Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (April 2026)
21 slides from Lipocine's investor presentation, April 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 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 Short Treatment
Slide 4: 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 5: 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 6: 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 7: 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 Brexanolone Zuranolone SSRIs/SNRIs more rapid relief of PPD than approved (LPCN 1154) (ZURZUVAE®) Off-Label Use treatments, with only a
Slide 8: LPCN 1154 – Phase 3 Safety and Efficacy Study Design
LPCN 1154 – Phase 3 Safety and Efficacy Study Design Utilizes same dose and regimen as the PK dose confirmation study Study design • Two arm, outpatient, randomized, blinded, placebo-controlled in women with postpartum depression at home administration with no medical monitoring Inclusion criteria E
Slide 9: Overall population
Overall population Baseline Demographics Characteristics LPCN 1154 Placebo Overall N 45 45 90 Age (years) (Mean, SD) 30.7 (5.41) 30.8 (6.52) 30.8 (5.96) BMI (kg/m2) (Mean, SD) 30.0 (5.96) 29.6 (6.06) 29.8 (5.98) Ethnicity (HISP; %) 64.4 60.0 62.2 Race (White; %) 62.2 66.7 64.4 AD use at baseline (%)
Slide 10: Efficacy Results
Efficacy Results Placebo-Adjusted HAM-D17 Score Change from Baseline History of Psychiatric Overall Population Condition Subset* N=90 Timepoint N=54 Placebo-adjusted Statistical Placebo-adjusted Statistical Difference Significance Difference Significance Hour 12 -3.9 P < 0.01 -7.2 P < 0.001 Hour 36
Slide 11: HAM-D Change From Baseline
Primary Endpoint: HAM-D CFB at Hour 60 Primary endpoint not met HAM-D Change From Baseline over Time 0 Hour 1 12 Hour2 36 Hour 60 3 Day 47 Day530 0 HAM-D Change From Baseline -5 ** -10 -15 -20 LPCN 1154 (N=45) Placebo (N=45) ** p<0.01 https://clinicaltrials.gov/study/NCT06979544 Mixed model for repe
Slide 12: Patients with PPD and Psychiatric Conditions
Patients with PPD and Psychiatric Conditions Appropriate for Subgroup Analysis ✓ Well defined condition characterized via standardized tool, MINI • Validated structured clinical interview for DSM and ICD psychiatric disorders • Commonly used in clinical trials • FDA agreed on using MINI to diagnose
Slide 13: PPD with History of Psychiatric Conditions
PPD with History of Psychiatric Conditions Baseline demographics Characteristics LPCN 1154 Placebo Overall N 24 30 54 Age (years) (Mean, SD) 31.0 (5.5) 30.8 (6.6) 30.9 (6.1) BMI (kg/m2) (Mean, SD) 31.6 (6.6) 30.1 (6.7) 30.8 (6.6) Ethnicity (HISP; %) 41.7 50.0 46.3 Race (White; %) 50.0 60.0 55.6 AD u
Slide 14: PPD with History of Psychiatric Conditions
PPD with History of Psychiatric Conditions HAM-D Change from Baseline * p<0.05; ** p<0.01; *** p<0.001 https://clinicaltrials.gov/study/NCT06979544 Mixed model for repeated measures, least squares means placebo-adjusted difference. P-values are nominal except for Hour 60 Overall Population. Lipocine
Slide 15: Overall Population Safety
Overall Population Safety LPCN 1154 was well tolerated LPCN 1154 PLACEBO Overall Parameter N=45 N=45 N=90 n (%) n (%) n (%) Any TEAE 8 (17.8) 8 (17.8) 16 (17.8) Any treatment-related TEAE 5 (11.1) 3 (6.7) 8 (8.9) Any severe TEAE 2 (4.4) 0 (0.0) 2 (2.2) Any serious TEAE 1 (2.2) 0 (0.0) 1 (1.1) TEAEs
Slide 16: Hypothesis Generating Results Support LPCN 1154’s Potential as a RAAD
Hypothesis Generating Results Support LPCN 1154’s Potential as a RAAD Clinically meaningful signals ✓ Consistent efficacy signal in patients with PPD and history of psychiatric conditions • HAM-D placebo adjusted change from baseline less than or equal to 4 at all timepoints • Supporting secondary r
Slide 17: LPCN 1154 - Significantly Better Tolerated
LPCN 1154 - Significantly Better Tolerated Comparison to Zurzuvae safety* LPCN 1154A Placebo Zuranolone Placebo Adverse Reaction (N=45) (N=45) (N=171) (N=169) Key Adverse Reactions Somnolence and sedation 4% 0% 19-36% 6-11% Dizziness 4% 0% 8-13% 6-9% Fatigue 0% 0% 5% 1-2% Diarrhea 0% 0% 5-9% 2-3% Me
Slide 18: LPCN 1154 Demonstrated Differentiated Efficacy Signal
LPCN 1154 Demonstrated Differentiated Efficacy Signal Zuranolone LPCN 1154: PPD with History of Psychiatric Conditions Mean CBL in HAM-D Total Score Over Time (Days) in Study 1 Mean CBL in HAM-D Total Score Over Time 0 Placebo HAM-D Change from Baseline Over Time LS Mean Change from Baseline (HAM- 0
Slide 19: LPCN 1154 – Differentiated Target Attributes as a Rapid-Acting PPD treatment
LPCN 1154 – Differentiated Target Attributes as a Rapid-Acting PPD treatment* Potential to meet RAAD criteria FDA Criteria for Rapid-Acting Efficacy demonstrated within 1 week Anti-Depressants (RAAD) Rapid relief as early as 12 hr over Zurzuvae of 3 days Rapid time to response 2.6 days over Zurzuvae
Slide 20: LPCN 1154 “Best-in-Class” Oral Treatment for PPD
LPCN 1154 “Best-in-Class” Oral Treatment for PPD Key takeaways • Credible signal in patients with PPD and history of psychiatric conditions – Next steps: finalize validation study protocol based on FDA feedback • Significant market opportunity • Differentiated product attributes addressing unmet nee
Slide 21: Business Development Contacts
Business Development Contacts Kongnara Papangkorn, Ph.D. Business Development Manager kp@lipocine.com