Lipocine Inc. · NASDAQ:LPCN
Lipocine — SMSNA 2019
10 slides from Lipocine's conference presentation, Oct 25, 2019
Slide 1: LPCN Oral T (TLANDO) Reduces Liver Fat in Men with Fatty Liver
1 Confidential 1 SMSNA 2019 October 25, 2019 LPCN Oral T (TLANDO) Reduces Liver Fat in Men with Fatty Liver Presenter: Irwin Goldstein, MD Director, Sexual Medicine, Alvarado Hospital, San Diego, CA Clinical Professor of Surgery, University of California at San Diego Authors: Irwin Goldstein, MD; Ki
Slide 2: LPCN Oral T Is Not Hepatotoxic
2 Confidential LPCN Oral T Is Not Hepatotoxic TLANDO™ (Testosterone Undecanoate) vs Methyl Testosterone LPCN Oral T (TLANDO ™ *) is a non - methylated, orally bioavailable prodrug of natural T Testosterone Undecanoate Testosterone 2 Methyl - TLANDO™ (Oral TU) * TLANDO, LPCN 1144, and LPCN 1021 inclu
Slide 3: TLANDO Improves Mental and Sexual Domains with 52-Week Treatment
3 Confidential TLANDO™ Improves Mental and Sexual Domains with 52 - Week Treatment TLANDO™ Restores Normal T Levels in Hypogonadal Males. * Study of Androgen Replacement (SOAR, NCT02081300); † Topical T: AndroGel 1.62% as active control ▪ SOAR* Trial: a 52 - wk, multicenter, active controlled (topic
Slide 4: NAFLD Pathways & Effect of Androgens
4 Confidential Non Alcoholic Fatty Liver Disease (NAFLD) Pathways & Effect of Androgens 4 NAFLD: Non Alcoholic Fatty Liver Disease, NASH: Non Alcoholic Steatohepatitis, LFT: Liver function test, TG: Triglycerides — Normal TGs — Normal LFTs — ↑ TGs — ↑ LFTs — ↑ Liver fat — ↑ TGs & LFTs — ↑ Liver fat
Slide 5: Low T is Associated with NAFLD Across the Full Disease Spectrum
5 Confidential Low T is Associated with NAFLD Across the Full Disease Spectrum Kim et al., BMC Gastroenterol 2012 “Men with low testosterone are at high risk for NAFL” “Low T levels in cirrhotic men are associated with the mortality or transplantation” Sinclair et al., Liver Transplant 2016 NAFL* (N
Slide 6: TLANDO Clinical Experience
6 Confidential TLANDO™ Clinical Experience More than 700 subjects have been exposed to TLANDO™ across 14 clinical studies ▪ Two studies involved the assessment of liver health (liver fat changes and liver injury marker changes) Clinical Study # of Subjects Duration of Study Outcome Established SOAR*
Slide 7: Liver Fat Study: Longitudinal Improvement in Liver Fat with 4-Month TLANDO Treatment
7 Confidential Liver Fat Study: Longitudinal Improvement in Liver Fat with 4 - Month TLANDO™ Treatment ■ Non Alcoholic Fatty Liver (NAFL) Free (LF < 5%) ■ Non Alcoholic Fatty Liver (NAFL) (LF ≥ 5%) NAFLD Free NAFLD Free NAFLD Free NAFLD Free NAFLD Free NAFLD Free 52% 48% NAFL Free NAFL 63% 38% NAFL
Slide 8: SOAR: Improved Liver Injury Markers Post 52-Wk TLANDO Treatment
8 Confidential SOAR: Improved Liver Injury Markers Post 52 - Wk TLANDO™ Treatment 8 - 17% - 10% - 5% - 10% -25% -20% -15% -10% -5% 0% ALT AST ALP GGT Mean % Change from BL Mean BL* (U/L) 53.6 32.0 74.0 53.6 * BL: Baseline, TLANDO™ patients for ALT > 40 U/L at BL; SOAR (NCT02081300), N=42 N 42 4 6 36
Slide 9: SOAR: Differentiated TLANDO Effect on Biomarkers Compared to Topical T
9 Confidential SOAR: Differentiated TLANDO™ Effect on Biomarkers Compared to Topical T Post 52 - Week Treatment -10% -5% 0% 5% 10% 15% TLANDO Topical T ALP CBL* ALP Changes from Baseline P=0.009 -30 -20 -10 0 10 20 30 40 TLANDO Topical T TG CBL (mg/dL) TG Changes from Baseline P=0.02 0 2 4 6 8 10 12
Slide 10: Conclusions
10 Confidential Conclusions ▪ TLANDO™ restores normal T levels in hypogonadal men with – Observed improvement on mental health domain by SF - 36 – Observed improvement on sexual domain by PDQ (maintained erection and full erection %). ▪ TLANDO™ is beneficial on liver health demonstrated by – Nonalco