Lipocine Inc. · NASDAQ:LPCN
Lipocine — Bio International Convention 2025
17 slides from Lipocine's conference presentation, June 2025
Slide 1: CNS Assets Presentation
CNS Assets Presentation Bio International Convention 2025 Lipocine │ January 2025 1
Slide 2: Background & CNS Pipeline
Background & CNS Pipeline • Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics • Lipocine has robust pipeline differentiated drug candidates in various stages of development targeting various CNS and metabolic diso
Slide 3: LPCN 2101: Neuroactive Steroid for Epilepsy
LPCN 2101 Neuroactive Steroid for Epilepsy
Slide 4: LPCN 2101: Bioidentical Neuroactive Steroid Epilepsy Targets
LPCN 2101: Lipocine Bioidentical Neuroactive Steroid Epilepsy Targets ~30-40 % of patients with epilepsy experience uncontrolled seizures despite the treatment Women With Focal Onset Epilepsy Seizure (FOS) (WWE) Acute Repetitive Seizure (ARS) • Neuroactive steroids (NAS) have shown anticonvulsant ac
Slide 5: Anti-Seizure Activities of NAS Comparable to AEDs in Preclinical Models
Anti-Seizures Activities of NAS Comparable to AEDs in Preclinical Models Epilepsy Foundation Pipeline Conference 2018 Reddy DS Journal of Neuroendocrinology. 2021;00:e13028 https://doi.org/10.1111/jne.13028 • Neuroactive steroids (NAS) activities in protection of mice in most of the tonic and/or clo
Slide 6: Validated Proprietary Lip'ral Technology Platform
Validated Proprietary Lip’ral Technology Platform Oral Enablement of Neuroactive Steroid (NAS) Achieved Relevant Systemic Levels in Phase 1 Study Observed PK Profile Post Oral Administration Mean Plasma Concentration of 70 60 50 NAS (ng/mL) 40 30 20 10 0 0 4 8 12 16 20 24 Time (hr) Study in post-men
Slide 7: LPCN 2101: Oral Bioidentical NAS
LPCN 2101: Oral Bioindentical NAS Enabled Oral Delivery Toxicokinetics study in dogs • ~10x estimated highest target therapeutic level • No LPCN 2101-related macroscopic findings, microscopic findings or organ weight alterations Two pharmacokinetic studies in healthy volunteers • Provide Cmax in the
Slide 8: Woman with Epilepsy (WWE)
Woman with Epilepsy (WWE)
Slide 9: WWE Patient Journey – AED Levels Fluctuation and Its Impacts
WWE PATIENT JOURNEY – AED LEVELS FLUCTUATION AND ITS IMPACTS DURING CHILDBEARING AGE Preconception Pregnancy Postpartum • Drug interaction with contraceptive • Lowest dose and monotherapy • Clearance reduce from pregnancy • Adjust and monitor both • Clearance increase and AED need to AED need to adj
Slide 10: Women with Epilepsy of Childbearing Age - Opportunity
Women with Epilepsy (WWE) of Childbearing Age - Opportunity Prevalence Standard of Care Limitations Unmet Need ~ 900,000 of women of childbearing Seizure control with low/no No drug approved specifically for (CB) suffer from active epilepsy in teratogenic risk WWE US1,2 Most approved ASMs have fetal
Slide 11: LPCN 2101: Novel Potential Alternative for WWE
LPCN 2101 Novel Potential Alternative for WWE Product Attributes Positive Allosteric Modulator (PAM) of the GABAA receptor Oral dosage form comprising a neuroactive steroid Product Candidate Differentiation Novel MOA specifically addressing WWE unmet needs Active molecule is endogenous to women Pote
Slide 12: Acute Repetitive Seizure (ARS)
Acute Repetitive Seizure (ARS) Potential for Orphan Drug Designation
Slide 13: Acute Repetitive Seizures
Acute Repetitive Seizures Background • Many names: cluster seizures, serial seizures, crescendo seizures, seizure flurries, recurrent seizures, or cyclical seizures • More than 2-3 seizures in 24 hours, or in some studies more than 2-3 seizures in 6-8 hours • Associated with an evolution into status
Slide 14: LPCN 2101 Differentiation
Novel mechanism of action • Target refractory epilepsy • Treated comorbidity (e.g., anxiety) • Synergistic with other ASMs Bioidentical to endogenous NAS LPCN 2101 • Superior benefit to risk profile DIFFERENTIATION • Less teratogenicity concerns Oral administration • No nasal/rectal irritation • Con
Slide 15: LPCN 2101 Development Status
LPCN 2101 Development Status IND enabling pre- clinicals completed Phase 1 Next Step IND cleared for • Well tolerated epilepsy study • PK dose proportionality Phase 2 POC study • PK dose completed proportionality Corporate Presentation September Lipocine Overview | 2025 2022 21
Slide 16: LPCN 2101 Additional Potential Indications
LPCN 2101 Additional Potential Indications Other Convulsion Disorders Status epilepticus Catamenial Generalized onset (SE) epilepsy seizures Lennox-Gastaut Absence seizures Dravet Syndrome Syndrome 16
Slide 17: Business Development Contacts
Business Development Contacts Kong Papangkorn, Ph.D. Business Development Manager kp@lipocine.com