Entera Bio Ltd. · NASDAQ:ENTX
Entera Bio — Investor Presentation (March 2023)
33 slides from Entera Bio's investor presentation, March 2023
Slide 1: Entera Bio Corporate Presentation
Entera Bio Corporate Presentation March 2023
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 Protein Therapies
Entera Bio: Leader in Oral Protein Therapies • First-in-class, daily mini tablets of protein and peptide replacement therapies designed for patients to live well as they manage their chronic diseases • Underserved conditions where oral administration can significantly shift treatment outcomes, versu
Slide 4: Brief Historical Overview of Our Lead Programs: 2022 Was a Foundational Year
Brief Historical Overview of Our Lead Programs: 2022 Was a Foundational Year for Entera EB613*: Potentially the First Daily Oral PTH Mini Tablets, OsteoAnabolic Treatment for Osteoporosis - FDA Discussions on Track for Phase 3 Initiation (H2 2023E) • June 2021: Phase 2 study met biomarker/PD (P1NP,
Slide 5: Experienced Leadership Team
Experienced Leadership Team Director at Entera since 2018 (CEO since 2022); 23 years of C-level leadership, principal Miranda Toledano, MBA investment and wall street/ transactional experience in the biotech sector; Previously co- founder, COO/CFO TRIGR (Acquired by Compass Therapeutics (Nasdaq: CMP
Slide 6: 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 7: 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 e
Slide 8: Internal Pipeline Focused On Oral Mini Tablets of Approved Injectable Proteins
Internal Pipeline Focused On Oral Mini Tablets of Approved Injectable Proteins Partnership Agreements Include Novel Undisclosed Targets Program Target Preclinical Phase 1 Phase 2 Phase 3 Partner EB613 Osteoporosis PTH 1-34PTH 1-34 505b2 EB613 Hypoparathyroidism nd EB612 PTH 1-34PTH EB612 (2 1-34 gen
Slide 9: EB613 (oral PTH (1-34), teriparatide)
EB613 (oral PTH (1-34), teriparatide) First Daily Oral Osteoanabolic Mini Tablets for the Treatment of Osteoporosis
Slide 10: EB613: First Daily Oral PTH Daily Mini Tablets for Osteoporosis
EB613: First Daily Oral PTH Daily Mini 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; 13 million estimated post-menop
Slide 11: 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 12: Current Osteoporosis Pharmacologic Treatment Is Segmented Into 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 13: Healthcare Providers Typically Use T-score BMD Classifications to Drive Therapy Selection
Healthcare Providers Typically Use T-score BMD Classifications, Patient Fracture History and Preference To Drive Therapy Selection • Injections deter many patients from using extremely effective PTH therapy, contributing to a treatment gap in high-risk patients T-Score Scale • An oral PTH analogue t
Slide 14: 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 15: 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 16: EB613 Positioning
EB613 Positioning • EB613, as a first in class daily oral tablet PTH treatment, seeks to offer a viable anabolic (bone forming) therapeutic option to lower the risk of fracture for many more high risk osteoporotic patients • PTH receptor activation is a validated mechanism of action for treating ost
Slide 17: A Six-Month Study of Oral PTH in Postmenopausal Women with Low Bone Mass
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 18: EB613 Phase 2 Clinical Trial Design
EB613 Phase 2 Clinical Trial Design • 6-Month, Randomized Dose-Ranging Placebo-Controlled Study in Post-Menopausal Women with Osteoporosis • Conducted at 4 sites in Israel between June 2019 and May 2021; Final enrollment = 161 patients Screening Treatment* Endpoints Randomization N=160 (target) Key
