Entera Bio Ltd. · NASDAQ:ENTX
Entera Bio — Investor Presentation (November 2022)
35 slides from Entera Bio's investor presentation, November 2022
Slide 1: Entera Bio Corporate Presentation November 2022
Entera Bio Corporate Presentation November 2022
Slide 2: Disclaimer
Disclaimer Various statements in this presentation are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this presentation regarding our prospects, plans, financial position, business
Slide 3: Entera Bio: Leader in Oral Delivery of Therapeutic Proteins
Entera Bio: Leader in Oral Delivery of Therapeutic Proteins Focused on High Unmet Clinical Needs where Oral Delivery of a Protein Therapy Can Significantly Improve the Standard of Care • Proprietary first-in-class oral PTH* daily tablet candidates with demonstrated clinical efficacy in phase 2 studi
Slide 4: Experienced Leadership Team
Experienced Leadership Team Miranda Toledano, MBA, 23 years of C-level leadership, principal investment and wall street/ transactional experience in Chief Executive Officer the biotech sector Art Santora, MD, PhD, 35 years of special care, academic research, FDA in endocrinology focusing on osteopor
Slide 5: Clinical & Scientific Advisory Board
Clinical & Scientific Advisory Board Vice-Chair, Department of Medicine for International Research and Education; Chief, Emeritus, of the Division of Professor John P. Bilezikian Endocrinology; Director, Emeritus, of the Metabolic Bone Diseases Program at Columbia University Medical Center Professor
Slide 6: Entera Proprietary Oral Delivery Platform
Entera Proprietary Oral Delivery Platform Synergistic Activity of Proteolysis Inhibition and Permeability Enhancement Oral delivery of most therapeutic proteins is challenging due to poor absorption into the blood stream, enzymatic degradation within the gastrointestinal tract, and variable drug exp
Slide 7: Internal Pipeline Focuses On Oral Formulations of Approved Injectable Proteins
Internal Pipeline Focuses On Oral Formulations of Approved Injectable Proteins Partnership Agreements Include Novel Undisclosed Targets Program Target Preclinical Phase 1 Phase 2 Phase 3 Partner Next Milestone Initiation of EB613 Osteoporosis PTH 1-34PTH 1-34 505b2 EB613 Phase 3 New Hypoparathyroidi
Slide 8: EB613 Oral Bone Forming / Anabolic Tablets for Osteoporosis
EB613 (oral PTH (1-34), teriparatide) Oral Bone Forming / Anabolic Tablets for the Treatment of Osteoporosis
Slide 9: EB613: Potentially First Oral PTH Daily Tablets for Osteoporosis
EB613: Potentially First Oral PTH Daily Tablets for Osteoporosis Indication Osteoporosis: Skeletal disease characterized by low bone mass, micro-architectural deterioration of bone tissue and increased bone fragility leading to an increased susceptibility to fractures. Molecule/ Drug Product Parathy
Slide 10: Osteoporosis Results From An Imbalance In The Bone Remodeling Cycle
Osteoporosis Results From An Imbalance In The Bone Remodeling Cycle That Occurs When Bone Resorption Outpaces Bone Formation Bone Density Healthy vs. Osteoporotic Osteoporosis and the Bone Remodeling Cycle The Bone Remodeling Cycle can be separated into two distinct processes: Resorption (osteoclast
Slide 11: Current Osteoporosis Pharmacologic Treatment: Anti-Resorptive & Anabolic Options
Current Osteoporosis Pharmacologic Treatment Is Segmented Into: Anti-Resorptive & Anabolic Options Stop or slow bone loss Osteoporosis Diagnosis Bone forming Antiresorptive Anabolic ENTERA BIO RANK-Ligand Monoclonal PTH receptor Bisphosphonates Estrogen*/HRT SERMs** Calcitonin Inhibitor Antibodies a
Slide 12: Healthcare Providers Use T-score BMD, Fracture History and Preference To Drive Therapy
