Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (November 2025)
47 slides from Lipocine's investor presentation, Nov 18, 2025
Slide 1: Corporate Presentation November 2025
Corporate Presentation November 2025 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 Candidate (Indication) Pre-Clinical Phase 1 Phase 2 Pivotal Next Steps/Status LPCN 1154 Postpartum Depression LPCN 2202 Treatment Resistant Depression (TRD) LPCN 2101 Drug Resistant Epilepsy (DRE) LPCN 2401 Obesity Management — adjunct to GLP-1 LPCN 1148 Liver Cirrhosis
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 https://www.tlando.com/ Biocon aon BP? ud -ANDO’ Bost care ‘a Yes, TLANDO’ 120 capsules Yc Ss Sp 4 120 capsules 4 is a large TLANDO® licensed t
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’ Northern Europe l 14% Eastern Europe 17% ae Eastern Asia 17% Switzerland — 22% Northern Africa 5 » Korea ~ 22% 19% i South-Eastern Asia » UK-21% ¢ Southern Asi 14% . Weste
Slide 7: High economic burden
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 ral Dosage Form Comprising Brexanolone Identical to endogenous 48-hour Fixed dose without titration outpatient dosing or taper required allopregnanolone LIPOCIN= Lipocine |
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 - Distinctive Pharmacological Pathway
LPCN 1154 - Distinctive Pharmacological Pathway Validated through approved IV Brexanolone Positive allosteric modulator of the GABA, receptor’ and TLR signaling modulator? Presynaptic Terminal Postsynaptic Terminal Synaptic GABA Receptor Benzodiazepine B / vining ste 8B a GABA bing sto a B o> ‘a NAS
Slide 12: 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 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 O Per 1st DSMB meeting, study to continue as planned* O 2"din
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: Treatment Resistant Depression (TRD)
Treatment Resistant Depression (TRD)
Slide 17: Treatment Resistant Depression Market Potential
Treatment Resistant Depression Market Potential One-third of major depressive disorder (MDD) patients fail to respond to antidepressant therapy TRD is defined as MDD that does not /s—e MDD prevalence adequately respond to at least two 8.4 % of population’ antidepressant therapies of adequate dose an
Slide 18: Limitation of Current TRD Therapies
Limitation of Current TRD Therapies Urgent need for a convenient, well-tolerated at-home rapid relief option Limitations of Current Therapies Subpar efficacy Symbyax (comprising fluoxetine) take ~ 8 weeks for efficacy Esketamine (Spravato®) nasal spray approved for TRD as a monotherapy: Primary effi
Slide 19: 2202 - Targeted Attribute-Based Product Differentiation
LPCN 2202 - Targeted Attribute-Based Product Differentiation Ideal for patients needing rapid relief, especially those with suicidal ideation LPCN 2202 BLO dUC ES TIDUS (Neuroactive steroid)* Mechanism of Actio Dosing Regi Positive GABA, modulator TRD Oral Induction phase and maintenance phase Hours
Slide 20: 2101 Treatment of Epilepsy
LPCN 2101 Treatment of Epilepsy
Slide 21: Epilepsy Facts
Epilepsy Facts Global epilepsy drugs market reached $9.5 billion in 2023 and is projected to hit $15.16 billion by 2032! Epilepsy is one of the most common neurological disorders characterized by recurrent, unprovoked seizures caused by abnormal electrical activity in the brain? epilepsy?, meaning t
Slide 22: 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 Drug-Resistant Epilepsy (DRE) is defined by ILAE as the failure of two appropriate anti-seizure medications (ASM
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 d trated dministrati lemonstrate: administration was Y Confirmed achiedng v . safe and well . Achieved ~ 10x of relevant th
Slide 26: Obesity Management — adjunct to GLP-1
Obesity Management — adjunct to GLP-1
Slide 27: 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 v T2DM v Weight management FDA approved indications Y Cardiovascular disease ¥ Chronic
