S. MEHRABAN 1 , B. J. BRUNO 1 , K. KIM 1 , K. PAPANGKORN 1 , N. CHIDAMBARAM 1 , M. V. PATEL 1 , A. DELCONTE 2 1 Lipocine Inc., Salt Lake City, UT, USA 2 Saint Joseph’s University, Philadelphia, PA, USA LPCN 1144 improves body composition in biopsy - confirmed NASH patients INTRODUCTION • Non - alcoholic Steatohepatitis (NASH) is a common cause of liver disease and rapidly rising to be the leading etiology for liver transplantation (1) • Sarcopenia, loss of muscle mass, occurs in 20 - 60% of patients with liver disease and reduces survival of cirrhotic patients (2) • There is an unmet need for addressing adverse body composition in advanced liver disease • A decrease in free Testosterone (T) and increase in Sex Hormone Binding Globulin (SHBG) are reported with progression of NAFLD (3) • LPCN 1144 is an oral prodrug of endogenous T under development for treatment of noncirrhotic NASH • Previously, LPCN 1144 has showed to reduce hepatic fat fraction, AST and ALT levels in noncirrhotic NASH subjects compared to placebo (p<0.001 and <0.05,respectively) CONCLUSIONS ▪ LPCN 1144 significantly improved body composition in biopsy - confirmed NASH male subjects ▪ Similar to the results shown in cirrhotic patients, oral testosterone resulted in significant improvement in APLM and reduction in WBFM in non - cirrhotic NASH subjects (4) ▪ This significant impact of LPCN 1144 on body composition can be beneficial in end stage diseases such as cirrhosis ▪ Larger longitudinal investigations are warranted to confirm these effects in end stage diseases RESULTS METHOD • The ongoing LiFT (Liver Fat intervention with oral Testosterone) study is a randomized, double - blind, paired biopsy, placebo - controlled, phase 2 study in men with NASH (NCT04134091) (N=56) • Biopsy - confirmed NASH subjects were randomized 1:1:1 to three arms: x Treatment A: 142 mg eq. oral T twice daily x Treatment B: 142 mg eq. oral T with tocopherol twice daily x O ral matching placebo twice daily • Body composition parameters were evaluated in all subjects with available baseline and week 20 Dual Energy X - ray Absorptiometry (DEXA) scans (N=38), including changes in: x A ppendicular Lean M uscle M ass (APLM) x W hole Body F at M ass (WBFM) x W hole Body L ean M ass (WBLM) • Other key outcomes measured at week 12 included changes in: x SHBG AIM To present topline body composition results post 20 weeks of treatment with oral testosterone . REFERENCES 1 . Bhanji RA et al . Sarcopenia in hiding: the risk and consequence of underestimating muscle dysfunction in nonalcoholic steatohepatitis. Hepatology. 2017 Dec;66(6):2055 - 65. 2. S. Dasarathy . Etiology and Management of Muscle Wasting in Chronic Liver Disease. Curr Opin Gastroenterol. 2016, 32(3): 159 – 165. 3. Fujihara et al . High sex hormone - binding globulin concentration is a risk factor for high fbrosis - 4 index in middle - aged Japanese men. Endoc J. 2019, 66 (7): 637 - 645. 4. Sinclair M , et al . Testosterone therapy increases muscle mass in men with cirrhosis and low testosterone: a randomised controlled trial. Journal of hepatology. 2016 Nov 1;65(5):906 - 13. □ Demographics and Baseline Characteristics All Subjects (N=56) Placebo (n=19) All Subjects (N=56) Placebo (n=19) Treatment A (n=18) Treatment B (n=19) Treatment A (n=18) Treatment B (n=19) CONTACT INFORMATION Shadi Mehraban, MD, PhD. sm@lipocine.com or admin@lipocine.com □ Percentage of subjects with increase in WBFM and decrease in WBLM LPCN 1144 treatment reduced progression of adverse muscle composition compared to placebo. □ Responders with decrease in WBFM and increase in WBLM 64% of the subjects receiving LPCN 1144 compared to 15.4% in the placebo arm had favorable body composition changes. □ Absolute Change from Baseline in SHBG LPCN 1144 significantly decreased SHBG levels from baseline at 12 weeks compared to placebo. Free T is expected to increase after treatment with LPCN 1144. □ Relative change in Appendicular Lean Muscle Mass All Subjects (N=56) Placebo (n=19) All Subjects (N=56) Placebo (n=19) Treatment A (n=18) Treatment B (n=19) Treatment A (n=18) Treatment B (n=19) □ Relative Change in Whole Body Fat Mass LPCN 1144 treatment significantly elevated APLM, and significantly reduced WBFM in biopsy - confirmed NASH subjects after 20 weeks compared to placebo. □ Relative Change in Whole Body Lean Mass Exhibit 99.5