EB613 Phase 2 Data Demonstrating Consistent Efficacy across Younger Post-Menopausal Women with Osteoporosis and its Impact on Trabecular and Cortical Bone Indices, Highlighted at NAMS and ASBMR
Next-Generation EB613 Remains on Track for Phase 1 Initiation in Late 2025
Pre-Clinical Data for Oral OXM in Obesity and Oral GLP-2 in Short Bowel Syndrome in Collaboration with OPKO Presented at ENDO2025 and ESPEN
JERUSALEM, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX) ("Entera" or the "Company"), a leader in the development of oral peptide and protein replacement therapies, today reported financial results and key business updates for the quarter ended September 30, 2025.
"Our achievements this quarter are testament to Entera's leadership position in oral peptide innovation and our team's unrelenting mission to deliver transformative treatments to patients, starting with post-menopausal women with osteoporosis," said Miranda Toledano, Chief Executive Officer of Entera. "Our FDA agreement for EB613 this July is unprecedented and underscores the strength of our data and the promise for EB613 to close the treatment chasm in osteoporosis, a disease which disproportionately afflicts women and remains grossly undertreated globally. EB613 data continues to be highlighted across major medical conferences focused on advancing novel treatments in bone metabolism, endrocrine and women's health, while our N-Tab™ platform consistently delivered across pipeline programs, including our oral GLP-2 program for short bowel syndrome and our oral OXM program in metabolic diseases in partnership with OPKO Health ("OPKO")."
Key Recent Highlights
EB613: First Oral PTH(1-34) Anabolic Tablet Treatment for Osteoporosis
FDA Agreement on BMD as Primary Endpoint: In a written response to a Type A meeting, the FDA agreed with Entera's proposal that a single multinational, randomized, double-blind, placebo-controlled, 24-month Phase 3 study where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures as the key secondary endpoint, would support an NDA marketing application for EB613.
Strong Phase 2 Data Reinforce Early Onset of EB613 Anabolism: At the ASBMR 2025 Annual Meeting, Entera presented post-hoc 3D-DXA results showing significant increases in both trabecular and cortical bone indices after just six months of EB613 treatment, comparable to injectable teriparatide and abaloparatide. Mechanistically, the findings suggest that bone strengthening and fracture resistance may occur rapidly with EB613.
Expanded Evidence in Early Postmenopausal Women: At the NAMS 2025 Meeting, new Phase 2 analysis demonstrated EB613 ability to drive significant and consistent gains in BMD at the spine, femoral neck and hip in younger women within 10 years of menopause, with improvements comparable to those observed in women more than 10 years post-menopause. For younger high-risk women without a prior fracture, BMD is the single most important predictor of osteoporotic fractures. Today, it is estimated that less than 15% of women are willing to take or have access to currently approved anabolics, which require daily or monthly injections.
Next-Gen EB613: Preclinical PK data presented at ASBMR showed comparable pharmacokinetic exposure to the current formulation using a single fixed dose regimen, validating the N-Tab™ platform and potential franchise expansion. A Phase 1 trial of Next-Gen EB613 currently remains on track to initiate in late 2025.
GLP-2 Program for Short Bowel Syndrome (in collaboration with OPKO)
Positive PK data presented at ESPEN 2025: The joint Entera-OPKO abstract highlighted a plasma half-life of approximately 15 hours, representing an 18-fold improvement over teduglutide (Gattex®), the only approved GLP-2 therapy, which requires a daily injection. The daily GLP-2 tablet candidate could fundamentally change how SBS patients are treated, offering a less-invasive administration that can be titrated to enable personalized dosing in this rare and heterogeneous condition.
Dual GLP-1/Glucagon OXM Tablet Program (in collaboration with OPKO)
Encouraging preclinical data presented at the Endocrine Society (ENDO) 2025 annual meeting: In the abstract titled "First-in-Class Oral Dual GLP-1/Glucagon Agonist for Patients with Obesity and Metabolic Disorders" PK data reported from a minipig study show plasma levels of OPK-88006 consistent with those reported in humans for the highest, 2.4 mg subcutaneous dose of Wegovy (semaglutide) weekly injection, a standard of care for the treatment of obesity. An IND for oral OXM is planned for H1 2026.
EB612: Oral PTH(1-34) Peptide Replacement Therapy for Hypoparathyroidism
Collaborative studies evaluating a novel, long-acting PTH analog remain on track to deliver first PK/PD pre-clinical data for a single tablet candidate by year-end 2025.
Financial Results for the Quarter Ended September 30, 2025
Cash and cash equivalents were $16.6 million as of September 30, 2025, including $8.0 million in restricted cash designated to fund the OPKO collaboration through Phase 1 studies of oral GLP-1/glucagon candidate OPK-88006. Cash on hand is expected to support operations through the middle of the third quarter of 2026.
Net loss was $3.2 million, or $0.07 per ordinary share, for the three months ended September 30, 2025, compared to $3.0 million, or $0.08 per ordinary share, for the three months ended September 30, 2024.
Research and development expenses were $1.6 million for the three months ended September 30, 2025, compared to $1.5 million for the same period in 2024, an increase of $0.1 million, primarily reflecting continued regulatory and Phase 3 preparation activities for EB613.
General and administrative expenses were $1.6 million for the three months ended September 30, 2025, compared to $1.5 million for the prior-year quarter.
Total operating expenses were $3.3 million for the three months ended September 30, 2025, compared to $3.0 million for the three months ...
