 study population (N=90) of patients with PPD, LPCN 1154 did not show a statistically significant reduction from baseline in HAM-D17 total score compared to placebo at hour 60 (primary endpoint); the primary endpoint was not met In a post hoc analysis of participants (n=54) who had a history of psychiatric conditions, LPCN 1154 demonstrated nominal statistically significant and clinically meaningful reductions in HAM-D scores compared to placebo as early as hour 12 and sustained through day 30 In the overall population, LPCN 1154 was well tolerated and demonstrated a differentiated safety profile with no reported adverse event, including somnolence or dizziness, occurring in more than 5% of the LPCN 1154-treated participants The Company plans to evaluate all available options going forward SALT LAKE CITY, April 2, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced topline results from its Phase 3 placebo-controlled trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD). For more information on the trial design, refer to clinicaltrials.gov: NCT06979544. LPCN 1154 did not show a statistically significant reduction from baseline in HAM-D total score compared to placebo at hour 60 in the full analysis set and the primary was not met. The results showed LPCN 1154 to be well tolerated and demonstrated a favorable safety profile to support outpatient administration without the need for healthcare provider monitoring. No treatment-related severe or serious adverse events (SAEs) were reported; no cases of excessive sedation or loss of consciousness were observed; and no treatment-related discontinuations were reported. In a post hoc analysis of participants with a history of psychiatric conditions diagnosed using Mini-International Neuropsychiatric Interview (MINI, a structured diagnostic interview used to screen for and diagnose psychiatric disorders using DSM/ICD criteria), the Company identified signals that could indicate a potential development path for LPCN 1154. Table: Placebo-Adjusted HAM-D17 Score Change from Baseline NSS: Not Statistically Significant. Mixed model for repeated measures, least squares means placebo-adjusted difference. P-values are nominal except for Hour 60 Overall Population. Based on the results of the post hoc analysis of efficacy among participants with a history of psychiatric condition based on the MINI, the Company has applied for breakthrough therapy and fast track designations for LPCN 1154 in patients with PPD. While the Company is waiting for feedback from the FDA on such designations, the Company plans to preserve capital and engage with stakeholders, including investors, regulators, and advisors, to evaluate all options available to the Company going forward. Such options may include, but are not limited to, continued development of LPCN 1154, including the potential submission of a validation study protocol, development of other product candidates, strategic transactions, partnerships, and other opportunities. The Company intends to complete its full analysis of the trial data in the coming weeks and plans to present the results at upcoming conferences. The Company thanks patients, investigators, and site staff for their contributions. About LPCN 1154 LPCN 1154 is an oral formulation of brexanolone being developed to provide rapid relief of postpartum depression in a convenient, at-home treatment. It has potential as first line treatment choice for women with PPD. It also has characteristics that could be particularly beneficial to patients with severe PPD (including those with elevated suicide risk) for whom rapid improvement is a priority. LPCN 1154 is expected to offer a compelling safety profile for breastfeeding mothers. About Postpartum Depression and Unmet Needs PPD is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting up to 12 months after childbirth. Hormonal changes leading to GABA dysfunction are common in depression and pregnancy. Symptoms of PPD include hallmarks of major depression, including, but not limited to, sadness, depressed mood, loss of interest, change in appetite, insomnia, sleeping too much, fatigue, difficulty thinking/concentrating, excessive crying, fear of harming the baby/oneself, and/or thoughts of death or suicide. Results from a recent survey (Truist Securities Research, January 2024) show that obstetricians believe approximately 20-40% of their patients may suffer from PPD. Further, obstetricians are comfortable making a diagnosis and prescribing antidepressants for PPD. Traditional antidepressants, not approved for PPD, have slow onset of action, side effects such as weight gain, and do not demonstrate adequate remission. 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 development pipeline includes: LPCN 1154 for the treatment of postpartum depression, LPCN 2202 for treatment of treatment resistant depression, LPCN 2101 for the treatment of epilepsy, LPCN 2203 targeted for the management of essential tremor, LPCN 2401 as an aid for improved body composition in obesity management, LPCN 1148 targeted for the management of symptoms associated with liver cirrhosis, and LPCN 1107 our candidate for prevention of preterm birth. 