Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (July 2025)
60 slides from Lipocine's investor presentation, July 2025
Slide 1: Corporate Presentation
Corporate Presentation July 2025 Lipocine │July 2025 1
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 Phase 3 LPCN 1154 Topline results Q2/26 Postpartum Depression POC study with GLP-1 – LPCN 2401 expected patient dosing Obesity Management - adjunct to GLP-1 Q3/25 LPCN 1148 P2 study completed
Slide 4: Validated Proprietary Lip'ral Technology Platform
Validated Proprietary Lip’ral Technology Platform Lip’ral based dosage form Drug + Carrier = Drug Loaded Carrier GI Aqueous Intestinal Systemic Lumen Barrier Layer Wall Circulation Superior Oral Bioavailability e.g., TLANDO® Insoluble drug lipid composition GI Lumen Section of GI Insoluble drug lipi
Slide 5: TLANDO - FDA-Approved Oral Testosterone Replacement Therapy
TLANDO® - FDA-Approved Oral Testosterone Replacement Therapy Established commercialization partnerships in multiple territories First and only oral testosterone replacement therapy (TRT) • TLANDO® licensed to Verity Pharma in January 2024 for option that does not require dose titration commercializa
Slide 6: LPCN 1154 (BRLIZIO) Oral Brexanolone for Postpartum Depression
LPCN 1154 (BRLIZIO ) TM Oral Brexanolone for Postpartum Depression (PPD) Lipocine │July 2025 6 Brlizio is a brand name conditionally approved by FDA TM
Slide 7: LPCN 1154 - Oral Bioidentical Neuroactive Steroid for PPD
LPCN 1154 - Oral Bioidentical Neuroactive Steroid (NAS) for PPD Potential as “first line” therapy Brexanolone Mechanism of Action • Brexanolone is a positive allosteric modulator (PAM) of the GABAA receptor Brexanolone (allopregnanolone) Molecular Weight: 318.5 g/mol Lipophilic: Log P 5.0 Poor aqu
Slide 8: Postpartum Depression (PPD) Market Opportunity
Postpartum Depression (PPD) Market Opportunity Compelling pharmacoeconomic rationale • High economic burden Estimated patients in the U.S. with PPD3 • Goal of medical intervention is to prevent harm to mother and infant • Negative impact on family/society Pregnancies in the US4 3.6M • Among women re
Slide 9: LPCN 1154 - Oral Bioidentical NAS for PPD
LPCN 1154 - Oral Bioidentical NAS for PPD Potential for compelling advantages over current therapies LPCN 1154 SSRIs / SNRIs Zuranolone (Zurzuvae®) (BRLIZIOTM) Off-Label Use Description Bioidentical NAS Synthetic NAS Derivative Synthetic SSRI/SNRI Administration Oral Oral Oral Onset of Action Hours*
Slide 10: LPCN 1154 (Oral Brexanolone) Development
LPCN 1154 (Oral Brexanolone) Development Streamlined 505(b)(2) pathway to NDA submission PK Bridge Study Labeling Studies Pivotal Study • Food effect study Positive P3 Safety and • PK study in PPD Results • Metabolite Efficacy Study evaluation Completed Completed Expected Topline Results Q2/26 Lipoc
Slide 11: LPCN 1154 PK Bridge Study Results
LPCN 1154 PK Bridge Study Results LPCN 1154 met standard bioequivalence criteria to IV Brexanolone Comparative Exposure • LPCN 1154 was well tolerated • No sedation or somnolence events observed PK GMR (%) 90% CI LB 90% CI UB • All events were mild to moderate Parameter Test vs. Reference Test vs. R
Slide 12: LPCN 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 Prospective advantages Two arm, outpatient, randomized, blinded, placebo-controlled in women • Brexanolone has established with postpartum depression efficacy (I
Slide 13: LPCN 1154 Best in Class Oral Treatment for Depression
LPCN 1154 “Best in Class” Oral Treatment for Depression Key takeaways • Significant market opportunity • Differentiated product attributes addressing unmet needs • Streamlined pathway to NDA submission • PK bridge study: completed with positive results • Phase 3 safety & efficacy study: ongoing • To
Slide 14: LPCN 2401 Obesity Management
LPCN 2401 Obesity Management Lipocine │July 2025 14
Slide 15: Unprecedented Demand and Usage of GLP-1 Receptor Agonists
Unprecedented Demand and Usage of GLP-1 Receptor Agonists1-3 GLP-1 market trending toward oral once daily dosing Semaglutide: $30 billion sales in the US in 20244 ✓ T2DM Tirzepatide: $14 billion sales in the US in 20245 ✓ Weight management FDA approved ✓ Cardiovascular disease indications ✓ Chronic
Slide 16: Limitations of GLP-1 Use and Unmet Medical Needs
