Lipocine Inc. · NASDAQ:LPCN
Lipocine — HC Wainwright 22nd Annual Global Investment Conference (September 2020)
27 slides from Lipocine's conference presentation, Sep 14, 2020
Slide 1: Enabling Oral Drug Delivery to Improve Patient Compliance
Enabling Oral Drug Delivery to Improve Patient Compliance September 14, 2020 HC Wainwright 22nd Annual Global Investment Conference 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
HC Wainwright Conference 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 Replacemen
Slide 4: TLANDO: The First Oral TRT Without Titration Requirement
TLANDO™ The First Oral TRT Without Titration Requirement
Slide 5: TRT Market is Growing
HC Wainwright Conference Presentation I 2020 2019 2018 2017 2016 2014 2015 350 375 400 425 450 475 500 525 550 575 600 625 650 675 700 Oct 14 Dec 14 Feb 15 Apr 15 Jun 15 Aug 15 Oct 15 Dec 15 Feb 16 Apr 16 Jun 16 Aug 16 Oct 16 Dec 16 Feb 17 Apr 17 Jun 17 Aug 17 Oct 17 Dec 17 Feb 18 Apr 18 Jun 18 Aug
Slide 6: Issues with Current TRT Options
HC Wainwright Conference Presentation I Issues with Current TRT Options • Black box warning – Secondary exposure to testosterone – Pulmonary oil micro embolism (POME) and anaphylactic shock • Inconvenient application or painful injection • High incidence of erythrocytosis was reported in patients on
Slide 7: Most TRTs Require Dose Titration in Majority of Patients
HC Wainwright Conference Presentation I 0 X 37% 1 X 26% 2 X 20% 3 X 12% >3 X 5% Most TRTs Require Dose Titration in Majority of Patients Majority of Patients are NOT on Efficacious Dose at the Start of Therapy CONFIDENTIAL Number of Current TRT Dose Adjustments by Form* 0 X 47% 1 X 33% 2 X 15% 3 X 2
Slide 8: TLANDO Attributes
HC Wainwright Conference Presentation I f TLANDO ™ Attributes TRT Without Titration Requirement Convenient Oral Route • No inadvertent transference or Pulmonary Oil Micro Embolism risks • Patient and physician preferred ‒ Single strength and dose, less confusing Expected to be Easy to Prescribe and
Slide 9: TLANDO Regulatory Update
HC Wainwright Conference 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
Slide 10: TLANDO XR Once Daily Oral TRT
TLANDO XR (Testosterone Tridecanoate ) Once Daily Oral TRT
Slide 11: TLANDO XR: An Innovative Opportunity
HC Wainwright Conference Presentation I TLANDO XR: An Innovative Opportunity 11 Next Generation TRT Option Strong IP (new molecule & proprietary drug delivery technology) Positive Phase 2b study results Patients and physicians prefer once a day oral testosterone TLANDO XR is positioned to be the fir
Slide 12: Phase 2b Study: Result Summary
HC Wainwright Conference 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: Finalizing pivotal st
Slide 13: LPCN 1144 for Non-Cirrhotic NASH
LPCN 1144 for Non - Cirrhotic NASH
Slide 14: Association Between Testosterone and Liver Disease
HC Wainwright Conference 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. Sincl
Slide 15: Association Between Testosterone and Liver Disease: ADT
HC Wainwright Conference Presentation I Association Between Testosterone and Liver Disease – Clinical Evidence Liver Disease in Men Undergoing Androgen Deprivation Therapy (ADT) for Prostate Cancer 15 Gild et al. J Urol. 2018 Sep;200(3):573 - 581 Patients Receiving ADT were Significantly More L ikel
Slide 16: LPCN 1144: Androgen Receptor Agonist
HC Wainwright Conference 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/mood d
Slide 17: LPCN 1144: Potential Mode of Action
HC Wainwright Conference Presentation I LPCN 1144: Androgen Receptor Agonist Potential Mode of Action 17 Impact on pro - fibrotic inputs Anti - steatosis Anti - inflammatory Anti - oxidant LPCN 1144 (Oral Testosterone) Regeneration Booster ( ↑ IGF) Impact on fibrosis Anti - fibrosis ( ↓ TGF - β)
Slide 18: LPCN 1144: Liver Fat Imaging Study
HC Wainwright Conference 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%
Slide 19: LPCN 1144: Liver Fat Reduction
HC Wainwright Conference 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
Slide 20: LPCN 1144: LiFT Study Ongoing
HC Wainwright Conference Presentation I LPCN 1144: LiFT (Liver Fat intervenTion ) Study* Ongoing 20 Phase 2 Paired - Biopsy Clinical Study in NASH Subjects (NCT04134091) * Website: www.lift - study.com SCREENING Topline MRI - PDFF Results By End of 2020 Dose Start Topline Biopsy Results by End of 2Q
Slide 21: LPCN 1148 for Liver Cirrhosis
LPCN 1148 for Liver Cirrhosis
Slide 22: LPCN 1148: Oral T for Cirrhosis
HC Wainwright Conference Presentation I Common Causes 5 Alcoholic liver disease Nonalcoholic Fatty Liver Disease (NAFLD) Chronic hepatitis B Chronic hepatitis C Cryptogenic LPCN 1148: Oral T for Cirrhosis 22 1. Bentley & Phillips, Milliman Research Report 2017 4. Sarkar et al. J Hepatol. 2015 2. Sin
Slide 23: Unmet Need in Liver Cirrhosis
HC Wainwright Conference Presentation I Unmet Need in Liver Cirrhosis Improvement in quality of life while on waiting list Stay on transplant list Sarcopenia is a leading contributory cause of removal from the waitlist • 40 - 70% of cirrhotic patients are sarcopenic Improvement of post transplant su
Slide 24: Progressive Drop in T Level with Increasing Disease Severity
HC Wainwright Conference Presentation I Progressive Drop in T Level with Increasing Disease Severity 1,3 24 Reduced Testosterone Associated with Complications of Cirrhosis 1. Sinclair et al., Liver Transplantation, 2016; 2. Sinclair et al., J Gastroenterol Hepatol . 2016; 3. Paternostro et al, Hepat
Slide 25: Potential Key Effects of LPCN 1148 in Cirrhotic Patients
HC Wainwright Conference Presentation I Potential Key Effects of LPCN 1148 in Cirrhotic Patients 25 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
Slide 26: Upcoming Milestones
HC Wainwright Conference Presentation I Upcoming Milestones Near Term Value Drivers Event Expected Timing TLANDO™ PDUFA Date August 28, 2020* *Extended by FDA LPCN 1144 LiFT Primary Endpoint Results By End of 2020 LiFT Biopsy Results By End of 2Q 2021 IP Infringement Litigation Oral Jury Hearing Feb
Slide 27: Key Financial Metrics
HC Wainwright Conference 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 (9/11/20) $1.21/share Cash Balance (6/30/20) $23.3 million* Bank Debt (
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