Lipocine Inc. · NASDAQ:LPCN

Lipocine — H.C. Wainwright 3rd Annual NASH Investor Conference (October 2019)

13 slides from Lipocine's conference presentation, Oct 21, 2019

  1. Slide 1: Enabling Oral Drug Delivery to Improve Patient Compliance

    Enabling Oral Drug Delivery to Improve Patient Compliance October 21, 2019 H.C. Wainwright 3 rd Annual NASH Investor Conference Exhibit 99.1

  2. Slide 2: 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 statement s re

  3. Slide 3: Clinical Stage Biopharmaceutical Company

    Clinical Stage Biopharmaceutical Company Innovative Product Candidates for Metabolic and Endocrine Disorders 3 PRODUCT (Indication) PRE - CLINICAL PHASE 1 PHASE 2 PHASE 3 NDA TLANDO ™ (Oral Testosterone for Testosterone Replacement Therapy “ TRT”) PDUFA November 9, 2019 TLANDO XR (Long Acting Oral T

  4. Slide 4: Endocrine Dysfunction (Low T) is Common in Chronic Liver Disease

    4 Endocrine Dysfunction (Low T) is Common in Chronic Liver Disease 1. Sumida et al., Gastroenterol Hepatol 2015; 2. Sinclair et al., Liver Trans 2016; 3. Sinclair M. et al., J. of Gastro and Hepatology, 2015; 4. Sarkar et al., Gastroenterology 156(6):S - 1258 & Poster Sa1623, Digestive Disease Week

  5. Slide 5: 1144 Proposed Mechanism Across the Full Spectrum of NASH Pathogenesis

    LPCN 1144 Proposed Mechanism 5 Across the Full Spectrum of NASH Pathogenesis Healthy Liver Steatosis Inflammation NASH Fibrosis LPCN 1144 Regeneration Booster 3 ▪ Obesity ▪ Insulin Resistance ▪ Dyslipidemia ▪ Metabolic Syndrome ▪ Hypogonadism (Low T) The removal of pro - fibrotic inputs or the stren

  6. Slide 6: Liver Fat Imaging Study

    LPCN 1144: Liver Fat Imaging Study (“LFS”) ~Sixty Percent of Hypogonadal Subjects had Fatty Liver (LF ≥ 5%) 6 LFS was an open - label, multi - center single - arm 16 - week study (N=36) with LPCN 1144 in hypogonadal males LF = liver fat † NAFLD identified by MRI - PDFF ≥ 5% in LPCN 1144 Liver Fat St

  7. Slide 7: Liver Fat Study Results

    LPCN 1144: Liver Fat Study Results Meaningful Relative Liver Fat % Change and Responder Rate 7 - 33% - 42% - 40% -60% -50% -40% -30% -20% -10% 0% BL ≥ 5% BL ≥ 8% BL ≥ 10% % Liver Fat CBL ( ± SEM) Mean Relative Liver Fat % Change 71% 80% 75% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% BL ≥ 5% BL ≥ 8%

  8. Slide 8: Longitudinal Treatment Effect

    LPCN 1144: Longitudinal Treatment Effect ■ NAFLD Free (LF < 5%) ■ NALFD (LF ≥ 5%) Liver Fat Based Subject Distribution at Each Visit Continued Improvement with NAFLD Resolution Over Time * Full Analysis Set (FAS) 8 NAFLD Free NAFLD Free NAFLD Free NAFLD Free NAFLD Free NAFLD Free 52% 48% Interim (We

  9. Slide 9: Significant Reduction of Elevated ALT Levels

    LPCN 1144: Significant Reduction of Elevated ALT Levels Meaningful ALT Normalization and Responders at EOS 9 † N = 42 for ALT > 40 U/L at baseline (ALT normal range is ≤ 40 U/L) in 1 - yr SOAR Study (NCT 02081300) ‡ ALT responder: Above - normal at BL  Normal with at least 30 % reduction at EOS ▪ C

  10. Slide 10: Well Tolerated

    LPCN 1144: Well Tolerated Good Gastrointestinal Tolerability with No LDL - C Increase at EOS 10 * LDL - C upper normal limit is 160 mg/dL. Source: 52 - week SOAR study - 3 - 15 -25 -20 -15 -10 -5 0 BL = 114 mg/dL 175 mg/dL Overall (N=194) Above-Noraml at BL* (N=16) Mean LDL - C Change from BL (mg/dL

  11. Slide 11: Additional Health Benefits Observed in Hypogonadal Subjects with Elevated ALT

    LPCN 1144: Additional Health Benefits Observed in Hypogonadal Subjects with Elevated ALT* 11 -3 -2 -1 0 1 2 3 4 5 6 Mean Change from Baseline with 95% Confidence Interval PDQ & SF - 36 Change from Baseline (52 - Week SOAR Trial) Mental Composition Summary Meatal Health Role Emotional Maintained Erec

  12. Slide 12: LiFT Study - Ongoing

    LPCN 1144: LiFT Study* - Ongoing Liver Fat intervention with Oral Testosterone Study • Phase 2 paired - biopsy clinical study in NASH subjects – Three - arm, multi - center, double - blind, placebo controlled – ~75 biopsy confirmed NASH male subjects with NAS ≥ 4 – Paired biopsy at baseline and EOS

  13. Slide 13: Differentiated NASH Treatment Candidate

    LPCN 1144: Differentiated NASH Treatment Candidate Potential for Mono/Combo Chronic Therapy Meaningful POC Efficacy Results Well Tolerated 700+ subjects in 14 studies with up to 52 - week exposure Potential Additional Benefits Most biopsy confirmed male NASH have low testosterone • Over 40% relative

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