Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (January 2021)
38 slides from Lipocine's investor presentation, Jan 4, 2021
Slide 1: Enabling Oral Drug Delivery to Improve Patient Compliance
Enabling Oral Drug Delivery to Improve Patient Compliance January 2021 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
January 2021 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
Slide 4: TLANDO: The Convenient TRT without Titration Requirement
TLANDO™ The Convenient TRT without Titration Requirement
Slide 5: TRT Market is Growing
January 2021 Corporate 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 18
Slide 6: Issues with Current TRT Options
January 2021 Corporate 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 n
Slide 7: Most TRTs Require Dose Titration in Majority of Patients
January 2021 Corporate 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: Typical Titration for TRT Takes 3-6 Months
January 2021 Corporate Presentation I Physician Research Data* 8 8 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
Slide 9: TLANDO: De-Risked Regulatory Profile
January 2021 Corporate Presentation I TLANDO: De - Risked Regulatory Profile Opportunities • Post COVID pandemic launch • Adequate time for launch preparation/partnering • Improves TLANDO XR regulatory prospects Eligible to Launch After March 27, 2022 Current Status • Tentative approvals are clearan
Slide 10: LPCN 1144 for Non-Cirrhotic NASH
LPCN 1144 for Non - Cirrhotic NASH
Slide 11: LPCN 1144: Rationale to Target Non-Cirrhotic Male NASH Patients
January 2021 Corporate Presentation I LPCN 1144: Rationale to Target Non - Cirrhotic Male NASH Patients 11 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 Pat
Slide 12: Association Between Testosterone and Liver Disease
January 2021 Corporate Presentation I Association Between Testosterone and Liver Disease – Clinical Evidence Liver Disease in Men Undergoing Androgen Deprivation Therapy (ADT) for Prostate Cancer 12 Gild et al. J Urol. 2018 Sep;200(3):573 - 581 Patients Receiving ADT were Significantly More L ikely
Slide 13: LPCN 1144: Differentiated NASH Treatment Candidate
January 2021 Corporate 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 dys
Slide 14: LPCN 1144: Potential Mode of Action
January 2021 Corporate Presentation I LPCN 1144: Androgen Receptor Agonist Potential Mode of Action 14 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 15: LPCN 1144: Liver Fat Reduction
January 2021 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%
Slide 16: LPCN 1144: LiFT Study Ongoing
January 2021 Corporate Presentation I LPCN 1144: LiFT (Liver Fat IntervenTion ) Study* Ongoing 16 Phase 2 Paired - Biopsy Clinical Study in NASH Subjects (NCT04134091) * Website: www.lift - study.com SCREENING Topline MRI - PDFF Results in January 2021 Dose Start Topline Biopsy Results by Mid - 2021
Slide 17: TLANDO XR Once Daily Oral TRT
TLANDO XR (Testosterone Tridecanoate ) Once Daily Oral TRT
Slide 18: TLANDO XR: An Innovative Opportunity
January 2021 Corporate Presentation I TLANDO XR: An Innovative Opportunity 18 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 first
Slide 19: Phase 2b Study: Result Summary
January 2021 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: Food effect study 19 Me
Slide 20: LPCN 1148 for Liver Cirrhosis
LPCN 1148 for Liver Cirrhosis
Slide 21: LPCN 1148: Oral T for Cirrhosis
January 2021 Corporate 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 21 1. Bentley & Phillips, Milliman Research Report 2017 4. Sarkar et al. J Hepatol. 2015 2. Sincl
Slide 22: Unmet Needs For Patients with Liver Cirrhosis
January 2021 Corporate Presentation I Unmet Needs For Patients with 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
Slide 23: Sarcopenia in Liver Cirrhosis and MELD Score
January 2021 Corporate Presentation I Sarcopenia in Liver Cirrhosis Equivalent to Adding Significant Points to the MELD Score 23 References: Kim and J.W. Jang, World Journal of Gastroenterology, 2015; Sinclair et al., Journal of Gastroenterology and Hep ato logy (Australia), 2016; Moctezuma - Velazq
