Slide 1: LPCN 1111 Once Daily Oral Testosterone
LPCN 1111 Once Daily Oral Testosterone
Slide 2: Drug Delivery Technology Leader with Specialty Pharma Strategy
Drug Delivery Technology Leader with Specialty Pharma Strategy Initially Focused on Neuroendocrine and Metabolic Disorders Drug Loaded Drug + Carrier = Carrier Lip’ral Drug Delivery Technology Platform 1) Invented by Renowned Formulation Experts GI Aqueous Intestinal Systemic Lumen Barrier Layer Wal
Slide 3: Lipocine Pipeline
Lipocine Pipeline Development Candidate (Indication) Pre-Clinical Phase 1 Phase2/POC Pivotal Approved TLANDO® (Testosterone Replacement Therapy) LPCN 1111 (Once Daily Testosterone Replacement Therapy) LPCN 1107 (Prevention of Preterm Birth) LPCN 1144 (Non-Cirrhotic NASH) LPCN 1154 (Postpartum Depres
Slide 4: LPCN 1111: First Oral Once-A-Day Phase 3 Ready Candidate
LPCN 1111: First Oral Once-A-Day “Phase 3 Ready” Candidate Unique Prodrug of Testosterone Convenient option for Patients and physicians Positive Phase 2b study Strong IP Coverage large and growing preferred once a day oral results market testosterone LPCN 1111 Non-Confidential Presentation I 4
Slide 5: Hypogonadism Affects Up to 20M Men in the United States
Hypogonadism Affects Up to 20M Men1, 2 in the United States TLANDO Franchise has the Potential to Drive Market Expansion1,2 Diagnosed Untreated 19% 67% Hypogonadism Under Treatment in US Treatment- Treated experienced Close to 6M men with diagnosed hypogonadism3 11% Undiagnosed 2M men being treated4
Slide 6: Issues with Current TRT Options
Issues with Current TRT Options Potential Barrier To Newly Diagnosed and Existing Patients • Black box warning – Secondary exposure to testosterone – Pulmonary oil micro embolism (POME) and anaphylaxis shock • Inconvenient application or painful injection • High incidence of erythrocytosis was repor
Slide 7: TLANDO XR: Market Research
TLANDO XR: Market Research Physician Intent-to-Prescribe Statistically Higher1 with a QD Future Prescribing Patterns with Future Prescribing Patterns with Entrenchment of Product X BID Entrenchment of Product X QD 1% 1% 24% 31% 4% 53% 4% 64% 7% 1% 9% 1% CE11: Assume Product X is dosed QD vs, BID, ad
Slide 8: Phase 2b Study: Result Summary
Phase 2b Study: Result Summary Met Primary and Secondary Endpoints • Once daily dose for 14 days in an open label, multiple dose PK study in hypogonadal men (n=36 subjects) ✓ Phase 3 dose identified ✓ No Drug related SAEs ✓ Drug Related AEs are Mild to Moderate • Next step: Finalizing pivotal study