Lipocine Inc. · NASDAQ:LPCN
Lipocine — NASH-TAG Conference 2019
21 slides from Lipocine's conference presentation, Jan 7, 2019
Slide 1: Exhibit 99.2
1 Exhibit 99.2
Slide 2: Enabling Oral Drug Delivery to Improve Patient Compliance
Enabling Oral Drug Delivery to Improve Patient Compliance NASH - TAG Conference Jan 2019 LPCN 1144 Improves NAFLD/NASH Biomarkers in Subjects at Risk of NAFLD/NASH Jonathan Baker, Ph.D.
Slide 3: 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 rel
Slide 4: Unique Specialty Pharmaceutical Company, Advanced Pipeline
Unique Specialty Pharmaceutical Company Advanced Pipeline Men's Health Oral Testosterone Replacement Therapy (“TRT”) Oral Androgen Therapy for Fatty Liver Disease (“NAFLD”/ “NASH”) Women's Health Oral Therapy for Prevention of Preterm Birth (“PTB”) Proprietary Drug Delivery Platform Significant Unme
Slide 5: LPCN 1144: Oral Delivery via Lymphatic System
LPCN 1144 Lymphatic Systemic Adipose Liver Other Target Tissue LPCN 1144: Oral Delivery via Lymphatic System 1144 MG - Fatty Acids Enterocyte Chylomicrons Gastrointestinal Tract TG TG TG TG TG TG Portal Vein 5
Slide 6: Androgen Receptor Signaling
Androgen Receptor Signaling Testosterone Dihydrotestosterone Androgens Nucleus Cytoplasm Testosterone Ester Esterase AR* AR* AR* AR* AR* AR AR DNA mRNA AR AR SHBG SHBG Free Testosterone ARE 6
Slide 7: Testosterone Deficiency in Liver Disease Models
Testosterone Deficiency in Liver Disease Models Numerous Liver Disease Models Are Run in Male Animals and Exhibit Testosterone Deficiency Model Phenotype Ob/ ob (Mouse) ↓ T Db/ db (Mouse) ↓ T Streptozotocin (Rat) ↓ T High Fat Diet (Rat, Mouse, Rabbit, Pig) ↓ T CCL 4 (Rat/Mouse) ↓ T 7
Slide 8: Inverse Clinical Associations of Testosterone with Liver Disease
Inverse Clinical Associations of Testosterone with Liver Disease Worse Disease/Progression Testosterone* * Total or Free T Steatosis 1 Ballooning 2 Fibrosis 3,4 T (1) Free T v. stage, lower in NASH v. NAFLD (2) Free T w/ FIB - 4 index and IV - 7S (T2D) Free T Cirrhosis 5 Inverse T w/ Mortality Sarco
Slide 9: Androgen in Steatosis
Androgen in Steatosis Adipose Free Fatty Acids Liver Steatosis: Abnormal Accumulation of Lipids in Liver Altered Glucose Homeostasis Insulin Sensitivity Serum Triglycerides Testosterone Improved Insulin Sensitivity Testosterone Less Deposition Of Lipids in Liver Modulation Lipid Metabolism/ Transpor
Slide 10: Androgen in Inflammation
Androgen in Inflammation Fatty Liver Steatosis Inflammation Fibrosis TNF - ߙ TGF - ߚ Mitochondrial Dysfunction Testosterone Reduces TNF - a & TGF - b Testosterone Improves Mitochondrial Function 10
Slide 11: Androgen in Fibrosis
Androgen in Fibrosis Hepatic Stellate Cell Activated Hepatic Stellate Cell “Myofibroblast” TGF - ߚ T RhoA /ROCK T 11
Slide 12: T Therapy Improves Liver Histology, MetS, and Inflammation
T Therapy Improves Liver Histology, MetS , and Inflammation* Rabbit Metabolic Syndrome ( MetS ) Model ǣ േ T, േ OCA 1)Elevated Glycaemia 2)Elevated Blood Pressure 3)Elevated Triglycerides 4)Elevated Cholesterol 5)Increased Visceral Fat RD HFD HFD+T HFD+OCA RD HFD HFD+T HFD+OCA Serum TNF - ߙ Liver T