Limitations of GLP-1 Use and Unmet Medical Needs 2 out of 3 patients on drugs like Wegovy stop within a year1 Functionality loss Lean mass loss Unmet Medical Needs and increase facture risk • Improve (quality/extent) weight/fat loss Weight/fat GLP-1 Use GI • Preserve lean mass/functionality rebound
Slide 17: 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 Loss1 Lean Mass Loss1 Functionality Loss1 Fracture Risk2,3 Proportion of Lean Mass and Fat Mass in Total Weight Loss Weight Loss Lean mass Loss Weight(kg) Loss Fat Loss F
Slide 18: Target Population - Elderly GLP-1 Users, Most Vulnerable Population
Target Population - Elderly GLP-1 Users, Most Vulnerable Population 8 years of expected age-related stair climb power loss in 4 months of GLP-1 use GLP-1 Use Related Decline in Elderly Estimated Elderly GLP-1 Users Pre-existing low lean mass Population in the US5 340 M High magnitude Loss of 4.1% of
Slide 19: LPCN 2401 Once Daily Oral Treatment for Obesity and Weight Management
LPCN 2401 Once Daily Oral Treatment for Obesity and Weight Management 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”
Slide 20: LPCN 2401 - Potential to Amplify Effects of Incretin Mimetics
LPCN 2401 - Potential to Amplify Effects of Incretin Mimetics ARA may increase weight loss through increased expression and activity of GLP1R 4,5 GLP-1 expression increase with ARA2 Non-Diabetic Diabetic Insulin Androgen Receptor Incretin Sensitivity3 Agonist (ARA) Mimetic Diabetes6,7 Veh ARA α-ARA
Slide 21: LPCN 2401 Novel Oral Treatment for Obesity Management
LPCN 2401 Novel Oral Treatment for Obesity Management Hypothesized benefits - improve body composition and functionality in weight management Quality weight loss Amplify fat loss Improve lean mass Minimize weight rebound Minimize fat regain Preserve functionality GLP-1 GLP-1 GLP-1 GLP-1 GLP-1 GLP-1
Slide 22: LPCN 2401 Novel Oral Treatment for Obesity Management
LPCN 2401 Novel Oral Treatment for Obesity Management Target benefits to improve weight loss and functionality LPCN 2401 + GLP-1 agonist treatment LPCN 2401 treatment post GLP-1 cessation Quality weight loss Maintain weight loss Preserve lean mass Primarily fat loss Minimize fat regain Minimize weig
Slide 23: 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 Fat Mass Lean Mass (kg) Appendicular Lean Mass (kg) Total Fat Mass Trunk Fat Mass 2.5 (kg) (kg) 2 1 2 * * 0.9 1.9 1.5 1.2 1.6 1 * * 0
Slide 24: LPCN 2401 – Amplify/Accelerate Fat Loss in Obesity Management
LPCN 2401 – Amplify/Accelerate Fat Loss in Obesity Management Fat Mass Loss Per FDA, weight reduction is a long- term reduction in excess adiposity (body fat) with a goal of reduced morbidity and mortality1 Semaglutide** LPCN 2401* Excess total body fat increases the risk of death and major comorbid
Slide 25: LPCN 2401 - Body Weight Changes During Weeks of Treatment
LPCN 2401 - Body Weight Changes During 72 Weeks of Treatment 2 1 Placebo-Controlled OLE Change from Baseline (kg) 0 0 36 72 -1 -2 -3 -4 -5 LPCN 2401 +/- E -6 LPCN 2401 Placebo -7 Placebo to LPCN 2401 -8 Time (weeks) • Participants who took placebo for 36 weeks then switched to LPCN 2401 during the 3
Slide 26: LPCN 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 • POC study in relevant obese and overweight population • Frequency and severity of TEAEs with LPCN 2401 were comparable to placebo • Frequency of SAEs with LPC
Slide 27: LPCN 2401 POC Phase 2 Study Objectives
LPCN 2401 POC Phase 2 Study Objectives Quality weight loss phase (Stage 1, GLP-1 treatment) • Objective 1 • Assess the co-administration of LPCN 2401 and incretin mimetic for weight loss and prevention of functional loss associated with incretin mimetic monotherapy Weight maintenance phase (Stage 2,
Slide 28: LPCN 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 approach6 with no increased risk of adverse cardiovascular outcomes7 LPCN 2401 Target Attributes Competitive Landscape* • Oral, QD, prodrug of bioidentical hormone • Myostatin /activin receptor modula
Slide 29: LPCN 2401 – Key Takeaways
LPCN 2401 – Key Takeaways Compelling opportunity with favorable benefit to risk profile • Addressing huge GLP-1 user market with unmet needs • Differentiated oral product for use in combination with GLP-1 or post-cessation of GLP-1 • Positive Phase 2 results in relevant subjects • Planned clinical s
Slide 30: LPCN 1148 Management of Liver Cirrhosis