Slide 19: EB613 Predictive Profile Of Bone Turnover Biomarkers (PD)
EB613 Predictive Profile Of Bone Turnover Biomarkers (PD) • Primary Endpoint: Statistically significant increases in P1NP (key anabolic marker) at Month 1 (p<0.001), Month 2 (p<0.005) and Month 3 (p<0.05), respectively for the 2.5 mg EB613 dose group • Statistically significant decrease in Serum CTX
Slide 20: EB613 Significant Dose Response – PTH (1-34) PK, P1NP Marker & BMDs
EB613 Significant Dose Response – PTH (1-34) PK, P1NP Marker & BMDs Concentration of hPTH(1-34) in plasma 400 15min post-dose (mean± SE)(pg/ml) EB613 (a.k.a. EBP05, hPTH(1-34) min-tablets) showed a PTH (1-34) 350 linear dose response across PTH exposure, P1NP R² = 0.9961 300 biomarker and BMD Measur
Slide 21: EB613 2.5 mg Dose Positively Impacts Lumbar Spine, Femoral Neck and Total Hip BMD
EB613 2.5 mg Dose Positively Impacts Lumbar Spine, Femoral Neck and Total Hip BMD at 6 Months EB613 Non-Titrated = Patients received EB613 Placebo Adjusted BMD Increases by Site of Measurement 2.5mg tabs daily for full 6 months of the study 5.5 EB613 Titrated = Patients received EB613 tabs 5 daily a
Slide 22: EB613: Placebo Adjusted BMD by Skeletal Site (2.5mg Dose Groups)
EB613: 6 Month Placebo Adjusted BMD by Skeletal Site (2.5mg Dose Groups) Placebo adjusted Lumbar Spine BMD 6 % change from Day 1 5 • At full 6 months of treatment with 4 3 EB613 tabs, the increase in 2 spine BMD was similar in 1 3.78 2.2 2.73 3.9 0 magnitude to that previously EB613 Non-Titrated EB6
Slide 23: 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 (1.5mg
Slide 24: 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 Double-Blind, Placebo-Controlled Registrational Study • Agreement on Total Hip (TH) BMD as Primary Endpoint Screening 24 M Treatment Endpoints Primary – 2:1 Randomizat
Slide 25: EB613 Phase 3 Clinical Trial Design Uses ASBMR-FNIH STEs
EB613 Phase 3 Clinical Trial Design Uses ASBMR-FNIH STEs • The primary endpoint agreed upon is Mean Change from Baseline in Total Hip BMD of EB613 vs. placebo at 24 months. As a key secondary endpoint, Entera intends to assess this using the pre-defined, published ASBMR- FNIH Surrogate Threshold Eff
Slide 26: EB612 Oral PTH (1-34) for the Treatment of Hypoparathyroidism
EB612 Oral PTH (1-34) First Daily Oral PTH Mini Tablet Peptide Replacement Therapy for the Treatment of Hypoparathyroidism
Slide 27: Hypoparathyroidism: PTH Orphan Indication with Sub-Par Clinical Care
Hypoparathyroidism: 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 • Approximat
Slide 28: 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 29: EB612 Positioning
EB612 Positioning • EB612 is potentially the first oral PTH (1-34) daily tablet peptide replacement therapy for the treatment of hypoparathyroidism • Hypoparathyroidism (HypoPT) is a rare condition in which the parathyroid glands fail to produce sufficient levels of Parathyroid hormone (PTH) • Pilot
Slide 30: Key Recent and Near-Term Milestones
Key Recent and Near-Term Milestones EB613 EB613 EB612 EB613 EB612 ENTERA BIO ✓ FDA Type C FDA Type D PK Data from 2nd Phase 3 Pivotal FDA discussions for Meeting onPhase Meeting on Generation Mini Tab Study Initiation Potential Phase 2/3 ✓ 3 Design (Executed, Revised Phase 3 Protocol Formulation for
Slide 31: Thank You
Thank You Contact: Entera Bio: Ms. Miranda Toledano Chief Executive Officer Email: miranda@enterabio.com
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: ASBMR-FNIH
ASBMR-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 Administration (FDA) Biomarkers Qualifica