Lipocine (LPCN) A.G.P.'s Virtual Healthcare Company Showcase 2025 summary

Company overview and pipeline focus

• Developing oral therapies for neuro and endocrine disorders, leveraging proprietary absorption technology.

• Lead assets are 1154 for postpartum depression and 2401 for obesity management, both addressing large unmet needs.

• Commercial product already on the market; robust pipeline in development.

Obesity management candidate (2401)

• 2401 is a bioidentical myostatin inhibitor designed as an adjunct to GLP-1 therapies, targeting quality fat loss and lean mass preservation.

• Positive phase II results in GLP-1 users show improved body composition and weight loss, with no significant tolerability issues.

• Upcoming phase II proof-of-concept trial as adjunct to GLP-1 to start in Q3, with first data expected late Q1 next year.

• Stage two of the trial will assess post-GLP-1 cessation effects, with results expected in Q3 next year.

• Actively seeking partnerships for further development after proof of concept; discussions with interested parties underway.

Postpartum depression candidate (1154)

• 1154 is an oral formulation of brexanolone, a GABA modulator, aiming for rapid symptom relief in postpartum depression.

• Phase III outpatient study underway, targeting 80 women with severe postpartum depression over 48 hours.

• FDA agreed a single phase III study should suffice for NDA submission; NDA filing projected in about a year.

• Product offers outpatient convenience versus current inpatient IV options, with low clinical and labeling risk.

• Market potential estimated at $500 million to $1 billion in the US, with 30%-50% share considered reasonable.