Entera Bio reports positive financial results, advancements in bone health and other medical conditions

From GlobeNewswire: 2025-05-09 16:05:00

Entera Bio Ltd. reported financial results for Q1 2025, extending cash runway to late 2026 through investments and partnerships. EB613 shows promising effects on bone compartments, with abstracts submitted to major conferences. Plans for a Phase 1 study for Next Gen EB613 are in progress, along with the development of Oral OPK-88006.

EB613, an oral anabolic “bone building” tablet, aims to address osteoporosis in postmenopausal women. Its potential impact on bone and heart health is significant, with statistics showing a high risk of fractures and mortality related to osteoporosis. Regulatory reform for osteoporosis drug approval is needed, with a focus on bone mineral density as a reliable predictor of fractures.

Recent highlights include positive results from EB613 trials, showing improvements in bone density and strength compared to a placebo. The findings support the potential for rapid bone strengthening and fracture resistance with EB613. Plans for Next Gen EB613 development are underway, with preparations for clinical trials in late 2025. A collaboration with OPKO for the development of an Oxyntomodulin peptide tablet for obesity has also been initiated. OPKO and Entera have entered an agreement for a GLP-2 peptide tablet program for Short Bowel Syndrome, with ownership interests and development costs split 60% and 40%. The companies aim to file an IND application with the FDA later this year or in early 2026. Abstracts for ENDO2025 and major clinical conferences are planned. Cherin Smith and Leslie Gautam have joined Entera as key team members, showcasing extensive experience in clinical operations and business development within biopharma, particularly in women’s health. Financially, Entera reported $20.6 million in cash and cash equivalents as of March 31, 2025, with enough funds to support operations until the middle of the third quarter of 2026. Research and development expenses for the quarter ended March 31, 2025 were $1.1 million, with general and administrative expenses totaling $1.4 million. Operating expenses amounted to $2.6 million, resulting in a net loss of $2.6 million for the same period. Entera Bio is a clinical-stage company focused on developing oral peptide and protein replacement therapies to address unmet medical needs, leveraging proprietary technology and a pipeline of oral peptide programs targeting various conditions, including osteoporosis. Their lead product candidate, EB613, has shown promise in Phase 2 studies and is advancing towards a Phase 3 registrational study for FDA qualification. Entera is developing the first oral oxyntomodulin and GLP-2 peptide tablets for obesity and rare malabsorption conditions like short bowel syndrome in collaboration with OPKO Health. For more information, visit their website or follow them on social media.

Entera Bio Ltd. reported a consolidated balance sheet with $12,573 in cash and cash equivalents, $645 in accounts receivable, and $8,000 in restricted cash as of March 31, 2025. They also reported a total shareholders’ equity of $19,379.

The company also disclosed their consolidated statements of operations for the first quarter of 2025, showing $42 in revenues and operating expenses totaling $2,563. The net loss for the quarter was $2,567, with a loss per share of $0.06.

These financial figures reflect Entera’s ongoing development of innovative oral peptide tablets for various medical conditions and their commitment to advancing healthcare solutions for patients in need.



Read more at GlobeNewswire:: Entera Bio Announces First Quarter 2025 Financial Results