Slide 1: 12-Week Phase 1b Study of Pemvidutide in NAFLD — Topline Results
12 - Week, Phase 1b Study of Pemvidutide in Overweight and Obese Subjects with Non - Alcoholic Fatty Liver Disease (NAFLD) — Topline Results NASDAQ: ALT Stephen Harrison, MD, Lead Investigator 14 September 2022
Slide 2: Forward-looking statements Safe-Harbor Statement
Forward - looking statements Safe - Harbor Statement This presentation has been prepared by Altimmune , Inc .. ("we," "us," "our," " Altimmune " or the "Company") and includes certain “forward - looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 , includin
Slide 3: Pemvidutide: balanced GLP-1:glucagon dual receptor agonist
VVVVVVVVV VVVVVVVVV Glucagon specificity GLP - 1 specificity Helix Stabilizer Increased potency EuPort ™ domain Weekly dosing, improved PK for improved GI tolerability Modified residue Protease stability COOH 3 P emvidutide 1 Balanced (1:1) GLP - 1:glucagon dual receptor agonist ↓ Food intake ↑ Insu
Slide 4: Pemvidutide Phase 1b NAFLD Trial Design
Pemvidutide Phase 1b NAFLD Trial Design • 94 subjects randomized 1:1:1:1 and dosed across 13 US sites to 1 of 4 treatment arms, stratified by the presence or absence of type 2 diabetes (T2D) • 12 - week, randomized, placebo - controlled study of pemvidutide in subjects with overweight/obesity and no
Slide 5: Study Population — Key Eligibility Criteria
Study Population — Key Eligibility Criteria • Men and women, ages 18 - 65 years • BMI ≥ 28 kg/m 2 • NAFLD, defined as liver fat content (LFC) by MRI - PDFF ≥ 10% • Absence of significant fibrosis, defined as FibroScan ® LSM < 10kPa • Non - diabetes OR diabetes if: • Stable dose (≥ 3 months) metformi
Slide 6: Study Endpoints
Study Endpoints Efficacy • Primary Endpoint: Reduction in liver fat content by MRI - PDFF • Key Secondary Endpoint: Percent (%) weight loss Safety • Adverse events (AEs) • Serious and severe AEs • AEs leading to discontinuation • GI tolerability • ALT elevations • Vital signs • Glycemic control (fas
Slide 7: Characteristics of Study Participants
Characteristics of Study Participants Characteristic Treatment Placebo (n = 24) 1.2 mg (n=23) 1.8 mg (n=23) 2.4 mg (n=24) Age, years mean (SD) 47.9 (14) 48.6 (11) 50.3 (9) 48.8 (8) Gender female, n (%) 14 (58.3%) 9 (39.1%) 12 (52.2%) 15 ( 62.5%) Race white, n (%) 21 (87.5%) 21 (91.3%) 20 (87.0%) 24
Slide 8: Study Disposition
8 Study Disposition 94 randomized and dosed Placebo n = 24 Pemvi 1.2 mg n = 23 Pemvi 1.8 mg n = 23 Pemvi 2.4 mg n = 24 Completed treatment n = 24 Completed treatment n = 21 Completed treatment n = 20 1 withdrawal consent 1 lost to follow - up 1 adverse event 3 withdrawal consent 1 lost to follow - u
Slide 9: Reduction in Liver Fat Content by MRI-PDFF at Week 12
Reduction in Liver Fat Content by MRI - PDFF at Week 12 9 Absolute Reduction Relative Reduction *** p < 0.001 vs. placebo, (ANCOVA)
Slide 10: Reduction in Liver Fat Content — Responder Analyses
10 Reduction in Liver Fat Content by MRI - PDFF at Week 12 — Responder Analyses * p < 0.05 *** p < 0.001 **** p < 0.0001 vs. placebo, (ANCOVA) 30% Reduction 50% Reduction Normalization (≤5% LFC)
Slide 11: ALT Reduction at Week 12
ALT Reduction at Week 12 11 All Subjects Subjects w/ Baseline ALT ≥ 30 IU/L * p < 0.05 vs. placebo, (MMRM1) 1 Mixed Model Repeated Measures
Slide 12: Weight Loss at Week 12 — Efficacy Estimand
Weight Loss at Week 12 — Efficacy Estimand 12 Non - diabetes Diabetes All Subjects * p < 0.05 ** p < 0.005 *** p < 0.001 vs. placebo, (MMRM)
Slide 13: Changes in Serum Lipids at Week 12
13 Changes in Serum Lipids at Week 12 Characteristic Treatment Placebo (n = 24) 1.2 mg (n=21) 1.8 mg (n=18) 2.4 mg (n=20) % Change from baseline to Week 12 Total cholesterol, mean (SE) % - 5.9 (4.4) - 10.1 (4.7) - 9.0 (4.5) - 12.2 (5.1) LDL, mean (SE) % 4.2 (8.1) 1.2 (8.6) 2.7 (8.1) 0.5 (9.6) HDL, m
Slide 14: Safety Overview
Characteristic Treatment Placebo (n = 24) 1.2 mg (n=23) 1.8 mg (n=23) 2.4 mg (n=24) Severe AEs n (%) 0 (%) 0 (%) 0 (%) 0 (%) SAEs n (%) 0 (%) 0 (%) 0 (%) 0 (%) AEs leading to treatment discontinuation n (%) 0 (%) 0 (%) 1 (4.3%) 1 (4.2%) Nausea Mild n (%) 3 (12.5%) 3 (13.0%) 6 (26.1%) 6 (25.0%) Moder
Slide 15: Blood Pressure and Heart Rate
Blood Pressure and Heart Rate 15 Mean HR increases of 1 - 3 bpm compared to placebo Blood Pressure Weeks 1 - 12 Heart Rate Weeks 1 - 12 Mean systolic BP decreases of 6 - 10 mmHg compared to placebo Mean diastolic BP decreases of 3 - 7 mmHg compared to placebo
Slide 16: Glycemic Variables — Non-diabetes and Diabetes
Glycemic Variables ─ Non - diabetes and Diabetes 16 Characteristic Treatment Placebo 1.2 mg 1.8 mg 2.4 mg NON - DIABETES N=18 N=16 N=16 N=17 Fasting glucose Baseline, mg/dL mean (SD) 99.9 (13.6) 99.4 (12.4) 95.1 (10.3) 97.9 (13.6) Week 12, mg/dL mean (SD) 101.6 (16.7) 99.5 (12.5) 96.0 (10.8) 100.1 (
Slide 17: Summary and Conclusions
Summary and Conclusions • Robust (>68%) relative liver fat reductions at 12 weeks, better than or equal to the effects of other leading NASH candidates • Significant reductions in serum ALT point to potent effects in NASH clinical trials • Non - diabetes — placebo - adjusted weight loss (4.7%) at We
Slide 18: Questions pertaining to this presentation
NASDAQ: ALT Questions pertaining to this presentation: Rich Eisenstadt, CFO reisenstadt@altimmune.com