Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (April 2026)
47 slides from Lipocine's investor presentation, Apr 2, 2026
Slide 1: Corporate Presentation April 2026
Corporate Presentation April 2026 LIPOCIN= ENHANCING HEALTH
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 (BRLIZIO™) (PPD) CD based on FDA feedback Major Depressive Disorder Neuroactive _LPCN 2201 (MDD) Phase 2ROCstudy Steroids LPCN 2
Slide 4: Lipocine's Proprietary Technology
Lipocine’s Proprietary Technology Overcoming oral drug delivery challenges A Lip’ral based 4 Dug Citiee = pits loaded dosage form ai farrier ag ==> Insoluble drug lipid composition GI Aqueous Intestinal Systemic Lumen Barrier Layer Wall Circulation Section of GI magnified to illustrate absorption Ef
Slide 5: Oral Brexanolone for PPD (Postpartum Depression)
Oral Brexanolone for PPD (Postpartum Depression) BRLIZIO“is the brand name conditionally approved by FDA
Slide 6: 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 economy"? Rapid relief bene
Slide 7: 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 with PPD®> with consequences beyond the mother + Treatment goalis rapid harm reduction for both mother and infant «
Slide 8: LPCN 1154 - Target Product Attributes Addresses Unmet Medical Need
LPCN 1154 - Target Product Attributes Addresses Unmet Medical Need Oral Dosage Form Comprising Brexanolone Identical to Fixed dose endogenous without titration allopregnanolone @ or taper required 48-hour outpatient dosing LIPOCIN= Lipocine | 2026 8
Slide 9: 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 more rapid relief of PPD than approved treatments, with only a short (48-hour) treatment requirement. Zuranolone (ZURZUVAE®) treatment is as
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 medical monitoring Inclusion criteria E
Slide 11: Overall population baseline demographics
Overall population Baseline Demographics Characteristics N Age (years) (Mean, SD) BMI (kg/m2) (Mean, SD) Ethnicity (HISP; %) Race (White; %) AD use at baseline (%) HAM-D at baseline (Mean, SD) History of psychiatric condition (based on MINI) (N, %) History of depression * 15 sites randomized partici
Slide 12: Efficacy Results
Efficacy Results History of Psychiatric Overall Population N=90 Condition Subset* Timepoint N=54 Placebo-adjusted Statistical Placebo-adjusted Statistical Difference Significance Difference Significance -3.9 P<0.01 -7.2 P<0.001 eff NSS -5.0 P<0.05 -1.3 NSS -6.1 P<0.01 Day 7 Gace. NSS -4.2 NSS Day 30
Slide 13: Primary Endpoint: HAM-D CFB at Hour 60
Primary Endpoint: HAM-D CFB at Hour 60 Primary endpoint not met HAM-D Change From Baseline over Time Hour 12 Hour 36 Hour 60 Day 7 Day 30 0 co) £ 7) o a 5 = o 2° irae 0 2 -10 a a oO o = q -15 = -20 e==LPCN 1154 (N=45) ===Placebo (N=45) ** )<0.01 LIPOCINE —_ Hsinicatiatsaoustudunicrosarosas — Mixed m
Slide 14: Patients with PPD and Psychiatric Conditions
Patients with PPD and Psychiatric Conditions Appropriate for Subgroup Analysis v 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 15: PPD with History of Psychiatric Conditions
PPD with History of Psychiatric Conditions Baseline demographics Characteristics LPCN 1154 Placebo N 24 30 Age (years) (Mean, SD) 31.0/(5.5) 30.8 (6.6) BMI (kg/m2) (Mean, SD) 31.6 (6.6) 30.1 (6.7) Ethnicity (HISP; %) 41.7 50.0 Race (White; %) 50.0 60.0 AD use at baseline (%) 12.5 i33 HAM-D at baseli
Slide 16: PPD with History of Psychiatric Conditions
PPD with History of Psychiatric Conditions HAM-D Change from Baseline HAM-D Change From Baseline over Time Hour 12 Hour 36 Hour 60 Day7 Day 30 oO o = Go a o a 5 £ & o aeK = -10 * 5 6 a ** =. Zz 15 * i -20 —=LPCN 1154 (N=24) ==Placebo (N=30) * p<0.05; ** p<0.01; *** p<0.001 LIPOCIN: hittps://clinical
Slide 17: 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 (Gl) 3 (6.7) 8 (8.9) Any severe TEAE 2 (4.4) 0 (0.0) 222) Any serious TEAE AN(272) 0 (0.0) AGrAg) TEAEs in 2 2 part
Slide 18: 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 Y 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 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 Anti-Depressants (RAAD) Superior tolerability following: Bioidentical, benign side-effect profile, and devoid of psychotomimetic effects For rapid-acting antide
Slide 20: Oral Brexanolone for Major Depressive Disorder
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Slide 21: Major Depressive Disorder (MDD)
Major Depressive Disorder (MDD) Definition and Facts = Major depression is acommon and treatable mood disorder characterized by changes in cognitive and physical symptoms lasting for at least 2 weeks! = ~332 million people with MDD worldwide? " Depression carries a high economic burden®and is a lead
Slide 22: MDD Market Potential
MDD Market Potential Total annual burden of medication-treated MDD among the US population was $92.7 billion’ Severe MDD is strongly linked to significant difficulty in work, social, and home acti met Needs in Depressi MDD prevalence 8.4% -) Rapid Relief c Hours/Days, especially for severe MDD of po
