Entera Bio Q2 net loss $2.7M; FDA agrees on EB613 Phase 3 design with BMD endpoint

Entera Bio Ltd.

2025-Q2 EPS reported $0.12 revenue$42,000

FDA provided written concurrence on Phase 3 study for EB613, using total hip BMD as primary endpoint for NDA via 505(b)(2) pathway.
FDA waived dedicated oral carcinogenicity and DART studies for EB613, reducing regulatory burden.
Next-generation EB613 enters Phase 1 in November 2025; OPKO collaboration GLP-1/glucagon candidate OPK-88006 IND expected H1 2026.
Cash $18.9M including $8M restricted for OPKO; runway through mid-Q3 2026.
Q2 net loss $2.7M ($0.06 per share) vs $2.1M ($0.06 per share) a year ago; R&D up to $1.5M from $1.1M.

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