Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (March 2026)
13 slides from Lipocine's investor presentation, March 2026
Slide 1: LPCN 1154 (Brlizio) Oral Brexanolone for Postpartum Depression
LPCN 1154 (BRLIZIO ) TM Oral Brexanolone for Postpartum Depression (PPD) Lipocine │May 2025 1 Brlizio is a brand name conditionally approved by FDA TM
Slide 2: PPD - A Significant Global Health Issue Affecting Families Worldwide
PPD - A Significant Global Health Issue Affecting Families Worldwide Estimated ~ 24 million new cases of PPD annually worldwide1 Prevalence of PPD in pregnant women Northern Europe 14% Eastern Europe 17% Northern Western Switzerland 22% America Asia 20% Korea 22% 17% Eastern Asia 17% UK 21% Northern
Slide 3: PPD – An Expanding Market Opportunity
PPD – An Expanding Market Opportunity Awareness drives diagnosis - empowering women with PPD through effective therapies • High clinical and economic burden Estimated patients in the U.S. with PPD5 with consequences beyond the mother • Treatment goal is rapid harm reduction for both mother and infan
Slide 4: PPD is a Life-Threatening Condition with Few Existing Treatment Options
PPD is a Life-Threatening Condition with Few Existing Treatment Options Rapid relief, short treatment duration, and superior tolerability advantages Maternal depression and suicide can have far-reaching consequences for child development, family function, and the nation's economy1-3 Rapid relief ben
Slide 5: LPCN 1154 - Target Product Attributes Addresses Unmet Medical Need
LPCN 1154 -Target Product Attributes Addresses Unmet Medical Need Strong potential to set the benchmark for first-line therapy Oral Dosage Form Comprising Brexanolone Identical to Fixed dose 48-hour Superior Rapid relief endogenous without titration outpatient dosing tolerability allopregnanolone or
Slide 6: LPCN 1154 - Oral Bioidentical Neuroactive Steroid (NAS) for PPD
LPCN 1154 - Oral Bioidentical Neuroactive Steroid (NAS) for PPD Overcoming brexanolone oral delivery challenges Brexanolone Oral enablement Molecular Weight: 318.5 g/mol Lipophilic: Log P 5.0 Poor aqueous solubility: Saq <1.0 g/mL Source: Giliyar et al. Drug Delivery Technology, Jan 2006, Vol 6 N
Slide 7: LPCN 1154 - Distinctive Pharmacological Pathway
LPCN 1154 - Distinctive Pharmacological Pathway Validated through approved IV Brexanolone Positive allosteric modulator of the GABAA receptor1 and TLR signaling modulator2 Modulation of GABAergic Inhibition1 • Synaptic GABAA receptors especially those containing the γ subunit which mediate phasic in
Slide 8: LPCN 1154 – Poised to Lead the Market and Set the Standard of Care
LPCN 1154 – Poised to Lead the Market and Set the Standard of Care Therapy overview – LPCN 1154 vs. existing options LPCN 1154 (Brlizio) is expected to provide Oral Zuranolone IV Brexanolone SSRIs / SNRIs more rapid relief of PPD than approved Brexanolone (ZURZUVAE®) (Zulresso®)8 Off-Label Use treat
Slide 9: LPCN 1154 – Dosing Regimen Confirmation Study Results
LPCN 1154 – Dosing Regimen Confirmation Study Results Results inform dosing regimen for Phase 3 safety and efficacy confirmatory study (NCT06979544) Bioequivalent to Zulresso Brexanolone was well tolerated independent of route GMR • No sedation or somnolence events observed PK Test vs. Parameter LPC
Slide 10: LPCN 1154 Phase 3 Safety and Efficacy Study (NCT06979544)
LPCN 1154 Phase 3 Safety and Efficacy Study (NCT06979544) Based on FDA feedback – outpatient setting with no medical monitoring requirement Study design Two arm, outpatient, randomized, blinded, placebo-controlled in women with postpartum depression Rationale for Success • Brexanolone has establishe
Slide 11: LPCN 1154 – Development Status
LPCN 1154 – Development Status Streamlined 505(b)(2) pathway to NDA submission targeted mid 2026 Dosing Regimen Labeling Clinical Studies Ongoing P3 Study Confirmation Study ✓ Positive Results ✓ Food effect study ✓ Dosing completed ✓ PK study in PPD ✓ Two DSMB data review ✓ Metabolite evaluation mee
Slide 12: LPCN 1154 – Potential “Game Changer” for Fast Acting Depression Therapy
LPCN 1154 – Potential “Game Changer” for Fast Acting Depression Therapy Key takeaways • Large, attractive market opportunity Treatment Duration • Differentiated product profile addressing unmet needs LPCN 1154 • Rapid relief, short treatment duration, superior tolerability (Brlizio) • Clear, streaml
Slide 13: Business Development Contacts
Business Development Contacts Kongnara Papangkorn, Ph.D. Business Development Manager kp@lipocine.com