LPCN 1148 Management of Liver Cirrhosis • Overt Hepatic Encephalopathy (OHE) • Sarcopenia in Decompensated Cirrhosis (Fast Track Designation) Lipocine │July 2025 30
Slide 31: 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 Positive P2 results in Positive P2 results with sarcopenia background SOC Analogue (Rifaximin) Sales Overt Hepatic Encephalopathy 300 Sarcopenia i
Slide 32: Sarcopenia in Cirrhosis
Sarcopenia in Cirrhosis A serious comorbidity Sarcopenia is a predictor for increased morbidity and mortality in cirrhosis2 • 3-fold higher mortality rate compared to no sarcopenia2 Sarcopenia in cirrhosis correlates with decompensation Survival (%) events, particularly hepatic encephalopathy (HE)3
Slide 33: Overt Hepatic Encephalopathy (OHE) in Cirrhosis
Overt Hepatic Encephalopathy (OHE) in Cirrhosis Presence of both sarcopenia and HE further increases risk of mortality5 Covert HE Overt HE Sarcopenia and myosteatosis are associated with increased risk of hepatic encephalopathy1,2 1. Bhanji et al. Hepatology International (2018) 12:377–386 2. Wijarn
Slide 34: LPCN 1148 for the Management of Cirrhosis
LPCN 1148 for the Management of Cirrhosis Product Candidate Attributes Oral androgen receptor agonist; dosage form comprising testosterone dodecanoate, a unique prodrug of an endogenous hormone Targeted Mechanism of Action Anabolic1 Androgenic Ammonia Lowering Stimulates muscle satellite activator,
Slide 35: 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) 25 ‡ 20 ‡ 15 % CBL L3-SMI ‡ ‡ ‡ 10 † 5 0 -5 Week LPCN 1148 Placebo Placebo to 1148 • ~9% increase in L3-SMI at week 24 • 33% of patients had resolution o
Slide 36: 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 from Placebo LPCN 1148 LPCN 1148 Parameter N=14 placebo N=15 N=11 N=8 History of HE prior to randomization 11 (79%) 11 (73%) 7 (64%) 6 (75%) (n) Recurrent Overt HE (e
Slide 37: 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 (Week 24 to
Slide 38: Value Through Partnering
Value Through Partnering
Slide 39: 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 Compelling efficacy rationale Acc
Slide 40: LPCN 1144 Novel MOA in non-cirrhotic NASH
LPCN 1144 Novel MOA in non-cirrhotic NASH Product Candidate Highlights NASH Resolution with No Worsening of Fibrosis1 Oral dosage form comprising testosterone ester Fast Track Designation Compelling P2 biopsy results in the FDA approvable endpoint ✓ Safety support with 72 weeks exposure Mono or adju
Slide 41: Appendix
Appendix
Slide 42: LPCN 1154 Opportunities in Additional Depression Disorders
LPCN 1154 Opportunities in Additional Depression Disorders Prevalence Significant Unmet Needs in Depression Disorders Robust Adequate and durable remission/response; treat anxiety MDD: Per NIMH, in 2020, an estimated Efficacy comorbidity 21.0 million adults (8.4%) in the US had at least one major de
Slide 43: Oral Brexanolone - Potential Additional Neuropsychiatric Indications
Oral Brexanolone - Potential Additional Neuropsychiatric Indications qEEG in healthy subjects administered single doses of oral brexanolone Indications Requiring Rapid Onset (e.g. anxiety) • Capsule formulations allow for rapid delivery of neuroactive steroids (Tmax 1.5 hours) Observed Capsule PK Pr
Slide 44: Obesity and Overweight: A Growing Epidemic in US
Obesity and Overweight: A Growing Epidemic in US Increases the risks of heart disease, stroke, type 2 diabetes and certain types of cancer1,2 38% of men and 51% of women ~110M adults4 would be interested in taking a Diabesity population 74% prescription drug for weight loss6 GLP-1 users in the US pr
Slide 45: Eligible GLP-1 Agonist Users in U.S. for Chronic Weight Management
Eligible GLP-1 Agonist Users in U.S. for Chronic Weight Management Total GLP-1 users in the U.S. may reach around 9% (30M) of the overall population by 20309 Obesity Prevalence Overweight Prevalence (BMI at or above 30.0) (BMI 25.0 to 29.9*) Adult with Obesity1,2 Adult with Overweight1,2 111 M 79 M
Slide 46: Drawbacks of Approved GLP-1 Receptor Agonists
Drawbacks of Approved GLP-1 Receptor Agonists Rebound weight/fat gain drawback post GLP-1 cessation Greatest amount of weight loss is by week 20, and plateaus at ~1 year1 Patients who discontinued treatment at week 20 had significant weight gain2 and HbA1c increase3 1. N Engl J Med, 384:989-1002, 20
