Lipocine Inc. · NASDAQ:LPCN
Lipocine — Lytham Partners Spring 2021 Investor Conference
25 slides from Lipocine's conference presentation, Mar 30, 2021
Slide 1: Enabling Oral Drug Delivery to Improve Patient Compliance
Enabling Oral Drug Delivery to Improve Patient Compliance March 30, 2021 LYTHAM PARTNERS SPRING 2021 INVESTOR 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: Innovative Product Candidates
Lytham Partners Spring 2021 Investor 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 Testosterone
Slide 4: TLANDO and TLANDO XR Oral TRT
TLANDO ΠThe Convenient Oral TRT without Titration Requirement TLANDO XR Once Daily Oral TRT
Slide 5: TRT Market is Growing
Lytham Partners Spring 2021 Investor Conference I Monthly TRT TRx Trend 5 TRT Market is Growing 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
Slide 6: Issues with Current TRT Options
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 non - oral • 67% on injectable T, 35% on pell
Slide 7: TLANDO Attributes
Lytham Partners Spring 2021 Investor 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 without del
Slide 8: TLANDO: De-Risked Regulatory Profile
Lytham Partners Spring 2021 Investor Conference I TLANDO: De - Risked Regulatory Profile 8 Eligible to Launch after March 27, 2022 Opportunities Post COVID pandemic launch Adequate time for launch preparation/partnering Current Status Tentative approvals are clearances for drugs to be marketed, but
Slide 9: TLANDO XR: An Innovative Opportunity
Lytham Partners Spring 2021 Investor Conference I TLANDO XR: An Innovative Opportunity 9 Next Generation TRT Option TLANDO XR is positioned to be the first Oral QD Product TLANDO XR is clinically differentiated from other orals Patients and physicians prefer once a day oral testosterone Strong IP (n
Slide 10: LPCN 1144 for Non-Cirrhotic NASH
LPCN 1144 for Non - Cirrhotic NASH Currently No Approved Treatment
Slide 11: LPCN 1144: Androgen Receptor Agonist Potential Mode of Action
Insulin - like Growth Factor (IGF - 1) Sex Hormone – Binding Globulin (SHBG) Free testosterone Anti - fibrosis (↓TGF - β) LPCN 1144: Androgen Receptor Agonist 11 Potential Mode of Action *You et al., Hepatology Communications, 2021 Regeneration Booster (↑IGF) Markers in Advanced Fibrosis* LPCN 1144
Slide 12: LPCN 1144: LiFT Study Design
LPCN 1144: LiFT ( Li ver F at Intervention with oral T estosterone) * 12 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 - PDFF, DXA, Biopsy Study Design □ Biopsy confirmed male NASH sub
Slide 13: LiFT Study Results: Liver Fat (MRI-PDFF) Changes from Baseline
LiFT Study Results : Liver Fat (MRI - PDFF) Changes from Baseline 13 Significant Response in Biopsy Established NASH Subjects with Baseline Liver Fat ≥ 5% *Based on available data (n = 52) ** Subjects with missing MRI data (baseline or Wk12) were excluded from analysis Responders with at least 30% r
Slide 14: LiFT Study Results: Key Liver Injury Marker Changes
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 at baseline **All Subject: Placebo n= 17, Treatment A n =16, Treatment B n =19; Eugonadal subjects T ≥ 300 ng/dL: Placebo n= 11
Slide 15: Summary: Positive Topline Results
Lytham Partners Spring 2021 Investor Conference I Leveraging the largest, multi - modal proprietary clinical database of its kind to expand a robust pipeline of predictive algorithms with regulatory grade evidence. Developing novel transformative algorithms to transform healthcare. Commercially vali
Slide 16: LiFT Study: Upcoming Data
Lytham Partners Spring 2021 Investor Conference I LiFT Study: Upcoming Data 16 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 weeks 20 and 36 Liver and other markers including (fibrosis and inflammation markers
Slide 17: LPCN 1148 for Liver Cirrhosis Management
LPCN 1148 for Liver Cirrhosis Management
Slide 18: LPCN 1148: Oral T for Cirrhosis Management Background
Common Causes 5 Alcoholic liver disease Nonalcoholic Fatty Liver Disease (NAFLD) Chronic hepatitis B Chronic hepatitis C Cryptogenic LPCN 1148: Oral T for Cirrhosis Management 18 Background 1. Bentley & Phillips, Milliman Research Report 2017 4. Sarkar et al. J Hepatol. 2015 2. Sinclair et al., Live
Slide 19: Unmet Needs for Patients with Liver Cirrhosis
Unmet Needs for Patients with Liver Cirrhosis 19 LPCN 1148 Targets Yoon and Chen, National Institute on Alcohol Abuse and Alcoholism; Surveillance Report #114, 2019 Scaglione et al., J clin Gastroenterol, 2015; Hart et al., Transplantation, 2016; United Network for Organ Sharing, 2019 Sinclair et al
Slide 20: LPCN 1148: Proof of Concept Study
Lytham Partners Spring 2021 Investor Conference I LPCN 1148: Proof of Concept Study 20 Phase 2, Multicenter, Double - Blinded, Placebo - Controlled Study Study Design • Male subjects with cirrhosis of the liver and sarcopenia • Two - arm (1:1 randomization, n=60) • Oral LPCN 1148 or Placebo Endpoint
Slide 21: LPCN 1107 Prevention of Preterm Birth
LPCN 1107 Prevention of Preterm Birth
Slide 22: Unmet Medical Need
Unmet Medical Need One Preterm birth (PTB) every minute 1 ≥ $26 billion economic impact annually 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 Preterm Birth is a Significant Public Health
Slide 23: LPCN 1107: Potential to be the Standard of Care for Prevention of PTB
LPCN 1107: Potential to be the Standard of Care for Prevention of PTB 23 Oral Hydroxyprogesterone Caproate (HPC) Convenient dosing No injection site reactions First and only oral enabling technology Solid IP coverage Orphan drug designated Next Step: Food effect study
Slide 24: Upcoming Milestones
Lytham Partners Spring 2021 Investor Conference I Upcoming Milestones Near Term Value Drivers Event Expected Timing LPCN 1148 First Patient Dosed 2H 2021 LPCN 1144 LiFT Biopsy Results August 2021 TLANDO ΠFinal FDA Approval Decision March 2022 24
Slide 25: Key Financial Metrics
Lytham Partners Spring 2021 Investor Conference I Key Financial Metrics 25 Stock Price, Market Cap, Cash Balance Ticker Symbol LPCN Closing Stock Price (3/24/21) $1.55/share Cash Balance (12/31/20) $24.7 million* Bank Debt (12/31/20) $5.0 million *Raised an add’l $28.7M gross in January 2021
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