Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (May 2026)
58 slides from Lipocine's investor presentation, May 7, 2026
Slide 1: Corporate Presentation May 2026
Corporate Presentation May 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 ey ee ieee . Major Depressive Disorder rti‘d Neuroactive LPCN 2201 aes) Phase 2 POC study Steroids ; LPCN 2203 Essential Tremor
Slide 4: Lipocine's Proprietary Technology
Lipocine’s Proprietary Technology Overcoming oral drug delivery challenges n ‘ rN = Drug Loaded Lip'ral based S&B Drug Carrier — A dosage form at a bested = sl Aqueous Intestinal Systemic Lumen Barrier Layer Wall Circulation Insoluble drug lipid composition Section of GI magnified to illustrate abso
Slide 5: First Oral Brexanolone for PPD
First Oral Brexanolone for PPD (Postpartum Depression) BRLIZIO“is the brand name conditionally approved by FDA.
Slide 6: Unmet Needs in PPD and Benefits of Product Target Attributes
Unmet Needs in PPD and Benefits of Product Target Attributes PPD i a life-threate n with few exi g condi ig treatment options Maternal depression and suicide can have far-reaching consequences for child development, family function, and the nation's economy™? hort Treatment Les ae | pus ieane — Dura
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 Estimated patients i e U.S. with PPD® High clinical and economic burden with consequences beyond the mother Treatment goal is rapid harm reducti
Slide 8: 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 Zuranolone SSRIs/SNRIs LPCN 1154 (Brlizio) is expected to provide (ZURZUVAE®) Off-Label Use rapid relief of PPD with a short (48-hour) treatment Synthetic NAS Description Synthetic SS
Slide 9: 1154 - Achieved Standard Bioequivalence to IV Brexanolone
LPCN 1154 - Achieved Standard Bioequivalence* to IV Brexanolone Dosing regimen confirmation study results Bioequivalent to Zulresso PK Parameter Cmax (ng/mL) AUCo..0 (h*ng/mL) AUCo-100 (h*ng/mL) LPCN 1154 120 4884 4266 IV Brexanolone 115 5019 4784 GMR Test vs. Reference (90% Cl) 105% (92-118) 97% (8
Slide 10: 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: 1154 - P3 Results Summary
LPCN 1154 - P3 Results Summary Strong efficacy signal in clinically relevant subgroups Overall Study Population LPCN 1154 showed a numerically greater reduction from baseline in HAM-D total score compared to placebo at Hour 60 (primary endpoint) but the improvement was not statistically significant
Slide 12: Overall Population Baseline demographics
Overall Population* Baseline demographics Characteristics N Age (years) (Mean, SD) BMI (kg/m2) (Mean, SD) Ethnicity (HISP; %) Race (White; %) Antidepressant use at baseline (%) HAM-D at baseline (Mean, SD) History of psychiatric condition** (N, %) History of depression condition** (N, %) *AIL15 site
Slide 13: 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 v Well defined condition characterized via standardized tool, MINI © Validated structured clinical interview for DSM and ICD psychiatric disorders + Majority of patients w
Slide 14: 1154 Subgroup - Baseline demographics
LPCN 1154 Subgroup — PPD with History of Psychiatric Condition* Baseline demographics Characteristics N Age (years) (Mean, SD) BMI (kg/m2) (Mean, SD) Ethnicity (HISP; %) Race (White; %) Antidepressant use at baseline (%) HAM-D at baseline (Mean, SD) History of psychiatric condition** (N, %) History
Slide 15: 1154 Subgroup - HAM-D Change From Baseline
LPCN 1154 Subgroup — PPD with History of Psychiatric Condition* Rapid, durable, and statistically significant improvement across multiple timepoints HAM-D Change From Baseline Overtime HAM-D Change From Baseline over Time History of Psychiatric Condition* aeeee 7. N=54 Hour 35 Hour 60 Dey7 Dey 30 Pl
Slide 16: 1154 Subgroup - 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 Lil hh Hour12 Hour36 Hour60 Day? — Day30 Cumulative flcumi2) (Eeues6: Houg
Slide 17: Comparison between Epidemiologic Outlier Site and Other Sites
Comparison between Epidemiologic Outlier Site and Other Sites** One site was identified as an outlier by treatment-by-site interaction analyses Outlier Site Outlier Site Vs Other 14 sites Outlier Site Vs Placebo Effect Vs Other 14 sites Other 14 sites Baseline Psychiatric Condition Characteristics R
