Entera Bio Q2 2024 Financial Results and Business Updates

Entera Bio Ltd., based in Jerusalem and listed on NASDAQ under the ticker ENTX, has recently announced its financial results and key business updates for the quarter ending June 30, 2024. Entera Bio specializes in the development of orally delivered peptides and small therapeutic proteins, focusing on innovative treatments for various medical conditions.

CEO Miranda Toledano highlighted the company's achievements in the second quarter, emphasizing significant milestones across their N-Tab™ oral peptide programs targeting OBGYN/endocrinology, gastrointestinal, and metabolic diseases. One of the pivotal events anticipated by Entera Bio is the FDA’s potential landmark ruling on the ASBMR-FNIH SABRE regulatory endpoint for osteoporosis drugs, expected within the next five months. This ruling could be a significant catalyst for EB613, Entera’s leading product candidate.

EB613 is poised to be the first oral PTH (1-34) daily osteoanabolic tablet designed to treat osteoporosis, particularly targeting post-menopausal women at high risk of fractures. In April 2024, the Journal of Bone and Mineral Research (JBMR) published positive results from a Phase 2 study of EB613, involving postmenopausal women with low bone mineral density (BMD) or osteoporosis. The study was randomized, placebo-controlled, and spanned six months.

In May 2024, Dr. Rachel Wagman joined Entera Bio as a Key Clinical Advisor to spearhead EB613’s clinical development. Dr. Wagman brings extensive experience, having successfully advanced five molecules, including notable osteoporosis treatments such as Forteo®, Prolia®, and Evenity®. By June 2024, the JBMR published an editorial praising EB613’s novel oral administration, noting its potential to model anabolism without increasing bone remodeling rates.

In July 2024, Entera Bio disclosed new comparative pharmacological data for EB613 versus Forteo®, which will be presented at the ASBMR Annual Meeting in Toronto. Additionally, the SABRE study is expected to provide updates during the same meeting.

EB612, Entera Bio's program focused on hypoparathyroidism, involves the development of the first oral PTH (1-34) peptide replacement therapy. In June 2024, Entera presented Phase 1 clinical data for EB612 at the Endocrine Society's ENDO 2024 Annual Meeting, supporting the potential advancement to Phase 2 development. The company is collaborating with third parties to develop another PTH replacement therapy for hypoparathyroidism.

Entera Bio is also exploring the first oral GLP-2 peptide tablets for short bowel syndrome. In March 2024, they announced positive in vivo pharmacokinetic results from their program in collaboration with OPKO Health. Further pharmacological data are anticipated early in the latter half of 2024.

Moreover, Entera Bio is working on the development of the first oral GLP-1/Glucagon Agonist (Oxyntomodulin) peptide tablets for obesity and other metabolic diseases. This project is also in collaboration with OPKO Health, and pharmacokinetic data for the oral Oxyntomodulin tablet are expected soon.

Financially, as of June 30, 2024, Entera Bio held $9.1 million in cash and cash equivalents. The company projects its existing cash resources will be sufficient to meet operating requirements into the third quarter of 2025. Research and development expenses for Q2 2024 were $1.1 million, slightly down from $1.2 million in Q2 2023, primarily due to decreased clinical expenses for the EB612 platform. General and administrative expenses remained steady at $1.1 million for both periods. The net loss for Q2 2024 was $2.1 million, or $0.06 per share, compared to $2.3 million, or $0.08 per share, in Q2 2023.

Entera Bio is a clinical-stage company dedicated to oral peptide or protein replacement therapies aimed at addressing unmet medical needs. Leveraging their proprietary N-Tab™ technology, the company boasts a pipeline of five first-in-class oral peptide programs, with clinical trials expected to span from Phase 1 to Phase 3 by 2025.