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Lipocine Reports Financial Results and Clinical Updates for Q3 2025

Lipocine Inc., a biopharmaceutical firm specializing in oral drug delivery, has unveiled its financial outcomes for the third quarter ending September 30, 2025. The company highlights fiscal performance alongside significant clinical trial advancements.

Key Developments and Clinical Trials

LPCN 1154 for Postpartum Depression

The cornerstone of Lipocine’s pipeline, LPCN 1154, aims to treat postpartum depression (PPD). This investigational oral formulation of brexanolone is currently under a Phase 3 safety and efficacy study. Patient enrollment is ongoing, with results anticipated in mid-2026. The company plans to provide safety updates following a meeting of the Data Safety Monitoring Board (DSMB) later this month, which will evaluate the safety data from the first third of trial participants.

Lipocine emphasizes the importance of the Phase 3 study data in shaping product labeling and seeking clinical investigation exclusivity for this treatment. Plans for a 505(b)(2) New Drug Application (NDA) submission in the United States are also underway, reflecting the company’s commitment to addressing the significant unmet need in PPD therapies.

LPCN 2101 for Epilepsy

Further reinforcing their research agenda, Lipocine is investigating LPCN 2101, a neuroactive steroid aimed at epilepsy treatment, focusing on drug-resistant cases and women with epilepsy. A possible Phase 2 proof-of-concept study may evaluate its safety and effectiveness pending resource allocation. Promising results from earlier studies indicate strong pharmacokinetics, safety, and tolerability, with upcoming presentations at the 2025 American Epilepsy Society meeting to highlight these findings.

LPCN 2401 for Obesity Management

LPCN 2401 represents Lipocine's approach to obesity management, targeting oral formulations with anabolic androgen receptor agonists. Plans for a Phase 2 proof-of-concept study are in the pipeline, contingent on regulatory guidance, and are aimed at helping elderly obese patients. Collaborations with external partners for commercialization are also being explored.

TLANDO™ Developments

The company retains exclusive licensing rights for TLANDO™, its oral testosterone replacement therapy, through Verity Pharma in the U.S. and Canada. This agreement is pivotal for expanding market reach into additional countries including South Korea and Brazil.

Financial Overview for Q3 2025

As of the end of September 2025, Lipocine held $15.1 million in unrestricted cash and equivalents, marking a decrease from $21.6 million reported at the end of 2024. The quarter recorded a loss of $3.2 million, equating to a per-share loss of $0.59, which reflects an increase in research and development expenses totaling $2.7 million.

The company also reported $115,000 in royalty revenue from TLANDO sales, a significant increase from prior quarters, indicating growing market acceptance.

Research and development costs related to ongoing clinical trials are higher than the previous year, reflecting parallel progress across multiple programs. General and administrative expenses were lower due to decreased business development fees and franchise tax obligations.

Nine-Month Summary

For the nine months ending September 30, 2025, Lipocine reported a net loss of $7.3 million, or $1.35 per diluted share, compared to $1.8 million for the same period in 2024. Total revenue for these nine months was less than the previous year, largely due to diminishing license agreements and lower royalty revenue.

Looking Ahead

Moving forward, Lipocine remains committed to addressing significant unmet medical needs through innovative product candidates. The upcoming months will be critical for further developments, particularly regarding LPCN 1154 and LPCN 2401. As the company navigates these clinical and financial landscapes, stakeholder engagement remains a priority.

For more detailed financial information, refer to the Form 10Q filed with the SEC, accessible via Lipocine's investor relations page. This report underscores the company’s strategic moves in leveraging its unique platform for therapeutic advancements while maintaining a keen eye on financial sustainability.

About Lipocine

Founded with a vision to innovate in the biopharmaceutical landscape, Lipocine focuses on developing patient-centric therapies that leverage its proprietary oral delivery technologies. The company targets significant healthcare challenges with its diverse pipeline, aimed at enhancing lives through effective treatment options. Interested individuals can find more about Lipocine's initiatives at www.lipocine.com.