Healthcare Providers Typically Use T-score BMD Classifications, Patient Fracture History and Preference To Drive Therapy Selection Injections deter many patients from using PTH, contributing to a treatment gap in high-risk patients. An oral formulation of PTH with adequate bioavailability, similar s
Slide 13: Anabolic Treated Patients Comprise Less Than 10% of Treated Osteoporosis Patients
Anabolic Treated Patients Comprise Less Than 10% of Currently Treated Osteoporosis Patients Estimated Treated Population by Class of Osteoporosis Medication Population Treated Share of Osteoporosis Treated by Class of Osteoporosis Medication (2021) Population by Medication Class 2% ENTERA BIO HCP Pr
Slide 14: EB613 Poised To Create A Paradigm Shift In The Treatment of Osteoporosis
EB613 Poised To Create A Paradigm Shift In The Treatment of Osteoporosis To Be The First Daily Tablet Anabolic Therapy Forteo® Tymlos® Evenity® Prolia® Bisphosphonates Entera Key Product Needs (Lilly) (Radius) (Amgen) (Amgen) (generics) EB613 Treats Osteoporosis Rebuilds Bone Oral Dosing ENTERA BIO
Slide 15: EB613 Positioning
EB613 Positioning • EB613, as a first in class daily tablet PTH treatment, seeks to offer a viable anabolic (bone forming) therapeutic option to lower the risk of fracture for low BMD and high risk osteoporotic patients • PTH receptor activation is a mechanistically validated and key target in the t
Slide 16: EB613 Phase 2 Six-Month BMD Results
EB613 Phase 2 Results A Six-Month Study of Oral PTH in Postmenopausal Women with Low Bone Mass – 6 Month Bone Mineral Density (BMD) Results
Slide 17: EB613 Phase 2 Clinical Trial Design
EB613 Phase 2 Clinical Trial Design • 6-Month, Randomized Dose-Ranging Placebo-Controlled Study • Conducted at 4 sites in Israel between June 2019 and May 2021; Final enrollment =161 Screening Treatment* Endpoints Randomization N=160 (target) Key inclusion criteria Arm 1: Placebo tablets QD Primary
Slide 18: EB613 Bone Biomarkers and Dose-Dependent Increases in BMD
EB613 Predictive Profile Of Bone Biomarkers and Significant Dose- Dependent Increases in BMD 2.5mg selected as Phase 3 dose – sustained “anabolic Oral PTH produced a statistically significant Dose window” from Month 3 to Month 6 in patients treated with Response in Lumbar Spine BMD (p<0.0001) EB613.
Slide 19: EB613 Positively Impacts Lumbar Spine, Femoral Neck and Total Hip BMD
EB613 Positively Impacts Lumbar Spine, Femoral Neck and Total Hip BMD at 6 Months, With Statistical Significance Placebo Adjusted BMD by Site of Measurement EB613 produced a statistically significant 5.5 3.78 * P< 0.05. ** P< 0.01 dose response in lumbar spine BMD 5 ** (p<0.0001), femoral neck BMD (
Slide 20: EB613: Placebo Adjusted BMD by Site at 2.5mg Dose
EB613: 6 Month Placebo Adjusted BMD by Site at 2.5mg Dose Placebo adjusted Lumbar Spine BMD 6 % change from Day 1 5 1.6% Placebo vs 5.5% Forteo® 4 3 Difference = 3.9% At 6 months of treatment 2 with 2.5mg EB613: 1 0 PTH 2.5mg Titrated PTH 2.5mg Non-Titrated The increase in spine BMD was ENTERA BIO P
Slide 21: EB613 Phase 2 Adverse Event Profile
EB613 Phase 2 Adverse Event Profile Adverse event profile similar to that observed with Forteo, and typical of orthostatic hypotension EB613 not associated with serum calcium increases or hypercalcemia adverse events Greater than 90% of subjects tolerated the 2.5 mg dose well, after titration (1.5m
Slide 22: EB613 Phase 3 Clinical Trial Design
EB613 Phase 3 Clinical Trial Design • Designed with FDA Concurrence (Pursuant to Type C Meeting) • A Single Global Phase 3, 24-Month, Registrational Study • Placebo-Controlled with Agreement on Total Hip BMD Primary Endpoint Screening 24 M Treatment Endpoints Key inclusion criteria Primary – Fractur
Slide 23: EB613 Phase 3 Trial Design Background – ASBMR-FNIH STEs
