Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (October 2026)
42 slides from Lipocine's investor presentation, October 2026
Slide 1: Corporate Presentation
Corporate Presentation October 2026 Lipocine │October 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 Highlights
Lipocine Highlights LPCN 1154 targets a large PPD market ZURZUVAE® sales reached $71M in Q2 2026, with projected peak sales of ~$1B, with a clear unmet need yet its CNS depressant effects (somnolence, dizziness) remain a limitation. LPCN 1154 has potential for rapid, Relief as early as 12 hours, wit
Slide 4: Lipocine's Proprietary Technology
Lipocine’s Proprietary Technology Overcoming oral drug delivery challenges Lipocine │October 2026 4
Slide 5: Lipocine Pipeline
Lipocine Pipeline Development Candidates Indication Phase 1 Phase 2 Pivotal Commercial Next Steps/Status LPCN 1154 Postpartum Depression (PPD) BLOOM (Phase 3) study: target 1st (BRLIZIO ) patient dose early Q4, 2026 Major Depressive Disorder LPCN 2201 (MDD) Phase 2 POC study Neuroactive Steroids LPC
Slide 6: TLANDO – FDA-Approved Oral Testosterone Replacement Therapy (TRT)
TLANDO® – FDA-Approved Oral Testosterone Replacement Therapy (TRT) Expanding commercial opportunity • TLANDO® commercialized in the USA, approved in Canada and UAE IMPORTANT SAFETY INFORMATION www.tlando.com • Partnered in multiple additional territories • Opportunity to expand indication • Treatmen
Slide 7: LPCN 1154 (BRLIZIO)
LPCN 1154 (BRLIZIO ) TM Potential First Oral Brexanolone for PPD (Postpartum Depression) BRLIZIO is the brand name conditionally accepted by FDA TM
Slide 8: 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 with Estimated patients in the U.S. with PPD5 consequences beyond the health of the mother • Treatment goal is rapid symptom relief to improve
Slide 9: LPCN 1154 – Poised to Lead the Market and Set a New Standard of Care
LPCN 1154 – Poised to Lead the Market and Set a New Standard of Care Therapy overview – LPCN 1154 vs. existing options Oral Brexanolone Zuranolone SSRIs/SNRIs LPCN 1154 (BRLIZIOTM) is expected to provide (LPCN 1154) (ZURZUVAE®) Off-Label Use rapid relief of PPD with a short (48-hour) treatment Synth
Slide 10: HAM-D Change From Baseline
Rapid, Durable, and Meaningful Improvement Across All Timepoints Subgroup analysis* HAM-D Change From Baseline Over Time HAM-D Change From Baseline over Time 0 Hour1 12 Hour 2 36 Hour 3 60 Day 4 7 Day530 0 HAM-D Change From Baseline Placebo-adjusted Statistical Time Difference Significance Cohen’s d
Slide 11: LPCN 1154 – Responder and Remitter Results Corroborate Strong Treatment Effect
LPCN 1154 – Responder and Remitter Results Corroborate Strong Treatment Effect* 38.5% HAM-D response at Hour 12 vs 6.3% for placebo Percent of Participants with HAM-D Response Percent of Participants with HAM-D Remission 80 60 HAM-D Remitter (%) HAM-D Responder (%) 60 40 40 20 20 0 0 Hour 12 Hour 36
Slide 12: LPCN 1154 – Fastest Observed Onset in PPD
LPCN 1154 – Fastest Observed Onset in PPD PK data 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)
Slide 13: 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 in Study* 0 0 Placebo LPCN 1154 (N=27) LS Mean Change from Baseline LS Mean Change from Baseline ZURZUVAE 50 mg -5 -5 Placebo (N=3
Slide 14: 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 15: 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 Oral LPCN 1154 (Brexanolone) N ≈ 120 48-hour oral dosing regimen • Women aged 15–45 years 1:1 • ≤18 months postpartum Matching placebo Randomiz
Slide 16: 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 17: LPCN 2201
LPCN 2201 Oral Brexanolone for Major Depressive Disorder (MDD)
Slide 18: 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 19: 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 20: 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 21: LPCN 2201 – Target Profile Aligned with FDA Guidance on RAAD
LPCN 2201 – Target Profile Aligned with FDA Guidance on RAAD MDD potential supported by LPCN 1154 data in PPD FDA Criteria for Rapid-Acting Anti-Depressants (RAAD) Efficacy demonstrated within 1 week For rapid-acting antidepressants, the timing of effect considerations include the following: • Effic
Slide 22: LPCN 2203
LPCN 2203 Oral Brexanolone for Essential Tremor
Slide 23: 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 24: ET – Daytime Efficacy and Improved Tolerability Remain an Unmet Need
ET – Daytime Efficacy and Improved Tolerability Remain an Unmet Need ET potential supported by observed superior tolerability of oral brexanolone Unmet Need Standard of Care Limitations Competitive Landscape Superior benefit to risk profile Unfavorable benefit to risk profile3 • Propranolol is the f
Slide 25: Investment Value Proposition
Investment Value Proposition Positioned for growth and near-term value creation Est. U.S. CNS program Target indication Program focus patients LPCN 1154 Postpartum Depression (PPD) Rapid-acting bioidentical oral NAS ~0.6M LPCN 2201 Major Depressive Disorder (MDD) Oral Rapid-Acting Antidepressant (RA
Slide 26: Appendix
Appendix
Slide 27: LPCN 2101
LPCN 2101 Treatment of Drug-Resistant Epilepsy
Slide 28: 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. 2,3 Clinical Increased risk of injury, hospitalization, mortality, and mental DRE is defined by ILAE as Impact hea
Slide 29: 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 30: LPCN 1148
LPCN 1148 Management of Liver Cirrhosis • Overt Hepatic Encephalopathy (OHE) • Sarcopenia in Decompensated Cirrhosis (Fast Track Designation)
Slide 31: 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 FDA granted Fast
Slide 32: LPCN 1148 Phase 2 Results – Sarcopenia Primary Endpoint Met
LPCN 1148 Phase 2 Results – Sarcopenia Primary Endpoint Met Resolution of 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 sar
Slide 33: 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 34: 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 35: LPCN 2401
LPCN 2401 Obesity Management – adjunct to GLP-1
Slide 36: 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 37: 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 38: 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 39: 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 40: 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 41: LPCN 1107
LPCN 1107 Pioneering A Solution to the Preterm Birth Health Crisis
Slide 42: 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