Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (May 2020)
11 slides from Lipocine's investor presentation, May 2020
Slide 1: Enabling Oral Drug Delivery to Improve Patient Compliance
Enabling Oral Drug Delivery to Improve Patient Compliance
Slide 2: LPCN 1148: Oral T for Cirrhosis
LPCN 1148: Oral T for Cirrhosis Common Causes3 Alcoholic liver disease Nonalcoholic Fatty Liver Disease (NAFLD) https://www.niddk.nih.gov/ Chronic hepatitis B Over 600K 45K Chronic hepatitis C patients with liver deaths in cirrhosis1 20172 Cryptogenic Liver Cirrhosis in US 1. Scaglione et al. J Clin
Slide 3: Complications of Cirrhotic Patients
Complications of Cirrhotic Patients Portal hypertension • Varices in esophagus, stomach, or intestines leading to internal bleeding • Edema • Ascites • Hepatic encephalopathy Infections Cachexia, malnutrition, and weight loss Sarcopenia, loss muscle mass and function Frailty with compromised energet
Slide 4: High Economic Burden of a Liver Transplant
High Economic Burden of a Liver Transplant Transplant Only Cure for Liver Cirrhosis Estimated Total of $812,500/ Transplant in U.S. 30 Days Pre-Transplant: $41,400 Procurement: $94,000 Hospital Transplant Admission: $463,200 Physician during Transplant Admission: $56,000 180 Days Post-Transplant Dis
Slide 5: Unmet Need in Liver Cirrhosis
Unmet Need in Liver Cirrhosis Improvement in survival rate Improvement in quality of life Sarcopenia is a leading contributory cause of Stay on transplant list removal from the waitlist • 40 -70% of cirrhotic patients are sarcopenic Improvement of post transplant survival/outcomes Yoon and Chen, Nat
Slide 6: Reduced Testosterone – Cirrhosis Association
Reduced Testosterone* – Cirrhosis Association Progressive Drop in T Level with Increasing Disease Severity1 Increased risk of major infections, death and/or transplantation rates1 Worsening of sarcopenia3 Increased risk of for hepatic decompensation3 Severity of portal hypertension and ascites3 *Mos
Slide 7: Testosterone (T)
Testosterone (T) An Independent Predictor of Mortality in Late Stage Cirrhosis1 ❑Low T (<8.3 nmol/L) associated with ❑ A significant association increased risk of major infections, death between testosterone levels and and/or transplantation rates1 sarcopenia in male patients2 7 1. Sinclair M. et al
Slide 8: Sarcopenia in Liver Cirrhosis
Sarcopenia in Liver Cirrhosis Equivalent to Adding 10 Points to the MELD Score A two-fold increase in waitlist mortality/decreased survival Hepatic Decompensation Increased risk of hospitalization/prolonged hospitalization Poor post-transplant outcomes Increased risk of Infections Malnutrition Refer
Slide 9: Potential Key Effects of LPCN 1148 in Cirrhotic Patients
Potential Key Effects of LPCN 1148 in Cirrhotic Patients Anti- Improve immuno- Anabolic Androgenic SHBG lowering Inflammatory dysregulation • Increase muscle • Induce • Reduce IL-1, IL- • Lower infection • Increase free T mass and hematopoiesis 6, and TNF-α rate strength • Improve sexual • Reduce fa
Slide 10: LPCN 1148: Oral Testosterone Therapy
LPCN 1148: Oral Testosterone Therapy Comprising Testosterone Tridecanoate Prodrug of endogenous testosterone (non-methylated) Known anabolic and androgenic agent Preferred route for self-administration 10
Slide 11: Phase 2: Proof of Concept Study
Phase 2: Proof of Concept Study • A Phase 2, randomized double-blind, placebo-controlled, multi- center study to assess the efficacy, safety, and tolerability of a 52-week treatment period of oral LPCN 1148 in male subjects with cirrhosis of the liver and sarcopenia (with interim results at 24 weeks