EB613 Phase 3 Clinical Trial Design Background – ASBMR-FNIH STEs • The primary endpoint proposed for EB613 Phase 3 is based on the ASBMR- FNIH’s Surrogate Threshold Effect (STE) using Total Hip (TH) BMD as the predictor of significant fracture reduction for all different fracture types. • Placebo adj
Slide 24: Change in Total Hip BMD - Primary End Point Analysis for Phase 3
Change in Total Hip BMD - Primary End Point Analysis for Phase 3 EB613 (Titrated 2.5mg dose, Phase 2) vs. FNIH Surrogate Threshold Effects (STEs*) Forteo® (Leder Study) at 6 Months at 24 Months to be Used in EB613 Phase 3 Total Hip BMD 2.5 % BMD Change vs Placebo 2.07 2.13 2 1.83 ENTERA BIO 1.5 1.42
Slide 25: EB612 Oral PTH (1-34) For the Treatment of Hypoparathyroidism
EB612 Oral PTH (1-34) For the Treatment of Hypoparathyroidism
Slide 26: Hypoparathyroidism: PTH Orphan Indication with Sub-Par Clinical Care
Hypoparathyroism: PTH Orphan Indication with Sub-Par Clinical Care Hypoparathyroidism Overview Unmet Need and Market Opportunity Hypoparathyroidism (HypoPT) is a rare condition in which the How many people are affected by HypoPT? parathyroid glands fail to produce sufficient levels of • Approximatel
Slide 27: EB612: Summary of PK and Pilot Phase 2 Data
EB612: Potentially First Oral PTH (1-34) Daily Tablets for Hypoparathyroidism, Summary of PK and Pilot Phase 2 Data Study Design Results Efficacy: Oral Calcium Intake Phase 2a, open-label, multicenter pilot Per Protocol Analysis (N=15) study to evaluate the safety, tolerability and 42% reduction (p=
Slide 28: EB612 Positioning
EB612 Positioning • EB612 is potentially the first oral PTH (1-34) daily tablet treatment of hypoparathyroidism • Hypoparathyroidism (HypoPT) is a rare condition in which the parathyroid glands fail to produce sufficient levels of Parathyroid hormone (PTH) • Pilot Phase 2 oral presentation (ASBMR 20
Slide 29: Key Recent and Near-Term Milestones
Key Recent and Near-Term Milestones EB613 EB613 EB612 EB613 EB612 ENTERA BIO ✓ASBMR FDA Type C PK Data from 2nd Phase 3 Pivotal FDA discussions for Additional Data Meeting on Phase Generation Study Initiation Potential Phase 2/3 ✓ from Phase 2 6-Month BMD 3 Protocol (Executed, Formulation for Hypopa
Slide 30: Thank You
Thank You Contact: Entera Bio: Ms. Miranda Toledano Chief Executive Officer Email: miranda@enterabio.com
Slide 31: Appendix
Appendix
Slide 32: ASBMR-FNIH BMD Regulatory Endpoint Backgrounder
ASBMR-FNIH BMD Regulatory Endpoint Backgrounder • Message from the president of the ASBMR on June 23rd 2022: The FDA Biomarkers Qualification Program accepted the ASBMR-Foundation for the National Institutes of Health (FNIH) Strategy to Advance BMD as a Regulatory Endpoint (SABRE) project team’s Qua
Slide 33: EB613 Phase 3 Clinical Trial Design - FNIH
EB613 Phase 3 Clinical Trial Design - FNIH June 23rd, 2022 message from the president of the ASBMR (American Society for Bone and Mineral research) Dr. Ebeling reported on the FNIH progress and support from the ASBMR1. “Dear Colleagues: I am very happy to announce that the US Food and Drug Administr
Slide 34: EB613 Phase 3 Clinical Trial Design Background - FNIH
EB613 Phase 3 Clinical Trial Design Background - FNIH • The Foundation for National Institutes of Health (FNIH) – Bone Quality Project (BQP), supported by the FDA and other public, private and academic partners has been evaluating the potential use of existing biomarkers such as BMD to enable the de
Slide 35: Entera Proprietary Oral Delivery Platform: Key Advantages and Validation
Entera Proprietary Oral Delivery Platform: Key Advantages and Validation ✓Significantly Increased Bioavailability of Macromolecules ✓Reduced Pharmacokinetic Variability ✓Versality Across Molecular Weight and Target Profile ENTERA BIO ✓Advantageous Stability versus Injectables ✓Controlled Onset of Ac