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LPCN 1144 Treatment Potential Assessment in a High Fat Diet Induced Rabbit Model of Hepatic Fibrosis and NASH INTRODUCTION R ESULTS – Cont’d ▪ The number of NASH cases in 2015 was estimated about 17 million cases in US. 1 ▪ Low free testosterone (T) level in men was independently associated with presence and severity of Non - Alcoholic Steatohepatitis (NASH). 2 ▪ A recent study (NCT03868059) reported LPCN 1144 resolves NAFLD in hypogonadal males with NAFLD. However, the effect of LPCN 1144 treatment on hepatic fibrosis and NASH features is unknown. 3 ▪ LPCN 1144 is a prodrug of bioidentical testosterone, orally absorbed via lymphatic route into the body avoiding first pass metabolism, unlikely methylated testosterone. ▪ The objective was to evaluate the impact of oral LPCN 1144 treatments on a non - genomic, 12 - week high fat diet (HFD) - induced, rabbit animal model of NASH and hepatic fibrosis. CONCLUSION ▪ HFD induced histological NASH features with fibrosis, altered key biomarkers, and lowered serum testosterone levels. ▪ LPCN 1144 treatments improved T levels in HFD - induced NASH rabbits with hypogonadism. ▪ Histological and biomarker analyses demonstrate that LPCN 1144 treatments improved NASH features and hepatic fibrosis. ▪ Pending confirmation in the ongoing LiFT clinical trial, these preclinical findings suggest therapeutic potential of LPCN 1144 in treatment of NASH and hepatic fibrosis. 1 Estes et al., Hepatol, 2018, 67 (1), 123 - 133 2 Sarkar et al., Clin Gastroenterol Hepatol, 2020, doi: https:// doi.org/10.1016/j.cgh.2019.11.053 3 Albhaisi et al., Hep Comm, 2020;4:1430 - 1440 Kilyoung Kim, PhD 1 ; Nachiappan Chidambaram, PhD 1 ; Anthony DelConte, MD 1,2 ; Paolo Comeglio, PhD 3 ; Sandra Filippi, PhD 3 ; Kiran Vangara, PhD 1 ; Joel Frank, BS 1 ; Kongnara Papangkorn, PhD 1 ; Benjamin J Bruno, PharmD, PhD 1 ; Mahesh V Patel, PhD 1 ; and Linda Vignozzi, MD 4 1 Lipocine Inc., Salt Lake City, Utah, USA; 2 Department of Pharmaceutical/Health Care Marketing, Saint Joseph’s University, Philadelphia, Pennsylvania, USA; 3 Department of Experimental and Clinical Biochemical Sciences “Mario Serio”, University of Florence, Florence, Italy; 4 Sexual Medicine and Andrology, University of Florence, Florence, Italy REFERENCES ▪ Male rabbits were randomly assigned to 5 groups and treated for 12 weeks: ▪ Histological scores were measured by Giemsa - PAS staining for inflammation (0 - 3 score), Masson’s trichrome staining for steatosis (0 - 1 score) and ballooning (0 - 2 score), and Pricosirius red staining for fibrosis (Ishak score: 0 - 6 score) with imaging analysis (fibrosis percentage of sampled area). ▪ Serum analysis and mRNA expression analysis for pro - inflammatory and pro - fibrotic biomarkers from liver tissues were performed for comparison. ▪ This study was funded by Lipocine Inc and performed by “Mario Serio” team at University of Florence, Italy. ▪ Contact info: Kilyoung Kim, kk@lipocine.com or admin@lipocine.com RESULTS M ETHODS □ HFD feeding induced NASH and liver fibrosis □ Both LPCN 1144 treatments reduced HFD - induced elevated levels of liver mRNA pro - inflammatory and pro - fibrotic biomarkers □ No stat. differences in histological NASH features and fibrosis between HFD and HFD+VEH arms □ Both LPCN 1144 treatments significantly improved T levels in HFD - induced hypogonadism □ Both LPCN 1144 treatments significantly reduced HFD - induced adiposity □ Both LPCN 1144 treatments improved HFD - induced histological NASH features and liver fibrosis ▪ % of subjects in advance of NASH features and fibrosis ▪ Fibrosis % in sampled area x Histological NASH features and liver fibrosis each worsened by HFD Exhibit 99.1