Entera Bio Reports Q1 2025 Financial Results with Increased Net Loss and Revenue Growth

Entera Bio Ltd. has reported its financial results for the first quarter of 2025, revealing a net loss of $2.57 million, an increase from a net loss of $2.02 million in the same period last year. The company's revenues for the quarter were $42,000, attributed to a research services agreement, marking a significant increase from zero revenue in the first quarter of 2024. Operating expenses rose to $2.56 million, up from $2.06 million in the prior year, primarily driven by increased research and development costs, which totaled $1.12 million compared to $735,000 in the previous year.

The company's accumulated deficit has reached $116.5 million as of March 31, 2025, reflecting its ongoing investment in research and development activities. Entera Bio's cash and cash equivalents, along with restricted cash, amounted to $20.67 million, with $8 million earmarked for collaboration activities under a recent agreement with OPKO Health. This financial position is expected to support the company's operations through the middle of the third quarter of 2026, although it raises concerns about the company's ability to continue as a going concern without additional funding.

Strategically, Entera Bio has made significant advancements, including the initiation of a collaboration agreement with OPKO Biologics for the development of oral peptide therapies targeting obesity and metabolic disorders. This partnership is expected to enhance Entera's product pipeline, which includes its lead candidate, EB613, an oral treatment for osteoporosis, and EB612, an oral therapy for hypoparathyroidism. The company is preparing to initiate a Phase 3 study for EB613, pending final discussions with the FDA regarding the qualification of a bone mineral density endpoint.

Operationally, Entera Bio has maintained a workforce of 20 employees, all based in Israel, and continues to focus on its N-Tab™ technology platform, which aims to facilitate the oral delivery of peptide therapies. The company has not yet achieved significant market penetration, as it awaits regulatory approvals for its product candidates. The ongoing geopolitical situation in Israel has not materially impacted the company's operations to date, although it remains a factor in the broader context of its business environment.

Looking ahead, Entera Bio acknowledges the need for additional capital to fund its ongoing research and development efforts, particularly for the Phase 3 program of EB613. The company is exploring various financing options, including public and private equity offerings, but faces uncertainty regarding the availability and terms of such funding. The successful commercialization of its product candidates will depend on regulatory approvals and market acceptance, which remain critical challenges for the company as it navigates its development pipeline.