Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (May 2020)
26 slides from Lipocine's investor presentation, May 11, 2020
Slide 1: Enabling Oral Drug Delivery to Improve Patient Compliance
Enabling Oral Drug Delivery to Improve Patient Compliance May 2020 Corporate Presentation Exhibit 99.1
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
Slide 3: Clinical Stage Biopharmaceutical Company: Innovative Product Candidates
2020 Corporate 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
Slide 4: TLANDO Fixed Dose Oral TRT
TLANDO™ Fixed Dose Oral TRT
Slide 5: Hypogonadism Affects Up to 20M Men
2020 Corporate Presentation I Hypogonadism Affects Up to 20M Men 1, 2 5 TLANDO Franchise has the Potential to Drive Market Expansionreated 1,2 1. US Census data. http:// www.infoplease.com /us/census/data/ demographic.html . 2. Mulligan T, et al. Int J Clin Pract . 2006 Jul;60(7):762 - 9. 3. Araujo,
Slide 6: TRT Market is Growing Without Oral Option
2020 Corporate Presentation I 350 375 400 425 450 475 500 525 550 575 600 625 650 675 Oct 14 Nov 14 Dec 14 Jan 15 Feb 15 Mar 15 Apr 15 May 15 Jun 15 Jul 15 Aug 15 Sep 15 Oct 15 Nov 15 Dec 15 Jan 16 Feb 16 Mar 16 Apr 16 May 16 Jun 16 Jul 16 Aug 16 Sep 16 Oct 16 Nov 16 Dec 16 Jan 17 Feb 17 Mar 17 Apr
Slide 7: Issues with Current Non-Oral TRT Options
2020 Corporate Presentation I Issues with Current Non - Oral TRT Options • Black Box Warning – Secondary exposure to testosterone – Pulmonary oil micro embolism (POME) and anaphylaxis shock • Inconvenient application or painful injection • Poor persistence reflects need for oral – Average days on th
Slide 8: TLANDO Has Potential to Improve Persistence
2020 Corporate Presentation I 0 X 37% 1 X 26% 2 X 20% 3 X 12% >3 X 5% TLANDO Has Potential to Improve Persistence Titration Requirements of Current TRTs CONFIDENTIAL Number of Current TRT Dose Adjustments by Form* 0 X 47% 1 X 33% 2 X 15% 3 X 2% >3 X 3% Gel (n=200) Injectable (n=137) * Current TRT n=
Slide 9: TLANDO Attributes
2020 Corporate Presentation I TLANDO ™ Attributes Fixed Dose Oral TRT Option Convenient Oral Route • Patient and Physician preferred Easy to Prescribe Fixed Dosing Regimen • No additional dose adjustment visits • Less prone to drop out after first Rx • The “right” dose from the start of therapy with
Slide 10: TLANDO Regulatory Update
2020 Corporate Presentation I TLANDO Regulatory Update Near Term PDUFA Date CRL received November 9, 2019 One deficiency: Did not meet the three secondary endpoints for maximal testosterone concentrations ( Cmax ) Post Action Meeting January 16, 2020 NDA Filed February 28, 2020 PDUFA Date August 28,
Slide 11: LPCN 1144 for Pre-Cirrhotic NASH
LPCN 1144 for Pre - Cirrhotic NASH
Slide 12: LPCN 1144: Rationale to Target Pre-Cirrhotic NASH
2020 Corporate Presentation I LPCN 1144: Rationale to Target Pre - Cirrhotic NASH 12 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 Patients 1,2 3.5 M Male NASH w
Slide 13: LPCN 1144: Oral Testosterone Therapy Differentiated NASH Treatment Candidate
2020 Corporate Presentation I LPCN 1144: Oral Testosterone Therapy Differentiated NASH Treatment Candidate Targets Unmet Need NASH resolution and/or fibrosis improvement Acceptable tolerability for chronic use Improvement of sarcopenia Improvement of sexual dysfunction Improvement of mental health P
Slide 14: Association Between Testosterone and Liver Disease
