Slide 1: LPCN 1144 for Non-Cirrhotic NASH: LiFT Key Topline Results
LPCN 1144 for Non-Cirrhotic NASH LiFT Key Topline Results August 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 include st
Slide 3: Summary of LiFT Results
Summary of LiFT Results Study Demonstrates Treatment Potential of LPCN 1144 in NASH • Primary endpoint met – Change in liver fat via MRI-PDFF at Week 12 • Both LPCN 1144 treatment arms met with statistical significance the pre-specified histology based regulatory endpoint of NASH resolution with no
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 male NASH subjects with F1-F3 ✓ Change in hepatic fat fraction via MRI-PDFF (W12) Three-arm, blinded, placebo-controlled Key
Slide 5: Histopathological Assessment Methodology
Histopathological Assessment Methodology Techniques Employed One Central Independent Hepatopathologist Digitalized Stained Slides Histopathological Slides Reading (H&E and Trichrome Paired Reading (Quantitative Artificial Staining) NASH CRN Scoring (Separately from CRN) Intelligence) • All (BL and E
Slide 6: LiFT Study: Baseline Characteristics
LiFT Study: Baseline Characteristics* Placebo Treatment A Treatment B Parameter (N=15) (N=15) (N=14) Mean Age (years) 50.5 50.0 54.0 Mean BMI (kg/m2) 36.7 36.5 34.7 Diabetes (%) 53.3 73.3 64.3 Hypertension (%) 73.3 60.0 57.1 Mean ALT (U/L) 49.5 58.7 53.3 Mean AST (U/L) 35.9 34.3 30.9 Mean fibrosis s
Slide 7: Primary Endpoint Met – Change in Liver Fat by MRI-PDFF at Week 12
Primary Endpoint Met – Change in Liver Fat by MRI-PDFF at Week 12 Both LPCN 1144 Treatments Resulted in Significant Reductions in Liver Fat Placebo (N=19) Treatment A (N=18) Treatment B (N=19) 0.0 -2.0 -1.54 Absolute Change (%) -4.0 -6.0 -8.0 -7.68 p < 0.0001 -9.17 -10.0 p < 0.0001 *All Subjects: IT
Slide 8: Key NASH Biopsy Outcomes: NASH CRN Scoring
Key NASH Biopsy Outcomes1 : NASH CRN Scoring Treatments Met NASH Resolution with No Worsening of Fibrosis End Point Placebo Treatment A Treatment B (N = 11) (N = 13) (N = 13) NASH Resolution Responders, n (%) 2 1 (9%) 7 (54%)* 9 (69%)** NASH Resolution with No Worsening of Fibrosis 0 (0%) 6 (46%)* 9
Slide 9: Histological Changes in NASH Components: NASH CRN Scoring
Histological Changes in NASH Components: NASH CRN Scoring Substantial Improvement in All NASH Components from Baseline Steatosis Inflammation Ballooning ≥ 1 Grade Increase 7% 13% 20% 27% 13% 47% Placebo 67% 73% 33% No Change 13% 13% 7% 20% 33% 27% Treatment A 67% 53% 67% ≥ 1 Grade Decrease 21% 21% 3
Slide 10: Key NASH Biopsy Outcomes: Paired Read Analysis
Key NASH Biopsy Outcomes 1 : Paired Read Analysis Paired Biopsy Analysis Concurs with NASH CRN Findings Placebo Treatment A Treatment B (N = 15) (N = 15) (N = 14) Improvement in NASH 2 Responders, n (%) 2 (13%) 9 (60%)* 8 (57%)* Improvement in NASH with No Worsening of 2 (13%) 9 (60%)* 8 (57%)* Fibr
Slide 11: Resolution of NASH with No Worsening of Fibrosis: Comparison with Other Drug Candidates
Resolution of NASH with No Worsening of Fibrosis Comparison† with Other Drug Candidates Placebo Dose/Treatment 1 Dose/Treatment 2 * p < 0.05, *** p < 0.001 vs placebo 80% *** 69% 70% 60% * *** 50% 46% 45% % of Subjects 40% ns * 33% ns 26% * ns * 30% 25% ns ns 22% 19% 19% 18% 20% 11% 12% 10% 8% 8% 6%
Slide 12: Fibrosis Outcomes Across Biopsy Assessment Techniques
Fibrosis Outcomes Across Biopsy Assessment Techniques1 Treatment Effects on Fibrosis Improvement Needs Confirmation in a Larger Study Placebo Treatment A Treatment B Histopathological Assessment Techniques (N = 15) (N = 15) (N = 14) NASH CRN: Fibrosis Improvement ≥ 1 Stage with No 6 (40%)† 4 (27%) 2
Slide 13: Key Liver Injury Markers
Key Liver Injury Markers† Early and Sustained Reductions in ALT and AST Support Beneficial Liver Effects Placebo Treatment A Treatment B Placebo Treatment A Treatment B (N=19) (N=18) (N=19) (N=19) (N=18) (N=19) Mean Baseline 49.0 U/L 53.9 U/L 51.5 U/L Mean Baseline 35.4 U/L 32.4 U/L 31.9 U/L * p < 0
Slide 14: Body Composition Changes
Body Composition Changes Positive Effects in Both Treatment Arms Relative Change in Appendicular Lean Mass Relative Change in Whole Body Fat Mass Treatment A Treatment B Treatment A Treatment B Placebo (N=14) (N=13) (N=13) Placebo (N=14) (N=13) (N=13) 5.0 4.0 1.78 4.0 Relative Change (%) Relative Ch
Slide 15: Safety Overview of LPCN 1144 Through Week 36
Safety Overview of LPCN 1144 Through Week 36 Well Tolerated with an Overall Safety Profile Comparable to Placebo • Frequency and severity of TEAEs in both treatment arms were comparable to placebo – Study drug-related TEAEs were mild to moderate • Discontinuance of study drug due to TEAEs – Four sub
Slide 16: Summary of LiFT Results
Summary of LiFT Results Study Demonstrates Treatment Potential of LPCN 1144 in NASH • Primary endpoint met – Change in liver fat via MRI-PDFF at Week 12 • Both LPCN 1144 treatment arms met with statistical significance the pre-specified histology based regulatory endpoint of NASH resolution with no