Slide 1: Enabling oral drug delivery to improve patient compliance
Enabling oral drug delivery to improve patient compliance August 7, 2018 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 statement s re
Slide 3: Unique Specialty Pharmaceutical Company
Men's Health Oral Testosterone Replacement Therapy (“TRT”) Oral Androgen Therapy for Fatty Liver Disease (“NAFLD”/ “NASH”) Women's Health Oral Therapy for Prevention of Preterm Birth (“PTB”) Proprietary Drug Delivery Platform Significant Unmet Need In Both Therapeutic Areas 3 Unique Specialty Pharma
Slide 4: Late-Stage Pipeline: Oral Product Candidates Targeting Significant Opportunities
Late - Stage Pipeline 4 Oral Product Candidates Targeting Significant Opportunities PRODUCT (Indication) PRECLINICAL PHASE 1 PHASE 2 PHASE 3 NDA MEN’S HEALTH TLANDO™ (Oral Testosterone Replacement Therapy, TRT) Phlebotomy and ABPM Studies Ongoing LPCN 1111 (Next Gen. Oral TRT) Phase 2 Completed LPCN
Slide 5: TLANDO
LIPOCIN= TLANDO™
Slide 6: TRT Market is Approaching Heights Experienced in 2013 and Growing
2018 2017 2016 2014 2015 350 375 400 425 450 475 500 525 550 575 600 625 650 Sep 14 Nov 14 Jan 15 Mar 15 May 15 Jul 15 Sep 15 Nov 15 Jan 16 Mar 16 May 16 Jul 16 Sep 16 Nov 16 Jan 17 Mar 17 May 17 Jul 17 Sept 17 Nov 17 Jan 18 Mar 18 May 18 Monthly TRx (000s) FDA Label Guidance Monthly TRT TRx Trend 6
Slide 7: Issues with Current Non-oral TRT Options
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 therapy is 100 days • More than
Slide 8: TLANDO: Path Forward for Resubmission Confirmed
TLANDO™: Path Forward for Resubmission Confirmed Post Action Meeting Completed Deficiencies and Plan for Resolution Determine extent, if any, of ex vivo conversion of TU to T Obtain definitive evidence pre - approval via ambulatory blood pressure monitoring study to exclude whether TLANDO causes cli
Slide 9: LPCN 1144
LIPOCIN= LPCN 1144
Slide 10: Non-Alcoholic Fatty Liver Disease (NAFLD) Clinical Progression
Non - Alcoholic Fatty Liver Disease (NAFLD) Clinical Progression 10 Fatty liver is a reversible condition wherein large vacuoles of triglyceride fat accumulate in liver cells via the process of steatosis LFTs: Liver function test, especially Alaninine amino transferase (ALT) and Aspartame amino tran
Slide 11: Fatty Liver Disease Prevalence in US
Fatty Liver Disease Prevalence in US ▪ NAFLD prevalence in general population is estimated to be 20 - 30% in the Western world 1 Estimated Prevalence of Fatty Liver Disease in US, 2015 ▪ By 2020, prevalence of NAFLD cirrhosis is set to overtake hepatitis B and hepatitis C related cirrhosis 2 ▪ The N
Slide 12: Androgen Receptor (AR) Effects Regulation of Liver Metabolism
Androgen Receptor (AR) Effects Regulation of Liver Metabolism* 12 * Shen M. and Shi H, Int J of Endocrinol, 2015 Androgens increase insulin receptor expression, decrease lipogenesis, and promote cholesterol storage in liver ▪ Regulate Lipid Homeostasis in the Liver ▪ Regulate Glucose Homeostasis in
Slide 13: Testosterone Association with NAFLD and Cirrhosis
Testosterone (T) Association with NAFLD and Cirrhosis 13 • NAFLD and T 1 • Cirrhosis survival and T 2 1. Kim et al., Gastroenterol: 2012 x After adjusting for age, smoking, diabetes, exercise, BMI, TG and HDL, the 1 st (lowest) T quintile (110 – 317 ng/dL) have OR of 5.12 (2.43 – 10.77) for NAFLD co
Slide 14: Consistent Lowering of Key Serum Biomarkers in Patients with Comorbidities Typical of NASH
Consistent Lowering of Key Serum Biomarkers Levels In Patients with Comorbidities Typical of NASH ▪ TG and Liver enzymes mean change from baseline (BL) post 52 week therapy* 14 - 15 - 43 - 26 - 67 - 4.0 - 2.0 - 2.9 - 4.5 - 1.8 - 0.3 - 1.1 - 1.4 - 4.5 - 4.1 - 4.8 - 7.1 - 1.7 - 2.8 0.4 - 5.7 -15 -13 -
Slide 15: Significant Reduction of Key Serum Biomarkers in Patients with Elevated ALT and TG
