Entera Bio Secures $275 Million to Fund Phase III Trial of First Oral Osteoanabolic Tablet for Osteoporosis
核心洞察
Entera Bio raised approximately $275 million in an oversubscribed private placement, more than 27 times its prior $10 million raise, extending its cash runway into 2030.
The funds will fully finance a 750-patient Phase III registrational trial of EB613, an oral PTH(1-34) (搜索) tablet for postmenopausal osteoporosis (搜索), with topline data expected in H2 2028.
EB613 aims to become the first oral osteoanabolic tablet, replacing daily subcutaneous teriparatide injections, following positive Phase II results and FDA feedback on trial design.
Israel-based Entera Bio Ltd. (Nasdaq: ENTX) has announced an oversubscribed private placement worth approximately $275 million, a sum that will fully fund the Phase III registrational program for its lead candidate EB613 and extend the company's cash runway into 2030. The financing, priced at $2.04 per ordinary share, represents a dramatic escalation from the $10 million BVF Partners-led placement closed in April 2026 — more than 27 times that amount — reflecting the capital demands of advancing from Phase III preparation into a full registrational trial.
The placement comprises 122,961,215 ordinary shares and pre-funded warrants for up to 11,842,695 additional shares. BVF Partners L.P. (搜索), an existing investor, led the round and will receive the right to designate two directors to Entera's board upon closing. New investors include 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. Leerink Partners acted as lead placement agent, with Evercore ISI, Guggenheim Securities, Cantor, LifeSci Capital, and Canaccord Genuity serving as co-placement agents.
EB613: A First-in-Class Oral Osteoanabolic Therapy
EB613 is designed as the first oral osteoanabolic tablet for osteoporosis, targeting the substantial patient population currently reliant on daily subcutaneous injections of teriparatide, a PTH(1-34) (搜索) peptide. The candidate has already demonstrated clinical proof-of-concept: a 161-patient Phase II trial met all primary bone turnover biomarker endpoints and secondary bone mineral density endpoints.
Following a protocol submission to the FDA in the first quarter of 2026 and positive agency feedback on trial design, Entera now plans to initiate a 750-patient, randomized, double-blind, placebo-controlled Phase III study. The trial is targeted to begin in late 2026, with topline data anticipated in the second half of 2028. A successful outcome would support a New Drug Application (NDA) submission to the FDA.
Pipeline Expansion and Strategic Positioning
Beyond EB613, the financing will also advance EB612, an oral long-acting PTH analog for hypoparathyroidism (搜索), into Phase I clinical development. EB612 is being co-developed under a 50/50 partnership with OPKO Health (搜索), with an Investigational New Drug (IND) filing targeted for late 2026. Remaining proceeds are allocated to working capital and general corporate purposes.
Entera Bio CEO Miranda Toledano, who assumed leadership in 2022 after the company had cycled through four CEOs in four years, described a comprehensive transformation. "In the last four years, Entera has changed its face," Toledano told Globes. "The company has always had good technology, but from 2022-2023, we almost completely replaced the management, the entire product pipeline that we have today is new, the regulatory track that we have built is new. We have transformed Entera into a company that is rooted in Israel but is fully competitive in its category in the international arena."
The company's oral delivery platform, originally founded on technology developed by Ormed — a Tel Aviv Stock Exchange-listed company with a market cap of NIS 522 million — has evolved significantly. In recent years, Entera has developed proprietary technology enabling once-daily pill administration, compared to the three-to-five-pill regimen required by earlier iterations. Under its collaboration with OPKO Health (搜索), also listed on the Tel Aviv Stock Exchange, the companies share both costs and revenue across three products, including a parathyroid-suppressing drug expected to enter clinical trials this year and two early-stage metabolic disease candidates combining GLP-1 and glucagon pathways.
Prior to the announcement, Entera Bio held a market cap of approximately $101 million, making the $275 million raise a transformative event for the company. The share price, which opened at $2.05 on the morning of the announcement, rose 75% to $3.57 in subsequent trading.