Slide 1: Corporate Presentation May 2026
Corporate Presentation May 2026 Lipocine │2026 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 product candidates and strategic plans an
Slide 3: Lipocine Pipeline
Lipocine Pipeline Development Candidates Indication Phase 1 Phase 2 Pivotal Commercial Next Steps/Status LPCN 1154 Postpartum Depression Finalize validation study protocol (PPD) based on FDA feedback (BRLIZIO ) Major Depressive Disorder Neuroactive LPCN 2201 (MDD) Phase 2 POC study Steroids LPCN 220
Slide 4: Lipocine's Proprietary Technology
Lipocine’s Proprietary Technology Overcoming oral drug delivery challenges Lip’ral based dosage form Drug + Carrier = Drug Loaded Carrier GI Aqueous Intestinal Systemic Lumen Barrier Layer Wall Circulation Insoluble drug lipid composition GI Lumen Section of GI Insoluble drug lipid magnified to comp
Slide 5: LPCN 1154 (BRLIZIO) First Oral Brexanolone for PPD
LPCN 1154 (BRLIZIO ) TM First Oral Brexanolone for PPD (Postpartum Depression) BRLIZIO is the brand name conditionally approved by FDA TM
Slide 6: Unmet Needs in PPD and Benefits of Product Target Attributes
Unmet Needs in PPD and Benefits of Product Target Attributes PPD is a life-threatening condition with few existing treatment options Maternal depression and suicide can have far-reaching consequences for child development, family function, and the nation's economy1-3 Short Treatment Rapid Relief Sup
Slide 7: PPD – Large Underpenetrated Market, Primed for a Better Treatment Option
PPD – Large Underpenetrated Market, Primed for a Better Treatment Option 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
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 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 9: LPCN 1154 – Achieved Standard Bioequivalence to IV Brexanolone
LPCN 1154 – Achieved Standard Bioequivalence* to IV Brexanolone Dosing regimen confirmation study results Bioequivalent to Zulresso FDA Type D meeting minutes PK GMR Test vs. “Given that the PK shape of the oral LPCN 1154 IV Brexanolone Parameter Reference formulation of proposed drug product, (90%
Slide 10: 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 required medical monitoring Inclusion c
Slide 11: LPCN 1154 – P3 Results Summary
LPCN 1154 – P3 Results Summary Strong efficacy signal in clinically relevant subgroups Overall Study Population Subgroup Analyses# • LPCN 1154 showed a numerically greater • Participant population at one outlier site differs reduction from baseline in HAM-D total score materially from overall study
Slide 12: 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 Antidepressant use at
Slide 13: 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 14: One Site Was Identified as an Epidemiologic Outlier
One Site Was Identified as an Epidemiologic Outlier Comparison between epidemiologic outlier site and other Sites** Outlier Site Outlier Site Outlier Site Baseline Psychiatric Placebo Effect Vs Vs Vs Characteristics Other 14 sites Condition Other 14 sites Other 14 sites Recruitment rate History of p
Slide 15: Subgroup Analysis Excluding Epidemiologic Outlier Site
Subgroup Analysis Excluding Epidemiologic Outlier Site Baseline demographics Characteristics LPCN 1154 Placebo Overall N 27 33 60 Age (years) 30.0 (5.9) 31.7 (6.6) 30.9 (6.3) BMI (kg/m2) 31.9 (6.4) 30.5 (6.4) 31.1 (6.4) Ethnicity (HISP; %) 40.7 45.5 43.3 Race (White; %) 55.6 54.5 55.0 Antidepressant
Slide 16: Subgroup Analysis Excluding Outlier Site: HAM-D Change From Baseline
Subgroup Analysis Excluding Epidemiologic Outlier Site# Rapid, durable, and statistically significant improvement across multiple timepoints HAM-D Change From Baseline Overtime HAM-D Change From Baseline over Time 0 Hour112 Hour 2 36 Hour 3 60 Day 4 7 Day 5 30 Excluding Outlier Site 0 N=60 HAM-D Cha
Slide 17: HAM-D Responder and Remitter Results
