Slide 1: LPCN 1144 for Nonalcoholic Steatohepatitis (NASH)
LPCN 1144 for Nonalcoholic Steatohepatitis (NASH) Oral Androgen Receptor Agonist
Slide 2: Validated Proprietary Lip'ral Technology Platform
Validated Proprietary Lip’ral Technology Platform Drug + Carrier = Drug Loaded Carrier • Invented by Renowned Formulation Experts GI Aqueous Intestinal Systemic Lumen Barrier Layer Wall Circulation • Validated Through a Recent FDA Drug Approval • Subject to Multiple Prior Partnerships Insoluble drug
Slide 3: LPCN 1144 (Testosterone Ester): Partnering Opportunity
LPCN 1144 (Testosterone Ester): Partnering Opportunity Unique Mechanism of Action with Fast Track Designation Targets High Unmet Need Potential to be “best in class” Mono- or adjunct therapy Strong IP Coverage Unique benefit to risk Differentiated profile Accelerated approval - Compelling P2 Biopsy
Slide 4: LPCN 1144: Market Potential
LPCN 1144: Market Potential NASH, A Silent Liver Disease Epidemic Current Target Population 17 M NAFLD Spectrum NASH Patients1 11 M NASH Male Patients1,2 3.5 M ~6.9 M Male NASH in 20301,2 With Fibrosis F2-F31,2 European Journal of Endocrinology 183, 3; 10.1530/EJE-20-0065 Multibillion Dollar Market
Slide 5: LPCN 1144: LiFT (Liver Fat Intervention with oral Testosterone)
LPCN 1144: LiFT (Liver Fat Intervention with oral Testosterone)*† Phase 2 Paired Biopsy Study in Men with NASH (NCT04134091) Study Design Primary Endpoint: Biopsy confirmed male NASH subjects with F1-F3 Change in hepatic fat fraction via MRI-PDFF (W12) Three-arm, blinded, placebo-controlled Key
Slide 6: Summary of LiFT Results
Summary of LiFT Results Study Demonstrates Treatment Potential of LPCN 1144 in NASH Statistical Treatment significance Met Primary effect observed Well tolerated NASH Benefits in key Endpoint – on fibrosis with an overall resolution with liver enzymes Liver Fat improvement safety profile no worsenin
Slide 7: Key Non-Histology Marker Results from LiFT Study
Key Non-Histology Marker Results from LiFT Study Liver Enzyme# Reductions and Body Composition Changes Liver Injury Marker Reduction Positive Effects on Body Composition† * Mean Baseline ALT AST (U/L) (U/L) Placebo 49.0 35.4 (N=19) Treatment A 53.9 32.4 (N=18) Treatment B 51.5 31.9 (N=19) † All avai
Slide 8: Comparison with Other Oral Drug Candidates
Comparison with Other Oral Drug Candidates Best in Class in NASH Resolution and Liver Fat Reduction NASH Resolution with No Worsening of Fibrosis Absolute Changes of Liver Fat from Baseline All numbers shown for other candidates use the highest reported treatment effect among multiple treatment grou
Slide 9: Safety Overview of LPCN 1144 Through Week 36
Safety Overview of LPCN 1144 Through Week 36 Well-Tolerated with an Overall Safety Profile Comparable to Placebo AEs of Interest, n Placebo Treatment A Treatment B (%) • Frequency and severity of TEAEs in both treatment arms were comparable to placebo Diarrhea 2 (10.5%) 1 (5.6%) 0 (0%) • Discontinua
Slide 10: LPCN 1144: Androgen Receptor Agonist
LPCN 1144: Androgen Receptor Agonist Differentiated NASH Treatment Candidate Targets Unmet Need Potential Mode of Action Clinical Experience Acceptable benefit to risk ratio Noninvasive dosing regimen • NASH resolution and/or fibrosis improvement Meaningfully reduced liver fat in POC study • Tolerab
Slide 11: LPCN 1144 Key Considerations
LPCN 1144 Key Considerations Compelling Opportunity in Non-Cirrhotic NASH • Market Opportunity for Non-Cirrhotic NASH – 3.5M male patients annually • Competitive Landscape: Numerous in development (injectables and orals) – Resmetirom approved March 2024 (metabolic MOA drug) • Unmet Need: – Approved
Slide 12: LPCN 1144 Key Considerations (cont)
LPCN 1144 Key Considerations (cont) Compelling Opportunity in Non-Cirrhotic NASH • Revenue Sustainability: • Exclusivity supported by IP portfolio with issued and pending patents • Clinical Development Opportunity: – Positive P2 study result – Differentiated benefit to risk profile vs competition: o
Slide 13: 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