Entera Bio reports Q2 2026 results, cites FDA alignment on EB613 Phase 3 design
Entera raised $275 million in a private placement led by BVF Partners to fund a registrational Phase 3 trial of its oral osteoporosis drug EB613 through NDA submission.
Entera Bio Ltd. released its second quarter 2026 financial results and business updates on August 7, 2026. The company issued the release detailing results for the three months ended June 30, 2026 alongside business updates.1
The company said the FDA agreed to Entera's plan for a single, randomized, double-blind, placebo-controlled Phase 3 trial enrolling roughly 750 postmenopausal women with osteoporosis, using percent change from baseline in total hip bone mineral density at Month 12 as the primary endpoint, to support a possible NDA filing.1 The NDA package is also expected to include a scientific bridge analysis against Forteo (teriparatide SC injection, Eli Lilly) under the 505(b)(2) pathway, along with a transiliac crest bone biopsy sub-study in some patients.1 Entera plans to start the registrational Phase 3 study in late 2026, with topline results expected in the second half of 2028.1
On the financing side, Entera disclosed after quarter end, in July 2026, an oversubscribed private placement that generated gross proceeds of about $275.0 million before fees and expenses.1 BVF Partners, an existing investor, led the round, joined by new investors such as 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, among others.1 As part of the deal, BVF gained the right to name two directors to Entera's board.1 Entera said the proceeds are meant to cover the EB613 Phase 3 program through an anticipated NDA submission, help move EB612 into clinical testing with partner OPKO, and stretch the company's cash runway into 2030.1
On the balance sheet, cash and equivalents stood at $11.3 million as of June 30, 2026, with restricted cash of $7.1 million earmarked mainly for the OPKO collaboration.1 R&D expenses rose to $3.2 million for the quarter, up from $1.5 million a year earlier.1 Net loss was $7.3 million, or $0.14 per share, compared with $2.7 million, or $0.06 per share, in the same period last year.1
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