Entera Bio Ltd. (ENTX): History, Ownership, Mission, How It Works & Makes Money

As a seasoned investor, you're looking at Entera Bio Ltd. (ENTX) and asking: can a clinical-stage biopharma company truly disrupt the injectable drug market with an oral tablet? The answer hinges on their proprietary N-Tab™ platform, which has already helped secure a pivotal FDA agreement in Q3 2025 for their lead candidate, EB613, an oral anabolic osteoporosis treatment. This progress is why the company maintains a market capitalization of $125.12 million and a solid cash position of $16.6 million as of September 30, 2025, even with a Q3 net loss of $3.2 million. To understand the real opportunity, you defintely need to see how their core mission-turning injections into pills-is funded by strategic partnerships and supported by an institutional ownership base of 22.36%.

Entera Bio Ltd. (ENTX) History

You need to understand where Entera Bio Ltd. came from to grasp its current valuation and future potential. This is a clinical-stage biotech company that started with a singular, complex goal: turning injectable large-molecule drugs, like peptides, into simple oral tablets. That's a huge technical hurdle, and their history is a roadmap of how they've tackled it, moving from a small Israeli lab to a Nasdaq-listed firm.

Given Company's Founding Timeline

Year established

Entera Bio Ltd. was established in 2009, focusing on its proprietary oral drug delivery platform, the N-Tab technology.

Original location

The company's roots are in Jerusalem, Israel, where its main research and development operations are still centered today. This location has fostered a deep scientific focus.

Founding team members

The company was founded by a team of scientific and management personnel dedicated to solving the oral drug delivery challenge. Dr. Phillip Schwartz, who currently serves as the President of R&D, was an early key leader in the organization.

Initial capital/funding

Initial capital came from private investments and venture funding. The first major public capital infusion came with the Initial Public Offering (IPO) in 2018, which raised approximately $11.2 million in gross proceeds to fund clinical development. To be fair, a clinical-stage biotech needs to constantly raise capital; as of September 30, 2025, their cash and cash equivalents stood at $16.6 million, a critical number that extends their runway.

Given Company's Evolution Milestones

Given Company's Transformative Moments

The company's trajectory has been defined by a few key decisions that fundamentally changed its risk profile and opportunity set. You can see the clear focus on de-risking the core platform and then expanding the pipeline.

• Validating the Core Technology: The 2021 Phase 2 success for EB613 (an oral parathyroid hormone, or PTH, analog) was the single most important moment. It proved the N-Tab technology could work in humans, which is defintely the biggest hurdle for oral peptide delivery.
• Strategic Pipeline Expansion: The March 2025 collaboration with OPKO Health Inc. was a smart move. Instead of solely funding a new program like the Oral OXM candidate for obesity, Entera Bio now shares the development costs and risks, with a 40% pro-rata ownership interest in that program. This is how a small biotech can efficiently pursue multiple high-value targets.
• Financial Discipline and Clarity: The recent Q3 2025 financials show a net loss of only $3.2 million for the quarter, which is relatively lean for a clinical-stage company. Plus, the FDA's agreement on the EB613 Phase 3 trial design in 2025 gives investors a clear, actionable endpoint-change in total hip bone mineral density (BMD)-which is a huge step toward an NDA (New Drug Application).

If you want to dive into what drives the team, you should look at the Mission Statement, Vision, & Core Values of Entera Bio Ltd. (ENTX).

Entera Bio Ltd. (ENTX) Ownership Structure

Entera Bio Ltd. (ENTX) is primarily controlled by a mix of individual retail investors and company insiders, a structure that can lead to higher stock volatility but also strong alignment between management and shareholder interests. This public company's governance is heavily influenced by its largest institutional holders, even though their combined stake is smaller than that of the general public.

Entera Bio Ltd.'s Current Status

You should know that Entera Bio Ltd. is a publicly traded, clinical-stage biopharmaceutical company. Its shares are listed on the Nasdaq Capital Market under the ticker symbol ENTX, which means all its financial and ownership data is available through public filings with the Securities and Exchange Commission (SEC). The company operates under the regulatory and reporting demands of a US-listed public entity. As of November 2025, the company reported a net loss of $3.2 million for the three months ended September 30, 2025, and a cash and cash equivalents total of $16.6 million, including $8.0 million restricted cash.

This cash position is defintely critical, as it is expected to fund operations through the middle of the third quarter of 2026, covering key milestones like the planned EB613 Phase 3 study.

Entera Bio Ltd.'s Ownership Breakdown

The company's ownership structure, as reported in early 2025 filings, shows a significant concentration of shares in the hands of the general public, a common trait for clinical-stage biotech firms. Institutional investors hold a notable but minority stake, with a total of 9,224,781 institutional shares held long as of November 13, 2025.

Knoll Capital Management LLC is the most prominent institutional holder, owning approximately 15.03% of the company as of February 2025, valued at around $12.47 million. This stake gives them a substantial voice in major decisions, so you should monitor their filings closely. For a deeper look at the major players, check out Exploring Entera Bio Ltd. (ENTX) Investor Profile: Who's Buying and Why?

Entera Bio Ltd.'s Leadership

The company's strategy is steered by an executive team focused on advancing its oral peptide drug delivery platform (N-Tab™) and moving its lead candidate, EB613, toward a Phase 3 trial. The leadership team has an average tenure that suggests a mix of experience and new direction.

