Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (February 2026)
44 slides from Lipocine's investor presentation, Feb 18, 2026
Slide 1: Corporate Presentation February 2026
Corporate Presentation February 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 i Caio) ee" Pe Ypres 7 . Major Depressive Disorder GD Neuroactive LPCN 2201 (MDD) Phase 2 POC study Steroids ; LPCN 2203 Essential Tremor (ET) Gap Phase 1 study completed LPCN 2101 Brug
Slide 4: Oral Brexanolone for PPD (Postpartum Depression)
Oral Brexanolone for PPD (Postpartum Depression) me conditionally approved by FDA
Slide 5: 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 benef
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 with consequences beyond the mother Treatment goal is rapid harm reduction for both mother and infant Meaningful negative impact on family stabil
Slide 7: 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 Bromeatone Zuranolone |IV Brexanolone] SSRIs / SNRIs more rapid relief of PPD than approved een (ZURZUVAE®) (Zulresso®)® Off-Label Use treat
Slide 8: 1154 - Target Product Attributes Addresses Unmet Medical Need
LPCN 1154 - Target Product Attributes Addresses Unmet Medical Need Strong potential to set the benchmark for first-line therapy Oral Dosage Form Comprising Brexanolone Identical to endogenous Fixed dose 48-hour : ji . without titration outpatient dosing allopregnanolone @ or taper required LIPOCIN=
Slide 9: 1154 — Oral Bioidentical Neuroactive Steroid (NAS) for PPD
LPCN 1154 —- Oral Bioidentical Neuroactive Steroid (NAS) for PPD Overcoming brexanolone oral delivery challenges Brexanolone ral enablement Lip’ral based rey ostostori TBRowe + igo = Ba Drug loaded e = | ol Aqueous Intestinal Systemic Barrier Layer Wall _—_ Circulation Insoluble drug lipid compositi
Slide 10: 1154 - Formulation Screening and Dose Finding/Confirmation Studies
LPCN 1154 - Formulation Screening and Dose Finding/Confirmation Studies Seven clinical studies conducted prior to P3 study Oral bioavailability of LPCN 1154 confirmed Formulation selected Linear PK (AUC and C,,,,) across all dose strengths evaluated Single-dose and multi-dose regimens qEEG provides
Slide 11: 1154 — Dosing Regimen Confirmation Study Results
LPCN 1154 — Dosing Regimen Confirmation Study Results Results inform dosing regimen for Phase 3 safety and efficacy confirmatory study (NCT06979544) Bioequivalent to Zulresso Brexanolone was well tolerated independent of route PK wae No sedation or somnolence events observed Paraivister LPCN 1154 IV
Slide 12: 1154 — Phase 3 Safety and Efficacy Study
LPCN 1154 — Phase 3 Safety and Efficacy Study Based on FDA feedback — outpatient setting with no medical monitoring requirement Study design * Two arm, outpatient, randomized, blinded, placebo-controlled in women with postpartum depression * Utilizes same dose and regimen as the PK dose confirmation
Slide 13: 1154 - Phase 3 Study Updates and Rationale for Success
LPCN 1154 - Phase 3 Study Updates and Rationale for Success Study Updates . Two DSMB data review meetings complete Enrollment and dosing complete (N=90) Expected topline results: Early Q2 2026 E> Rationale for Success Efficacy of brexanolone established in multiple IV infusion (Zulresso) studies LPC
Slide 14: 1154 - Safety Update
LPCN 1154 - Safety Update Favorable safety profile Phase 3 Study’ Safety Update (Blinded) » Allreported nervous system disorders AEs were mild to moderate in severity » No reports of drug discontinuations » Unlike IV brexanolone (Zulresso”™), no reported cases of: ~ Excessive sedation — Loss of cons
Slide 15: 1154 - Development Status
LPCN 1154 - Development Status Streamlined 505(b)(2) pathway to NDA submission targeted mid 2026 Dosing Regimen Confirmation Study Labeling Clinical Studies Ongoing P3 Study VY Positive Results V Food effect study VY Dosing completed V PK study in PPD V Two DSMB data review VY Metabolite evaluation
Slide 16: 1154 - Potential “Game Changer” for Fast Acting Depression Therapy
LPCN 1154 - Potential “Game Changer” for Fast Acting Depression Therapy Key takeaways Large, attractive market opportunity /— Treatment Duration —————\ Differentiated product profile addressing unmet needs ' tated’ procuct prom —_ . LPCN 1154 Rapid relief, short treatment duration, superior tolerabi
Slide 17: Oral Brexanolone for Major Depressive Disorder (MDD)
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 billion’ Severe MDD is strongly linked to significant difficulty in work, social, and home activities n Disorders Ee MDD prevalence 8.4% \) H H Hours/D: ially for re MDD of population? E@) Rapid Reli
Slide 19: 2201 - Targeted Attribute-Based Product Differentiation
