Lipocine (LPCN) investor relations material

Unmet need and market opportunity

• Postpartum depression (PPD) affects ~24 million women annually worldwide, with prevalence rates ranging from 10% to 40% depending on the region.

• PPD imposes a high clinical and economic burden, impacting family stability, child development, and society.

• Suicide is a leading cause of maternal death in the first year postpartum, and up to 30% of women with PPD report suicidal ideation.

• Increased awareness and effective therapies are expected to expand diagnosis and treatment rates.

• The U.S. market opportunity is significant, with 240,000 diagnosed PPD patients and 144,000 receiving prescription treatment annually.

Product profile and differentiation

• LPCN 1154 (Brlizio) is an oral bioidentical brexanolone, conditionally approved by the FDA for PPD.

• Designed to overcome oral delivery challenges of brexanolone, improving absorption and enabling at-home use.

• Acts as a positive allosteric modulator of the GABA receptor and modulates TLR signaling, reducing neuroinflammation.

• Offers rapid onset of action (median 2.6 days), ultrashort 48-hour treatment, and superior tolerability compared to existing options.

• Demonstrates lower rates of CNS depressant adverse events and no treatment-related severe or serious adverse events.

Clinical trial design and results

• Phase 3 study: randomized, blinded, placebo-controlled, outpatient trial in women with severe PPD (HAM-D ≥26), N=90.

• Primary endpoint (HAM-D change at hour 60) was not met in the overall population.

• Subgroup with history of psychiatric conditions (N=54) showed statistically significant and clinically meaningful improvements at multiple timepoints.

• Efficacy signals included rapid onset (as early as 12 hours), sustained effect up to 30 days, and consistent superiority over placebo in this subgroup.

• Safety profile was favorable, with all adverse events mild to moderate and resolving without intervention.