Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (January 2026)
38 slides from Lipocine's investor presentation, Jan 12, 2026
Slide 1: Corporate Presentation January 2026
Corporate Presentation January 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 Obesity Management adjunct to GLP-1 Seeking regulatory clarity for P2 study Development Candidate (Indication) _ Pre-Clinical Phase 1 Phase 2 Pivotal Next Steps/Status Phase 3 LPCN 1154 I + Zier safety update 1/26 Postpartum Depression + Topline results Q2/26 Ta > rroco Major Depre
Slide 4: 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/ » = ~ Brae ona-2 Rony Pe le iy, . PATLANDO: -ANDC - 120 capsules 120 capsules TLANDO® licensed to Verity Pharma in January 2024
Slide 5: Oral Brexanolone for PPD
Oral Brexanolone for PPD (Postpartum Depression) me conditionally approved by FDA
Slide 6: PPD - A Significant Global Health Issue Affecting Families Worldwide
PPD - A Significant Global Health Issue Affecting Families Worldwide Estimated ~ 24 million new cases of PPD annually worldwide’ Prevalence of PPD in pregnant women Northern Europe Switzerland 22% oa taster Asia ech ane 17% UK 21% 4 = Brazil 21% A South-Eastern Asia China 18% Southern Asia 9 14% Wes
Slide 7: Postpartum Depression (PPD) - An Expanding Market Opportunity
High economic burden Goal of medical intervention is to prevent harm to mother and infant Negative impact on family/society Among women reporting PPD symptoms, 64% reported comorbid anxiety symptoms” Suicide is a leading cause of maternal death in the first year following childbirth’ - Upto 30% of w
Slide 8: 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 9: 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= L
Slide 10: 1154 - Oral Bioidentical Neuroactive Steroid (NAS) for PPD
LPCN 1154 - Oral Bioidentical Neuroactive Steroid (NAS) for PPD Overcoming brexanolone oral delivery challenges — Brexanolone Oral enablement Lip’ral based Ae a DrugLoaded dosage form at Dug + Senter = Carrier e = | ol Aqueous Intestinal Systemic Luinen Barrier Layer Wall _—_ Circulation Insoluble d
Slide 11: 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 » Minimal disruption to the mother-chil
Slide 12: 1154 Dosing Regimen Confirmation Study Results
LPCN 1154 Dosing Regimen Confirmation Study Results LPCN 1154 met standard bioequivalence criteria to 1V Brexanolone Comparative Exposure PK GMR (%) 90% CILB 90% Cl UB LPCN 1154 was well tolerated Parameter Test vs. Test vs. Test vs. No sedation or somnolence events observed a < . All events were mi
Slide 13: 1154 Phase 3 Safety and Efficacy Study (NCT06979544)
LPCN 1154 Phase 3 Safety and Efficacy Study (NCT06979544) 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 Inclusion criteria Endpoints Rationale for Success
Slide 14: 1154 - Development Status
LPCN 1154 - Development Status Streamlined 505(b)(2) pathway to NDA submission Dosing Regimen Confirmation Study Labeling Studies Evaluation Ongoing P3 Study Y Positive Results V Food effect study V PK study in PPD Y Metabolite evaluation © Per 2"4 DSMB meeting, study to continue as planned © Study
Slide 15: 1154 - Potential “Game Changer” for Fast Acting Depression Therapy
LPCN 1154 - Potential “Game Changer” for Fast Acting Depression Therapy Key takeaways Significant market opportunity Differentiated product attributes addressing unmet needs Rapid relief, short treatment duration, superior tolerability Streamlined pathway to NDA submission Dosing regimen confirmed P
Slide 16: Major Depressive Disorder (MDD)
Major Depressive Disorder (MDD)
Slide 17: Major Depressive Disorder Market Potential
Major Depressive Disorder 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 ant Unmet Needs in Depression Disorders ma MDD prevalence 8.4% \) ii i Hour
Slide 18: 2201- Differentiated Mechanism of Action
LPCN 2201- Differentiated Mechanism of Action Neuroactive Steroid, proven efficacy in PPD, an episodic MDD Positive allosteric modulator of the GABA, receptor’ and TLR signaling modulator? Presynaptic Terminal Postsynaptic Terminal ‘Synaptic GABA Receptor Benzodiazepine a B 7 binding sito Extrasynap
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 SSRI/SNRI ee Product Attribute! (Neuroactive Steroid) (Esketamine)! (Dextromethorphan + bupropion)? Serotonin reuptake inhibition (SSRI) or serotonin + norepinephrin
Slide 20: 2201 - Oral RAAD for Acute Major Depression Disorders
LPCN 2201 - Oral RAAD for Acute 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 . Conv
Slide 21: Treatment of Epilepsy
LPCN 2101 Treatment of Epilepsy
Slide 22: Drug-Resistant Epilepsy (DRE)
Drug-Resistant Epilepsy (DRE) A significant clinical challenge in epilepsy care with high social and occupational limitations! Prevalence Clinical Impact Drug-Resistant Epilepsy (DRE) is defined by ILAE as the failure of two appropriate anti-seizure medications (ASMs) to achieve sustained seizure fr
Slide 23: 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 24: 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 25: 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 26: Management of Liver Cirrhosis
Management of Liver Cirrhosis Overt Hepatic Encephalopathy (OHE) Sarcopenia in Decompensated Cirrhosis (Fast Track Designation)
Slide 27: 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 background SOC Analogue (Rifaximin) Sales +—Validated regulatory pathway 250 = |_| Acommercially successful 21° surrogate
Slide 28: 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 29: 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 30: 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 31: Obesity Management — adjunct to GLP-1
Obesity Management — adjunct to GLP-1
Slide 32: 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 v Weight management FDA approved indications Y Cardiovascular disease ¥ Chronic
Slide 33: 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 34: 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 35: 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 36: 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 weightregain Attenuate functionality loss Maintain/improve functionality More
Slide 37: Through Partnering
hrough Partnering
Slide 38: 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