The pharmacokinetic (PK) and pharmacodynamic (PD) profiles of single tablet EB613, multi-tablet EB613 and Forteo® reported for the first time as an oral presentation at ENDO 2026 Single tablet EB613 achieved a comparable PK/PD profile to Forteo® and multi-tablet EB613, which was evaluated in Entera’s Phase 2 study in postmenopausal women with osteoporosis and low bone mass This major scientific achievement supports advancing single tablet EB613 into Entera’s planned Phase 3 study of EB613 in postmenopausal women with osteoporosis TEL AVIV, June 15, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides, today reported comparative Phase 1 data evaluating single-tablet and multi-tablet oral EB613 with Forteo® (teriparatide SC injection, Eli Lilly). The oral presentation “Transforming Anabolic Treatments for Osteoporosis: New Clinical Data Supports a Single EB613 Tablet [Oral PTH(1-34)] as the Final Candidate for a Phase 3 Study” was presented by Clinical Pharmacologist Helen S. Pentikis, PhD, as a Late-Breaking Oral Presentation at ENDO 2026, the annual meeting of the Endocrine Society, taking place in Chicago, Illinois. Substantial evidence supports the use of anabolic (bone-building) therapies over anti-resorptive drugs for rapidly lowering fracture risk in osteoporosis patients at high risk of fractures. However, the three approved agents (Forteo®, Tymlos®, Evenity®) require daily or monthly injections and are used in only a minority of eligible patients. Entera is developing EB613 as the first oral, anabolic tablet treatment for patients with osteoporosis. In the Phase 1 (NCT05965167) study, a cohort of 15 healthy participants each received single-tablet EB613, multi-tablet oral EB613, and subcutaneous Forteo ® at doses ranging from 1 mg to 3 mg, to evaluate and compare the three treatments’ pharmacokinetic (PK) and pharmacodynamic (PD) profiles. Key findings included: Single tablet EB613 showed a PK profile comparable to multi-tablet EB613, with similar Cmax, Tmax, and total systemic exposure (AUC). The AUC of single tablet and multi-tablet EB613 was comparable with Forteo ® , exhibiting a slightly shorter duration of exposure, which is consistent with prior Phase 1 studies. Comparable calcemic effects (serum calcium) and consistent suppression of endogenous PTH(1-84) were shown for both oral EB613 treatments and Forteo®. The safety profile of EB613 was consistent with Forteo ® , with no drug-related serious adverse events; all other adverse events were mild and resolved with no action taken. Based on an administration experience quality-of-life questionnaire, 14 of 15 participants preferred the single tablet to multi-tablet EB613, and all participants preferred a daily oral EB613 over the daily injection. “Our ability to simplify the proposed dosing regimen for patients from the multi-tablet presentation of EB613, which was shown to be safe and effective in our Phase 2 osteoporosis study, to a single daily tablet is a significant scientific achievement. A single daily oral PTH tablet (EB613) could make anabolic treatment far more acceptable to many patients and health care providers and have a substantial impact toward reducing the treatment gap in patients with osteoporosis,” said Miranda Toledano, Chief Executive Officer of Entera. About EB613 Substantial evidence supports the efficacy of anabolic therapies over bisphosphonates for lowering fracture risk in osteoporosis patients at high risk. However, all available anabolic therapies are administered by subcutaneous (SC) injection and used in a minority of eligible patients. Entera’s EB613 program (oral PTH(1-34), teriparatide) is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis. EB613 completed a Phase 2, 6-month, 161-patient, placebo-controlled study that met all biomarker and BMD endpoints without significant safety concerns in women with postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid dose-proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increases in lumbar spine, total hip, and femoral neck BMD. The effects of EB613 on trabecular and cortical bone using 3D-DXA showed increases with EB613 compared with placebo in a variety of indices, including integral volumetric BMD and trabecular volumetric BMD, cortical thickness, and cortical surface BMD. Mechanistically, the findings suggest that bone strengthening and fracture resistance may occur rapidly with EB613. Furthermore, the data is consistent with that of published subcutaneous teriparatide at the 6-month time point. About Osteoporosis Osteoporosis is a chronic, progressive disorder in which bone resorption exceeds formation, resulting in decreased bone strength and increased susceptibility to fracture. Osteoporosis is a major and growing public health issue, responsible for over 2 million fractures