Slide 24: LPCN 1107 Prevention of Preterm Birth
LPCN 1107 Prevention of Preterm Birth
Slide 25: Preterm Birth is a Significant Public Health Issue
January 2021 Corporate Presentation I Unmet Medical Need • One Preterm birth (PTB) every minute 1 • ≥ $26 billion economic impact 2 • 10% of all US pregnancies 3 • A leading cause of neonatal mortality and morbidity • Medical costs for PTB infants are ~10x higher than for full term infants 4 25 Pret
Slide 26: LPCN 1107: Potential Standard of Care for Prevention of PTB
January 2021 Corporate Presentation I LPCN 1107: Potential To Be The Standard of Care for Prevention of PTB 26 Oral Hydroxyprogesterone Caproate (HPC) Convenient dosing No injection site reactions First oral enabling technology Solid IP coverage Orphan drug designated Next Step: Pivotal study agreem
Slide 27: Impact of Potential Market Withdrawal of Makena
January 2021 Corporate Presentation I Impact of Potential Market Withdrawal of Makena and Its Generics 27 An Opportunity for LPCN 1107 No approved standard of care for prevention of PTB Improved market potential Enriched target population: Not losing high risk patients to active control (injectable
Slide 28: Upcoming Milestones
January 2021 Corporate Presentation I Upcoming Milestones Near Term Value Drivers Event Expected Timing TLANDO™ Full Approval March 28, 2022 LPCN 1144 LiFT Primary Endpoint Results January 2021 LiFT Biopsy Results Mid 2021 28
Slide 29: Key Financial Metrics
January 2021 Corporate Presentation I Key Financial Metrics 29 Stock Price, Market Cap, Cash Balance Ticker Symbol LPCN (Nasdaq Capital Market) Closing Stock Price (12/28/20) $1.39 /share Cash Balance (9/30/20) $23.8 million Bank Debt (9/30/20) $6.4 million
Slide 30: Appendix
Appendix
Slide 31: TLANDO Attributes
January 2021 Corporate Presentation I f TLANDO ™ Attributes* Convenient Oral Route No inadvertent transference or Pulmonary Oil Micro Embolism risks Single strength and dose TRT without titration requirement Enables selection of an effective dose at the start of therapy without delay No “eff
Slide 32: LPCN 1144: Liver Fat Imaging Study
January 2021 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) o f LPCN 1144 225 mg BID in hypogonadal males LF ≥ 10% N = 8 LF ≥ 8% N = 10 LF ≥ 5% N
Slide 33: LPCN 1148 in Cirrhotic Patients
January 2021 Corporate Presentation I LPCN 1148 in Cirrhotic Patients 33 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., Digestive Diseases and
Slide 34: LPCN 1107 Prevention of Preterm Births
LPCN 1107 Prevention of Preterm Births Enabling Oral Drug Delivery to Improve Patient Compliance 34
Slide 35: Preterm Birth (PTB) Basic Facts
January 2021 Corporate Presentation I Preterm Birth (PTB) • Risks of adverse outcome for preterm infants rise sharply with decreasing gestation • Early PTB babies have higher rates of death and disability ▪ PTB <35 week has ~6x more relative death risk in first 28 days than full term babies 35 Basic
Slide 36: Status of MAKENA and its Approved Generic Equivalents
January 2021 Corporate Presentation I Status of MAKENA and its Approved Generic Equivalents ● Confirmatory (PROLONG) study failed to verify clinical benefit and FDA concluded that the available evidence does not show that Makena is effective for its approved use ● CDER has issued a notice of opportu
Slide 37: Impact of HPC Plasma Concentration on PTB Rate
January 2021 Corporate Presentation I Impact of HPC Plasma Concentration on PTB rate 37 PK - PD Correlation: HPC Concentration and PTB Rate 1 1. Caritis et al., Am J Obstet Gynecol. 2014 (N=315 subjects) 2. Ctrough for IM HPC Cavg , Makena • Lower % (~4.3%) PTB rate can be expected with daily Cavg
Slide 38: Comparative Steady State PK Profiles
January 2021 Corporate Presentation I Phase 3 Dose Mean Cavg 34.8 ng/mL Mean Cavg 11.3 ng/mL 8.2 ng/ml Reported lower PTB rate threshold Comparative Steady State PK profiles* to 250 mg/week Injectable HPC LPCN 1107 Target Regimen Results in Higher Target HPC Levels in Majority of Patients * PK resul