Slide 13: LPCN 1144: Well Characterized Safety
LPCN 1144: Well Characterized Safety □ LPCN 1144 is a Prodrug of Bioidentical Sex Hormone □ Extensive Clinical Safety Database with LPCN 1144 ▪ 591 subjects in 12 studies with up to 52 week exposure ▪ Well tolerated with no deaths or MACE events; no drug related SAEs ▪ Good gastrointestinal tolerabi
Slide 14: LPCN 1144: Liver Specific Safety
LPCN 1144: Liver Specific Safety □ No Adverse Drug Reactions Reported in Hepatic System Organ Class with LPCN 1144 ▪ The safety of LPCN 1144 administered twice daily in hypogonadal subjects who continued to receive treatment for up to 52 weeks was evaluated in SOAR Trial. No adverse drug reactions (
Slide 15: LPCN 1144: Significant Reductions in Liver Enzyme Levels
LPCN 1144: Significant Reductions in Liver Enzyme Levels □ Placebo Controlled 4 Week Study (M12 - 778) 15 - 47.4% - 47.3% - 11.5% - 21.0% - 11.0% - 6.6% - 15.8% - 16.7% -60% -50% -40% -30% -20% -10% 0% LPCN 1144 225mg BID LPCN 1144 300mg BID Placebo - adjusted Mean Change ALT AST ALP GGT
Slide 16: LPCN 1144: Significant Reductions in ALT and TG
LPCN 1144: Significant Reductions in ALT and TG □ 52 Week SOAR Trial 16 Mean BL (U/L) 53.6 54.4 54.9 54.3 57.4 55.0 † Patients with ALT > 40 U/L at BL in SOAR Trial * Metabolic syndrome: obesity + diabetes + hypertension Mean BL (UL**) 1.6xUL 1.5xUL 2.0xUL 1.6xUL 1.9xUL 2.1xUL † Patients with TG > 2
Slide 17: LPCN 1144: Substantial % of Patients Normalized from Elevated ALT
LPCN 1144: Substantial % of Patients Normalized from Elevated ALT at BL □ Comparable LPCN 1144 ALT Responder Rate, Known to Improve Liver Histology, to Vitamin E in PIVENS* 17 52% 43% 48% 0% 10% 20% 30% 40% 50% 60% ALT Normalization† by LPCN 1144 (SOAR) LPCN 1144 ALT Responders‡ (SOAR) Vitamin E ALT
Slide 18: LPCN 1144: Improves Mental and Sexual PROs
□ 52 Week SOAR Trial LPCN 1144: Improves Mental and Sexual PROs Mental Component Summary Mental Health Role Emotional Maintained Erection Sexual Activity Negative Mood Positive Mood Overall Sexual Desire -4 -2 0 2 4 6 8 Mean Change ( “ 95% CI) from Baseline SF - 36 PDQ SF - 36, Short Form - 36 (0 -
Slide 19: LPCN 1144: Increased Prevalence of NAFLD with Increasing BMI
□ LPCN 1144 MRI - PDFF Study LPCN 1144: Increased Prevalence of NAFLD* with Increasing BMI 19 43% 68% 100% 0% 20% 40% 60% 80% 100% No OBS OBS Morbidly OBS BMI<30 BMI 30-40 BMI >40 % of NAFLD Population * NAFLD Confirmed by MRI - PDFF based liver fat ≥ 5%
Slide 20: Substantially Increased NAFLD in Hypogonadal Obese Male Patients
LPCN 1144: Substantially Increased NAFLD † in Hypogonadal Obese Male Patients 20 † NAFLD: Identified by Ultrasonography in US population (NHANES) and confirmed by MRI - PDFF based liver fat ≥ 5% (LPCN 1144 Liver Fat Study) * Lazo et al., AJE 2013 31% 49% 67% 86% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90
Slide 21: Conclusion
Conclusion □ Strong Rationale for Androgen Therapy in NAFLD/NASH Patients ▪ MRI - PDFF confirmed High (~70%) Prevalence of Fatty Liver in Hypogonadal men ▪ LPCN 1144 Improves Liver Function Tests & Serum Triglycerides in Subjects at Risk of NAFLD/NASH □ Well Tolerated LPCN 1144 Therapy with Potentia