Monitor FDA feedback on the Phase 3 protocol expected in late April 2026, which could confirm an accelerated path for EB613. The company remains dependent on clinical execution and future funding, with no revenue from product candidates yet.
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Executive Summary
Entera Bio reported financial results for 2025, showing increased net loss and R&D spending as it advances its oral peptide pipeline, particularly EB613 for osteoporosis. The company highlighted regulatory progress with FDA alignment on a Phase 3 trial design and submission of a streamlined protocol, while maintaining cash runway into Q3 2026.
Key Financial Metrics
Key Facts
- Net loss widened to $11.4 million in 2025 from $9.5 million in 2024, despite flat loss per share at $0.25 due to higher share count.
- Cash and cash equivalents totaled $14.9 million as of December 31, 2025, with non-restricted cash expected to fund operations through mid-Q3 2026.
- R&D expenses increased to $6.0 million from $4.5 million in 2024, driven by EB613 Phase 3 preparation and collaboration programs.
- FDA aligned in July 2025 on total hip BMD as primary endpoint for EB613 Phase 3 trial, supporting a potential NDA filing.
- Streamlined Phase 3 protocol submitted in March 2026 with primary endpoint at 12 months (vs. 24), aiming to accelerate development timeline.
- Expanded collaboration with OPKO on EB612 (oral PTH for hypoparathyroidism), with shared costs and 50% ownership; IND planned for late 2026.
Financial Impact
Net loss increased 20% YoY to $11.4M; cash runway extends to mid-Q3 2026 without additional financing.
Risk Factors
- Limited cash runway beyond Q3 2026 without additional funding or partnerships.
- Clinical development risk for EB613, including potential delays or negative trial outcomes.
- Heavy reliance on partnership with OPKO for advancement of key pipeline candidates.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3264088 |
Track record builds as more directional reports settle.
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 14, 2026 12d ago | DEF 14A | $2.77 | awaiting T+60 | — | $2.86 (+3.25%) |
Oct 6, 2026 20d ago | 8-K | $2.53 | awaiting T+60 | — | $2.86 (+13.04%) |
Aug 27, 2026 8w ago | Press Release | $3.08 | awaiting T+60 | — | $2.86 (−7.14%) |
Aug 18, 2026 9w ago | 8-K | $2.89 | awaiting T+60 | — | $2.86 (−1.04%) |
Aug 7, 2026 11w ago | Press Release | $3.04 | awaiting T+60 | — | $2.86 (−5.92%) |
Jul 29, 2026 12w ago | Press Release | $3.00 $3.02 | ▲ +0.67% | ▼ −4.06% | $2.86 (−4.67%) |
Jun 16, 2026 18w ago | Press Release | $1.18 $2.79 | ▲ +136.44% | ▲ +135.44% | $2.86 (+142.37%) |
May 28, 2026 21w ago | Press Release | $1.22 $3.23 | ▲ +164.75% | ▲ +163.02% | $2.86 (+134.43%) |
May 18, 2026 23w ago | EFFECT | $1.23 $2.80 | ▲ +127.64% | ▲ +122.79% | $2.86 (+132.52%) |
May 8, 2026 24w ago | S-3 | $1.17 $2.81 | ▲ +140.17% | ▲ +135.78% | $2.86 (+144.44%) |
US Market Status
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