Entera Bio Ltd. · NASDAQ:ENTX
Entera Bio — Technical Presentation (September 2025)
19 slides from Entera Bio's technical presentation, September 2025
Slide 1: Effects of EB613 Tablets on Trabecular and Cortical Bone Using 3D-DXA
Effects of EB613 Tablets [Oral PTH(1-34)] on Trabecular and Cortical Bone Using 3D-DXA: Post-Hoc Results from Phase 2 Study Gregory Burshtein, Constantin Itin, Hillel Galitzer, Michal Kushnir, Miranda Toledano, Ludovic Humbert, Serge L Ferrari, Rachel B Wagman, Felicia Cosman 1
Slide 2: Disclosures
Disclosures ▪ Rachel B Wagman – Chief Clinical Advisor, Entera Bio Ltd ▪ Felicia Cosman – Chair, Scientific Advisory Board, Entera Bio Ltd ▪ Serge L Ferrari – Scientific Advisory Board Member, Entera Bio Ltd ▪ Ludovic Humbert – Employee and Stockholder of 3D-Shaper Medical ▪ Gregory Burshtein, Const
Slide 3: Osteoporosis Treatment Paradigm
Osteoporosis Treatment Paradigm Anti-Resorptive EB613 Injectable Anabolic • Osteoporosis at High Risk of Fracture 1st Line: Very High Risk • Very High Risk who Refuse Injectable 1st Line 2nd Line Suboptimal Response to Anabolic Therapies Other Treatment • Intolerant of Other Therapies EB613 Bisphosp
Slide 4: EB613 Consistently Demonstrates Rapid Increases in PTH(1-34) Plasma Levels
EB613 Consistently Demonstrates Rapid Increases in PTH(1-34) Plasma Levels and Robust Bioavailability in Phase 1 Studies • Brief intermittent exposures (30 to 60 minutes) 500 EB613 Oral PTH(1-34) Pharmacokinetics1 PTH(1-34) plasma concentration (pg/ml) of high PTH concentrations stimulate bone EB613
Slide 5: EB613 Phase 2 Clinical Study Design
EB613 Phase 2 Clinical Study Design Primary Endpoint Key Inclusion Criteria Placebo QD • Serum PINP % change from • 50+ years old baseline (placebo-adjusted) • 3+ years post-menopause EB613 0.5 mg QD at Month 3 • Low bone mass EB613 1.0 mg QD Secondary Endpoints • High risk; no prior fracture Screen
Slide 6: EB613 Increased Bone Formation (PINP) and Decreased Bone Resorption (CTX)
EB613 Increased Bone Formation (PINP) and Decreased Bone Resorption (CTX) EB613 2.5 mg 50 40 p<0.001 • EB613 significantly increased P1NP Mean % Change from Baseline 30 20 p<0.005 while also decreasing CTX p<0.05 PINP 10 • This anabolic profile does not have the 0 Anabolic window typical increase in
Slide 7: EB613 Increased BMD from Baseline to Month 6 at All Measured Skeletal Sites
EB613 Increased BMD from Baseline to Month 6 at All Measured Skeletal Sites Placebo EB613 2.5 mg 3 2.57* Mean % Change from Baseline 2.5 * 1.98 2 1.34 † 1.5 1 0.5 0 -0.5 -0.16 -0.50 -1 -0.78 Lumbar Spine Femoral Neck Total Hip EB613 2.5 mg dose includes titrated and non-titrated groups EB613 vs base
Slide 8: EB613 Safety Profile Consistent with PTH Agonists
EB613 Safety Profile Consistent with PTH Agonists Most Common Treatment Emergent AE (≥5% of participants) EB613 Treated (N=118) • Similar AE profile to that reported with Forteo® and other n (%) PTH agonists Headache 21 (17.8) • Mechanistic symptoms of orthostatic hypotension Nausea 18 (15.3) • Head
Slide 9: Objective of Current Study
Objective of Current Study Characterize effects of EB613 on trabecular & cortical bone of the proximal femur using 3D-DXA modeling at 6 months 9