Slide 18: Subgroup Analysis Excluding Epidemiologic Outlier Site
Subgroup Analysis Excluding Epidemiologic Outlier Site Baseline demographics Characteristics LPCN 1154 N 2 Age (years) 30.0 (5.9) BMI (kg/m?) 31.9 (6.4) Ethnicity (HISP; %) 40.7 Race (White; %) 55.6 Antidepressant use at baseline (%) 110 HAM-D at baseline (Mean, SD) 28.8 (3.3) History of psychiatric
Slide 19: Subgroup Analysis Excluding Outlier Site - HAM-D Change
Subgroup Analysis Excluding Epidemiologic Outlier Site* Rapid, durable, and statistically significant improvement across multiple timepoints HAM-D Change From Baseline Overtime Hour 60 HAM-D Change From Baseline s===LPCN 1154 (N=27) ==Placebo (N=33) * p<0.05; ** p<0.01; *** p<0.001. Excluding Outlie
Slide 20: Subgroup Analysis Excluding Outlier Site - Responder and Remitter
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 80 60 E oo g G @ 40 3 2 fe} [= % 40 Z ee 9 on = 20 2 20 | ] x : 1 [| | , in ' li Hour 12
Slide 21: 1154 - PK/PD Correlation
LPCN 1154 — PK/PD Correlation Rapid and sustained target engagement * B band qEEG activity is a validated, objective biomarker of GABA-A receptor modulation * Significant increase in B band amplitude — Confirms target engagement (GABA-A receptor) — Early (2h) and sustained (12h) effects — Consistent
Slide 22: 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 History of Psychiatric Excluding Outlier Site Condition (N=60) (N=54) HAM-D17! “7.2 Tp) 88 HAM-At -6.3 ** -6.3 ** AME DHE 37.5% vs 6.7% ** 38.5% vs 6.3% ** Response? (
Slide 23: 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 + PPD with history of psychiatric condition * Study population that is consistent with PPD epidemiol
Slide 24: Overall Population Safety
Overall Population Safety LPCN 1154 was well tolerated Any TEAE 8 (17.8) 8 (17.8) Any treatment-related TEAE B71) 3 (6.7) Any severe TEAE 2 (4.4) 0 (0.0) Any serious TEAE 1 (2.2) 0 (0.0) "TEAEs in 22 participants in LPCN 1184 arm Headache 2(4.4) 3 (6.7) Dizziness 2(4.4) 0 (0.0) Somnolence 2 (4.4) 0
Slide 25: 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 SG Consistent and coherent efficacy signalin patients with PPD * HAM-D placebo adjusted change from baseline less than or equal to 4 at all timepoints * Supporting secondary responder and remission e
Slide 26: 1154 - Differentiated Tolerability
LPCN 1154 - Differentiated Tolerability Comparison to Zurzuvae safety* iAdvorse|Roseticn LPCN 1154A Placebo Zurzuvae Placebo (N=45) (N=45) (N=171) (N=169) Key Adverse Reactions Somnolence and sedation 19-36% 6-11% 8-13% Fatigue 0% 0% 5% Diarrhea 0% 0% 5-9% 2-3% Memory impairment 0% 0% 3% 0% Tremor 0
Slide 27: 1154 Demonstrated Differentiated Efficacy Signal
LPCN 1154 Demonstrated Differentiated Efficacy Signal Zurzuvae Mean CBL in HAM-D Total Score Over Time in Study" 0 2-e*+Placebo —e— ZURZUVAE 50 mg LS Mean Change from Baseline (HAM-D Total Score) Time (day) Differential HAMD-17 Total Score at Day 15* Study Number —_ Mean Placebo Subtracted Differenc
Slide 28: 1154 Next Regulatory Steps
LPCN 1154 Next Regulatory Steps @ e @ 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 LIPOCIN= Lipocine | 2026 28
Slide 29: 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: ao =
Slide 30: LPCN 2201 Oral Brexanolone for Major Depressive Disorder
Slide 31: 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 lea
Slide 32: 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 ac MDD prevalence 8.4% of population? 61% received treatment? 38% with suicidal ideation? ~33% severe SPRAVA
Slide 33: 2201 - Targeted Attribute-Based Product Differentiation
LPCN 2201 - Targeted Attribute-Based Product Differentiation Potential Rapid Acting Anti-Depressant (RAAD) AUVELITY Product Attribute* fants Demue id) pice (Dextromethorphan + SSRI/SNRI Psychedelics roel bupropion)? A Serotonin reuptake NMDA receptor antagonist inhibition (SSR) or Mechanism of Posit
Slide 34: Differentiated Target Attributes as a Rapid-Acting PPD treatment
