Entera Bio Has $265.9 Million To Back Planned Late-Stage Osteoporosis Tablet Trial
Management expects funding to cover EB613 results and an FDA application, with operations supported into 2030.
Entera Bio, which develops tablet versions of therapies usually given by injection, reported $265.9 million in cash and equivalents Friday as it prepares a late-stage osteoporosis trial. In results accompanying its SEC filing, the company said its resources should cover the planned EB613 program through results and an anticipated FDA approval application, and support operations into 2030.
July financing funds clinical push
The September 30 cash balance follows a July 2026 private placement that brought approximately $275.0 million in gross proceeds, before fees and expenses. Existing investor BVF Partners led the financing; new participants included Longitude Capital, Vivo Capital, TCGX, Spruce Street Capital, Venrock Healthcare Capital Partners, RA Capital Management, Perceptive Advisors, Driehaus Capital Management, Logos Capital and Catalio Capital Management.
Entera also held $6.5 million in restricted cash, primarily reserved for its OPKO collaboration. Research spending reached $4.9 million in the third quarter, against $1.6 million a year earlier. The company attributed the $3.3 million increase mainly to preparations for the osteoporosis trial and work with OPKO.
The quarterly net loss widened to $15.6 million, or $0.11 per share, from $3.2 million, or $0.07 per share. Entera said a $7.5 million non-cash adjustment to the value of pre-funded warrants primarily drove the increase; those warrants came from April and July 2026 financings and were reclassified as equity in August. Administrative expenses were $2.3 million, versus $1.6 million a year earlier.
EB613 targets approximately 900 women
EB613, Entera's most advanced candidate, is an experimental oral teriparatide treatment designed to build bone. Entera has global rights to the drug and no approved products. Its N-Tab platform aims to protect large peptides during digestion and enable their absorption into the bloodstream.
The planned trial will enroll approximately 900 women with postmenopausal osteoporosis, assigning approximately 600 to EB613 and 300 to placebo. Participants will be ages 50–90, at least five years past their last menstrual period, with bone-density scores of -2.5 or lower at specified hip or spine sites.
The main measure is the percentage change in total hip bone mineral density after 12 months. Women completing treatment can enter a planned extension through month 24. Entera said the FDA accepted its proposed development plan in June 2026 and that the trial may support an approval application. The package also calls for analyses connecting EB613 with Eli Lilly's injectable Forteo, drug-absorption studies and a bone-biopsy substudy.
A mid-stage, dose-ranging study involving 161 women met its main bone-turnover goal and secondary bone-density measures. At the American Society for Bone and Mineral Research meeting on October 9, 2026, Entera presented a follow-up analysis showing stronger bone-turnover effects among women with lower bone density—the population planned for the late-stage trial.
Miranda Toledano, chief executive officer of Entera Bio, said, "Our team is fully focused on ensuring a seamless trial launch, with expected first site activation in late 2026."
Clinical hires and OPKO development
Entera expanded its team with chief medical officer Riccardo Paolo Camisasca, senior vice president of medical affairs Michele McDermott, early clinical development head Ofer Spiegelstein and clinical development vice president and study lead Graziella Soulban.
Laura Hamill and Juan Camilo Arjona Ferreira are scheduled to join the board on December 1, 2026. Hamill previously led worldwide commercial operations at Gilead Sciences, while Arjona Ferreira heads research and development and serves as chief medical officer at Organon.
Entera plans an early-stage, single-dose escalation study in 2027 for EB612, its oral hormone-replacement candidate for hypoparathyroidism, developed with OPKO. Other programs include oral GLP-1/Glucagon for obesity and metabolic disorders and oral GLP-2 for short bowel syndrome. Entera and OPKO retain 40% and 60% of proceeds, respectively, from the GLP-1/Glucagon program.
Entera anticipates initial results from the planned EB613 late-stage trial in the second half of 2028.
Sources
- 8-K Filing — Entera Bio Ltd. (ENTX) — SEC EDGAR
- Exhibit exhibit_99-1.htm — Entera Bio Ltd. 8-K exhibit — SEC EDGAR
- Entera Announces Third Quarter 2026 Financial Results and — globenewswire.com