LPCN 2201 - Targeted Attribute-Based Product Differentiation Potential Rapid Acting Anti-depressant (RAAD) LPCN 2201 SPRAVATO AUVELITY (Neuroactive Steroid) (Esketamine)' (Dextromethorphan + bupropion)? SSRI/SNRI Product Attribute* Serotonin reuptake inhibition (SSRI) or serotonin + norepinephrine r
Slide 20: 2201 - Oral RAAD for Major Depression Disorders
LPCN 2201 - Oral RAAD for Major Depression Disorders Potential to set rapid relief benchmark for MDD 7 Attributes ————W——— ( Y High unmet need for oral RAAD; large market potential LPCN 2201 @ Rapid Relief Y Leverage expertise/credibility and investment/value in oral NAS created to date Convenient O
Slide 21: Slide 21
Slide 22: Essential Tremor (ET)
Essential Tremor (ET) Market potential - $3B+ blockbuster opportunity as 2nd line with 20% peak adoption Estimated prevalence 2.2 % of population’ 20% peak adoption $3.6B* 1, Louis ED, Ottman R. Tremor Other Hyperkinet Mov (N Y). 2014;4:259. 2. Gerbasi etal. Patient experiences in essential tremor:
Slide 23: 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 Superior benefit to risk profile * Improve efficacy » Fewer side effects * Somnolence * Dizziness * Constipation » Address anxiety/depression comorbidity * Dise
Slide 24: 2101 Treatment of Epilepsy
LPCN 2101 Treatment of Epilepsy
Slide 25: Drug-Resistant Epilepsy (DRE)
Drug-Resistant Epilepsy (DRE) A significant clinical challenge in epilepsy care with high social and occupational limitations! DRE is defined by ILAE as the failure of two appropriate anti-seizure medications (ASMs) to achieve sustained seizure freedom Prevalence Clinical Impact Economic Burden Trea
Slide 26: Unmet Needs in DRE
Unmet Needs in DRE Seizure freedom without adverse effects, while improving the patient's quality of life L ns 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 success
Slide 27: 2101 - Eltanolone for Epilepsy Treatment
LPCN 2101 - Eltanolone for Epilepsy Treatment Positive Allosteric Modulator (PAM) of the GABA, receptor Product Candidate Differentiation * Novel MOA specifically addressing DRE * Active molecule is bioidentical to endogenous NAS * Potential to address psychiatric comorbidities (depression, anxiety,
Slide 28: 2101 Development Status
LPCN 2101 Development Status Phase 2 ready Preclinical PK Preclinical Toxicity Phase 1 Studies Next Steps Vv First oral enablement VY Chronic Vv IND cleared O Initiate P2 study demonstrated arena was Y Confirmed oral Y Achieved ~10x of enablement tolerated estimated highest target therapeutic level
Slide 29: TLANDO® Testosterone Replacement Therapy (TRT)
&TLANDO® Testosterone Replacement Therapy (TRT)
Slide 30: 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. P $11 million upfront payment to Lipocine y
Slide 31: Appendix
Slide 32: Management of Liver Cirrhosis
Management of Liver Cirrhosis Overt Hepatic Encephalopathy (OHE) Sarcopenia in Decompensated Cirrhosis (Fast Track Designation)
Slide 33: 1148 - Unique Opportunity Addressing Two Distinct Liver Disease Markets
LPCN 1148 - Unique Opportunity Addressing Two Distinct Liver Disease Markets Positive POC Phase 2 results in treatment of sarcopenia and OHE in cirrhosis Analogue (Rifaximin) Sales 200 00 a LP EPL PLL ORE 8 BofA Global Research, Pharmaceutical Scripts/Sales Data Report 21 January 2025 Sales ($M) Ss
Slide 34: 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) % CBL L3-SMI Week =<@= (PCN 1148 @@= Placebo =@= Placebo to 1148 ~9% increase in L3-SMI at week 24 40% 30% 20% 10% Resolution of Sarcopenia at Week 24 0%
Slide 35: 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) Through Week 24 Placebo LPCN 1148 N=14 N=15 11 (79%) 11 (73%) 6 sl oD 114 Week 24 to EOS LPCN 1148
Slide 36: 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 Placebo LPCN 1148 LP
Slide 37: Obesity Management — adjunct to GLP-1
i Y F fr 41 Obesity Management — adjunct to GLP-1
Slide 38: 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 20245 As of 2024, around 12 percent of U.S. adults reported having used a GLP-1 medication at
Slide 39: 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 Weight Loss Fat Loss Lean Mass Loss ° 8.6% comaglutide Mean change from Significant weight loss is from lean mass loss in 16 weeks! 32% Lean mass 68% Fat mass The median percentage of total
Slide 40: 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 41: 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 25 4 (kg) (kg) >| 2 1 * 09 1S + 16 12 ~ 14 0 0 g a a 05 4 — zZ 6 a a 0
Slide 42: 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 1 1 Preserve lean mass Primarily fat loss Minimize fat regain Minimize weight regain Attenuate functionality loss Maintain/improve functionality Mor
Slide 43: 1107 Prevention of Preterm Birth (PTB)
LPCN 1107 Prevention of Preterm Birth (PTB)
Slide 44: 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