Lipocine (LPCN) investor relations material

Key presentations and announcements

• Highlighted a robust CNS pipeline with lead candidates targeting postpartum depression, major depressive disorder, essential tremor, and drug-resistant epilepsy.

• LPCN 1154 (oral brexanolone) positioned as a rapid, durable, and well-tolerated therapy for postpartum depression, with a 48-hour oral regimen and strong efficacy and safety data.

• TLANDO®, an FDA-approved oral testosterone therapy, expanded its commercial reach with licensing in the US, Canada, and other territories, and benefited from recent FDA label updates removing key safety warnings.

• Out-licensing and partnering opportunities for non-core assets were emphasized as a value creation strategy.

• Forward-looking statements included plans for pivotal trials, NDA submissions, and expansion into additional depressive and neurological indications.

Clinical and market insights

• LPCN 1154 demonstrated rapid onset of action (significant improvement at 12 hours), superior tolerability, and a differentiated profile compared to existing treatments like zuranolone and SSRIs/SNRIs.

• The postpartum depression market is expanding, driven by increased awareness, high unmet need, and compelling pharmacoeconomic rationale for early intervention.

• Major depressive disorder and essential tremor represent large, underserved markets with significant unmet needs for rapid, effective, and well-tolerated therapies.

• LPCN 2201 and LPCN 2203 are positioned as oral neuroactive steroid therapies with potential advantages in efficacy, safety, and patient convenience over current standards.

• Essential tremor management remains a major unmet need, with no new drugs approved in over 50 years and high discontinuation rates for current therapies.

Financial and strategic outlook

• Reported a cash balance of $23.3M as of June 30, 2026, with no debt or warrants, supporting near-term development plans.

• Technology platform validated by an approved product, with ongoing royalty streams and additional value expected through strategic partnerships.

• Market opportunities for lead programs are substantial, with PPD, MDD, and ET populations estimated at 0.6M, 21M, and 7M in the US, respectively.

• Projected market sizes for MDD and ET are $31B and $3B+, respectively, with pricing benchmarks established by recent entrants.

• Strategic focus remains on advancing CNS pipeline assets and monetizing non-core programs through partnerships.