Significant Reduction of Key Serum Biomarker Levels In Patients with Elevated ALT and TG at Baseline ▪ TG and liver enzymes mean change from BL to 52 week post - therapy from SOAR Trial (13 - 001 Study) † 15 * Barritt 4 th et al, Contemp Clin Trials, 2017 ** Sanyal et al, Hepatol , 2015 *** TG norma
Slide 16: Lymphatic Oral T Therapy Unique Triglyceride Reduction
Lymphatic Oral T Therapy Unique Triglyceride (TG) Reduction ▪ Comparative mean TG change post therapy in patients on oral T vs non - oral T Therapy 16 * TG normal range: 45 – 200 mg/dL - 63.7 ( - 15%) 13.7 (+3%) -80 -60 -40 -20 0 20 40 60 Mean BL = 320 mg/dL 323 mg/dL N = 73 (35%) 34 (33%) Oral T To
Slide 17: Summary of Clinical Key Serum Biomarkers Results and Next Steps
Summary of Clinical Key Serum Biomarkers Results and Next Steps Summary: ▪ Consistent lowering of key serum biomarkers levels in patients with comorbidities typical of NASH ▪ Significant reduction of key serum biomarkers levels in patients with elevated ALT and TG at baseline ▪ Unique TG reduction w
Slide 18: LPCN 1111
LIPOCIN= LPCN 1111 Q LPCN 1111 >>
Slide 19: LPCN 1111: Next-Generation Oral TRT
LPCN 1111: Next - Generation Oral TRT ▪ Novel prodrug of testosterone for oral delivery ▪ Once - daily potential expected to sustain and improve market share of oral T franchise ▪ Once - daily feasibility established in Phase 2a and 2b clinical trials – Single - daily oral dose provides T levels in
Slide 20: LPCN 1107
LIPOCIN= LPCN 1107
Slide 21: LPCN 1107: Prevention of Preterm Birth, US Market Landscape
LPCN 1107: Prevention of Preterm Birth (PTB) United States Market Landscape $1B Market Opportunity 3 December 31, 2017 Makena Net Revenue ($M) 4 Makena ® 1 50% Off Guidance 2 30% Compounded 17 - HPC 20% $334 $385 2016 2017 15% 1. Amag estimates Makena market share based on distributor dispensing dat
Slide 22: LPCN 1107: First Oral PTB Candidate
LPCN 1107 - Oral HPC ▪ Potential for superior efficacy with Phase 3 target dose ▪ No patient discomfort upon administration ▪ Steady state achieved in 7 days ▪ Orphan drug designation – Major contribution to patient care ▪ Next steps: – Explore partnering opportunities LPCN 1107: First Oral PTB Cand
Slide 23: Upcoming Milestones
Upcoming Milestones 23 Near Term Value Drivers Event Expected Timing TLANDO™ Complete definitive phlebotomy study ABPM study results 4Q 2018 1Q 2019 LPCN 1144 Complete In - Vivo model Proof - Of - Concept study in biopsy - confirmed NASH POC clinical study results in imaging - confirmed NAFLD/NASH p
Slide 24: Key Financial Metrics
Key Financial Metrics 24 Stock Price, Market Cap, Cash Balance Ticker Symbol LPCN (Nasdaq Capital Market) Closing Stock Price (8/1/18) $1.39/share Market Capitalization (8/1/18) $29.6 million Fully Diluted Shares Outstanding (6/30/18) $25.2 million Cash Balance (6/30/18) $25.1 million* Bank Debt (6/
Slide 25: Lipocine Investment Highlights
MEN’S HEALTH • TLANDO™ : Potential first oral TRT option - Differentiated product targeting ~$2.0 billion established US TRT market • LPCN 1144 : Oral androgen therapy for NASH - Positive clinical serum marker data in patients with typical comorbidities of NASH • LPCN 1111 : Next generation potentia
Slide 26: Appendix
LIPOCIN= Appendix
Slide 27: TLANDO SOAR Study Blood Pressure Data
-4 -3 -2 -1 0 1 2 3 4 5 6 Mean SPB Change (mmHg) 13-001 TLANDO Week 3 (n=193) 13-001 TLANDO Week 7 (n=182) 13-001 TLANDO Week 13 (n=157) 13-001 TLANDO Week 26 (n=144) 13-001 TLANDO Week 39 (n=138) 13-001 TLANDO Week 52 (n=130) 13-001 TLANDO Overall (n=944) TLANDO™ SOAR Study Blood Pressure Data Syst
Slide 28: NASH Liver Disease Pathogenesis
NASH Liver Disease Pathogenesis 28 ALT ↑ AST ↑ Modified from Source: Evercore ISI Research ↑ ↑
Slide 29: Comorbidities Prevalence and Fatty Liver Disease