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 development of LPCN 1154 and related efforts with the FDA, the potential uses and benefits of LPCN 1154 on the treatment of PPD, the commercial potential for LPCN 1154, and potential strategic opportunities. 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, safety and efficacy 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, 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. View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocine-reports-topline-safety-and-efficacy-results-for-lpcn-1154-in-patients-with-postpartum-depression-302732160.html

SALT LAKE CITY, March 10, 2026 /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 full year ended December 31, 2025 and provided a corporate update. "We believe 2025 was a pivotal year for Lipocine as we continue to advance our pipeline and expand our market presence. The progress we've made, especially with our postpartum depression therapeutic, LPCN 1154, demonstrates the strength of our science and our team's commitment to delivering more effective treatments for patients in need," said Dr Mahesh Patel, Lipocine President and CEO. "We're excited about the near-term milestones ahead and remain committed to advancing our pipeline proficiently." Neuroactive Steroids (NAS) LPCN 1154 for Postpartum Depression (PPD) Lipocine is developing LPCN 1154, a rapid onset, short treatment duration oral product candidate comprising the neuroactive steroid brexanolone for the treatment of postpartum depression. The last patient completed the final study visit (Last Patient/Last Visit) in a confirmatory Phase 3 safety and efficacy study evaluating LPCN 1154 as a treatment for PPD in February 2026. The study enrolled 90 patients in total and top line results are expected early in April 2026. If successful, 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 mid-2026. LPCN 2201 for Major Depressive Disorders (MDD) Lipocine is advancing LPCN 2201, a unique oral brexanolone formulation, as a novel, rapid relief oral treatment option for MDD with the goal of improving outcomes without the limitations of existing therapies. LPCN 2201 is chemically identical to the endogenous human hormone allopregnanolone, a positive allosteric modulator of y-aminobutyric acid (GABAA) receptor. LPCN 2101 for Epilepsy Lipocine is developing 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. Two posters related to LPCN 2101 were presented at the 2025 American Epilepsy Society (AES) Annual Meeting that took place in December 2025 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 Based on FDA review of the protocol and agreement to proceed, the Company plans to 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. 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 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 endpoints 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, if approved. Also in 2024, Lipocine entered into a distribution and license agreement with SPC Korea Limited for the development and commercialization of TLANDO for TRT in South Korea and Lipocine signed an exclusive supply and distribution agreement with Pharmalink to commercialize TLANDO in the Gulf Cooperation Council (GCC) countries. In 2025, Lipocine entered into a license and supply agreement with Aché in Brazil. The Company is exploring further partnerships for TLANDO outside of North America, South Korea, the GCC countries and Brazil. Full year Ended December 31, 2025, Financial Results As of December 31, 2025, Lipocine had $14.9 million of unrestricted cash, cash equivalents and marketable investment securities compared to $21.6 million as of December 31, 2024. Lipocine reported a net loss of $9.6 million, or ($1.69) per diluted share, for the year ended December 31, 2025, compared with net income of $8,352, or ($0.00) per diluted share, for the year ended December 31, 2024. Revenues were $2.0 million during the year ended December 31, 2025, compared to revenue of $11.2 million during the year ended December 31, 2024. Revenue in 2025 primarily consisted of license revenue from the Company's licenses with Verity and Aché of $1.5 million, and royalty revenue from TLANDO sales of $480,000. Revenue in 2024 primarily consisted of $10.9 million in license revenue from licenses with Verity, SPC and Pharmalink and royalty revenue from TLANDO sales of $298,000. Research and development expenses were $8.6 million and $7.4 million, respectively, for the years ended December 31, 2025 and 2024. The increase in research and development expenses during the year ended December 31, 2025 primarily related to an increase in clinical study costs, in addition to other increases in supplies and research costs and in personnel-related costs. General and administrative expenses were $3.8 million and $5.0 million, respectively, for the years ended December 31, 2025 and 2024. The decrease in general and administrative expenses during the year ended December 31, 2025 was primarily due to a decrease in business development, strategic advisory services and corporate legal fees, a decrease in estimated franchise taxes, a decrease in other various professional fees, and a decrease in corporate insurance expense, offset by an increase in personnel related expenses, an increase in patent related fees and an increase in other general and administrative expenses. Interest and investment income was $0.7 million and $1.2 million for the years ended December 31, 2025 and 2024, respectively. The decrease in interest and investment income during the year ended December 31, 2025 was mainly due to declining cash and marketable investment securities balances in 2025 compared to 2024. As of March 6, 2026, the Company had unrestricted cash, cash equivalents and marketable investment securities of approximately $24.7 million. The higher balance compared with the balance at December 31, 2025 was primarily a result of the sale of shares of common stock by means of an "At the Market ("ATM") Offering" under a sales agreement with A.G.P./Alliance Global Partners ("A.G.P") entered into in April 2024. For further details on Lipocine's financial results from the year ended December 31, 2025, refer to Form 10K 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 development pipeline includes: LPCN 1154 for the treatment of postpartum depression, LPCN 2201 for treatment of major depressive disorder, LPCN 2101 for the treatment of epilepsy, LPCN 2203 targeted for the management of essential tremor, LPCN 2401 as an aid for improved body composition in obesity management, LPCN 1148 targeted for the management of symptoms associated with liver cirrhosis, and LPCN 1107 our candidate for prevention of preterm birth. 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, our Phase 3 safety and efficacy study relating to LPCN 1154, including the timing and potential results of the study, the timing of any submission of a NDA for LPCN 1154, 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, safety and efficacy 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, 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. View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocine-announces-financial-results-for-the-full-year-ended-december-31-2025-302709002.html

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 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. View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocine-announces-financial-results-for-the-third-quarter-ended-september-30-2025-302606486.html

SALT LAKE CITY, Aug. 5, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced financial results for the second quarter ended June 30, 2025 and provided a corporate update. Neuroactive Steroids LPCN 1154 (oral brexanolone product candidate) is a non-invasive, 48-hour treatment option targeted for rapid symptom relief of postpartum depression (PPD), a serious unmet medical need. LPCN 1154 could have advantages with respect to limitations on daily activities, treatment duration, and time to effect. During the second quarter, Lipocine began treating patients with PPD in the pivotal Phase 3 safety and efficacy study of LPCN 1154. This outpatient trial is expected to support a global registration package for LPCN 1154 in PPD, with topline results expected in the second quarter of 2026 and a 505(b)(2) New Drug Application (NDA) submission in the U.S. expected in mid-2026. On July 9, 2025, Lipocine hosted a virtual R&D investor event featuring a presentation by Kristina M. Deligiannidis, MD (Zucker Hillside Hospital, Northwell Health, New York) discussing the current treatment landscape and unmet needs in PPD, followed by a company management presentation which reviewed the target attributes of LPCN 1154, provided a clinical development progress update including relevant data and rationale for success, and discussed next steps in the product development. A replay of the webinar can be accessed here. Lipocine may explore the possibility of partnering LPCN 1154 with a third party for commercialization. LPCN 2401 for Management of GLP-1 Agonist Use in Obesity LPCN 2401 is targeted to be a once daily oral formulation comprising a proprietary anabolic androgen receptor agonist, a regulator of myostatin. It is expected to have a favorable benefit to risk profile as a non-invasive option as an adjunct to GLP-1 receptor agonist use for quality weight loss though improved body composition and/or as a monotherapy for weight maintenance and/or newly achieved glycemic status post cessation of GLP-1 receptor agonist use with demonstrated liver benefits. Lipocine plans to initiate a proof-of-concept Phase 2 study for LPCN 2401 in obese and overweight GLP-1 eligible patients, with appropriate body composition and functional endpoints such as measured by stair climb performance with first patient dosing targeted for the third quarter of 2025. 