Slide 47: Androgen Treatment Improved Body Composition and Functionality
Androgen Treatment Improved Body Composition and Functionality Six months intervention in older men Body Composition Improvement Improve in functionality Total lean mass Total fat mass 1.5 +1.2 kg 1 Mean CI −2.2 (−1.4, −3.1), 0.5 P<.0001 0 CBL (kg) -0.5 -1 Mean CI 1.6 (0.8, 2.4), P <.0001 -1.5 -2 -2
Slide 48: LPCN 2401 – Regulatory Outlook on Efficacy
LPCN 2401 – Regulatory Outlook on Efficacy Appropriate population and endpoints selection Per FDA Guidance (2025)1,2, for efficacy claim related to changes in body composition, trial design should include appropriate choice of population and selection of endpoints that measure how a patient feels, f
Slide 49: Stair Climb Test: A Relevant Clinical Functional Measurement
Stair Climb Test: A Relevant Clinical Functional Measurement Clinically relevant with patient-centric outcomes Regulatory Perspectives • High reliability and validity1 • Well-defined, standardized, supporting multicenter trials1,2 • Regulatory precedents: DUVYZAT®, ELEVIDYS® Patient & Physician Pers
Slide 50: LPCN 2401+E – Targeted Mechanisms of Action
LPCN 2401+E – Targeted Mechanisms of Action Obesity is associated with systemic chronic inflammation and oxidative stress Fat Muscle Bone Androgen • Induces lipolysis1 • Stimulates muscle satellite activator, • Lowers lipogenesis 1 FGF23 • Acts directly on osteoblasts and Receptor • Inhibits express
Slide 51: Summary of Preclinical Results in Diet Induced Model
Summary of Preclinical Results in Diet Induced Model LPCN 2401+E significantly improved oral glucose tolerance test and reduced VAT OGTT 12-week study in male rabbit model of 250.0 * * metabolic syndrome 200.0 †,# OGTT (iAUC) 150.0 RD Control • Regular Diet (RD control), n=10 100.0 • High Fat Diet (
Slide 52: Phase 2 Study in Patients with Obesity
Phase 2 Study in Patients with Obesity NCT04134091 study design Three-arm, blinded, placebo-controlled trial in male subjects with metabolic dysfunction associated steatohepatitis (n=56) • High prevalence of obesity and weight related comorbid conditions such as dyslipidemia, T2DM, and hypertension
Slide 53: LPCN 2401 Significant Improvement in Patients' Body Composition
LPCN 2401 Significant Improvement in Patients’ Body Composition Increased lean mass and decreased fat mass Body Composition Analysis Set1 Body Composition Results (36 Weeks) LPCN 2401 LPCN 2401 + E Placebo Fat Mass: Lean Mass Ratio Parameter at Baseline (N=13) (N=13) (N=14) 4 2 Mean Age (years) 53.2
Slide 54: LPCN 2401 Significant Improvement in Patients' Body Composition
LPCN 2401 Significant Improvement in Patients’ Body Composition Increased lean mass and decreased fat mass Fat Mass (36 Weeks) Lean Mass (36 Weeks) Fat Mass Android Fat (% of TM) (% of Fat Mass) Visceral Fat Lean Mass (% of TM) Appendicular Lean Mass 5 * * 10 4 8 6 3 * 4 2 % CBL 2 1 % CBL 0 0 -2 -1
Slide 55: LPCN 2401+E – Amplify Total Fat and Visceral Fat Loss in Obesity Management
LPCN 2401+E – Amplify Total Fat and Visceral Fat Loss in Obesity Management • Visceral fat is primarily responsible for the risks associated with abdominal fat such as cardiovascular, cerebrovascular, metabolic, liver, renal, and joint diseases2,3 Combination of LPCN 2401+E and GLP-1 may amplify VAT
Slide 56: 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 Cirrhosis3 Glutaminase Odds Ratio, 95% CI glutamine Hepatic Encephalop
Slide 57: Rifaximin History and Current Status
Rifaximin History and Current Status • Rifaximin was initially approved in 2004 for the treatment of Travelers Diarrhea Rifaximin in Prevention of Breakthrough HE • It was repurposed and approved by the FDA in Rifaximin March 2010inforPrevention of Breakthrough the reduction HE of risk of recurrence
Slide 58: 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 • Stress can aggravate tremor in social setting 2.2 % of population1 ~7 M • Major impact on activities of daily living leading t
Slide 59: LPCN 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 Mean Plasma Concentration administered No sedation or dizziness Dose 2 across 4 AE reported single dose studies to 37 Dose 3 par
Slide 60: LPCN 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 GABAA receptor Oral dosage form comprising a neuroactive steroid Product Candidate Differentiation Novel MOA specifically addres