Subgroup Analysis Excluding Epidemiologic Outlier Site Responder and remitter results corroborate strong treatment effect Percent of Participants with HAM-D Response Percent of Participants with HAM-D Remission 60 80 HAM-D Remitter (%) HAM-D Responder (%) 60 40 40 20 20 0 0 Hour 12 Hour 36 Hour 60 D
Slide 18: LPCN 1154 Subgroup – PPD with History of Psychiatric Condition
LPCN 1154 Subgroup – PPD with History of Psychiatric Condition A well characterized, high prevalence and most in need population ✓ Well defined condition characterized via standardized tool, MINI o Validated structured clinical interview for DSM and ICD psychiatric disorders o Commonly used in clini
Slide 19: Subgroup – PPD with History of Psychiatric Condition: Baseline Demographics
LPCN 1154 Subgroup – PPD with History of Psychiatric Condition* 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; %
Slide 20: Subgroup – History of Psychiatric Condition: Improvement Across Timepoints
LPCN 1154 Subgroup – PPD with History of Psychiatric Condition# Rapid, durable, and statistically significant improvement across multiple timepoints HAM-D Change From Baseline Overtime History of Psychiatric Condition# N=54 Time Placebo-adjusted Statistical Cohen’s d Difference Significance Hour 12
Slide 21: Subgroup – History of Psychiatric Condition: Responder and Remitter Results
LPCN 1154 Subgroup – PPD with History of Psychiatric Condition# Responder and remitter results corroborate strong treatment effect Percent of Participants with HAM-D Response Percent of Participants with HAM-D Remission 80 60 HAM-D Responder (%) HAM-D Remitter (%) 60 40 40 20 20 0 0 Hour 12 Hour 36
Slide 22: LPCN 1154 – PK/PD Correlation
LPCN 1154 – PK/PD Correlation Rapid and sustained target engagement PK/PD Correlation: Mechanistic Validation (qEEG EC) • β band qEEG activity is a validated, 140 70 objective biomarker of GABA-A receptor Mean Brexanolone Plasma Concentration (ng/ml) Mean qEEG % CBL Beta power EC (12 - 25 HZ) 120 Br
Slide 23: LPCN 1154 – Consistent Efficacy Signals Indicate the Fastest Relief for PPD
LPCN 1154 – Consistent Efficacy Signals Indicate the Fastest Relief for PPD# Robust HAM-D and HAM-A efficacy at 12 hours post-dosing Excluding Outlier Site History of Psychiatric At 12 Hours (N=60) Condition (N=54) HAM-D171 -7.1 *** -7.2 *** HAM-A1 -6.3 ** -6.3 ** HAM-D17 38.5% vs 6.3% ** 37.5% vs 6
Slide 24: LPCN 1154 – Summary of Subgroup Efficacy Analyses
LPCN 1154 – Summary of Subgroup Efficacy Analyses Consistently outperformed placebo across multiple outcome measures • HAM-D analyses data support rapid and durable treatment effect in both subgroups • Subgroup population that is consistent with PPD epidemiology • PPD with history of psychiatric con
Slide 25: Overall Population Safety
Overall Population Safety LPCN 1154 was well tolerated LPCN 1154 Placebo Parameter N=45 N=45 n (%) n (%) Any TEAE 8 (17.8) 8 (17.8) Any treatment-related TEAE 5 (11.1) 3 (6.7) Any severe TEAE 2 (4.4) 0 (0.0) Any serious TEAE 1 (2.2) 0 (0.0) TEAEs in ≥ 2 participants in LPCN 1154 arm Headache 2 (4.4)
Slide 26: Hypothesis Generating Results Support LPCN 1154's Potential as a RAAD
Hypothesis Generating Results Support LPCN 1154’s Potential as a RAAD Clinically meaningful outcomes Consistent and coherent efficacy signal in patients with PPD • HAM-D placebo adjusted change from baseline less than or equal to 4 at all timepoints • Supporting secondary responder and remission end
Slide 27: LPCN 1154 – Differentiated Tolerability
LPCN 1154 – Differentiated Tolerability Comparison to Zurzuvae safety* LPCN 1154A 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
Slide 28: LPCN 1154 Demonstrated Differentiated Efficacy Signal
LPCN 1154 Demonstrated Differentiated Efficacy Signal Zurzuvae LPCN 1154 – Excluding Epidemiologic Outlier Site Mean CBL in HAM-D Total Score Over Time in Study 1 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
Slide 29: LPCN 1154 Next Regulatory Steps