Slide 23: LPCN 2201 - Targeted Attribute-Based Product Differentiation
LPCN 2201 - Targeted Attribute-Based Product Differentiation Potential Rapid Acting Anti-depressant (RAAD) Product Attribute* Mechanism of Action Onset of Efficacy Monitoring/ LPCN 2201 (Neuroactive Steroid) Positive GABA, modulator Oral Hours to days TBD Plier Not expected/At home SPRAVATO (Esketam
Slide 24: 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 Y High unmet need for oral RAAD; large market potential Y Leverage LPCN 1154 data G Streamlined development G Issued and pending patent claims for MDD indication -~
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Slide 26: Essential Tremor (ET)
Essential Tremor (ET) Market potential - $3B+ blockbuster opportunity as 2nd line with 20% peak adoption : Tremor is highly disabling and stigmatizing t Estimated prevalence 2.2 % of population’ Stress can aggravate tremor in social setting Major impact on activities of daily living leading to unemp
Slide 27: 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 Ga GF) Unmet Need Standard of Care Limitations Superior benefit to risk profile Unfavorable benefit to risk profile? « Improve efficacy » Most patients are intolerant or h
Slide 28: LPCN 2101 for Epilepsy
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Slide 29: Drug-Resistant Epilepsy (DRE)
Drug-Resistant Epilepsy (DRE) A significant clinical challenge in epilepsy care with high social and occupational limitations! Prevalence Affects 30-40% of epilepsy patients in the U.S. 2 Clinical Increased risk of injury, hospitalization, mortality, and mental health i. 1 DRE is defined by ILAE as
Slide 30: Unmet Needs in DRE
Unmet Needs in DRE Seizure freedom without adverse effects, while improving the patient's quality of life tations 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 limited succe
Slide 31: LPCN 2101 — NAS for Epilepsy Treatment
LPCN 2101 — NAS for Epilepsy Treatment Positive Allosteric Modulator (PAM) of the GABA, receptor Product Candidate Anti-Seizure Activity in First Oral Enablement Differentiation Preclinical Models Phase 1 Results * Novel MOA specifically ¢ Effective in most of the tonic 5 § addressing DRE and/or clo
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Slide 33: TLANDO® Testosterone Replacement Therapy (TRT)
TLANDO® Testosterone Replacement Therapy (TRT)
Slide 34: 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. af P $11 million upfront payment to Lipocin
Slide 35: LPCN 1148 Management of Liver Cirrhosis
& q a PCN 1 Management of Liver Cirrhosis Overt Hepatic Encephalopathy (OHE) Sarcopenia in Decompensated Cirrhosis (Fast Track Designation)
Slide 36: LPCN 1148 - Unique Opportunity Addressing Two Distinct Liver Disease Markets
LPCN 1148 - Unique Opportunity Addressing Two Distinct Liver Disease Markets Positive POC Phase 2 results in treatment of sarcopenia and OHE in cirrhosis Analogue (Rifaximin) Sales 100 0 2D DD gh gb ob nb gh ah ah gh ah Po me PD DP PD FKL FM FW KK VP of Sales ($M) g Bofft Global Research, Pharmaceut
Slide 37: 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) a x 1 x 33% 2 = 30% s 5 g 5 = 3 a 3 S 20% z 8 x) & 10% 3 g Week 2 os 0% 2@"1PCN 1148 eG} Placebo mm Placebo to 1148 LPCN 1148 Pinedo ~9% increase in L3-S
Slide 38: 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 Parameter: Placebo LPCN 1148 LPCN 1148 from placebo N=14 N=15 N=11 LY N=8 History of HE prior to randomization (n) 11 (79%) 11 (73%) 7 (64%) 6 (75%) Recurrent Overt H
Slide 39: 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 40: LPCN 2401 Obesity Management
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Slide 41: Unprecedented Demand and Usage of GLP-1 Receptor Agonists
Unprecedented Demand and Usage of GLP-1 Receptor Agonists” GLP-1 market trending toward oral once daily dosing Semaglutide: $30 billion sales in the US in 20244 v T2DM Tirzepatide: $14 billion sales in the US in 20245 y¥ Weight management FDA approved indications v Cardiovascular disease y Chronic k
Slide 42: 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 Loss" Functionality Loss' Fracture Risk23 Weight Loss FatLoss__ Lean Mass Loss. o i, 32% g mSemaglutide 3 FH Placebo > Lean mass &, : s 3 a PB 68% a $4 Fat mass 3 . x 5 °
Slide 43: 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 44: 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 (kg) Appendicular Lean Mass (kg) Total Fat Mass Trunk Fat Mass 254 (kg) (kg) re 2 4 rd il * 09 15 4 12 hea * * 04 + 0 SB a SB x S SB
Slide 45: 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 More ab
Slide 46: LPCN 1107 Prevention of Preterm Birth
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Slide 47: 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