Entera Bio Announces Q1 2024 Financial Results and Business Updates

JERUSALEM, May 10, 2024 — Entera Bio Ltd. (NASDAQ: ENTX), a pioneer in developing orally administered peptides and small therapeutic proteins, released its financial results and significant business updates for the first quarter ending March 31, 2024.

Miranda Toledano, CEO of Entera, remarked on the company’s robust start to 2024, attributing it to the strategic growth plan launched in 2023. This plan expanded Entera's N-Tab™ pipeline, introducing potential first-in-class oral treatments such as GLP-2, GLP-1/glucagon, and PTH(1-34) peptides. These treatments target various disorders, including GYN/endocrine, metabolic, and gastrointestinal diseases. Toledano expressed gratitude to shareholders and affirmed the company's commitment to becoming a leading oral peptide therapeutic provider, with numerous updates expected across various programs as the year advances.

In March 2024, Entera welcomed the American Society for Bone and Mineral Research's (ASBMR) announcement that the U.S. Food and Drug Administration (FDA) plans to issue a ruling within 10 months on qualifying bone mineral density (BMD) as a surrogate endpoint for fractures. This ruling is crucial for initiating the Phase 3 study of EB613, the first oral PTH(1-34) daily osteoanabolic tablet meant for osteoporosis. Osteoporosis affects around 200 million women worldwide, with fracture rates and associated morbidity and mortality rising despite existing treatments. EB613 promises a unique, oral alternative to currently available injectable therapies. In April 2024, the Journal of Bone and Mineral Research (JBMR) published Phase 2 trial results for EB613, highlighting its distinctive dual mechanism of action and favorable BMD profile compared to injectable treatments.

In April 2024, Entera submitted pharmacokinetic (PK) and early pharmacodynamic (PD) data from a Phase 1 study on EB612, the first oral PTH(1-34) peptide replacement therapy for hypoparathyroidism, to the Endocrine Society Annual Meeting (ENDO 2024).

For the first oral GLP-2 peptide tablets aimed at treating short bowel syndrome, Entera shared positive in vivo PK results in March 2024. This program integrates OPKO Health Inc.’s long-acting GLP-2 analogue with Entera's N-Tab™ technology. The oral GLP-2 tablets demonstrated systemic exposure levels approximately 10 times higher than those reported for teduglutide (Gattex®). Further pharmacology data is anticipated in the early second half of 2024.

Entera continues its collaborative efforts with OPKO to develop oral GLP-1/glucagon agonist (Oxyntomodulin) peptide tablets for obesity and other metabolic conditions. PK data for the oral OXM tablet is expected by mid-2024, followed by a pharmacology study.

In partnership with experts in orthopedics and sports medicine, Entera is also investigating the use of its proprietary oral PTH(1-34) tablets for treating stress fractures in young female athletes. Details on this Phase 2 study will be provided later in 2024.

Financially, Entera reported having $9.2 million in cash and equivalents as of March 31, 2024. The company believes this will cover operational needs into the third quarter of 2025. For the first quarter of 2024, research and development expenses were $0.7 million, down from $0.9 million in the same period last year. General and administrative expenses remained consistent at $1.3 million. Overall operating expenses were $2.1 million, slightly lower than last year's $2.2 million. Net loss for the quarter was $2.0 million, or $0.05 per share, compared to $2.2 million or $0.08 per share in the previous year.

Entera Bio continues to leverage its innovative N-Tab™ platform to develop oral peptide therapies addressing significant unmet medical needs. Its pipeline includes five pioneering oral peptide programs expected to enter clinical trials from Phase 1 to Phase 3 by 2025. The company’s leading candidate, EB613, aims to be the first oral osteoanabolic treatment for post-menopausal women with osteoporosis. The pipeline also includes EB612 for hypoparathyroidism, an oral GLP-1/glucagon peptide for obesity, and an oral GLP-2 peptide for short bowel syndrome, developed in collaboration with OPKO Health.