Slide 1: LPCN 1107: Pioneering a Convenient Solution to the Preterm Birth Health Crisis
LPCN 1107 Pioneering A Convenient Solution to the Preterm Birth Health Crisis Non-Confidential 1
Slide 2: Pioneering a Patient Preferred Solution to the PTB Health Crisis
Pioneering a Patient Preferred Solution to the PTB Health Crisis Overview of the Partnering Opportunity LPCN-1107 is a late-stage “de-risked” blockbuster women’s health opportunity that addresses an urgent medical need Preterm birth (“PTB”) is a health crisis in the US and globally, and is estim
Slide 3: Preterm Birth (PTB) - A Significant Global Public Health Issue
Preterm Birth (PTB) - A Significant Global Public Health Issue High Unmet Medical Need with No Effective Treatment o Every year, ca 15 million babies are born preterm worldwide o Globally, the rate of PTB ranges from 5% to 18% of babies born o In the US, 10% of all pregnancies, ca 1 PTB every minute
Slide 4: Infant Mortality/Morbidity Related to Gestational Age
Infant Mortality/Morbidity Related to Gestational Age Benefit of Prolonging Gestation Age Mortality and Major Morbidity Survival with No Complications* 60 100 Death Survival with no 50 complications Major Morbidity 80 % of Newborns 40 % of Newborns 60 30 40 20 10 20 0 0 23 24 25 26 27 28 29 30 31 32
Slide 5: Dose Finding Study Design
Dose Finding Study Design Open-label, four period, four treatment study 12 healthy pregnant women • Age of 18-35 years: Screened at gestation age in 16-18 weeks Periods • Period 1 to 3 (Oral dose) Day 1: Single dose – PK sampling for 24 hours Day 2 to 7: Two doses daily (approximately 12 h
Slide 6: Comparative Steady State PK profiles to Injectable HPC
Comparative Steady State PK profiles* to Injectable HPC Dosing Regimen Ensures ALL Patients Above Reported Lower PTB Rate Threshold *PK results obtained from post 35 days for weekly IM Injection & post 8 days of BID dosing for oral from the dose finding study Achieve Higher Target Blood Levels Soone
Slide 7: Success Focused Clinical Design Scenario
Success Focused Clinical Design Scenario Summary Immediately prior QD Levels: minimizing subjects below the efficacy threshold Early Therapy Initiation GAQD < 35 wks. with >50% population with GAQD <32 wks. Lipocine | 2025 7
Slide 8: LPCN 1107 – Phase 3 Ready Partnering Opportunity
LPCN 1107 – “Phase 3 Ready” Partnering Opportunity Potential to be the Only Product Approved for Preterm Birth (PTB) On the Market >$1B US Market Oral, a Major Contribution Accelerated Approval Orphan Drug Designation Potential to Patient Care Pathway Strong pharmaco- Self administration Compelling
Slide 9: Business Development Contact
Business Development Contact Kongnara Papangkorn, Ph.D. Business Development Manager kp@lipocine.com