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Lipocine (LPCN) investor relations material

Lipocine Q3 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q3 2025 earnings summary6 Nov, 2025

Executive summary

  • Focus on oral drug delivery for CNS disorders, liver diseases, hormone supplementation, postpartum depression, epilepsy, and obesity management, with a pipeline including LPCN 1154, LPCN 2401, LPCN 2101, and LPCN 2203.

  • Commercialization of TLANDO (oral testosterone therapy) through licensing agreements in the US, Canada, South Korea, GCC, and Brazil, with milestone and royalty payments.

  • Ongoing Phase 3 trial for LPCN 1154 in postpartum depression, with top-line data expected in Q2 2026 and NDA submission planned for 2026.

  • Exploring proof-of-concept studies for epilepsy (LPCN 2101) and obesity (LPCN 2401), with partnership discussions ongoing.

Financial highlights

  • Total revenue for Q3 2025 was $115,000, all from royalty revenue; no license revenue recognized in the quarter.

  • Net loss for Q3 2025 was $3.2 million ($0.59 per share), compared to $2.2 million ($0.44 per share) in Q3 2024.

  • For the nine months ended September 30, 2025, revenue was $831,000 (license: $500,000; royalty: $331,000), down from $7.7 million in the prior year period.

  • Research and development expenses increased to $2.7 million in Q3 2025, mainly due to the LPCN 1154 Phase 3 trial.

  • Cash, cash equivalents, and marketable investment securities totaled $15.1 million as of September 30, 2025.

Outlook and guidance

  • Existing capital resources are expected to fund operations through at least November 6, 2026, including ongoing clinical studies.

  • Top-line data from the LPCN 1154 Phase 3 trial expected in Q2 2026; NDA submission planned for 2026.

  • Additional capital will be needed for further development, regulatory compliance, and potential new clinical trials.

  • The company is actively seeking partnerships and licensing opportunities for pipeline assets.

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Frequently asked questions

Lipocine Inc. is a biopharmaceutical company focused on the development of oral drug delivery technologies for treating metabolic and endocrine disorders. The company specializes in hormone therapeutics, leveraging its proprietary Liprocol technology to enhance drug absorption and bioavailability. Lipocine's pipeline includes treatments for conditions such as testosterone deficiency, liver disease, and neuroendocrine disorders. The company is headquartered in Salt Lake City, Utah, and its shares are listed on the NASDAQ.

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