Slide 28: 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 29: 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 30: 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 31: 2401 - Amplify/Accelerate Fat Loss in Obesity Management
LPCN 2401 - Amplify/Accelerate Fat Loss in Obesity Management Per FDA, weight reduction is a long-term Fat Mass Loss reduction in excess adiposity (body fat) with a goal of reduced morbidity and mortality’ Excess total body fat increases the risk of death and major comorbidities such as type 2 diabe
Slide 32: 2401 Safety Data Support Differentiated Product Profile
LPCN 2401 Safety Data Support Differentiated Product Profile Well-tolerated with liver benefits and no safety signals upon 72-week exposure Liver Injury Marker Reduction ae “ “e eer POC study in relevant obese and overweight population 3° | i Frequency and severity of TEAEs with LPCN 2401 were 7° 5
Slide 33: 2401 - Potential for Differentiated Benefit to Risk Profile for Chronic Use
LPCN 2401 - Potential for Differentiated Benefit to Risk Profile for Chronic Use A liver beneficial approach® with no increased risk of adverse cardiovascular outcomes’ LPCN 2401 Target Attributes Competitive Landscape* Oral, QD, prodrug of bioidentical hormone Fat loss amplification + Lower fat mas
Slide 34: Management of Liver Cirrhosis
Management of Liver Cirrhosis Overt Hepatic Encephalopathy (OHE) Sarcopenia in Decompensated Cirrhosis (Fast Track Designation)
Slide 35: 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 oo a LP EL ESE EPO ES BofA Global Research, Pharmaceutical Scripts/Sales Data Report 21 January 2025 ul IN= POC = Proof
Slide 36: 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% 25 q “ 33% = = 30% 3 5 g = is 4 o S 3 Z 20% x 8 = °° S 10% = =} 3 Week g om 0% |@=@ 1PCN 1148 @@e Placebo =@=— Placebo to 1148 LPCN 1148 Placebo * ~9
Slide 37: 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 from Parameter Placebo LPCN 1148 LPCN 1148 — aramete! N=14 N=15 N=11 placebo N=8 History of HE prior to randomization (n) 11 (79%) 11 (73%) 7 (64%) 6 (75%) Recurrent
Slide 38: 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 Placebo LPCN 1148 LPCN 1148 vlacebo (Week 24 to, Parameter (Through We
Slide 39: Appendix
Slide 40: 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
Slide 41: 1144 Novel MOA in non-cirrhotic NASH
LPCN 1144 Novel MOA in non-cirrhotic NASH Product Candidate igh Oral dosage form comprising testosterone ester Fast Track Designation Compelling P2 biopsy results in the FDA approvable endpoint v Safety support with 72 weeks exposure Mono or adjunct therapy Differentiated profile Y Oral with unique
Slide 42: Value Through Partnering
Slide 43: Presence of Sarcopenia is Associated with Higher Risk of HE
Presence of Sarcopenia is Associated with Higher Risk of HE Muscle key organ for ammonia detoxification in the setting of decompensated cirrhosis Sarcopenia and the Increased Risk of HE Ammonia Metabolism and Trafficking in Liver Cirrhosis? Odds Ratio, 95% Cl Glutaminase Va \ —— ———_— —— Hepatic ad
Slide 44: Rifaximin History and Current Status
Rifaximin History and Current Status * Rifaximin was initially approved in 2004 for the treatment of Travelers Diarrhea ¢ Itwas repurposed and approved by the FDA in March 2010 for the reduction of risk of recurrence of overt hepatic encephalopathy in adult patients ¢ Approved in 2015 for IBS-D * Ri
Slide 45: 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: b
Slide 46: 2203 Oral GABA Positive Allosteric Modulator
LPCN 2203 Oral GABA Positive Allosteric Modulator Achieved relevant target levels with good tolerability in Phase 1 studies Typical single dose PK profiles Dose 1 84 doses administered No sedation or dizziness across 4 AE reported single dose studies to 37 participants Mean Plasma Concentration Time
Slide 47: 2101 — Novel Potential Alternative for Women With Epilepsy (WWE)
LPCN 2101 — Novel Potential Alternative for Women With Epilepsy (WWE) Endogenous neuroactive steroid Product Candidate Attribute Positive Allosteric Modulator (PAM) of the GABA, receptor Oral dosage form comprising a neuroactive steroid Product Candidate Differentiation Novel MOA specifically addres