Entera Bio Raises $275 Million After FDA Aligns on EB613
Gross proceeds of about $275.0 million from an oversubscribed BVF-led private placement are expected to fund EB613 through an NDA and operations into 2030.
Entera Bio Ltd. (ENTX), a clinical-stage developer of oral peptide therapies, said the U.S. Food and Drug Administration accepted its plan for a single 12-month registrational Phase 3 trial of EB613, the first oral anabolic tablet in development for postmenopausal women with osteoporosis.
The agency agreed to a randomized, double-blind, placebo-controlled study in approximately 750 patients, with percent change from baseline in total hip bone mineral density at Month 12 as the primary endpoint, sufficient to support a new drug application. The proposed package would also include a scientific bridge analysis with Forteo (teriparatide subcutaneous injection, Eli Lilly) under the 505(b)(2) pathway and a transiliac crest bone biopsy substudy. The FDA also agreed to a 24-month open-label extension under a separate protocol. Entera plans to start the trial in late 2026, with topline data anticipated in the second half of 2028.
That timeline matched the schedule the company had already given after submitting a streamlined Phase 3 protocol in March. In June, Entera presented Phase 1 data showing that a single-tablet EB613 formulation produced a pharmacokinetic and pharmacodynamic profile comparable with both the multi-tablet version used in Phase 2 and Forteo, including comparable calcemic effects and consistent suppression of endogenous PTH(1-84). Those results support advancing the single tablet into Phase 3. New Phase 2 analysis of EB613 in high-fracture-risk women was selected for a plenary poster at ASBMR in October.
Subsequent to quarter-end, Entera closed an oversubscribed private placement that provided about $275.0 million in gross proceeds before fees, led by existing investor BVF Partners L.P. with participation from 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. Upon closing, BVF was granted the right to designate two directors. Chief Executive Officer Miranda Toledano said the company believes the transaction is the largest biotech PIPE and the ninth-largest PIPE, including the high-tech sector, on record in Israel.
On a pro forma basis, cash resources are expected to be sufficient to fully fund the planned Phase 3 registrational program of EB613 through topline results and the anticipated NDA submission, advance EB612 into the clinic with OPKO Health, and support operations into 2030.
Cash and cash equivalents were $11.3 million as of June 30, 2026, with restricted cash of $7.1 million primarily designated to fund the OPKO collaboration. In April, Entera completed a smaller BVF-led placement of about $10.0 million in gross proceeds, with potential proceeds of up to $24.5 million on full exercise of accompanying five-year warrants.
For the three months ended June 30, 2026, research and development expenses were $3.2 million, up from $1.5 million a year earlier. The $1.7 million increase was primarily attributable to materials, production, and other costs related to preparation of the EB613 Phase 3 program and to activities under the OPKO collaboration. General and administrative expenses were $1.4 million.
Net loss was $7.3 million, or $0.14 a share, compared with $2.7 million, or $0.06 a share, a year earlier. The increase was primarily driven by a $2.7 million non-cash fair-value remeasurement of pre-funded warrants issued in the April 2026 private placement and classified as a financial liability.
EB612, a first-in-class oral long-acting PTH(1-34) replacement tablet for hypoparathyroidism, remains in IND-enabling studies. Entera and OPKO intend to file an IND in the first half of 2027, later than the late-2026 intention stated in the prior quarter. At ENDO 2026, Entera reported that single oral doses of EB612 produced robust bioavailability and rapid, sustained increases in serum calcium lasting about three days across rat, minipig, and nonhuman primate models, with no safety concerns identified.
EB618, an oral dual GLP-1/glucagon (oxyntomodulin) tablet for obesity and metabolic disorders, showed dose-proportional systemic exposure and a dose-proportional effect on postprandial blood glucose in nonhuman primates and was well tolerated at doses exceeding the anticipated clinical range by more than tenfold. Entera expects to evaluate initiation of EB618 clinical development after analysis of Phase 1 SAD/MAD studies of subcutaneous injectable OXM being conducted by OPKO.
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