Comorbidities Prevalence and Fatty Liver Disease 29 Obesity (40% in US) 1 Diabetes (9% in US) 2 Metabolic Syndrome ( MeS ) (>30% in US) 4 NAFLD NASH Cirrhosis Hypogonadism (13% in US) 3 1. CDC, Jun 2018 2. CDC, Jul 2017 3. Dandona and Rosenberg, Int J Clin Pract , 2010 (US Census Bureau, Aug 2008) 4
Slide 30: NASH-Comorbidity Association
NASH - Comorbidity Association 30 Comorbidity Prevalence of Comorbidity in NASH * Prevalence of NASH in Comorbidity Obesity 82% 37% 1 Hypertension 68% 78% 2 Diabetes 44% 25% 2 Metabolic syndrome 71% 40% 3 *Among biopsied NAFLD patients ( Younossi et al, Hepatology, 2016) Liver fat is correlated with
Slide 31: Hypogonadism is Associated with Chronic Liver Disease
Hypogonadism is Associated with Chronic Liver Disease 1 Androgen receptor signaling appears to be a key impacting liver health in men . 2 Androgen effects: ▪ Alter lipid profile : 3 – Potential to lower fatty acid, decrease lipid deposition/storage in liver, decrease lipogenesis, decrease lipolysis,
Slide 32: Study Details for Serum Biomarker Data Analysis
Study Details for Serum Biomarker Data Analysis ▪ “Study of Oral Androgen Replacement (SOAR) Trial” or 13 - 001 Study – 52 week therapy with oral T and topical active control in 314 hypogonadal subjects • Liver enzyme and lipid levels were monitored • Subgroup analyses with comorbid conditions typic
Slide 33: SOAR Trial Demographics Oral T versus Topical T
52 - Week SOAR Trial Demographics Oral T versus Topical T 52 Wks SOAR Trial Oral T (N = 210) Topical T ( N = 104) Age ( yrs ), mean 52.6 54.2 Race, % Asian 1.4 2.9 Black or African American 15.2 9.5 White 81.9 87.6 Other 1.4 0 BMI (kg/m 2 ), mean 30.8 31.0 Weight (kg), mean 97.1 99.2 Comorbidity, %
Slide 34: SOAR Trial Comorbidity Distribution
SOAR Trial Comorbidity Distribution 34 56% 48% 22% 9% 0% 10% 20% 30% 40% 50% 60% Obesity (OBS) Hypertension (HTN) Diabetes (Diab.) Metabolic syndrome (Obs. + Diab. + HTN) % of Patients in SOAR Trial % of Patients in 52 Wks SOAR Trial, N=210 1. Machado et al, J Hepatol , 2006 2. Williams et al, Gastr
Slide 35: Mean Baseline Liver Enzymes and TG Levels in Patients with Comorbidity Typical of NASH
Mean Baseline Liver Enzymes and TG levels in Patients with Comorbidity Typical of NASH 35 SOAR Trial (13 - 001) Overall (N=210) Obesity (N=118) Diabetes (N=46) Hypertension (N=100) OBS + Diab + HTN (N=19) ALT (U/L) 30.5 33.3 29.4 29.0 30.2 AST (U/L) 24.2 24.7 21.1 23.5 22.4 ALP (U/L) 71.8 71.7 73.3
Slide 36: Significant Number of Patients Shift from Above-Normal Levels to Normal
Significant Number of Patients Shift from Above - Normal Levels at Baseline to Normal † Levels at End of Study* 36 * 52 Wk N = 134 52% 31% 34% 0% 10% 20% 30% 40% 50% 60% ALT (U/L); N=42 GGT (U/L); N=36 TG (mg/dL); N=73 % of Patients in SOAR Trial † Normal range: ALT (10 - 40 U/L), GGT (10 - 49 U/L),
Slide 37: Consistent Marker Reduction Independent of Therapy Duration/Study
Consistent Marker Reduction Independent of Therapy Duration/Study ▪ TG and liver enzymes mean change post therapy in patients* with elevated serum markers in two separate studies 37 * Patients are for 4 th Quartile (above or upper normal level) of each lab at baseline. - 67 - 6.5 - 2.9 - 16.5 - 11.7
Slide 38: LPCN 1107: First Oral PTB Candidate
LPCN 1107: First Oral PTB Candidate 38 Characteristics Of The Only Approved Product Options for PTB IM HPC, Makena ® : ▪ 20 - 25% patients below reported better efficacy HPC level threshold ▪ Total of 18 - 22 injections – Injection location: Upper - outer quadrant of the gluteus maximus – Weekly vis
Slide 39: LPCN 1107: Advancing to Phase 3 Readiness
LPCN 1107: Advancing to Phase 3 Readiness Phase 3 Special Protocol Assessment – Progress ▪ Concurrence with FDA to date: – Study Design Elements • Single Phase 3 study • Open label, active comparator, two parallel arms (1:1 randomization) • General inclusion and exclusion criteria and treatment dura