SALT LAKE CITY, Nov. 6, 2025 /PRNewswire/ -- Lipocine Inc. $(LPCN)$, 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$(TM)$

   -- 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

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