Lipocine (LPCN) investor relations material

Pipeline overview and development status

• Multiple oral neuroactive steroid candidates in development for postpartum depression (PPD), major depressive disorder (MDD), essential tremor (ET), and drug-resistant epilepsy (DRE).

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

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

LPCN 1154 (Brlizio™) for postpartum depression

• First oral brexanolone for PPD, with conditional FDA brand name approval.

• Addresses significant unmet needs: rapid relief, short treatment duration, superior tolerability, and at-home access.

• Large underpenetrated market with high clinical and economic burden; estimated 240,000 diagnosed PPD patients in the US.

• Demonstrated rapid onset (median 2.6 days), durable efficacy, and favorable safety profile in Phase 3, especially in patients with psychiatric history.

• Differentiated from existing options by faster onset, shorter duration, and lower CNS adverse events compared to zuranolone and SSRIs/SNRIs.

Phase 3 clinical results and subgroup analyses

• Phase 3 study showed numerically greater HAM-D score reduction vs placebo at 60 hours, with nominal significance at 12 hours.

• Subgroup with psychiatric history (60% of study) showed rapid, statistically significant, and sustained improvement across multiple endpoints.

• Exclusion of an epidemiologic outlier site further strengthened efficacy signals and aligned study population with PPD epidemiology.

• Consistent efficacy across HAM-D, MADRS, and HAM-A scales; 40% of treated participants reported feeling 'very much better' at day 30.