ENTX

EX-99.1

2 exhibit_99-1.htm

EXHIBIT 99.1

Exhibit 99.1

Entera Announces Third Quarter 2026 Financial Results and Business Updates

Clinical Preparations Advanced for EB613 Phase 3 Osteoporosis Study, with First Site Activation Expected in Late 2026

Clinical and Commercial Leadership Expanded with Appointment of Senior Executives and Directors

EB613 Enhanced Anabolic Effect Highlighted at ASBMR Plenary Poster Presentation

IND-Enabling Activities Ongoing for EB612,

in Development with OPKO for Hypoparathyroidism

TEL AVIV, Israel, November 6, 2026 -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides, today reported financial results and key business updates for the quarter ended September 30, 2026.

“The third quarter of 2026 transitioned our expanding team into late-stage clinical execution mode. The opportunity to evaluate the safety and efficacy of EB613 as the first oral anabolic treatment for osteoporosis has generated excitement among clinical investigators and patients. Our team is fully focused on ensuring a seamless trial launch, with expected first site activation in late 2026. Additionally, the post-hoc analysis that we presented at ASBMR 2026 demonstrated that our Phase 2 6-month clinical data with EB613 show rapid stimulation of bone formation and robust early bone mineral density (BMD) accrual, especially in patients who start with lower BMD and who need the largest gains. These are the women we plan to enroll in our Phase 3 study. Finally, we continue to invest in expanding our human capital at Entera with early and late-stage clinical leadership and board appointments,” said Miranda Toledano, Chief Executive Officer of Entera.

Key Recent Highlights

•Core Team Expansion: Entera has expanded its clinical and early development teams, including the following senior appointments:

oRiccardo Paolo Camisasca, M.D., Chief Medical Officer, is a physician with more than 30 years of experience in late-stage clinical development and regulatory approvals, with previous leadership roles at Takeda, Novartis and Sumitomo Pharma Switzerland.

oMichele McDermott, M.D., Senior Vice President, Medical Affairs, formerly Amgen US Bone Health Medical Director, is an endocrinologist with extensive clinical, research and biopharmaceutical experience focused on mid-life and older women. Dr. McDermott directed a Menopause and Osteoporosis center of excellence in Austin, Texas and was an investigator for over 40 women’s health trials evaluating new treatments for menopause and osteoporosis.

oOfer Spiegelstein, Ph.D., Vice President and Head of Early Clinical Development, is an experienced clinical pharmacologist with over 20 years of experience advancing novel drug candidates from early preclinical research through clinical execution and regulatory milestones, including 16 years at Teva Pharmaceuticals, where he most recently served as Head of Clinical Pharmacology & Pharmacometrics.

oGraziella Soulban, Ph.D., Vice President, Clinical Development and Study Lead, is an accomplished clinical development leader with over 30 years of experience leading clinical research, operations and medical affairs with a particular focus on women’s health research, most recently having served at Sumitomo Pharma America and Myovant Sciences.

•Board of Directors Appointments: Entera announced the appointments of Laura Hamill and Juan Camilo Arjona Ferreira, M.D., to its Board of Directors, each effective December 1, 2026. Ms. Hamill brings more than 35 years of global commercial, market access and business leadership experience and most recently served as Executive Vice President, Worldwide Commercial Operations at Gilead Sciences, Inc., following nearly two decades in leadership roles at Amgen Inc. Dr. Arjona Ferreira currently serves as Head of Research & Development and Chief Medical Officer at Organon & Co., and brings more than 20 years of global clinical development experience, including roles at Myovant Sciences, Shionogi and Merck & Co.

EB613: First Oral PTH(1-34) Anabolic Tablet for Osteoporosis

•New Phase 2 Analysis Presented as Plenary Poster at ASBMR 2026: On October 9, 2026, Entera presented new Phase 2 post-hoc analysis of EB613 in postmenopausal women with osteoporosis at high risk of fracture in a plenary poster presentation at the American Society for Bone and Mineral Research (ASBMR) 2026 Annual Meeting. Changes in bone turnover markers (increase in bone formation and suppression of bone resorption) were enhanced in women with T-scores of -2.5 or lower. This post-hoc analysis supports the potential benefit of EB613 within the population that is intended to be enrolled in Entera’s Phase 3 study.

•Phase 3 Study Design Presented at ASBMR 2026: In October 2026, Entera presented the design of its planned Phase 3 study of EB613 at the ASBMR 2026 Annual Meeting. The study is expected to enroll approximately 900 postmenopausal women with osteoporosis, randomized 2:

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