LPCN 1154 Next Regulatory Steps Applied for Breakthrough Planned guidance Submit Phase 3 validation Therapy and Fast Track meeting to discuss the study protocol Designations with FDA completed Phase 3 study Lipocine │2026 29
Slide 30: LPCN 1154 Potential Best-in-Class Oral Treatment for PPD
LPCN 1154 Potential “Best-in-Class” Oral Treatment for PPD Key takeaways • Credible signal in patients with PPD • Significant market opportunity • Differentiated product attributes addressing unmet needs • Streamlined pathway to NDA submission • Issued and pending patents worldwide Lipocine │2026 30
Slide 31: LPCN 2201 Oral Brexanolone for Major Depressive Disorder
LPCN 2201 Oral Brexanolone for Major Depressive Disorder (MDD)
Slide 32: Major Depressive Disorder (MDD)
Major Depressive Disorder (MDD) Definition and facts ▪ Major depression is a common and treatable mood disorder characterized by changes in cognitive and physical symptoms lasting for at least 2 weeks1 ▪ ~332 million people with MDD worldwide 2 ▪ Depression carries a high economic burden3 and is a l
Slide 33: 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 in work, social, and home activities Significant Unmet Needs in Depression Disorders MDD prevalence 8.4% Rapid Relief Hours/Days, espe
Slide 34: 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 35: Differentiated Target Attributes as a Rapid-Acting treatment
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 Median Time to Response* Onset: 2.6 days For rapid-acting antidepressants, the ti
Slide 36: LPCN 2201 – Oral Non-Dissociative RAAD for Major Depression Disorders
LPCN 2201 – Oral Non-Dissociative (Psychotomimetic) RAAD for Major Depression Disorders Potential to set rapid relief benchmark for MDD Attributes High unmet need for oral RAAD; large market potential LPCN 2201 Rapid Relief Leverage LPCN 1154 data Convenient Oral At-Home Use Streamlined development
Slide 37: Appendix
Appendix
Slide 38: LPCN 2203 Oral Brexanolone for Essential Tremor
LPCN 2203 Oral Brexanolone for Essential Tremor
Slide 39: 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 40: 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 profile3 • Propranolol is the first line therapy
Slide 41: LPCN 2101 Treatment of Epilepsy
LPCN 2101 Treatment of Epilepsy
Slide 42: Drug-Resistant Epilepsy (DRE)
Drug-Resistant Epilepsy (DRE) A significant clinical challenge in epilepsy care with high social and occupational limitations1 Prevalence Affects 30-40% of epilepsy patients in the U.S. 2 Clinical Increased risk of injury, hospitalization, mortality, and mental DRE is defined by ILAE as Impact healt
Slide 43: Unmet Needs in DRE
Unmet Needs in DRE Seizure freedom without adverse effects, while improving the patient's quality of life Limitations of Current Options • 30–40% of patients still do not achieve freedom from seizures, despite being on multiple medications • Many patients with DRE go through multiple ASMs with limit
Slide 44: LPCN 2101 – NAS for Epilepsy Treatment
LPCN 2101 – NAS for Epilepsy Treatment Positive Allosteric Modulator (PAM) of the GABAA receptor Product Candidate Anti-Seizure Activity in First Oral Enablement Differentiation Preclinical Models Phase 1 Results 40 • Novel MOA specifically • Effective in most of the tonic Mean Plasma Concentration
Slide 45: TLANDO Testosterone Replacement Therapy
TLANDO® Testosterone Replacement Therapy (TRT)
Slide 46: TLANDO – FDA-Approved Oral Testosterone Replacement Therapy
TLANDO® – FDA-Approved Oral Testosterone Replacement Therapy Established commercialization partnerships in multiple territories IMPORTANT SAFETY INFORMATION TLANDO® licensed to Verity Pharma in January 2024 for www.tlando.com/ commercialization in the U.S. • $11 million upfront payment to Lipocine •
Slide 47: LPCN 1148 Management of Liver Cirrhosis
LPCN 1148 Management of Liver Cirrhosis • Overt Hepatic Encephalopathy (OHE) • Sarcopenia in Decompensated Cirrhosis (Fast Track Designation)
