# Entera Bio Ltd.

> Clarifo company profile — qualitative business description generated from
> the company's filings. Financial statements, charts and ratios are
> available on Clarifo (https://www.clarifo.com/fi/companies/Entera Bio Ltd.).

## Overview

Entera Bio Ltd. is a clinical-stage biotechnology company developing oral tablet versions of peptide and protein replacement therapies. Its lead work centers on the N-Tab platform and first-in-class oral programs in osteoporosis and metabolic disease, including EB613, EB612, and oral GLP-1/GLP-2-related candidates.

## Products & services

• N-Tab™ oral peptide/protein delivery platform
• EB613 oral PTH(1-34) program for osteoporosis
• EB612 next-generation oral PTH program
• Oral OXM (GLP-1/Glucagon tablet) program with OPKO
• Oral GLP-2 and other peptide replacement candidates
• Research services under collaboration agreements

- **Oral peptide therapeutics** (0%) — Development of oral tablet formulations designed to replace injectable peptide and protein therapies.
- **Lead clinical programs** (0%) — EB613, EB612 and oral OXM programs targeting osteoporosis and metabolic disease.
- **Platform technology** (0%) — N-Tab™ delivery technology used to enable oral administration of biologics.
- **Collaborative research services** (100%) — Contract research and material transfer services performed for third parties.

- N-Tab™ platform for oral delivery of peptides and proteins
- EB613 oral PTH(1-34) candidate for osteoporosis
- EB612 next-generation oral PTH program
- Oral OXM (GLP-1/Glucagon tablet) with OPKO
- Oral GLP-2 and other differentiated peptide programs
- Research services and contract-based R&D work

## Customers

Entera does not yet sell approved products to commercial end customers; its current economic counterparties are research collaborators, grant providers, and development partners. The company’s future customers would be patients and prescribers in osteoporosis and metabolic disease if its oral peptide candidates are approved and commercialized.

- **Research collaboration counterparties** (primary) — Third parties that pay for material transfer and research services while Entera performs contract R&D work.
- **Future osteoporosis patients and physicians** (emerging) — Potential users of EB613 if approved, seeking an oral alternative to injectable PTH therapy.
- **Future metabolic disease patients and physicians** (emerging) — Potential users of oral GLP-1/Glucagon or GLP-2 therapies if the programs reach commercialization.
- **Strategic pharma partners** (secondary) — Partners that may license, co-develop, or fund oral peptide programs to access the platform.

- Research collaborators that pay for custom R&D services
- Granting bodies and public agencies supporting development work
- Potential future prescribers treating osteoporosis and metabolic disease
- Patients who would prefer oral alternatives to injections
- Strategic partners seeking oral peptide delivery capabilities

## Geography

Entera’s operations are centered in Jerusalem, Israel, where all employees are based and core R&D work is performed. The company also relies on advisors and contract manufacturing and clinical activity in the United States, the United Kingdom, Europe, and Asia, so its development footprint is international even though the operating base is Israeli.

- Jerusalem, Israel is the main operating and R&D base
- All employees are based in Israel
- Advisors are located in the United States, UK, Europe and Asia
- Contract manufacturing is performed through a UK-based CMO
- Clinical and regulatory work is international, reducing single-country dependence

## Strategy

Entera is focused on advancing first-in-class oral versions of peptide therapies that are normally delivered by injection, with the goal of changing treatment convenience and adherence. Near term, the company is prioritizing EB613 phase 3 preparation, next-generation EB613 work, and completion of oral OXM studies with OPKO while preserving cash and securing additional funding.

- **Advance EB613 toward phase 3** (short-term) — EB613 is the most advanced program and could validate the platform in a large osteoporosis market.
- **Progress oral OXM with OPKO** (short-term) — The collaboration can expand the pipeline into metabolic disease while sharing development burden.
- **Extend N-Tab platform value** (medium-term) — Platform validation across multiple peptides can improve partnering leverage and long-term optionality.
- **Secure non-dilutive or strategic funding** (short-term) — Clinical development requires capital and the company has stated additional funding will be needed.

- Advance oral peptide candidates toward clinical proof-of-concept
- Prepare EB613 for phase 3 development in osteoporosis
- Complete next-generation EB613 and oral OXM studies
- Use collaborations to share development cost and risk
- Preserve cash while seeking additional financing

## Risks

Entera is a pre-revenue clinical-stage company, so execution risk is concentrated in clinical outcomes, regulatory approvals, and financing. Its Israeli operating base also creates geopolitical and operational exposure, while future commercialization depends on proving that oral peptide delivery can work reliably and be accepted by regulators and partners.

- **Clinical development failure** [high] — EB613, EB612 and oral OXM are still in development and may not demonstrate safety or efficacy.
- **Financing risk** [high] — The company expects to need additional capital before commercialization and may not raise it on favorable terms.
- **Geopolitical risk in Israel** [high] — Employees and operations are based in Israel, so conflict could disrupt work, supply chains, or fundraising.
- **Regulatory risk** [high] — The company needs FDA and other regulatory alignment before advancing into later-stage trials and approval.
- **Partner and collaboration risk** [medium] — Development timelines and economics depend partly on third-party collaboration agreements.

- No product revenue yet; success depends on future approvals
- Clinical trial failure could impair the lead programs
- Additional financing may be unavailable or dilutive
- Israel geopolitical risk could disrupt operations or capital access
- Oral delivery platform may not prove commercially viable
- Partner dependence can affect timing and economics

## Accounting

Revenue is currently limited to contract research services and is recognized under ASC 606 over the contract term using labor hours and elapsed time, which makes reported revenue dependent on project activity. Because the company is still clinical-stage, investors should also watch estimates around share-based compensation, grant-related obligations, and the timing of R&D and regulatory spending, which can materially affect quarterly results.

- **Over-time revenue recognition for research services** — Quarterly revenue can be small and uneven
- **Grant-related royalty and repayment obligations** — Potential contingent liability and cash outflow
- **Clinical-stage expense recognition** — Material effect on reported earnings and burn rate
- **Share-based compensation** — Affects R&D and G&A expense

- ASC 606 revenue recognition for research services over time
- Very small and lumpy revenue base from collaboration work
- Share-based compensation affects R&D and G&A expense
- Grant-related royalty obligations may create contingent liabilities
- Clinical trial and manufacturing costs are expensed as incurred
- Capitalization and impairment judgments are limited but important

---

*Last updated: 2026-04-28T20:05:08.684816+00:00*
