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Author disclosures are on file at AASLD. This study was funded by Lipocine Inc. Contact info: Dr. Jonathan Baker, jb@lipocine.com or admin@lipocine.com RESULTS * LPCN 1144 Patients for ALT 40 U/L at BL (N=42); ALT mean B

Key Takeaway: Oral Testosterone (LPCN 1144) Undecanoate Normalizes Liver Function Measures and Serum Triglycerides in Subjects at Risk for Non - Alcoholic Fatty Liver Disease (NAFLD) INTRODUCTION RESULTS - Cont'd R ESULTS - Cont'd Clinical testosterone (T) deficiency is prevalent across the hi

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Oral Testosterone (LPCN 1144) Undecanoate Normalizes Liver Function Measures and Serum Triglycerides in Subjects at Risk for Non - Alcoholic Fatty Liver Disease (NAFLD) INTRODUCTION RESULTS - Cont'd R ESULTS - Cont'd Clinical testosterone (T) deficiency is prevalent across the histological spectrum of NAFLD. Hepatic Steatosis: Men with low testosterone are at high risk for NAFLD. 1 NASH: Patients with NASH show significantly lower free T than those with nonalcoholic fatty liver (NAFL). Levels of free T decreased significantly with the increased incidence of : 2 x Lobular inflammation, hepatocyte ballooning, NAFLD activity score, and fibrosis Cirrhosis: Low T levels in cirrhotic men are associated with the combined outcome of death or transplantation. 3 Significant overlap of NAFLD/NASH comorbidities (e.g., obesity, diabetes, hypertension, metabolic syndrome) associated with male hypogonadism 4,5 T therapy demonstrated histological improvement in multiple biopsy confirmed high fat/cholesterol diet induced models. LPCN 1144, an oral prodrug of bioidentical testosterone, is well tolerated in multiple clinical studies up to 52 week exposure. The objectives of this investigation are: To investigate the effect of LPCN 1144 therapy on biomarkers often used in diagnosis of NAFLD/NASH To assess the effect of LPCN 1144 therapy in subgroups of T deficient male patients with comorbidities associated with NAFLD/NASH To assess collateral benefits of LPCN 1144 therapy in male patients with elevated alanine aminotransferases (ALT) CONCLUSION Testosterone deficiency in men is reportedly prevalent across the full spectrum of NAFLD. LPCN 1144, an oral testosterone therapy, consistently improved liver function and lipid biomarkers in hypogonadal patients at risk of NAFLD/NASH. LPCN 1144 therapy has the potential to provide collateral health benefits in patients with chronic liver disease. Results across multiple studies suggest LPCN 1144's unique therapeutic potential to safely treat patients with NAFLD/NASH. 1 Kim et al., Gastroenterol 2012; 2 Sumida et al., Gastroenterol Hepatol 2015; 3 Sinclair et al., Liver Trans 2016; 4 Younossi et al., Hepatol 2016; 5 Dhindsa et al., Diab Care 2010; 6 Kelly et al., Lif Sci 2014; 7 Nikolaenko et al., BMC Endocrinol 2014; 8 Vignozzi et al., Mol Cell Endocrinol 2014; 9 Cai et al., BMC Genomics 2015; 10 Tomizawa et al, Biomed Rep 2014; 11 Hoofnagle et al., Aliment Pharmacol Ther 2013 Arun J. Sanyal 1 , Nachiappan Chidu Chidambaram 2 , Satish Nachaegari 2 , Burke Byrne 2 , Kilyoung Kim 2 , Jonathan Baker 2 , and Mahesh V. Patel 2 1 Virginia Commonwealth University, Richmond, VA, USA; 2 Lipocine Inc., Salt Lake City, UT, USA REFERENCES Analyses of LPCN 1144 therapy results were performed with clinical studies involving hypogonadal male cohorts with baseline liver enzymes* and lipid**. Placebo - controlled, randomized, double blind study ( M12 - 778 ) with four week treatment x Analysis of 225mg/300mg BID and Placebo (N=24) Active - controlled, randomized, open label study ( SOAR , N=210) with 52 week treatment - 225mg 75mg BID Single - arm open label study ( 16 - 002 ), N=95 with three week treatment Exhibit 99.1 Author disclosures are on file at AASLD. This study was funded by Lipocine Inc. Contact info: Dr. Jonathan Baker, jb@lipocine.com or admin@lipocine.com RESULTS * LPCN 1144 Patients for ALT > 40 U/L at BL (N=42); ALT mean BL = 53.6 U/L * LPCN 1144 Patients for ALT > 40 U/L at BL; SOAR (N=42), 16 - 002 (N=13) Comparable LPCN 1144 ALT Responder Rate, Known to Improve Liver Histology, to Vitamin E 11 M ETHODS SF - 36, Short Form - 36 (0 - 100); PDQ, Psychosexual Daily Questionnaire (0 - 7); * ALT > 40 U/L at BL in SOAR Trial (N=33) SOAR Trial; * Metabolic syndrome: obesity + diabetes + hypertension * LPCN 1144 Patients for TG > 200 mg/dL at BL (N=73); TG mean BL = 320 mg/dL ALT normalization: Above - normal at BL Normal at EOS ALT responder: Above - normal at BL Normal with at least 30 % reduction at EOS TG and LDL - C normal range upper limit is 200 and 160 mg/dL, respectively; * N=73 (TG) and 26 (LDL - C) in SOAR Trial; ** N=16 (TG) and 10 (LDL - C) in 16 - 002 Study * ALT, AST, ALP, GGT; Persistent elevated ALT is a biomarker often used in clinical diagnosis of NAFLD/NASH. ** Triglyceride is strongly associated with nonalcoholic fatty liver disease. 10 Significant Reduction in Liver Enzyme Levels Placebo Controlled 4 Week Study (M12 - 778) Sustained Reductions of Elevated ALT Levels at BL SOAR LPCN 1144 SOAR Trial; * Metabolic syndrome: obesity + diabetes + hypertension Reduction of ALT in Patients with NAFLD/NASH Comorbidities Consistent Liver Function Improvement Across Studies* - Effects Observed as Early as Week 3 * LPCN 1144 Patients for ALT > 40 U/L at BL; SOAR (N=42), 16 - 002 (N=13) Substantial % of Patients Normalized from Elevated ALT at BL Reductions of TG in Potential NAFLD/NASH Patients Collateral Health Benefits Observed with LPCN 1144 Therapy* Significant % of Patients Experienced Normalization of TG and LDL - C
Last updated: Nov 9, 2018