Entera Bio raises $275m to fund EB613 oral osteoporosis Phase 3
Entera Bio has closed an oversubscribed $275 million private placement, led by existing investor BVF Partners, to finance a registrational Phase 3 programme for EB613, its oral parathyroid hormone analogue for postmenopausal osteoporosis. The round drew participation from a broad institutional syndicate including Longitude Capital, Vivo Capital, RA Capital Management, Perceptive Advisors and Venrock Healthcare Capital Partners, among others.
The proceeds extend Entera's cash runway to 2030 and are intended to fund EB613 through anticipated submission of a new drug application to the FDA, without requiring a further fundraise, the company said. Entera's cash position stood at $11.3 million as at 30 June 2026, prior to the placement closing in July.
EB613: the Phase 3 blueprint
The FDA has aligned with Entera's proposal to conduct a single, randomised, double-blind, placebo-controlled Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, using percent change in total hip bone mineral density at 12 months as the primary endpoint. The company plans to initiate the study in late 2026, with topline results anticipated in the second half of 2028.
Entera's regulatory strategy relies on the 505(b)(2) pathway, anchored by a scientific bridge analysis to Forteo, Eli Lilly's established injectable teriparatide. That approach, if accepted at the NDA stage, would allow Entera to leverage existing efficacy and safety data for the reference product. The NDA package will also incorporate a transiliac crest bone biopsy sub-study, and a 24-month open-label extension will generate longer-term durability and safety data. Phase 1 data presented at ENDO 2026 showed that a single-tablet formulation of EB613 produced pharmacokinetic and pharmacodynamic profiles comparable to the multi-tablet version used in Phase 2 and to Forteo itself, supporting the move to a simplified commercial presentation.
Pipeline and competitive context
Beyond EB613, Entera is advancing EB612, a long-acting oral PTH(1-34) analogue for hypoparathyroidism, through IND-enabling studies in collaboration with OPKO Health, with an IND filing targeted for the first half of 2027. A third asset, EB618, a dual GLP-1/glucagon oral tablet for obesity and metabolic disorders, showed dose-proportional pharmacology in non-human primates at ENDO 2026, though clinical timelines remain contingent on readouts from OPKO's subcutaneous injectable programme.
The oral bone-building space has historically been the preserve of bisphosphonates and, more recently, injectable anabolic agents such as teriparatide and romosozumab. No approved oral anabolic therapy for osteoporosis currently exists, which underpins Entera's positioning. However, oral formulation of peptide hormones has proved technically challenging across the industry, and the 505(b)(2) bridge strategy will face scrutiny from regulators on the adequacy of the comparability evidence. Investors will also note that the primary endpoint window of 12 months for BMD change, while precedented, may not be sufficient to characterise fracture risk reduction in the absence of powered fracture data.
Chief executive Miranda Toledano described the placement as "transformational" for the company, characterising it as the largest biotech PIPE and the ninth-largest PIPE across all sectors on record in Israel.
R&D expenses for the second quarter of 2026 rose to $3.2 million from $1.5 million in the same period of 2025, reflecting increased manufacturing and programme-preparation activity for the Phase 3 study. The net loss of $7.3 million for the quarter included a $2.7 million non-cash fair value charge on pre-funded warrants classified as a financial liability. BVF was granted the right to designate two directors to Entera's board following the closing of the placement.