Slide 1: LPCN 1148 Management of Liver Cirrhosis
LPCN 1148 Management of Liver Cirrhosis • Overt Hepatic Encephalopathy (OHE) • Sarcopenia in Decompensated Cirrhosis (Fast Track Designation) Lipocine │ May 2025 1
Slide 2: LPCN 1148 - Unique Opportunity Addressing Two Distinct Liver Disease Markets
LPCN 1148 - Unique Opportunity Addressing Two Distinct Liver Disease Markets Positive POC P2 results in treatment of sarcopenia and OHE in cirrhosis Positive P2 results in Positive P2 results with sarcopenia background SOC Analogue (Rifaximin) Sales Overt Hepatic Encephalopathy 300 FDA granted Fast
Slide 3: Sarcopenia in Cirrhosis: A serious comorbidity
Sarcopenia in Cirrhosis A serious comorbidity Sarcopenia is a predictor for increased morbidity and mortality in cirrhosis2 • 3-fold higher mortality rate compared to no sarcopenia2 Sarcopenia in cirrhosis correlates with decompensation Survival (%) events, particularly hepatic encephalopathy (HE)3
Slide 4: Overt Hepatic Encephalopathy (OHE) in Cirrhosis
Overt Hepatic Encephalopathy (OHE) in Cirrhosis Presence of both sarcopenia and HE further increases risk of mortality5 Covert HE Overt HE Sarcopenia and myosteatosis are associated with increased risk of hepatic encephalopathy1,2 1. Bhanji et al. Hepatology International (2018) 12:377–386 2. Wijarn
Slide 5: LPCN 1148 for the Management of Cirrhosis
LPCN 1148 for the Management of Cirrhosis Product Candidate Attributes Oral androgen receptor agonist; dosage form comprising testosterone dodecanoate, a unique prodrug of an endogenous hormone Targeted Mechanism of Action Anabolic1 Androgenic Ammonia Lowering Stimulates muscle satellite activator,
Slide 6: LPCN 1148 Phase 2 Results – Sarcopenia Primary Endpoint Met
LPCN 1148 Phase 2 Results – Sarcopenia Primary Endpoint Met Resolution for sarcopenia and significantly increased SMI 25 ‡ 20 ‡ 15 % CBL L3-SMI ‡ ‡ ‡ 10 † 5 0 -5 Week LPCN 1148 Placebo Placebo to 1148 • ~9% increase in L3-SMI at week 24 • 33% of patients had resolution of sarcopenia* at week 24 LS m
Slide 7: LPCN 1148 Phase 2 Results – HE Endpoint Met
LPCN 1148 Phase 2 Results – HE Endpoint Met Fewer events of overt hepatic encephalopathy Through Week 24 Week 24 to EOS LPCN 1148 switch from Placebo LPCN 1148 LPCN 1148 Parameter placebo N=14 N=15 N=11 N=8 History of HE prior to randomization 11 (79%) 11 (73%) 7 (64%) 6 (75%) (n) Recurrent Overt HE
Slide 8: LPCN 1148 Phase 2 Results
LPCN 1148 Phase 2 Results Overall LPCN 1148 was well tolerated • Rates and severities of AEs similar to those in Stage 1 with placebo • Fewer participants experienced severe AEs when switched from placebo to LPCN 1148 LPCN 1148 switch from Placebo LPCN 1148 LPCN 1148 placebo (Week 24 to Parameter (T
Slide 9: Business Development Contacts
675 Arapeen Drive, Suite 202 Salt Lake City, Utah-84108 Business Development Contacts Kong Papangkorn, Ph.D. Business Development Manager kp@lipocine.com