Differentiated Target Attributes as a Rapid-Acting PPD treatment* Potential to meet RAAD criteria FDA Criteria for Rapid-Acting Anti-Depressants (RAAD) Efficacy generally should be demonstrated within 1 week for a rapid-acting antidepressant. Some novel antidepressants are thought to be effective wi
Slide 35: 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 7~ Attributes ————— SY High unmet need for oral RAAD; large market potential LPCN 2201 @ Rapid Relief Gi Leverage LPCN 1154 data Convenient Oral bam At-Home Use EXD
Slide 36: Appendix
Appen
Slide 37: LPCN 2203 Oral Brexanolone for Essential Tremor
Slide 38: 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 ; : ravi re r ial $—* 2.2% of population Stress can aggravate tremor in social setting * Major impact on activities of daily l
Slide 39: 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 Ba? CE Gl) Unmet Need Standard of Care Limitations Competitive Landscape Superior benefit to risk profile Unfavorable benefit to risk profile? * Propranolol is the first
Slide 40: LPCN 2101 Treatment of Epilepsy
Pf. PCN 2101 @> o i? Treatment of Epilepsy
Slide 41: 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 Impact health issues" DRE is defined b
Slide 42: Unmet Needs in DRE
Unmet Needs in DRE Seizure freedom without adverse effects, while improving the patient's quality of life imitations 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 su
Slide 43: 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 addressing DRE and/or clonic,
Slide 44: TLANDO Testosterone Replacement Therapy (TRT)
TLANDO® Testosterone Replacement Therapy (TRT)
Slide 45: TLANDO - FDA-Approved Oral Testosterone Replacement Therapy
TLANDO® - FDA-Approved Oral Testosterone Replacement Therapy Established commercialization partnerships in multiple territories IMPORTANT SAFETY INFORMATION, www.tlando.com/ Capsules n25 ms G, seen 120 capes TRT is a large and grow LOS TLANDO® licensed to Verity Pharma in January 2024 for commercial
Slide 46: Management of Liver Cirrhosis
Management of Liver Cirrhosis Overt Hepatic Encephalopathy (OHE) Sarcopenia in Decompensated Cirrhosis a, (Fast Track Designation) ¢z x ee x ,
Slide 47: 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 Sales ($M) Perr om Pm me PP oo LEP EO LS ILS Both Global Recearch Pharmaceutical Scrpt/Sale: DataReport 21 January 2025
Slide 48: 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) 40% 2 a x 33% 2 = 30% 3 = s = c b 4 ao | a 3 3 20% & & 6 S 10% 3 FA Week J oy 0% PCN 1148 Placebo Placeb« 1148 =O LPCN 1148 @@= Placebo ew Placebo to 11
Slide 49: 1148 Phase 2 Results - HE Endpoint Met
LPCN 1148 Phase 2 Results — HE Endpoint Met Fewer overt hepatic encephalopathy events Parameter History of HE prior to randomization (n) Recurrent Overt HE (events) Time to first recurrent event (days) Placebo N=14 11 (79%) Through Week 24 35 CHE is defined as an adverse event of HE with CTCAE sever
Slide 50: 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 Parameter Total AEs Serious AEs Severe AEs Deaths LPCN 1148 switch fro
Slide 51: Obesity Management - adjunct to GLP-1
AG 71 Za | | & Obesity Management — adjun to GLP-1 ii
Slide 52: 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 Tirzepatide: $14 billion sales in the US in 2024° v T2DM v Weight management FDA approved indications vy Cardiovascular disease v Chronic k
Slide 53: 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 Risk?> Weight Loss FatLoss Lean Mass Loss ° ‘2 32% g mSemaglutide 3 = Placebo ae Lean mass fe H 3 P 68% a a4 Fat mass 3 = & s eI Signif
Slide 54: 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 55: 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 > GD Lean Mass (kg) Appendicular Lean Mass (kg) Total Fat Mass Trunk Fat Mass 254 (kg) (kg) e 2 1 : xe 09 154 ie 12 we * si oO oO 3S S SB 2 o S
Slide 56: 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 57: Prevention of Preterm Birth (PTB)
Prevention of Preterm Birth (PTB)
Slide 58: 1107 for Prevention of Preterm Birth
LPCN 1107 for Prevention of Preterm Birth Product candidate highlights Oral dosage form comprising 17-hydroxyprogesterone caproate >$2B market potential with no approved drug Strong pharmaco-economic justification Potential to be SOC in prevention of preterm birth Oral, a Major Contribution to Patie