Slide 1: LPCN 2401 for Obesity Management
LPCN 2401 for Obesity Management
Slide 2: Unprecedented Demand and Usage of GLP-1 Receptor Agonists
Unprecedented Demand and Usage of GLP-1 Receptor Agonists1-3 GLP-1 market trending toward oral once daily dosing Semaglutide: $30 billion sales in the US in 20244 ✓ T2DM Tirzepatide: $14 billion sales in the US in 20245 ✓ Weight management FDA approved ✓ Cardiovascular disease indications ✓ Chronic
Slide 3: Limitations of GLP-1 Use and Unmet Medical Needs
Limitations of GLP-1 Use and Unmet Medical Needs 2 out of 3 patients on drugs like Wegovy stop within a year1 Functionality loss Lean mass loss Unmet Medical Needs and increase facture risk • Improve quality weight loss Weight/fat GLP-1 Use GI • Preserve lean mass/functionality rebound tolerability
Slide 4: Drawbacks of Approved GLP-1 Receptor Agonists
Drawbacks of Approved GLP-1 Receptor Agonists Rapid loss of lean mass and functionality in elderly GLP-1 users Low Quality Weight Loss1 Lean Mass Loss1 Functionality Loss1 Fracture Risk2,3 Proportion of Lean Mass and Fat Mass in Total Weight Loss Weight Loss Lean mass Loss Weight(kg) Loss Fat Loss F
Slide 5: Target Population - Elderly GLP-1 Users, Most Vulnerable Population
Target Population - Elderly GLP-1 Users, Most Vulnerable Population 8 years of expected age-related stair climb power loss in 4 months of GLP-1 use GLP-1 Use Related Decline in Elderly Estimated Elderly GLP-1 Users Pre-existing low lean mass Population in the US5 340 M High magnitude Loss of 4.1% of
Slide 6: LPCN 2401 Once Daily Oral Treatment for Obesity and Weight Management
LPCN 2401 Once Daily Oral Treatment for Obesity and Weight Management Proven potential to improve body composition - quality weight loss with quality fat loss Product Candidate Attributes • Proprietary androgen receptor agonist, testosterone ester(s), targeted for once-a-day treatment - “LPCN 2401”
Slide 7: LPCN 2401: Potential to Amplify Effects of Incretin Mimetics
LPCN 2401: Potential to Amplify Effects of Incretin Mimetics ARA may increase weight loss through increased expression and activity of GLP1R 4,5 GLP-1 expression increase with ARA2 Non-Diabetic Diabetic Insulin Androgen Receptor Incretin Sensitivity3 Agonist (ARA) Mimetic Diabetes6,7 Veh ARA α-ARA V
Slide 8: Novel Oral Treatment for Obesity Management
LPCN 2401 Novel Oral Treatment for Obesity Management Hypothesized benefits - improve body composition and functionality in weight management Quality weight loss Amplify fat loss Improve lean mass Minimize weight rebound Minimize fat regain Preserve functionality On GLP-1 GLP-1 On GLP-1 GLP-1 On GLP
Slide 9: Novel Oral Adjunct Treatment with GLP-1
LPCN 2401 Novel Oral Adjunct Treatment with GLP-1 Targeted to aid in chronic weight/diabetes management Quality Weight Loss Maintain Weight Loss Preserve lean mass Primarily fat loss Minimize fat regain Minimize weight regain Amplify fat loss Maintain/improve functionality More abdominal fat loss Im
Slide 10: LPCN 2401 – Clinical Data Show Significant Improvement in Body Composition
LPCN 2401 – Clinical Data Show Significant Improvement in Body Composition Phase 2 results demonstrate increased lean mass and decreased fat mass at Week 20 Lean Mass Fat Mass Lean Mass (kg) Appendicular Lean Mass (kg) Total Fat Mass Trunk Fat Mass 2.5 (kg) (kg) 2 1 2 * * 0.9 1.9 1.5 1.2 1.6 1 * * 0
Slide 11: LPCN 2401 Safety Data Support Differentiated Product Profile
LPCN 2401 Safety Data Support Differentiated Product Profile Well-tolerated with liver benefits and no safety signals upon 72-week exposure • POC study in relevant obese and overweight population • Frequency and severity of TEAEs with LPCN 2401 were comparable to placebo • Frequency of SAEs with LPC
Slide 12: LPCN 2401 POC Phase 2 Study Objectives
LPCN 2401 POC Phase 2 Study Objectives Quality Weight Loss Phase • Objective 1 • Assess the co-administration of LPCN 2401 and incretin mimetic for weight loss and prevention of functional loss associated with incretin mimetic monotherapy Weight Maintenance Phase • Objective 2: • Evaluate the use of
Slide 13: LPCN 2401 - Potential for Differentiated Benefit to Risk Profile
LPCN 2401 - Potential for Differentiated Benefit to Risk Profile A liver beneficial approach6 with no increased risk of adverse cardiovascular outcomes7 LPCN 2401 Target Attributes Competitive Landscape* • Oral, QD, prodrug of bioidentical hormone • Myostatin /activin receptor modulators (e.g. bimag
Slide 14: LPCN 2401 – Regulatory Outlook on Efficacy
LPCN 2401 – Regulatory Outlook on Efficacy Appropriate population and endpoints selection Per FDA Guidance (2025)1,2, for efficacy claim related to changes in body composition, trial design should include appropriate choice of population and selection of endpoints that measure how a patient feels, f
Slide 15: Stair Climb Test: A Relevant Clinical Functional Measurement
Stair Climb Test: A Relevant Clinical Functional Measurement Clinically relevant with patient-centric outcomes Regulatory Perspectives • High reliability and validity1 • Well-defined, standardized, supporting multicenter trials1,2 • Regulatory precedents: DUVYZAT®, ELEVIDYS® Patient & Physician Pers
Slide 16: LPCN 2401: Key Takeaways
LPCN 2401: Key Takeaways Compelling Opportunity with favorable benefit to risk profile • Addressing huge GLP-1 user market with unmet needs • Differentiated oral product for use in combination with GLP-1 or as a monotherapy • Positive Phase 2 results in relevant subjects • Planned Clinical study wit
Slide 17: Business Development Contacts
Business Development Contacts Kong Papangkorn, Ph.D. Business Development Manager kp@lipocine.com