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Entera Bio Ltd. 10-K Summary (Fiscal Year Ended December 31, 2025)

Business Context and Reporting Period

Entera Bio Ltd. is a clinical-stage biopharmaceutical company incorporated in Israel, focused on developing first-in-class oral tablet formats of peptides and protein replacement therapies using its proprietary N-Tab® platform. The company targets underserved chronic conditions, primarily osteoporosis, hypoparathyroidism, obesity, and short bowel syndrome. This report covers the fiscal year ended December 31, 2025.

Key Financial Metrics

Note: Revenue is derived from research services agreements, not product sales. The company has no commercial product revenue.

Material Changes vs. Prior Period

• Increased Losses: Net loss increased by approximately 20% year-over-year, driven by higher operating expenses.
• R&D Growth: Research and development expenses rose by 33% ($1.5 million increase), primarily due to regulatory fees for FDA Type A meetings, optimization of the EB613 Phase 3 program, and costs associated with the OPKO collaboration.
• Liquidity Position: Cash and cash equivalents increased significantly to $14.9 million (including $7.8 million restricted cash for OPKO obligations) compared to $8.7 million in 2024, bolstered by financing activities.
• Financing Activity: The company raised approximately $13.7 million in net cash from financing activities in 2025, including proceeds from an At-The-Market (ATM) offering and a strategic equity issuance to OPKO Health Inc.

Guidance, Outlook, and Risks

Going Concern: The company's independent auditors have expressed substantial doubt about Entera Bio's ability to continue as a going concern. Management estimates current cash resources will fund operations through the middle of the third quarter of 2026, excluding the initiation of the pivotal Phase 3 study for EB613. Additional funding is required to commence this study.

Outlook and Milestones:

• EB613 (Osteoporosis): In February 2026, the company submitted a clinical amendment to the FDA for a streamlined Phase 3 protocol. The study is planned to initiate in the second half of 2026, contingent on regulatory feedback and additional funding.
• EB612 (Hypoparathyroidism): Preclinical data supports a once-daily long-acting PTH analog. The company expects to submit an IND application in late 2026.
• OPKO Collaboration: Expanded collaboration agreements cover the development of oral OXM (GLP-1/Glucagon) and LA-PTH. OPKO holds a 60% interest in the OXM program and 50% in the LA-PTH program.

Key Risks:

• Capital Requirements: Failure to secure additional capital could force delays or termination of clinical trials.
• Geopolitical Instability: Ongoing conflicts in the Middle East (Israel-Hamas, Iran, Hezbollah) pose risks to operations, workforce availability, and supply chains, though the company currently reports no material impact.
• Regulatory Uncertainty: Success depends on FDA approval of the BMD surrogate endpoint and successful execution of Phase 3 trials.

Investor Verification Checklist

• Cash Runway: Verify the specific timeline for cash depletion and the company's concrete plans for raising the capital required to initiate the EB613 Phase 3 study.
• Restricted Cash: Confirm the terms of the $7.8 million restricted cash held for OPKO obligations and the conditions under which it can be utilized.
• Phase 3 Protocol: Monitor FDA feedback on the February 2026 clinical amendment submission to ensure the proposed BMD endpoint remains acceptable.
• Geopolitical Exposure: Assess the potential impact of escalating regional conflicts on the company's Israeli-based R&D workforce and manufacturing supply chain.
• Collaboration Terms: Review the specific opt-out rights and funding responsibilities under the amended OPKO collaboration agreements.