Entera Bio Ltd.

What they do

Entera Bio is a clinical-stage company leveraging its N-Tab platform to develop oral versions of peptide and protein therapies, which are typically administered by injection. Its lead candidate, EB613 (oral PTH[1-34]), is being developed as the first oral osteoanabolic tablet for osteoporosis under a 505(b)(2) pathway referencing Forteo. The pipeline also includes EB612 for hypoparathyroidism and earlier-stage programs targeting GLP-1/Glucagon (OXM) and GLP-2, the former under a collaboration with OPKO.

Revenue drivers

• EB613 — Lead product candidate; no commercial revenue yet. The Phase 3 program is designed to support an NDA with Forteo as the listed drug.
• EB612 — Oral PTH replacement for hypoparathyroidism; IND-enabling studies ongoing, no revenue expected near term.
• Collaborations — Pipeline includes a collaboration with OPKO for OXM (GLP-1/Glucagon) and GLP-2 programs; potential future milestones and royalties, but no current revenue reported.

Recent performance

For the quarter ended June 30, 2026, Entera reported no revenue and continued net losses. Full-year 2025 revenue was $42,000 with a net loss of $11.4 million; 2024 revenue was $181,000 with a net loss of $9.5 million. Operating cash flow for 2025 was -$7.4 million. As of June 30, 2026, cash and equivalents were $11.3 million, and the company had an accumulated deficit of $125.4 million at year-end 2025.

Strategy

Management’s stated strategy is to advance EB613 through a registrational Phase 3 study to support an NDA, leveraging FDA alignment on a single 12-month study with a primary endpoint of total hip BMD change. The company also plans to file an IND for EB612 in the first half of 2027. Entera is pursuing the 505(b)(2) pathway with a scientific bridge to Forteo to potentially reduce development risk. A $275 million private placement led by BVF Partners, announced July 27, 2026, is intended to fund EB613 through NDA submission.

Risks

• Going concern and funding — Existing cash was only sufficient through mid-Q3 2026 before the July 2026 private placement; failure to secure additional funding would delay the EB613 Phase 3 program.
• Clinical development risk — Phase 3 results may not replicate Phase 2 findings, and the FDA may not accept the proposed single-study registration package despite recent alignment.
• Regulatory and approval uncertainty — The 505(b)(2) pathway depends on the ability to rely on Forteo’s safety and efficacy data, which could be challenged.
• Commercialization and market acceptance — Even if approved, oral anabolic therapy may not achieve expected adoption by physicians, patients, or payors in a competitive osteoporosis market.

Outlook

Management plans to initiate the EB613 Phase 3 registrational study in late 2026, with topline data expected in the second half of 2028. The company anticipates submitting a 120-day safety update with up to 18 months of data as part of the NDA, and complete 2-year data from an open-label extension. EB612 IND filing is expected in the first half of 2027.