Slide 48: LPCN 1148 – Unique Opportunity Addressing Two Distinct Liver Disease Markets
LPCN 1148 - Unique Opportunity Addressing Two Distinct Liver Disease Markets Positive POC Phase 2 results in treatment of sarcopenia and OHE in cirrhosis Positive P2 results with Positive P2 results in background SOC sarcopenia Analogue (Rifaximin) Sales Overt Hepatic Encephalopathy 300 FDA granted
Slide 49: LPCN 1148 Phase 2 Results – Sarcopenia Primary Endpoint Met
LPCN 1148 Phase 2 Results – Sarcopenia Primary Endpoint Met Resolution for sarcopenia and significantly increased skeletal muscle mass index (SMI) 25 ‡ 20 ‡ 15 % CBL L3-SMI ‡ ‡ ‡ 10 † 5 0 -5 Week LPCN 1148 Placebo Placebo to 1148 ~9% increase in L3-SMI at week 24 33% of patients had resolution of sa
Slide 50: LPCN 1148 Phase 2 Results – HE Endpoint Met
LPCN 1148 Phase 2 Results – HE Endpoint Met Fewer overt hepatic encephalopathy events Through Week 24 Week 24 to EOS LPCN 1148 switch Placebo LPCN 1148 LPCN 1148 Parameter N=14 from placebo N=15 N=11 N=8 History of HE prior to randomization (n) 11 (79%) 11 (73%) 7 (64%) 6 (75%) Recurrent Overt HE (e
Slide 51: LPCN 1148 Phase 2 Results Safety Data
LPCN 1148 Phase 2 Results Safety Data Overall LPCN 1148 was well tolerated • Rates and severities of AEs similar to those in Stage 1 with placebo • Fewer participants experienced severe AEs when switched from placebo to LPCN 1148 LPCN 1148 switch from Placebo LPCN 1148 LPCN 1148 placebo Parameter (T
Slide 52: LPCN 2401 Obesity Management – adjunct to GLP-1
LPCN 2401 Obesity Management – adjunct to GLP-1
Slide 53: Unprecedented Demand and Usage of GLP-1 Receptor Agonists
Unprecedented Demand and Usage of GLP-1 Receptor Agonists 1-3 GLP-1 market trending toward oral once daily dosing Semaglutide: $30 billion sales in the US in 20244 ✓ T2DM Tirzepatide: $14 billion sales in the US in 20245 ✓ Weight management FDA approved ✓ Cardiovascular disease indications ✓ Chronic
Slide 54: Drawbacks of Approved GLP-1 Receptor Agonists
Drawbacks of Approved GLP-1 Receptor Agonists Rapid loss of lean mass and functionality in elderly GLP-1 users Low Quality Weight Loss1 Lean Mass Loss1 Functionality Loss1 Fracture Risk2,3 Weight Loss Lean mass Loss Weight(kg) Loss Fatloss Fat Loss(%) Lean Mass (%) Loss 0 3 Semaglutide % Subjects wi
Slide 55: LPCN 2401 Once Daily Oral as An Adjunct to GLP-1 Treatment
LPCN 2401 Once Daily Oral as An Adjunct to GLP-1 Treatment Proven potential to improve body composition - quality weight loss with quality fat loss Product Candidate Attributes Proprietary androgen receptor agonist, testosterone ester(s), targeted for once-a-day treatment - “LPCN 2401” • Androgen re
Slide 56: LPCN 2401 – Clinical Data Show Significant Improvement in Body Composition
LPCN 2401 – Clinical Data Show Significant Improvement in Body Composition Phase 2 results demonstrate increased lean mass and decreased fat mass at Week 20 Lean Mass Fat Mass Lean Mass (kg) Appendicular Lean Mass (kg) Total Fat Mass Trunk Fat Mass 2.5 (kg) (kg) 2 1 2 * * 0.9 1.9 1.5 1.2 1.6 1 * * 0
Slide 57: LPCN 2401 Novel Oral Treatment for Obesity Management
LPCN 2401 Novel Oral Treatment for Obesity Management Target benefits to improve weight loss and functionality Quality Weight Loss Maintain Weight Loss Preserve lean mass Primarily fat loss Minimize fat regain Minimize weight regain Attenuate functionality loss Maintain/improve functionality Amplify
Slide 58: LPCN 1107 Prevention of Preterm Birth
LPCN 1107 Prevention of Preterm Birth (PTB)
Slide 59: LPCN 1107 for Prevention of Preterm Birth
LPCN 1107 for Prevention of Preterm Birth Product candidate highlights Oral dosage form comprising Oral, a Major Contribution to Patient Care (MC to 17-hydroxyprogesterone caproate PC), including no injection site reaction >$2B market potential with no approved drug Phase 3 ready with compelling eff