Slide 10: Methods
Methods ▪ All Phase 2 study subjects from the EB613 2.5 mg (n=21) and placebo (n=38) groups who had DXA scans of the proximal femur at baseline and 6 months were included ▪ 3D-DXA analyses were performed using 3D-Shaper® software to assess trabecular and cortical compartments ▪ For each parameter, %
Slide 11: Demographics and Baseline Characteristics
Demographics and Baseline Characteristics EB613 2.5 mg Placebo Parameter (Mean, SD) (N = 21) (N= 38) Age 62.2 (4.5) 61.2 (5.4) Body mass index 26.6 (4.3) 25.3 (5.1) Baseline T-score Lumbar spine -2.2 (0.8) -2.3 (0.7) Total hip -1.9 (0.7) -2.0 (0.6) Femoral neck -2.2 (0.5) -2.1 (0.6) 11 Subgroup anal
Slide 12: Percentage Change from Baseline to Month 6 in aBMD by DXA and vBMD by 3D-Shaper
Percentage Change from Baseline to Month 6 in aBMD by DXA and vBMD by 3D-Shaper Placebo- Group EB613 Placebo Parameter adjusted Difference (N = 21) (N = 38) (Mean % Change, SD) % change p-value Areal BMD Total hip 1.4 (2.7) -0.5 (2.8) 1.8 <0.01 Femoral neck 1.9 (2.5) -0.7 (3.9) 2.6 <0.01 Integral vB
Slide 13: Percentage Change from Baseline to Month 6 in Selected Cortical Parameters by 3D-Shaper
Percentage Change from Baseline to Month 6 in Selected Cortical Parameters by 3D-Shaper Placebo- Group EB613 Placebo Parameter adjusted Difference (N = 21) (N = 38) (Mean % Change, SD) % change p-value Cortical vBMD Total hip 0.4 (4.3) 0.0 (3.4) 0.4 0.36 Femoral neck 0.6 (3.7) -0.1 (3.2) 0.7 0.21 Co
Slide 14: Distribution of Average Cortical Surface BMD % Change from Baseline to Month 6
Distribution of Average Cortical Surface BMD % Change from Baseline to Month 6 Placebo (N = 38) EB613 (N = 21) Posterior View Anterior View Posterior View Anterior View Total Hip, mean (SD): -0.8 (3.0) Total Hip, mean (SD): 0.7 (3.4) 14 Cortical sBMD (mg/cm2) is calculated as the multiplication of t
Slide 15: Evaluation of Subcutaneous Teriparatide and Abaloparatide on 3D-DXA Modeling
Evaluation of Subcutaneous Teriparatide and Abaloparatide on 3D-DXA Modeling Indices of Cortical Bone for Total Hip at 6 Months in Cross-Study Comparison Parameter EB613 Placebo Teriparatide Abaloparatide Placebo (Mean % Change) (N = 21) (N = 38) (N = 250) (N = 250) (N = 250) Phase 2 Study Phase 3 S
Slide 16: Summary
Summary ▪ 6 months of treatment with EB613 showed evidence of an early effect on both trabecular and cortical bone of the proximal femur ▪ Findings are consistent with the dual mechanism of increased bone formation and decreased resorption ▪ Safety and efficacy of EB613 will be further evaluated in
Slide 17: We thank the investigators and study subjects for their participation
We thank the investigators and study subjects for their participation 17
Slide 18: Entera Bio
13 | & Entera Bio TT
Slide 19: Evaluation of Subcutaneous Teriparatide and Abaloparatide on 3D-DXA Modeling
Evaluation of Subcutaneous Teriparatide and Abaloparatide on 3D-DXA Modeling Indices of Cortical Bone PBO, placebo; ABL, abaloparatide; TPTD, teriparatide; vBMD, volumetric BMD; sBMD, surface BMD 19 Cortical vBMD (mg/cm3); cortical thickness (mm); cortical sBMD (mg/cm2), calculated as the multiplica