Lipocine (LPCN) Corporate presentation summary

Pipeline overview and development status

• Multiple candidates in development for CNS disorders, including postpartum depression, major depressive disorder, essential tremor, and drug-resistant epilepsy.

• Commercial product TLANDO® for testosterone replacement is licensed and generating royalties.

• Out-licensing opportunities exist for liver cirrhosis, obesity management (adjunct to GLP-1), and preterm birth prevention candidates.

LPCN 1154 (Brlizio™) for postpartum depression

• Oral brexanolone offers rapid, sustained relief with a 48-hour outpatient regimen and superior tolerability.

• Phase 3 study did not meet the primary endpoint in the overall population but showed significant efficacy in patients with a history of psychiatric conditions.

• Demonstrated rapid onset (as early as 12 hours) and durable effect in the psychiatric history subgroup.

• Well-tolerated safety profile with no severe or serious treatment-related adverse events.

• Positioned to set a new standard of care versus existing oral and SSRI/SNRI treatments.

Market opportunities and competitive landscape

• PPD and MDD represent large, underserved markets with high clinical and economic burdens.

• ZURZUVAE® and SPRAVATO® are key competitors, but current treatments have limitations in onset, tolerability, and access.

• Essential tremor and drug-resistant epilepsy markets are sizable, with significant unmet needs for safer, more effective therapies.

• Obesity management market is expanding rapidly due to GLP-1 agonist adoption, but current therapies cause lean mass loss.