Lipocine (LPCN) Corporate presentation summary

Pipeline overview and development status

• Multiple clinical-stage candidates targeting CNS, metabolic, and endocrine disorders, including postpartum depression, major depressive disorder, essential tremor, drug-resistant epilepsy, liver cirrhosis, obesity, and preterm birth.

• Lead asset LPCN 1154 (oral brexanolone) for postpartum depression is in Phase 3, with topline results expected early Q2 2026 and NDA submission targeted for mid-2026.

• TLANDO®, an oral testosterone therapy, is FDA-approved and commercialized via partnerships, generating upfront and royalty revenues.

• Additional candidates include LPCN 2201 (MDD, Phase 2 ready), LPCN 2203 (essential tremor, Phase 1 complete), LPCN 2101 (drug-resistant epilepsy, Phase 2 ready), LPCN 1148 (liver cirrhosis, positive Phase 2), LPCN 2401 (obesity, positive Phase 2), and LPCN 1107 (preterm birth, Phase 3 ready).

LPCN 1154 (oral brexanolone) for postpartum depression

• Designed for rapid relief with a 48-hour oral regimen, aiming to outperform current therapies in speed, tolerability, and convenience.

• Phase 3 study is fully enrolled (n=90), with no drug discontinuations or severe adverse events reported; topline data expected early Q2 2026.

• Demonstrated bioequivalence to IV brexanolone (Zulresso®) and favorable safety profile with no excessive sedation or loss of consciousness.

• Streamlined 505(b)(2) regulatory pathway with patent protection extending to 2044+.

• Large market opportunity with significant unmet need; platform potential for expansion into other depressive disorders.

Other CNS and metabolic pipeline highlights

• LPCN 2201 targets major depressive disorder as a rapid-acting oral neuroactive steroid, aiming for at-home use and improved tolerability over current options.

• LPCN 2203 addresses essential tremor, a $3B+ market with high unmet need for second-line therapies; Phase 1 completed.

• LPCN 2101 (eltanolone) for drug-resistant epilepsy has demonstrated oral enablement, safety, and preclinical efficacy; Phase 2 ready.

• LPCN 1148 for liver cirrhosis showed positive Phase 2 results in sarcopenia and overt hepatic encephalopathy, with Fast Track Designation and patent protection through 2044.

• LPCN 2401, an androgen receptor agonist, demonstrated improved body composition in obesity management as an adjunct to GLP-1 therapy in Phase 2.

• LPCN 1107 is a Phase 3-ready oral candidate for prevention of preterm birth, with orphan drug designation and strong market potential.