Lipocine Inc. · NASDAQ:LPCN
Lipocine — Raymond James 42nd Annual Institutional Investors Conference (March 2021)
27 slides from Lipocine's conference presentation, Mar 1, 2021
Slide 1: Enabling Oral Drug Delivery to Improve Patient Compliance
Enabling Oral Drug Delivery to Improve Patient Compliance March 1 - 3, 2021 Raymond James 42nd Annual Institutional Investors Conference Exhibit 99.2
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
Slide 3: Clinical Stage Biopharmaceutical Company
Raymond James 42nd Annual Institutional Investors Conference 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 Π(Oral Testosterone for
Slide 4: TLANDO: The Convenient TRT without Titration Requirement
TLANDO ΠThe Convenient TRT without Titration Requirement
Slide 5: TRT Market is Growing
Raymond James 42nd Annual Institutional Investors Conference 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 Fe
Slide 6: Issues with Current TRT Options
Raymond James 42nd Annual Institutional Investors Conference 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
Slide 7: TLANDO Attributes
Raymond James 42nd Annual Institutional Investors Conference I f TLANDO ΠAttributes* 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 with
Slide 8: TLANDO: De-Risked Regulatory Profile
Raymond James 42nd Annual Institutional Investors Conference I TLANDO: De - Risked Regulatory Profile Opportunities • Post COVID pandemic launch • Adequate time for launch preparation/partnering • Potential exclusivity • Improves TLANDO XR development prospect Eligible to Launch After March 27, 2022
Slide 9: LPCN 1144 for Non-Cirrhotic NASH
LPCN 1144 for Non - Cirrhotic NASH Currently No Approved Treatment
Slide 10: LPCN 1144: Androgen Receptor Agonist Potential Mode of Action
Raymond James 42nd Annual Institutional Investors Conference I LPCN 1144: Androgen Receptor Agonist Potential Mode of Action 10 Impact on pro - fibrotic inputs Anti - steatosis Anti - inflammatory Anti - oxidant LPCN 1144 (Oral Testosterone) Regeneration Booster ( ↑ IGF) Impact on fibrosis Anti - fi
Slide 11: LPCN 1144: LiFT (Liver Fat Intervention with oral Testosterone)
Raymond James 42nd Annual Institutional Investors Conference I LPCN 1144: LiFT ( Li ver F at Intervention with oral T estosterone) * 11 Phase 2 Paired Biopsy Study in Men with NASH (NCT04134091) *Website: www.lift - study.com ** Open Label Extension Study SCREENING MRI - PDFF (W12) Dose Start MRI -
Slide 12: LiFT Study Results: Liver Fat (MRI-PDFF) Changes from Baseline
Raymond James 42nd Annual Institutional Investors Conference I LiFT Study Results : Liver Fat (MRI - PDFF) Changes from Baseline 12 Significant Response in Biopsy Established NASH Subjects with Baseline Liver Fat ≥ 5% Relative Change Responders with at least 30% reduction** From Baseline to Week 12*
Slide 13: LiFT Study Results: Absolute Change in Liver Fat (MRI-PDFF)
Raymond James 42nd Annual Institutional Investors Conference I LiFT Study Results: Absolute Change in Liver Fat (MRI - PDFF) 13 Significant Reductions Independent of Hypogonadal* Status of Biopsy Established NASH Subjects All Subjects Eugonadal Subjects From Baseline at Week 12 * Hypogonadal:T < 300
Slide 14: LiFT Study Results: Key Liver Injury Marker Changes
Raymond James 42nd Annual Institutional Investors Conference I LiFT Study Results: Key Liver Injury Marker Changes 14 Significant Changes Independent of Subject Hypogonadal Status * Hypogonadal:T < 300 ng/dl, Eugonadal : T ≥ 300 ng/dL **All Subject: Placebo n= 17, Treatment A n =16, Treatment B n =1
Slide 15: LiFT Study Results: Subgroup Analysis
Raymond James 42nd Annual Institutional Investors Conference I LiFT Study Results: Subgroup Analysis 15 68% Subjects on Treatment B Showed Concurrent Reductions in Liver Fat, ALT and AST NS = Not Statistically Significant Liver Fat - MRI - PDFF ALT AST From Baseline to Week 12
Slide 16: Summary: Positive Topline Results
Raymond James 42nd Annual Institutional Investors Conference I Summary: Positive Topline Results Statistically significant reduction in liver fat was observed compared to placebo independent of hypogonadal status Statistically significant reduction in markers of liver injury were observed compared t
Slide 17: LiFT Study: Upcoming Data
Raymond James 42nd Annual Institutional Investors Conference I LiFT Study: Upcoming Data 17 • Histological change in NASH activity and fibrosis at week 36 • MRI - PDFF liver fat data at week 36 • Body composition data from DXA scan (at 20 weeks and 36 weeks) • Liver and other markers including (fibr
Slide 18: TLANDO XR: Once Daily Oral TRT
TLANDO XR Once Daily Oral TRT |
Slide 19: TLANDO XR: An Innovative Opportunity
Raymond James 42nd Annual Institutional Investors Conference I TLANDO XR: An Innovative Opportunity 19 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 p
Slide 20: LPCN 1148 for Liver Cirrhosis
LPCN 1148 for Liver Cirrhosis
Slide 21: LPCN 1148: Oral T for Cirrhosis
Raymond James 42nd Annual Institutional Investors Conference 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.
Slide 22: Unmet Needs For Patients with Liver Cirrhosis
Raymond James 42nd Annual Institutional Investors Conference 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 sarco
Slide 23: LPCN 1107 Prevention of Preterm Birth
LPCN 1107 Prevention of Preterm Birth
Slide 24: Unmet Medical Need
Raymond James 42nd Annual Institutional Investors Conference 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 fu
Slide 25: LPCN 1107: Potential To Be The Standard of Care for Prevention of PTB
Raymond James 42nd Annual Institutional Investors Conference I LPCN 1107: Potential To Be The Standard of Care for Prevention of PTB 25 Oral Hydroxyprogesterone Caproate (HPC) Convenient dosing No injection site reactions First and only oral enabling technology Solid IP coverage Orphan drug designat
Slide 26: Upcoming Milestones
Raymond James 42nd Annual Institutional Investors Conference I Upcoming Milestones Near Term Value Drivers Event Expected Timing TLANDO ΠFinal FDA Approval Decision March 2022 LPCN 1144 LiFT Biopsy Results July/August 2021 26
Slide 27: Key Financial Metrics
Raymond James 42nd Annual Institutional Investors Conference I Key Financial Metrics 27 Stock Price, Market Cap, Cash Balance Ticker Symbol LPCN (Nasdaq Capital Market) Closing Stock Price (1/26/21) $1.59/share Cash Balance (12/31/20) $24.7 million* Bank Debt (9/30/20) $6.4 million *Raised an add’l
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