2020 Corporate Presentation I Association Between Testosterone and Liver Disease 14 Clinical Evidence 1. Sarkar et al., Gastroenterology 156(6):S - 1258 & Poster Sa1623, Digestive Disease Week 2019 2. Sumida et al., Gastroenterol Hepatol 2015; 3. Sinclair et al., Liver Trans 2016; 4. Sinclair M. et
Slide 15: LPCN 1144 Proposed Mechanism Across NASH Pathogenesis
2020 Corporate Presentation I LPCN 1144 Proposed Mechanism 15 Across the Full Spectrum of NASH Pathogenesis 1. Bianchi VE, J Endoc Soc 2019; 2. Vignozzi et al., unpublished clinical data 2018; 3. Vic et al., Hepatol 1982; 4. Lucía Cordero - Espinoza and Meritxell Huch , J Clin Invest 2018 Healthy Li
Slide 16: LPCN 1144: Liver Fat Imaging Study
2020 Corporate 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) with 225 mg BID LPCN 1144 in hypogonadal males LF ≥ 10% N = 8 LF ≥ 8% N = 10 LF ≥ 5% N = 21 Ev
Slide 17: LPCN 1144: Liver Fat Reduction
2020 Corporate 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%
Slide 18: LPCN 1144: Reduction of Liver Injury Markers
2020 Corporate 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 enzymes mean change from baseline to end of study (1 - Yr), NCT02081300 x2
Slide 19: LPCN 1144: LiFT Study Ongoing
2020 Corporate Presentation I LPCN 1144: LiFT Study* Ongoing 19 Liver Fat Intervention with Oral Testosterone Study * Website: www.lift - study.com SCREENING Topline MRI - PDFF Results 4Q 2020 Dose Start Topline Biopsy Results 2Q 2021 MRI - PDFF Biopsy Phase 2 paired - biopsy clinical study in NASH
Slide 20: LPCN 1148 for Liver Cirrhosis
LPCN 1148 for Liver Cirrhosis
Slide 21: LPCN 1148: Oral T for Cirrhosis Background
2020 Corporate Presentation I Common Causes 3 Alcoholic liver disease Nonalcoholic Fatty Liver Disease (NAFLD) Chronic hepatitis B Chronic hepatitis C Cryptogenic LPCN 1148: Oral T for Cirrhosis 21 1. Sinclair et al., Liver Transplantation, 2016; 2. Sinclair et al., J Gastroenterol Hepatol . 2016; 3
Slide 22: Reduced Testosterone – Cirrhosis Association
2020 Corporate Presentation I Reduced Testosterone* – Cirrhosis Association 22 Progressive Drop in T Level with Increasing Disease Severity 1 1. Sinclair et al., Liver Transplantation, 2016; 2. Sinclair et al., J Gastroenterol Hepatol . 2016; 3. Paternostro et al, Hepatol Res 2019 MELD Score: Model
Slide 23: Potential Key Effects of LPCN 1148 in Cirrhotic Patients
2020 Corporate Presentation I Potential Key Effects of LPCN 1148 in Cirrhotic Patients 23 References: Trivedi and Tapper, Gastroenterol Rep ( Oxf ), 2018; Berzigotti et al., Hepatology, 2017; Chen and Dunn, Clin Liver Dis ( Hoboken ), 2018; Sinclair et.al , Liver international, 2016; Neff et al., Di
Slide 24: Upcoming Milestones
2020 Corporate Presentation I Upcoming Milestones Near Term Value Drivers Event Expected Timing TLANDO™ PDUFA Date August 28, 2020 LPCN 1144 LiFT Primary Endpoint Results 4Q 2020 24
Slide 25: Key Financial Metrics
2020 Corporate Presentation I Key Financial Metrics 25 Stock Price, Market Cap, Cash Balance * $5M restricted and becomes unrestricted upon TLANDO approval Ticker Symbol LPCN (Nasdaq Capital Market) Closing Stock Price (5/8/20) $0.66/share Market Capitalization (5/8/20) $31.8 million Cash Balance (3
Slide 26: Lipocine Investment Highlights
2020 Corporate Presentation I Lipocine Investment Highlights Near Term TLANDO PDUFA with a Promising Pipeline Potential to be a TRT Market Leader TLANDO™: Differentiated product profile with potential for market expansion TLANDO XR: Unique long acting oral with potential to maintain leadership • ~$2