Lipocine Inc. · NASDAQ:LPCN

Lipocine — H.C. Wainwright 4th Annual NASH Investor Conference (October 2020)

14 slides from Lipocine's conference presentation, Oct 5, 2020

  1. Slide 1: LPCN 1144 for Non-Cirrhotic NASH

    LPCN 1144 for Non - Cirrhotic NASH H.C. Wainwright 4 th Annual NASH Investor Conference October 5, 2020 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 statements

  3. Slide 3: Clinical Stage Biopharmaceutical Company: Innovative Product Candidates

    LPCN 1144 Presentation I Clinical Stage Biopharmaceutical Company Innovative Product Candidates for Metabolic and Endocrine Disorders PRODUCT (Indication) PRE - CLINICAL PHASE 1 PHASE 2 PHASE 3 NDA Propriety Drug Delivery Platform TLANDO™ (Oral Testosterone for Testosterone Replacement Therapy “TRT”

  4. Slide 4: Rationale to Target Non-Cirrhotic Male NASH Patients

    LPCN 1144 Presentation I LPCN 1144: Rationale to Target Non - Cirrhotic Male NASH Patients 4 Currently No Approved Treatment 1. Estes et al., Hepatol 2018. 2. Williams et al., Gastroenterology 2011. *2015 data ~6.9 M Male NASH F2 - F3 in 2030 1,2 17 M NASH Patients 1 11 M NASH Male Patients 1,2 3.5

  5. Slide 5: Association Between Testosterone and Liver Disease

    LPCN 1144 Presentation I Association Between Testosterone and Liver Disease 5 Clinical Evidence 1. Sarkar et al., Gastroenterology 156(6):S - 1258 & Poster Sa1623, Digestive Disease Week 2019 2. Sumida et al., Gastroenterol He patol 2015; 3. Sinclair et al., Liver Trans 2016; 4. Sinclair M. et al.,

  6. Slide 6: Association Between Testosterone and Liver Disease – Clinical Evidence

    Association Between Testosterone and Liver Disease – Clinical Evidence Liver Disease in Men Undergoing Androgen Deprivation Therapy (ADT) for Prostate Cancer 6 Gild et al. J Urol. 2018 Sep;200(3):573 - 581 Increased Liver Disease Risk Relative to No ADT NAFLD 54% ↑ Any Liver Disease 47% ↑ Necrosis 4

  7. Slide 7: Androgen Receptor Agonist Potential Mode of Action

    LPCN 1144 Presentation I LPCN 1144: Androgen Receptor Agonist Potential Mode of Action 7 Impact on pro - fibrotic inputs Anti - steatosis Anti - inflammatory Anti - oxidant LPCN 1144 (Oral Testosterone) Regeneration Booster ( ↑ IGF1) Impact on fibrosis Anti - fibrosis ( ↓ TGF - β)

  8. Slide 8: Androgen Receptor Agonist Differentiated NASH Treatment Candidate

    LPCN 1144 Presentation I LPCN 1144: Androgen Receptor Agonist Differentiated NASH Treatment Candidate Targets Unmet Need Acceptable benefit to risk ratio • NASH resolution and/or fibrosis improvement • Tolerability for chronic use Improvement of sarcopenia Improvement of sexual dysfunction Improveme

  9. Slide 9: Liver Fat Imaging Study (LFS)

    LPCN 1144 Presentation I LPCN 1144: Liver Fat Imaging Study (“LFS”) Study Design and Baseline Liver Fat Subject Distribution LFS was an open - label, multi - center, single - arm 16 - week study (N=36) o f LPCN 1144 225 mg BID in hypogonadal males LF ≥ 10% N = 8 LF ≥ 8% N = 10 LF ≥ 5% N = 21 Evaluat

  10. Slide 10: Liver Fat Reduction

    LPCN 1144 Presentation I LPCN 1144: Liver Fat Reduction Meaningful Relative Liver Fat % Change and Responder Rate - 42% - 40% -60% -50% -40% -30% -20% -10% 0% Mean BL LF = 18.3% Mean BL LF = 20.5% BL ≥ 8% BL ≥ 10% Relative % Change of Liver Fat % (n=10) (n=8) 80% 75% 0% 10% 20% 30% 40% 50% 60% 70% 8

  11. Slide 11: Longitudinal Treatment Effect: Improved NAFL Resolution Over Time

    LPCN 1144 Presentation I LPCN 1144: Longitudinal Treatment Effect 11 Improved NAFL Resolution Over Time 34% 52% 63% 0% 20% 40% 60% 80% Baseline 8 Wk 16 Wk NAFL - Free % of Population NAFL Resolution to < 5% Liver Fat (N=31) (N=32) (N=32) NAFL is non - alcoholic fatty liver with ≥ 5% liver fat; NCT03

  12. Slide 12: LPCN 1144: Reduction of Liver Injury Markers

    LPCN 1144 Presentation I - 11.1 - 4.2 - 4.5 - 6.5 -16.0 -14.0 -12.0 -10.0 -8.0 -6.0 -4.0 -2.0 0.0 2.0 Mean Change from Baseline LPCN 1144: Reduction of Liver Injury Markers In Patients with Elevated ALT at Baseline Liver markers mean change from baseline to end of study (1 - Yr), NCT02081300 x2 x5 S

  13. Slide 13: GI Safety Profile

    LPCN 1144 Presentation I LPCN 1144: GI Safety Profile No Notable Gastrointestinal Tolerability Issue 13 *NCT02081300 0 5 10 % Subjects *

  14. Slide 14: LiFT (Liver Fat intervenTion) Study

    LPCN 1144 Presentation I LPCN 1144: LiFT (Liver Fat intervenTion ) Study* Ongoing 14 Phase 2 paired - biopsy clinical study in NASH subjects – completed enrollment * Website: www.lift - study.com , NCT04134091 SCREENING Topline MRI - PDFF Results Jan 2021 Dose Start Topline Biopsy Results Mid - 2021

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