Lipocine Inc. · NASDAQ:LPCN
Lipocine — H.C. Wainwright 28th Annual Global Investment Conference 2026
22 slides from Lipocine's conference presentation, September 2026
Slide 1: H.C. Wainwright 28th Annual Global Investment Conference
H.C. Wainwright 28th Annual Global Investment Conference September 14-16, 2026 Lipocine │HCW 27th│ 2025 1
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding our development of our products and product c
Slide 3: Lipocine Pipeline
Lipocine Pipeline Development Candidates Indication Phase 1 Phase 2 Pivotal Commercial Next Steps/Status LPCN 1154 Postpartum Depression Phase 3 BLOOM study initiated (PPD) Target 1st patient dosing - early Q426 (BRLIZIO ) Major Depressive Disorder Neuroactive LPCN 2201 (MDD) Phase 2 POC study Stero
Slide 4: TLANDO – FDA-Approved Oral Testosterone Replacement Therapy (TRT)
TLANDO® – FDA-Approved Oral Testosterone Replacement Therapy (TRT) Expanding commercial opportunity • TLANDO® licensed to Verity Pharma for commercialization in the U.S. and Canada • Canadian NDS under review IMPORTANT SAFETY INFORMATION www.tlando.com/ • TLANDO® licensed to 5 territories including
Slide 5: LPCN 1154 (BRLIZIO)
LPCN 1154 (BRLIZIO ) TM First Oral Brexanolone for PPD (Postpartum Depression) BRLIZIO is the brand name conditionally approved by FDA TM
Slide 6: 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 health of the mother • Treatment goal is rapid symptom relief to improve
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 Oral Brexanolone Zuranolone SSRIs/SNRIs LPCN 1154 (Brlizio) is expected to provide (LPCN 1154) (ZURZUVAE®) Off-Label Use rapid relief of PPD with a short (48-hour) treatment Synthetic
Slide 8: HAM-D Change From Baseline
Rapid, Durable, & Meaningful Improvement Across All Timepoints Subgroup analyses: non-outlier sites (https://clinicaltrials.gov/study/NCT06979544) HAM-D Change From Baseline Over Time HAM-D Change From Baseline over Time 0 Hour1 12 Hour 2 36 Hour3 60 Day4 7 Day530 Placebo-adjusted Statistical 0 Time
Slide 9: Responder & Remitter Results Corroborate Strong Treatment Effect
LPCN 1154 - Responder & Remitter Results Corroborate Strong Treatment Effect Subgroup analysis: non-outlier sites (https://clinicaltrials.gov/study/NCT06979544) Percent of Participants with HAM-D Response Percent of Participants with HAM-D Remission 80 60 HAM-D Remitter (%) HAM-D Responder (%) 60 40
Slide 10: LPCN 1154 – Fastest Observed Onset in PPD
LPCN 1154 – Fastest Observed Onset in PPD PK support rapid target engagement resulting in clinically meaningful relief at 12 hours Subgroup Analysis: Non-Outlier Sites (https://clinicaltrials.gov/study/NCT06979544) Excluding Outlier Site At 12 Hours (N=60) HAM-D171 -7.1 *** (Cohen’s d = -1.10) -6.3
Slide 11: LPCN 1154 Demonstrated Differentiated Efficacy Signal
LPCN 1154 Demonstrated Differentiated Efficacy Signal Zurzuvae LPCN 1154* LS Mean CBL in HAM-D Total Score Over Time in Study1 LS Mean CBL in HAM-D Total Score Over Time 0 0 Placebo LS Mean Change from Baseline LS Mean Change from Baseline ZURZUVAE 50 mg -5 -5 (HAM-D Total Score) (HAM-D Total Score)
Slide 12: LPCN 1154 – Differentiated Tolerability
LPCN 1154 – Differentiated Tolerability Comparison to Zurzuvae safety* LPCN 1154 Placebo Zurzuvae 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% Memory i
Slide 13: Brexanolone Lifting Outcomes Of Moms (BLOOM)
Brexanolone Lifting Outcomes Of Moms (BLOOM) Phase 3: Randomized, double-blind, placebo-controlled US study in severe postpartum depression Study population N ≈ 120 Oral LPCN 1154 (Brexanolone) • Women aged 15–45 years 48-hour oral dosing regimen • ≤18 months postpartum • HAM-D17 ≥26 at screening an
Slide 14: LPCN 1154 – Potential Game Changer for Fast Acting Depression Therapy
LPCN 1154 – Potential “Game Changer” for Fast Acting Depression Therapy Key takeaways LPCN 1154 Large, attractive market opportunity Rapid & Durable Relief Differentiated product profile addressing unmet needs Streamlined path to NDA submission Superior Tolerability Issued and pending patent protect
Slide 15: LPCN 2201
LPCN 2201 Oral Brexanolone for Major Depressive Disorder (MDD)
Slide 16: MDD Market Potential
MDD Market Potential Total annual burden of medication-treated MDD among the US population was $92.7 billion1 Severe MDD is strongly linked to significant difficulty with work, social, and home activities Significant Unmet Needs in Depression Disorders MDD prevalence 8.4% Rapid Relief Hours/Days, es
Slide 17: HAM-D Change From Baseline
Rapid, Durable, & Statistically Significant Improvement Across Multiple Timepoints Subgroup Analysis: PPD with History of Psychiatric Diagnosis HAM-D Change From Baseline Overtime HAM-D Change From Baseline over Time 0 Hour1 12 Hour 2 36 Hour 3 60 Day 4 7 Day 5 30 0 Placebo-adjusted Statistical Time
Slide 18: LPCN 2201 – Targeted Attribute-Based Product Differentiation
LPCN 2201 – Targeted Attribute-Based Product Differentiation Potential Rapid Acting Anti-Depressant (RAAD) LPCN 2201 SPRAVATO AUVELITY Product Attribute* (Dextromethorphan + SSRI/SNRI Psychedelics (Neuroactive Steroid) (Esketamine)1 bupropion)2 Serotonin reuptake NMDA receptor antagonist inhibition
Slide 19: LPCN 2203
LPCN 2203 Oral Brexanolone for Essential Tremor
Slide 20: Essential Tremor (ET)
Essential Tremor (ET) Market potential - $3B+ blockbuster opportunity as 2nd line with 20% peak adoption • Tremor is highly disabling and stigmatizing Estimated prevalence • Stress can aggravate tremor in social setting 2.2 % of population1 ~7 M • Major impact on activities of daily living leading t
Slide 21: Essential Tremor Management – No New Drugs Approved In 50+ Years
Essential Tremor Management – No New Drugs Approved In 50+ Years Daytime efficacy and improved tolerability remain an unmet need Unmet Need Standard of Care Limitations Competitive Landscape Superior benefit to risk profile Unfavorable benefit to risk profile1 • Propranolol is the first line therapy
Slide 22: Investment Highlights
Investment Highlights Positioned for growth and near-term value creation Est. U.S. CNS program Target indication Program focus Postpartum Rapid-acting bioidentical patients $23.3M LPCN 1154 ~0.6M Cash balance* Depression (PPD) oral NAS Major Depressive Oral Rapid-Acting LPCN 2201 ~21M Disorder (MDD)
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