Entera Bio Ltd., a clinical-stage biopharmaceutical company focused on developing oral peptide therapies, reported a net loss of $9.5 million for the fiscal year ending December 31, 2024, compared to a loss of $8.9 million in 2023. The company’s accumulated deficit has now reached $113.9 million. Revenue for 2024 was $181,000, primarily from a research services agreement, marking a significant increase from zero revenue in the previous year. The company’s operating expenses totaled $9.6 million, with research and development expenses remaining stable at approximately $4.5 million for both years, while general and administrative expenses rose by 15% to $5.1 million.

In terms of strategic developments, Entera Bio is advancing its lead product candidate, EB613, an oral PTH(1-34) tablet for osteoporosis, which is preparing for a Phase 3 registrational study. The FDA has agreed that a placebo-controlled study with Total Hip BMD as the primary endpoint could support a new drug application. Additionally, the company is developing EB612, an oral peptide replacement therapy for hypoparathyroidism, and has entered into a collaboration agreement with OPKO Biologics to develop oral formulations of GLP-2 and OXM peptides. This collaboration is expected to enhance Entera's product pipeline and market reach.

Operationally, Entera Bio has maintained a small workforce, with 20 employees as of December 31, 2024, all based in Israel. The company has not reported significant changes in customer counts or user statistics, as it is still in the clinical development phase. The ongoing geopolitical situation in Israel, including the Israel-Hamas conflict, has not materially impacted the company’s operations to date, although the situation remains fluid and could affect future activities.

Looking ahead, Entera Bio anticipates that its existing cash resources, totaling $21 million as of March 20, 2025, will be sufficient to fund operations into the third quarter of 2026, excluding the initiation of the Phase 3 study for EB613. However, the company acknowledges the need for additional funding to support its clinical trials and operational expenses. The ability to secure this funding remains uncertain, and any delays in obtaining necessary capital could hinder the company’s development plans and overall business strategy.

About Entera Bio Ltd.

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