Entera Bio Ltd. reported its financial results for the third quarter and the nine months ended September 30, 2025, revealing a continued focus on its clinical development programs while facing significant operating losses. The company generated revenues of $42,000 for the nine months ended September 30, 2025, a decrease of 58% compared to $99,000 in the same period of 2024. The decline in revenue was attributed to the completion of obligations under a research services agreement, which resulted in no revenue recognition for the third quarter of 2025. The cost of revenues also decreased, totaling $42,000 for the nine months ended September 30, 2025, down from $90,000 in the prior year.
Operating expenses for Entera Bio increased to $8.5 million for the nine months ended September 30, 2025, compared to $7.2 million for the same period in 2024, marking a 17% rise. This increase was primarily driven by a 30% rise in research and development expenses, which reached $4.3 million, reflecting heightened investment in the development of its lead product candidate, EB613, and collaboration efforts with OPKO Health, Inc. General and administrative expenses also rose to $4.2 million, up from $4.0 million in the previous year. The net loss for the nine months ended September 30, 2025, was $8.4 million, compared to a loss of $7.2 million in the same period of 2024.
In terms of operational developments, Entera Bio's most advanced product candidate, EB613, is being developed as an oral treatment for post-menopausal osteoporosis. The company has received FDA agreement to support its New Drug Application (NDA) filing with a single multinational Phase 3 study, which is a significant step forward in its clinical program. Additionally, Entera Bio is advancing its collaboration with OPKO to develop oral formulations of GLP-1/glucagon dual agonists and GLP-2 peptides, which are aimed at addressing obesity and metabolic disorders.
As of September 30, 2025, Entera Bio had cash and cash equivalents of $8.6 million, with an additional $8.0 million in restricted cash earmarked for funding obligations under the 2025 Collaboration Agreement with OPKO. The company believes its existing cash resources will be sufficient to support operations through the middle of the third quarter of 2026, although it will require additional funding to initiate the Phase 3 program for EB613. Entera Bio's total accumulated deficit reached $122.4 million as of the end of the reporting period, raising concerns about its ability to continue as a going concern without securing further financing.
Looking ahead, Entera Bio's management is focused on advancing its clinical programs while exploring various financing alternatives to support ongoing research and development activities. The company remains committed to its goal of developing innovative oral peptide therapies, which could significantly improve treatment options for patients with chronic conditions. However, the need for additional capital and the uncertainties surrounding clinical development timelines and regulatory approvals present ongoing challenges for the company.
About Entera Bio Ltd.
Entera Bio Ltd. develops oral peptide and protein replacement therapies targeting chronic conditions like osteoporosis and hypoparathyroidism. Utilizing its proprietary N-Tab platform, the company aims to replace injectable treatments with convenient daily tablets. Its pipeline includes first-in-class oral PTH and GLP programs, focusing on underserved markets and leveraging strategic collaborations to advance innovative, patient-friendly therapeutics.
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