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, if approved. In addition to the Verity License Agreement, Lipocine has entered into license/distribution agreements with SPC Korea for South Korea and Pharmalink for the GCC countries. In June 2025, Verity Pharma filed a New Drug Submission (NDS) for TLANDO® in Canada. In April 2025, Lipocine entered a license and supply agreement with Aché Laboratórios Farmacêuitcos S.A., granting an exclusive license to commercialize TLANDO in Brazil. Under the agreement, Lipocine is entitled to receive fees upon the achievement of certain regulatory milestones, royalties on net sales and will supply TLANDO to Aché at an agreed transfer price. TLANDO is expected to be the first oral testosterone product to be registered in Brazil. Second Quarter Ended June 30, 2025, Financial Results As of June 30, 2025, Lipocine had $17.9 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 $2.2 million, or ($0.41) per diluted share, for the quarter ended June 30, 2025, compared with net loss of $3.1 million, or ($0.57) per diluted share, for the quarter ended June 30, 2024. The company recognized royalty revenue from TLANDO sales of $123,000 during the three months ended June 30, 2025, compared to royalty revenue of $90,000 during the three months ended June 30, 2024. In addition, License revenue of $500,000 was recognized in the three months ended June 30, 2025. There was no license revenue in the comparable period of 2024. Research and development expenses were $2.1 million and $1.9 million, respectively, for the quarters ended June 30, 2025 and 2024. The increase in research and development expenses was due to an increase in costs related to the initiation of our LPCN 2401 clinical studies, and an increase in other research and development costs. General and administrative expenses were $0.9 million and $1.5 million, respectively, for the quarters ended June 30, 2025 and 2024. The decrease in general and administrative expenses during was primarily a result of a decrease in business development fees and consulting expenses compared to what was incurred in 2024, a decrease in legal fees, a decrease in Delaware franchise tax as a result of the reduction in authorized common stock from 200,000,000 down to 75,000,000 shares, a decrease in other professional fees and general and administrative related costs, and a decrease in corporate insurance premiums. Six Months Ended June 30, 2025, Financial Results Lipocine reported a net loss of $4.1 million, or ($0.76) per diluted share, for the six months ended June 30, 2025, compared with net income of $0.4 million, or ($0.10) per diluted share, for the six months ended June 30, 2024. Lipocine recognized revenue of $717,000 and $7.7 million during the six months ended June 30, 2025 and 2024, respectively. Revenue during the six months ended June 30, 2025, consisted 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 six months ended June 30, 2025, and 2024, the company recognized royalty revenue from TLANDO sales of $217,000 and $207,000, respectively. Research and development expenses were $3.2 million and $4.7 million, respectively, for the six month periods ended June 30, 2025 and 2024. The decrease was a result of lower costs related to the initiation of the LPCN 1154 Phase 3 clinical study in 2025 as compared to LPCN 1154 studies which occurred in 2024 in addition to a decrease in other research and development related costs and supplies in 2025, offset by an increase in costs related to the initiation of our LPCN 2401 clinical studies and an increase in personnel related costs. General and administrative expenses were $2.0 million and $3.1 million, respectively, for the six month periods ended June 30, 2025 and 2024. The decrease was a result of the one-time business development fees incurred in 2024 in conjunction with the Verity Pharmaceutical license agreement, as well as decreases in other business development expenses, legal fees, corporate insurance premiums, professional fees and other general and administrative costs. Interest and investment income was $0.4 million and $0.6 million, respectively, for the six months ended June 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 six months ended June 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 PPD, LPCN 2101 for the potential treatment of refractory 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 PPD, 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, 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, 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 non-core assets, safety and efficacy 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, 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. View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocine-announces-financial-results-for-the-second-quarter-ended-june-30-2025-302521416.html SOURCE Lipocine Inc.

