Slide 1: LPCN 1144 for Non-Cirrhotic NASH: LiFT Topline Results at Week 12
LPCN 1144 for Non-Cirrhotic NASH LiFT Topline Results at Week 12 January 2021
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements about Lipocine, Inc. (the “Company”). These forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to
Slide 3: Summary: Positive Topline Results
Summary: Positive Topline Results Both LPCN 1144 Treatment Arms Met the Primary Endpoint with Statistical Significance Statistically significant reduction in liver fat was observed compared to placebo • Up to a mean 9.2% absolute and 46.9% relative reduction in liver fat Statistically significant re
Slide 4: LPCN 1144: LiFT (Liver Fat Intervention with oral Testosterone)
LPCN 1144: LiFT (Liver Fat Intervention with oral Testosterone)* Phase 2 Paired Biopsy Study in Men with NASH (NCT04134091) Study Design Primary Endpoint: • Biopsy confirmed 56 male NASH subjects with F1-F3 • Change in hepatic fat fraction via MRI-PDFF (W12) • Three-arm, placebo controlled with 1:1:
Slide 5: LiFT Study: Baseline Characteristics
LiFT Study: Baseline Characteristics Parameter Placebo Treatment A Treatment B Started the study (N) 19 18 19 Completed WK 12 (N) 18 18 19 Age (years) 53.6 51.3 53.4 BMI (kg/m2) 37.3 36.9 34.5 Diabetes (%) 52.6 72.2 57.9 Hypertension (%) 68.4 66.7 57.9 Hepatic Fat Fraction (%) 20.06 16.73 20.87 ALT
Slide 6: Absolute Change in Liver Fat (%)
Absolute Change in Liver Fat (%) Baseline to Week 12* Placebo (N=19) Treatment A (N=18) Treatment B (N=19) 0.0 -2.0 -1.65 Absolute Change (%) -4.0 -6.0 -8.0 p = 0.0001 -7.72 -10.0 p < 0.0001 -9.18 NS *All Subjects: ITT Dataset, n = 56, missing data imputed using multiple imputation NS = Not Statisti
Slide 7: Percent of Subjects with ≥ 30% Relative Reduction in Liver Fat
Percent of Subjects with ≥ 30% Relative Reduction in Liver Fat Baseline to Week 12* Placebo (N=19) Treatment A (N=18) Treatment B (N=19) 100 NS p = 0.0026 80 p = 0.0058 66.7 63.2 % Responders 60 40 20 15.8 0 *Subjects with missing MRI data are considered non-responders; All Subjects: ITT Dataset, n
Slide 8: Absolute Change in Liver Fat (%) in Subjects with Baseline Liver Fat ≥ 5%
Absolute Change in Liver Fat (%) in Subjects with Baseline Liver Fat ≥ 5% Baseline at Week 12* Placebo (N=18) Treatment A (N=17) Treatment B (N=17) 0.0 -2.0 -1.75 Absolute Change (%) -4.0 -6.0 -8.0 -8.02 P < 0.0001 -10.0 -9.45 p < 0.0001 -12.0 NS *Based on available data; n = 52 NS = Not Statistical
Slide 9: Relative Change in Liver Fat (%) in Subjects with Baseline Liver Fat ≥ 5%
Relative Change in Liver Fat (%) in Subjects with Baseline Liver Fat ≥ 5% Baseline at Week 12* Placebo (N=18) Treatment A (N=17) Treatment B (N=17) 0.0 -10.0 -9.93 Relative Change (%) -20.0 -30.0 -40.0 -39.96 p = 0.0002 -50.0 p < 0.0001 -46.88 *Based on available data (n=52) NS NS = Not Statisticall
Slide 10: Liver Injury Marker Changes: Alanine Aminotransferase (ALT)
Liver Injury Marker Changes: Alanine Aminotransferase (ALT) Absolute Change from Baseline at Week 12* Placebo (N=17) Treatment A (N=16) Treatment B (N=19) 5.0 1.8 0.0 -5.0 Absolute Change (U/L) -10.0 -9.4 p = 0.0164 -15.0 -20.0 -25.0 -22.4 p < 0.0001 p = 0.005 *Based on available data (n=52) LPCN 11
Slide 11: Liver Injury Marker Changes: Aspartate Aminotransferase (AST)
Liver Injury Marker Changes: Aspartate Aminotransferase (AST) Absolute Change from Baseline at Week 12* Placebo (N=17) Treatment A (N=16) Treatment B (N=19) 4.0 2.8 2.0 Absolute Change (U/L) 0.0 -2.0 -4.0 -6.0 -4.9 p = 0.0216 -8.0 -10.0 -10.4 -12.0 p = 0.0001 *Based on available data (n=52) NS NS =
Slide 12: Longitudinal Changes of Key Liver Injury Markers
Longitudinal Changes of Key Liver Injury Markers Absolute Changes (U/L) from Baseline up to Week 12 ALT AST 10 5 0 0 CBL (U/L) * CBL (U/L) * -10 -5 *** ** ** -10 Placebo *** -20 Placebo *** Treatment A Treatment A Treatment B -15 Treatment B N=9 -30 0 4 8 12 0 4 8 12 Week Week * < 0.05, ** < 0.01, *
Slide 13: LiFT Study: Upcoming Data
LiFT Study: Upcoming Data Mid-2021 Histological change in NASH activity and fibrosis at week 36 MRI-PDFF liver fat data for week 36 Body composition data from DXA scan (at 20 weeks and 36 weeks) • Whole body lean mass, fat mass, arm leg lean mass, and bone mineral density Liver and other markers inc