Lipocine Inc. · NASDAQ:LPCN
Lipocine — Corporate Update (September 2014)
14 slides from Lipocine's corporate update, Sep 24, 2014
Slide 1: Top-line Efficacy Results
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 Top - line Efficacy Results September 24, 2014 Exhibit 99.2
Slide 2: Forward Looking Statements
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 2 Forward Looking Statements This presentation contains and our discussions during this conference may include forward - looking statements about Lipocine Inc. (the “Company”).
Slide 3: LPCN 1021 Overview
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 3 LPCN 1021 has the potential to be a leader in Testosterone R eplacement T herapy (TRT) LPCN 1021 is a twice - a - day Oral TRT product candidate with three simple dosing o
Slide 4: Current Regulatory Paradigm
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 4 Current Regulatory Paradigm 1 Meet primary end points • Responder analysis relating to average serum concentration 0 to 24 hours ( C avg ) and lower bound Confidence Interva
Slide 5: Phase 3 Study Design
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 5 Open label, randomized, active - controlled study of LPCN 1021 in men with low testosterone Phase 3 Study Design Screening N = 315 0 Week 4 Week 8 Randomization LPCN 1021 22
Slide 6: Dataset Definition
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 6 Primary Analysis Set Efficacy Population (N=152) : Subjects randomized into the study with at least one PK profile and no significant protocol deviations Imputed missing
Slide 7: Primary Endpoint: Responder Analysis
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 7 Primary Endpoint: Responder Analysis Measure Efficacy Population Safety Set Number of subjects 152 210 % subjects with C avg w ithin normal range 88.2% 80.0% 95 % CI lower bou
Slide 8: Primary Endpoint: Cavg and Distribution in Subjects
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 8 Primary Endpoint: C avg and Distribution in Subjects Range Efficacy Population C avg < 300 ng / dL 11.2 % C avg betwee n 300 and 1140 ng/ dL 88.2 % C avg > 1140 ng / dL 0.7 %
Slide 9: Final Dose Distribution of Subjects
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 9 Dose (mg TU, BID) % of subjects 150 36% 225* 51% 300 13% Final Dose Distribution of Subjects Dataset: Efficacy population, N=152 *starting dose x Majority of subjects with fin
Slide 10: Titration Outcome
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 10 Titration Outcome Dataset: Efficacy population, N=152 Parameter % of subjects % subjects requiring no more than one dose change (either after week 3 or week 7) 85% % subjects
Slide 11: Secondary Endpoints
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 11 Secondary Endpoints Measure FDA Threshold Efficacy Population Number of subjects 152 C max < 1500 ng/ dL ≥ 85 % 82.9% 1800 ≤ C max ≤ 2500 ng/ dL ≤ 5 % 4.6% C max > 2500 ng/ d
Slide 12: LPCN 1021 Excessive T Repletion Outliers
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 12 Excessive T repletion outliers were observed in three subjects These observed excessive T repletion outliers were transient, sporadic, isolated, and not clinically meanin
Slide 13: Adverse Events Summary in LPCN 1021 Arm
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 13 Safety study is on - going 3% of the subjects reported a serious adverse event • There were no drug related Serious AEs 46% of the subjects experienced at least one adv
Slide 14: Top Line Results Summary
29 60 97 206 17 65 9 34 63 35 52 73 108 139 176 93 126 176 155 48 75 134 6 38 148 76 35 202 128 86 127 127 127 217 217 217 14 Met primary efficacy endpoint by successfully restoring testosterone levels to the normal range in 88% of the subjects • Primary endpoint robust to sensitivity analysis L