SALT LAKE CITY, May 8, 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 first quarter ended March 31, 2025 and provided a corporate update. Neuroactive Steroids Lipocine has initiated an outpatient Phase 3 safety and efficacy study of LPCN 1154, a non-invasive, rapid onset, oral formulation of brexanolone for the treatment of postpartum depression (PPD). Dosing of the first patient is anticipated in the second quarter of 2025. The Phase 3 study is expected to support a 505(b)(2) New Drug Application (NDA) submission in 2026. Lipocine is exploring the possibility of partnering LPCN 1154 with a third party. 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 therapies and/or as a monotherapy post cessation of GLP-1 receptor agonist therapies with demonstrated benefits to the liver. Based on a pre-IND meeting and 2025 FDA draft guidance on Obesity and Overweight, the FDA recommends identifying the appropriate patient population for treatment, and also recommends that an approvable endpoint would be one that measures how a patient feels, functions, or survives. Therefore, in an upcoming proof-of-concept study of LPCN 2401 as an adjunct to GLP-1 agonist, Lipocine plans to target the elderly patient population, reportedly the population most vulnerable to lean mass and functionality loss while on GLP-1 agonist treatment, with plans to include functionality measures. Lipocine is exploring the possibility of partnering LPCN 2401 with a third party. TLANDO® Lipocine has an exclusive License Agreement with Verity Pharma (Verity), entered into in 2024, under which Verity has the rights to market TLANDO, its oral testosterone replacement therapy, in the United States and Canada, if approved. In April 2025, Lipocine entered into a license and supply agreement with Aché granting exclusive rights to market TLANDO® in Brazil. Aché is a Brazilian pharmaceutical company founded nearly 60 years ago with a mission to improve people's lives. Today, Aché's products reach more than 20 countries across Latin America, Africa, Asia, and Europe, in addition to its home base in Brazil. Lipocine continues to explore partnering TLANDO in territories outside the U.S., Canada, South Korea, the GCC countries and Brazil. First Quarter Ended March 31, 2025, Financial Results As of March 31, 2025, Lipocine had $19.7 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 $1.9 million, or ($0.35) per diluted share, for the quarter ended March 31, 2025, compared with net income of $3.5 million, or $0.66 per diluted share, for the quarter ended March 31, 2024. The company recognized royalty revenue from TLANDO sales of $94,000 during the quarter ended March 31, 2025, compared to royalty revenue of $117,000 during the quarter ended March 31, 2024. No license revenue was recognized during the quarter ended March 31, 2025, compared to $7.5 million in the quarter ended March 31, 2024. The license revenue in 2024 resulted from our license with Verity. Research and development expenses were $1.1 million and $2.8 million, respectively, for the quarters ended March 31, 2025 and 2024. The decrease in research and development expenses was primarily a result of a decrease in costs related to our LPCN 1154 clinical studies in 2025 as compared to 2024, a decrease related to the wind down of our LPCN 1148 study in 2024, and a decrease in TLANDO related costs in 2025. These were offset by an increase in other research and development related costs and supplies in 2025. General and administrative expenses were $1.1 million and $1.6 million, respectively, for the quarters ended March 31, 2025 and 2024. The decrease in general and administrative expenses primarily consisted of a decrease related to the one-time business development fees incurred in 2024 in conjunction with the Verity Pharmaceutical license agreement. About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics. 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, our P3 safety and efficacy study relating to LPCN 1154, the timing and potential results of the safety and efficacy study relating to LPCN 1154, 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 non-core assets, safety and efficacy 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, 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. View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocine-announces-financial-results-for-the-first-quarter-ended-march-31-2025-302449462.html SOURCE Lipocine Inc.