Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (July 2020)
28 slides from Lipocine's investor presentation, Jul 20, 2020
Slide 1: Enabling Oral Drug Delivery to Improve Patient Compliance
Enabling Oral Drug Delivery to Improve Patient Compliance July 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
July 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 The
Slide 4: TLANDO: The First Oral TRT Without Titration Requirement
TLANDO™ The First Oral TRT Without Titration Requirement
Slide 5: Hypogonadism Affects Up to 20M Men
July 2020 Corporate Presentation I Hypogonadism Affects Up to 20M Men 1, 2 5 TLANDO Franchise has the Potential to Drive Market Expansion 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: Monthly TRT TRx Trend: TRT Market is Growing
July 2020 Corporate Presentation I Monthly TRT TRx Trend 6 TRT Market is Growing
Slide 7: Issues with Current TRT Options
July 2020 Corporate Presentation I Issues with Current TRT Options • Black Box Warning – Secondary exposure to testosterone – Pulmonary oil micro embolism (POME) and anaphylaxis shock • Inconvenient application or painful injection • Most require dose titrations (up titrations) – More than 50% of pa
Slide 8: Persistence Issue with TRTs
July 2020 Corporate Presentation I Persistence Issue with TRTs High Discontinuation Rates with Products Requiring Titration 8 8 *Donatucci C, et al. J Sex Med. 2014 Source: Adheris Health 2017 Cohort Period: February 2016 – January 2017 Analysis Period: 12 Months 0% 10% 20% 30% 40% 50% 60% 70% 80% 9
Slide 9: Titration Requirements of Current TRTs
July 2020 Corporate Presentation I 0 X 37% 1 X 26% 2 X 20% 3 X 12% >3 X 5% Titration Requirements of Current TRTs Majority of Patients Need Dose Adjustment 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
Slide 10: Physician Research Data: Average Titration Time
July 2020 Corporate Presentation I Physician Research Data* 10 10 Average titration time to steady state dose N = 402 physicians; 150 primary care, 102 urology, 150 endocrinology 11% 16% 8% 41% 45% 33% 28% 43% 9% 10%36% 6% Primary Care 3% 1% 100% Endo - 2% 2% 1% 2% Urology 3% 1% % physicians 3 - 4 m
Slide 11: TLANDO Attributes
July 2020 Corporate Presentation I f TLANDO ™ Attributes TRT without Titration Requirement Convenient Oral Route • Patient and physician preferred Easy to Prescribe and Use • Enables selection of an effective dose at the start of therapy • Potential for higher persistence/adherence • No burden of ad
Slide 12: TLANDO Regulatory Update
July 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 Augus
Slide 13: TLANDO XR (Testosterone Tridecanoate) Once Daily Oral TRT
TLANDO XR (Testosterone Tridecanoate ) Once Daily Oral TRT
Slide 14: Phase 2b Study: Result Summary
July 2020 Corporate Presentation I Phase 2b Study: Result Summary • Once daily dose for 14 days in an open label, multiple dose PK study in hypogonadal men (n=36 subjects) x Phase 3 dose identified x No Drug related SAEs x Drug Related AEs are Mild to Moderate • Next step: Pivotal study protocol sub
Slide 15: LPCN 1144 for Non-Cirrhotic NASH
LPCN 1144 for Non - Cirrhotic NASH
Slide 16: LPCN 1144: Rationale to Target Non-Cirrhotic NASH
July 2020 Corporate Presentation I LPCN 1144: Rationale to Target Non - Cirrhotic NASH 16 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 M M
Slide 17: Association Between Testosterone and Liver Disease
July 2020 Corporate Presentation I Association Between Testosterone and Liver Disease 17 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
Slide 18: LPCN 1144: Oral Testosterone Therapy Differentiated NASH Treatment
July 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 hea
Slide 19: LPCN 1144: Liver Fat Imaging Study
July 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 =
Slide 20: LPCN 1144: Liver Fat Reduction
July 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%
Slide 21: LPCN 1144: Reduction of Liver Injury Markers
July 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), NCT020813
Slide 22: LPCN 1144: LiFT Study
July 2020 Corporate Presentation I LPCN 1144: LiFT Study* Ongoing 22 Liver Fat Intervention with Oral Testosterone Study * Website: www.lift - study.com SCREENING Topline MRI - PDFF Results By End of 2020 Dose Start Topline Biopsy Results by End of 2Q 2021 MRI - PDFF Biopsy Phase 2 paired - biopsy c
Slide 23: LPCN 1148 for Liver Cirrhosis
LPCN 1148 for Liver Cirrhosis
Slide 24: LPCN 1148: Oral T for Cirrhosis Background
July 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 24 1. Sinclair et al., Liver Transplantation, 2016; 2. Sinclair et al., J Gastroenterol Hepatol . 20
Slide 25: Reduced Testosterone: Cirrhosis Association
July 2020 Corporate Presentation I Reduced Testosterone* – Cirrhosis Association 25 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: M
Slide 26: Upcoming Milestones
July 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 By End of 2020 LiFT Biopsy Results By End of 2Q 2021 IP Infringement Litigation Oral Jury Hearing February 2021 26
Slide 27: Key Financial Metrics
July 2020 Corporate Presentation I Key Financial Metrics 27 Stock Price, Market Cap, Cash Balance * $5M restricted and becomes unrestricted upon TLANDO approval Ticker Symbol LPCN (Nasdaq Capital Market) Closing Stock Price (7/16/20) $1.33/share Cash Balance (3/31/20) $20.6 million* Bank Debt (3/31/
Slide 28: Lipocine Investment Highlights
July 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