Entera Bio Ltd. · NASDAQ:ENTX
Entera Bio — Investor Presentation (August 2022)
34 slides from Entera Bio's investor presentation, Aug 1, 2022
Slide 1: Entera Bio Corporate Presentation August 2022
Entera Bio Corporate PresentationAugust 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 Founded in 2009 (Jerusalem, Israel); IPO in 2018 (Nasdaq: ENTX) Proprietary 1st in Class Oral PTH Candidates with Demonstrated Clinical Efficacy in Phase 2 Studies External Strategic Partnerships to Diversify Pipeline and Revenue Streams (e
Slide 4: Management team
Miranda Toledano, MBA, Chief Executive Officer 23 years of C-level leadership, principal investment and wall street/ transactional experience in the biotech sector Art Santora, MD, PhD, Chief Medical Officer 35 years of special care, academic research, FDA in endocrinology focusing on osteoporosis a
Slide 5: Scientific advisors
Professor John P. Bilezikian Vice-Chair, Department of Medicine for International Research and Education; Chief, Emeritus, of the Division of Endocrinology; Director, Emeritus, of the Metabolic Bone Diseases Program at Columbia University Medical Center Professor Maria Luisa Brandi Professor of Endo
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: Pipeline programs
Program Target Preclinical Phase 1 Phase 2 Phase 3 Partner Next Milestone EB613 Osteoporosis Phase 3 EB612 Hypoparathyroidism (Orphan Disease) Human PK EB613 Non-Union Fractures Internal Review GLP-2 Short Bowel Syndrome Undisclosed hGH GH deficiency Undisclosed Undisclosed Anti- inflammatory Undisc
Slide 8: EB613 Oral PTH for Treatment of Osteoporosis
EB613 (oral PTH (1-34), teriparatide) Oral Bone Forming / Anabolic for the Treatment of Osteoporosis
Slide 9: EB613: First Oral PTH Drug Candidate for Osteoporosis
EB613: First Oral PTH Drug Candidate for Osteoporosis *P1NP: amino pro-peptide of type 1 collagen 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. Currentl
Slide 10: Osteoporosis and the bone remodeling cycle
Osteoporosis Results From An Imbalance In The Bone Remodeling Cycle That Occurs When Bone Resorption Outpaces Bone Formation The Bone Remodeling Cycle can be separated into two distinct processes: Resorption (osteoclasts) and Formation (osteoblasts) Sources: International Osteoporosis foundation acc
Slide 11: Osteoporosis treatment landscape
Notes: * Estrogen products are indicated for prevention of osteoporosis as a secondary benefit when used to control menopausal symptoms. Not a 1st line treatment due to adverse reactions, **SERMs – Selective estrogen receptor modulators Sources: Osteoporosis, accessed March 2022, retrieved from: hop
Slide 12: Therapy selection and treatment gap by BMD category
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: Treated osteoporosis population by medication class
Source: IQVIA prescription data (note the capture rate of IQVIA may be low due to injectable administration of anabolic drugs on the market); TIG Primary Research Apr. 2022 IQVIA-Based HCP Primary-Based Total Osteoporosis Treated Population ~3.16M ~3.23M Bisphosphonate Patients ~1.74M (~55%) ~1.74M
Slide 14: EB613 positioned as first oral anabolic therapy
EB613 Poised To Create A Paradigm Shift In The Treatment of Osteoporosis As The First Oral Anabolic Therapy Key Product Needs Forteo® (Lilly) Tymlos® (Radius) Evenity® (Amgen) Prolia® (Amgen) Bisphosphonates(generics) Entera EB613 Treats Osteoporosis Rebuilds Bone Oral Dosing No Refrigeration Self-A
Slide 15: EB613 Phase 2 Results
EB613 Phase 2 ResultsA Six-Month Study of Oral PTH in Postmenopausal Women with Low Bone Mass – 6 Month Bone Mineral Density (BMD) Results
Slide 16: EB613 Phase 2 Clinical Trial Design
EB613 Phase 2 Clinical Trial Design Arm 1: Placebo tablets QD Arm 2: 0.5 mg * Arm 3: 1.0 mg * Arm 4: 1.5 mg QD Arm 5: 2.5 mg QD * ** Arm 6: 2.5mg titrated QD ** Key inclusion criteria 50+ years old and 3+ years post menopause Low bone mass Key exclusion criteria Osteoporosis treatment within last 2
