Slide 1: LPCN 2401 for Obesity Management Clinical Study Results
LPCN 2401 for Obesity Management Clinical Study Results
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding the development and commercialization of LPCN
Slide 3: LPCN 2401 for Obesity Management: Potential to Improve Body Composition
LPCN 2401 for Obesity Management Potential to Improve Body Composition Product Candidate Attributes Proprietary oral formulation comprising an anabolic androgen receptor agonist (ARA) and α- tocopherol, an antioxidant and a metabolic modifier Targeted MOA • Stimulates muscle satellite activator, FGF
Slide 4: Importance of Lean Mass and Fat Overshoot
Importance of Lean Mass (LM) LM of around 70% for women and 90% for men is considered to be healthy Importance of Muscle Mass Fat overshoot • Significant role in metabolic health and disease prevention1 − High caloric demand2 • Contributes to physical strength, active lifestyle • Rapid loss of LM ha
Slide 5: Consequences of Excess Total Body Fat (TBF)
Consequences of Excess Total Body Fat (TBF) Having excess fat in the android region, AF (fat in the area roughly between the pelvis and ribs), is more strongly associated Excess TBF increases the with negative health outcomes than TBF% or BMI3 risk of death and major comorbidities such as type 2 Vis
Slide 6: Limitations of Incretin Mimetics (GLP-1 agonists)
Limitations of Incretin Mimetics (GLP-1 agonists) Significant loss of lean mass and fat rebound potential upon cessation Loss of lean mass Plateauing of weight loss Rebound weight gain Weight Loss Fat Loss Lean mass Loss Change from baseline (kg) -5.44 -9.23 -14.7 Semaglutide N Engl J Med 2021;384:9
Slide 7: Unmet Need in Incretin Mimetic Based Chronic Weight Management
Unmet Need in Incretin Mimetic Based Chronic Weight Management Oral agent with improved benefit to risk profile: • Ameliorate the loss of lean mass loss • Provide long-term option to maintain due to GLP-1/GIP treatment (a higher weight upon cessation of GLP-1 therapy quality weight loss) • Prevent r
Slide 8: LPCN 2401 Preclinical and Clinical Results
LPCN 2401 Preclinical and Clinical Results
Slide 9: Summary of Preclinical Results in Diet Induced Model
Summary of Preclinical Results in Diet Induced Model LPCN 2401 significantly improved oral glucose tolerance test and reduced VAT 12-week study in male rabbit model of OGTT 250.0 * metabolic syndrome 200.0 * †,# OGTT (iAUC) • Regular Diet (RD control), n=10 150.0 RD Control 100.0 • High Fat Diet (HF
Slide 10: Phase 2 Study in Patients with Obesity
Phase 2 Study in Patients with Obesity NCT04134091 study design Three-arm, blinded, placebo-controlled trial in subjects with metabolic dysfunction associated steatohepatitis (n=56) • High prevalence of obesity and weight related comorbid conditions such as dyslipidemia, T2DM, and hypertension • 1:1
Slide 11: Baseline Demographics
Baseline Demographics Body composition analysis set* Parameter Treatment B (N=13) Treatment A (N=13) Placebo (N=14) Mean Age (years) 53.8 53.2 51.1 Mean Weight (kg) 107.8 111.3 118.6 Mean BMI (kg/m2) 34.7 35.9 37.2 Fat Mass (DXA) % of total mass 37.2 39.5 39.3 Lean Mass (DXA) % of total mass 62.8 60
Slide 12: LPCN 2401 Body Composition Results
LPCN 2401 Body Composition Results Significantly increased lean mass and decreased fat mass Fat Mass:Lean Fat Mass Lean Mass Android Fat Bone Mineral Mass Ratio (% of TM) (% of TM) (% of Fat Mass) Content Improvement in fat:lean ratio 6 * • Reduction of fat mass * 4 Placebo Adjusted % CBL • Increase
Slide 13: Changes in Body Composition: Comparison to Incretin Mimetics
Changes in Body Composition Comparison† of LPCN 2401 to injectable incretin mimetics clinical data LPCN 2401 and Semaglutide LPCN 2401 and Tirzepatide Fat Mass Lean Mass Lean Mass Fat Mass Lean Mass (% of TM) (% of TM) (kg, CBL) 6 10 * 5 * * 4 * Placebo Adjusted CBL 0 2 Placebo Adjusted % CBL, kg -5
Slide 14: Comparison of LPCN 2401 and T Monotherapy (Treatment A)
Comparison of LPCN 2401 and T Monotherapy (Treatment A) Differentiated impacts LPCN 2401 vs Monotherapy LPCN 2401 vs Monotherapy Android Fat Systolic Blood Diastolic Blood (% of Fat Mass) Bone Mineral Content Pressure Pressure HbA1c 4 6 0.5 3 * Placebo Adjusted HbA1c absolute CBL, % 0.4 4 Placebo Ad
Slide 15: Safety Overview of LPCN 2401 Through Week 36
Safety Overview of LPCN 2401 Through Week 36 Well-tolerated with an overall safety profile comparable to placebo Adverse Events – Safety Set • Frequency and severity of TEAEs with LPCN 2401 were Preferred Term Placebo N=19 LPCN 2401 N=19 comparable to placebo Diarrhea 2 (10.5%) 0 (0%) • Frequency of
Slide 16: Obesity and Overweight: A Growing Epidemic in US
Obesity and Overweight: A Growing Epidemic in US Increases the risks of heart disease, stroke, type 2 diabetes and certain types of cancer1,2 • The est. annual medical cost of obesity was ~ $173 B in 20193 74% • Diabesity population (~110mn adults)4 – ~24M obese elderly, group most vulnerable to los
Slide 17: Recent Trends and Complications in Weight Management
Recent Trends and Complications in Weight Management Current clinical use prioritizes weight loss over healthy body composition Recent Trends Issues with Incretin Mimetics US Obesity (2017-March 2020)1 Substantial lean mass loss • Increased from ~31% to ~42% Rebound weight gain upon cessation2 • Pre
Slide 18: LPCN 2401 – Novel Oral Treatment for Obesity and Weight Management
LPCN 2401 – Novel Oral Treatment for Obesity and Weight Management Key Take Aways Potential for improved body composition in Significant body composition combination with GLP-1 agonists: improvement in men with at least • Ameliorate muscle loss • Amplify fat loss one weight-related comorbidity Poten