Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (June 2021)
23 slides from Lipocine's investor presentation, Jun 14, 2021
Slide 1: Enabling Oral Drug Delivery to Improve Patient Compliance
Enabling Oral Drug Delivery to Improve Patient Compliance June 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: Innovative Product Candidates
Corporate Presentation June 2021 I Clinical Stage Biopharmaceutical Company Innovative Product Candidates for Metabolic and Endocrine Disorders PRODUCT (Indication) PRE - CLINICAL PHASE 1 PHASE 2 PHASE 3 NDA TRT TLANDO Π(Oral Testosterone for Testosterone Replacement Therapy) Tentative Approval TLA
Slide 4: TLANDO: The Convenient Oral TRT without Titration Requirement
TLANDO ΠThe Convenient Oral TRT without Titration Requirement TLANDO XR Once Daily Oral TRT
Slide 5: Hypogonadism Affects Approximately 20M Men
Corporate Presentation June 2021 I Hypogonadism Affects Approximately 20M Men 5 TLANDO Franchise has the Potential to Drive Market Expansion 1. US Census data. http://www.infoplease.com/us/census/data/demographic.html. 2. Mulligan T, et al. Int J Clin Pract . 2006 Jul;60(7):762 - 9. 3. Araujo, et al
Slide 6: TLANDO Market Potential
Corporate Presentation June 2021 I Overall TRT Market • ~24% of TRT market • ~1.8M 2020 TRx Topical Segment • 33% of ~2M patients • ~660K annually Naïve Patient Segment TLANDO Market Potential 6 Attributes Particularly Attractive for Topical Switch, and Treatment Naive Patients Source: Sources: IQVI
Slide 7: TLANDO Attributes
Corporate Presentation June 2021 I f TLANDO Œ 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 “effica
Slide 8: TLANDO XR: An Innovative Opportunity
Corporate Presentation June 2021 I TLANDO XR: An Innovative Opportunity 8 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 (new molecule & p
Slide 9: LPCN 1144 for Non-Cirrhotic NASH
LPCN 1144 for Non - Cirrhotic NASH Currently No Approved Treatment
Slide 10: LPCN 1144: LiFT Phase 2 Paired Biopsy Study
LPCN 1144: LiFT ( Li ver F at Intervention with oral T estosterone) * 10 Phase 2 Paired Biopsy Study in Men with NASH (NCT04134091) *Website: www.lift - study.com ** Open Label Extension Study (36 weeks) SCREENING MRI - PDFF (W12) Dose Start MRI - PDFF, DXA, Biopsy Study Design □ Biopsy confirmed ma
Slide 11: Summary: Positive Topline Results Post 12 Week Treatment
Corporate Presentation June 2021 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 validated across 3
Slide 12: LPCN 1144 DEXA Results in Biopsy-Confirmed NASH Patients
Corporate Presentation June 2021 I LPCN 1144 DEXA Results In Biopsy - Confirmed NASH Patients (Week 20) Significantly Improved Body Composition in Both Treatment Arms 12 Late Breaker Presentation at EASL: International Liver Congress 2021 (23 - 26 June 2021) https://easl.eu/event/the - international
Slide 13: LPCN 1148 for the Management of Liver Cirrhosis
LPCN 1148 for the Management of Liver Cirrhosis (an End Stage Disease)
Slide 14: Liver Cirrhosis in US
Corporate Presentation June 2021 I Liver Cirrhosis in US Over 2 million cases 1 Over 500k living with decompensated cirrhosis 2 62% of individuals on the liver transplant (LT) waitlist 3 are males 40 - 70% of male cirrhotic patients are sarcopenic 4,5 High ( ~$812,500/Transplant) Economic Burden 6 1
Slide 15: LPCN 1148 for Management of Cirrhosis
Corporate Presentation June 2021 I LPCN 1148 for Management of Cirrhosis • Pre - transplant patients and the others who opt - out or are denied being on the transplant list Event free survival/Improve quality of life • Decreased hospital readmissions • Shorter length of hospitalization Improvement o
Slide 16: Potential MOA of LPCN 1148 in Cirrhotic Patients
Corporate Presentation June 2021 I Potential MOA of LPCN 1148 in Cirrhotic Patients 16 Multi - Modal Action Increase muscle mass and strength Reduce fat mass Increase bone density Inhibit myostatin Improve nutritional status* Anabolic Induce hematopoiesis Improve sexual dysfunction Androgenic Reduce
Slide 17: LPCN 1148: Proof of Concept Study
Corporate Presentation June 2021 I LPCN 1148: Proof of Concept Study 17 Phase 2, Multicenter, Double - Blinded, Placebo - Controlled Study Study Design • Male subjects with cirrhosis of the liver and sarcopenia • Two - arm (1:1 randomization) • Oral LPCN 1148 or Placebo Endpoints: • Primary: Change
Slide 18: LPCN 1154 Oral Neuro-Steroid for Depression Disorder
LPCN 1154 Oral Neuro - Steroid for Depression Disorder
Slide 19: Postpartum Depression (PPD)
Corporate Presentation June 2021 I Postpartum Depression (PPD) ~ 1 in 7 women suffer from PPD after giving birth Only 50% (~400,000) of patients are currently diagnosed and treated in US Negative impact on maternal and infant outcomes Negative impact on spouse 19 A Major Depressive Episode Within We
Slide 20: LPCN 1154 – Potential Oral Alternative for Post Partum Depression
Corporate Presentation June 2021 I LPCN 1154 – Potential Oral Alternative for Post Partum Depression x No hospitalization requirement x No facility REMS requirements x Opportunity to provide options for all women ▪ Lower cost, easier access, and no hospital logistics issues x Provide the required le
Slide 21: LPCN 1154: Next Steps Proof of Concept Clinical Studies
LPCN 1154 : Next Steps 21 Proof of Concept Clinical Studies Received IND clearance for Phase 2 study • Phase 2 – Pilot POC Study • Objective: Safety and efficacy in PPD patients • Projected 1 st patient dosed 4Q 2021 - PK study in July 2021 Objective: Dose proportionality Projected top - line result
Slide 22: Upcoming Milestones
Corporate Presentation June 2021 I Upcoming Milestones Near Term Value Drivers Event Expected Timing LPCN 1144 LiFT Biopsy Results August 2021 LPCN 1154 POC Studies PK results : Q3 2021 P2 patient Dosing : Q4 2021 LPCN 1148 First Patient Dosed 2H 2021 TLANDO ΠFinal FDA Approval Decision March 2022
Slide 23: Key Financial Metrics
Corporate Presentation June 2021 I Key Financial Metrics 23 Stock Price, Market Cap, Cash Balance Ticker Symbol LPCN Closing Stock Price (6/7/21) $1.27/share Cash Balance (3/31/21) $50.0 million Bank Debt (3/31/21) $4.8 million