Slide 17: EB613 bone biomarkers and dose-dependent BMD increases
EB613 Predictive Profile Of Bone Biomarkers and Significant Dose-Dependent Increases in BMD 2.5mg selected as Phase 3 dose – sustained “anabolic window” from Month 3 to Month 6 in patients treated with EB613. A significant dose response of 0.5, 1.0, 1.5 and 2.5 mg doses on Month 1 P1NP and Osteocalc
Slide 18: EB613 impact on lumbar spine, femoral neck and total hip BMD
Notes: 1. Cosman, et al. Current Osteoporosis Reports (2021) 19:189–205; 2. Leder BZ et.al. JCEM (2015) (historical data from Abaloparatide vs. Forteo) * P< 0.05. ** P< 0.01 * ** ** ** 0.8% Placebo vs 1.1% Teriparatide Difference = 0.3% at Femoral Neck2 0.4% Placebo vs 0.5% Teriparatide Difference =
Slide 19: Placebo adjusted BMD by site at 2.5mg dose
EB613: 6 Month Placebo Adjusted BMD by Site at 2.5mg Dose Presented at Late Breaker LB-1116 and Poster FRI-237– ASBMR 2021 At 6 months of treatment with 2.5mg EB613: The increase in spine BMD was similar in magnitude to that previously reported with SC injection Forteo Increases in total hip and fe
Slide 20: 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 21: EB613 proposed Phase 3 clinical trial design
18 M Treatment Screening EB613 Proposed Phase 3 Clinical Trial Design Arm 1: EBP05 2.5mg (N=400) 2:1 Randomization N=600 (target) A Global Phase 3, 18-Month, Placebo-Controlled Study (2:1), with a 6-Month Alendronate Extension Designed to address FDA suggestion - Placebo-Controlled study, BMD endpoi
Slide 22: 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 Quali
Slide 23: Phase 3 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 adjuste
Slide 24: EB613 Positioning
EB613 Positioning EB613, as a first in class oral PTH treatment, may potentially offer a viable anabolic (bone formation) therapeutic option to lower the risk of fracture for high risk (based on low BMD score or prior fracture history) osteoporotic patients PTH receptor activation is a mechanistical
Slide 25: EB612 Oral PTH for Hypoparathyroidism
EB612 Oral PTH (1-34) For the Treatment of Hypoparathyroidism
Slide 26: Hypoparathyroidism: orphan indication with sub-par clinical care
Hypoparathyroism: PTH Orphan Indication with Sub-Par Clinical Care References: https://rarediseases.org/rare-diseases/hypoparathyroidism https://www.takeda.com/en-us/newsroom/news-releases/2019/takeda-issues-us-recall-of-natpara-parathyroid-hormone-for-injection-due-to-the-potential-for-rubber-parti
Slide 27: EB612 summary of PK and pilot Phase 2 data
EB612: First Oral PTH (1-34) Tablets for Hypoparathyroidism, Summary of PK and Pilot Phase 2 Data Efficacy: 42% reduction (p=0.001) from baseline in median calcium supplement use Maintenance of median Ca levels above the lower target level for Hypoparathyroidism patients (>7.5 mg/dL) throughout the
Slide 28: EB612 Positioning
EB612 Positioning EB613 is potentially the first oral PTH (1-34) 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 2015) and peer-review
Slide 29: Key Short-Term Catalysts
Key Short-Term Catalysts EB613 FDA Type C Meeting on Phase 3 Protocol (H2’2022E) ASBMR Additional Data from Phase 2 6-Month BMD Study (September 11, 2022E) EB613 EB612 PK Data from 2nd Generation Formulation for Hypoparathyroidism (H1’2023E) EB613 Phase 3 Pivotal Study Initiation for Osteoporosi
Slide 30: Thank You
Thank YouContact:Entera Bio:Ms. Miranda ToledanoChief Executive OfficerEmail: miranda@enterabio.com
Slide 31: Appendix
Appendix ZF EnteraBio
Slide 32: EB613 Phase 3 design: FNIH message from ASBMR president
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. https://www.asbmr.org/about/council/presidents-corner-detail/message-from-asbmr-p
Slide 33: EB613 Phase 3 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 deve
Slide 34: 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 Advantageous Stability versus Injectables Controlled Onset of Action, Minutes to