The key figures guiding the organization as of November 2025 are:

• Miranda Toledano: Chief Executive Officer (CEO). She was appointed in July 2022 and her total yearly compensation is approximately $1.15 million.
• Dana Yaacov-Garbeli: Chief Financial Officer (CFO).
• Dr. Arthur Santora: Chief Medical Officer (CMO).
• Dr. Phillip Schwartz: President of Research & Development (R&D).

The CEO's compensation is above the average for similar-sized companies in the US market, which is something to note, especially since the company is still pre-revenue and unprofitable. This structure shows the board's commitment to attracting and retaining leadership with the expertise to navigate the complex clinical development path. You need to see this team execute on the Phase 3 plan to justify the current valuation.

Entera Bio Ltd. (ENTX) Mission and Values

Entera Bio Ltd.'s core purpose is to revolutionize chronic disease treatment by converting injectable large-molecule drugs into convenient oral tablets, directly addressing significant patient compliance issues and unmet medical needs. This mission is grounded in a deep commitment to innovation and improving patient quality of life, which drives their entire research and development pipeline.

Entera Bio Ltd.'s Core Purpose

You are looking for the driving force behind the company's strategy, and it's simple: they want to make injections obsolete for certain chronic conditions. Their proprietary oral drug delivery platform (N-Tab™) is the technical engine for this patient-centric goal, focusing on diseases like osteoporosis and hypoparathyroidism where long-term compliance is critical. For example, their R&D expenses were $1.6 million in Q3 2025, a clear sign of their continued investment in this core purpose.

Official mission statement

The company's mission is centered on transforming the patient experience by enabling the oral delivery of large-molecule therapeutics, which traditionally require injections. The focus is on three key areas:

• Innovation in Oral Delivery: Develop technologies to allow oral absorption of large molecule drugs, fundamentally changing how these medications are administered.
• Addressing Unmet Medical Needs: Target therapeutic areas like osteoporosis and hypoparathyroidism where a convenient oral formulation can offer substantial benefits over existing injectable therapies.
• Improving Patient Outcomes: Enhance patient convenience and compliance, leading to better overall treatment results.

The CEO recently highlighted their 'unrelenting mission to deliver transformative treatments to patients, starting with post-menopausal women with osteoporosis.' That's the defintely the focus.

Vision statement

Entera Bio Ltd. envisions itself as a leader in oral delivery solutions for biologics and other large molecule therapeutics. This vision is intrinsically linked to improving the daily lives of patients.

• Become the market leader for oral peptide and protein replacement therapies.
• Significantly improve patient compliance and quality of life across various chronic indications.
• Transform the standard of care by providing an oral tablet form for treatments currently only available via injection.

This vision is backed by concrete progress, like the Phase 3 readiness of their lead candidate, EB613, for osteoporosis.

Entera Bio Ltd. slogan/tagline

While a short, catchy slogan isn't officially published, the company consistently defines its identity through its technical and market position. They are a 'leader in the development of oral peptide and protein replacement therapies.'

• Focus on being the 'First Oral PTH(1-34) Anabolic Tablet Treatment for Osteoporosis.'
• Demonstrate superiority, as seen with their oral GLP-2 candidate, which showed a plasma half-life of approximately 15 hours-an 18-fold improvement over the approved injectable alternative.

Their mission and values are the true measure of their culture, which you can explore further here: Mission Statement, Vision, & Core Values of Entera Bio Ltd. (ENTX).

Entera Bio Ltd. (ENTX) How It Works

Entera Bio Ltd. operates by solving the toughest problem in drug delivery: getting large-molecule therapeutics-like peptides and proteins-into the bloodstream via a simple oral tablet instead of a painful injection. The company's core value is created by its proprietary N-Tab™ oral drug delivery platform, which transforms injectable treatments for chronic conditions into convenient, once-daily pills, fundamentally changing the standard of care for patients.

Entera Bio Ltd.'s Product/Service Portfolio

Entera Bio Ltd.'s Operational Framework

As a clinical-stage biopharmaceutical company, Entera Bio's operational model centers on research, development, and strategic collaboration, not yet on commercial product sales. The company channels the majority of its capital into advancing its pipeline through clinical trials using its N-Tab™ platform, which is designed to protect peptides from degradation in the gastrointestinal (GI) tract and enhance their absorption into the bloodstream.

The financial engine is driven by strategic partnerships and licensing agreements, not product revenue. For the twelve months ending June 30, 2025, the company reported total revenue of only $166.00K, which is typical for a pre-commercial biotech firm. For the third quarter of 2025 (Q3 2025), total operating expenses were $3.3 million, with research and development expenses accounting for $1.6 million, reflecting the intense focus on clinical execution. Honestly, R&D is the whole game right now.

The collaboration with OPKO Health is a key operational element. Entera Bio retains a 40% economic stake in the Oral OXM program, but OPKO is responsible for 60% of the development costs, which helps manage Entera Bio's cash burn. As of September 30, 2025, Entera Bio had $16.6 million in cash and equivalents, with $8.0 million restricted and dedicated to funding its share of the OPKO collaboration through Phase 1 studies.

Entera Bio Ltd.'s Strategic Advantages

The primary advantage for Entera Bio is its proprietary technology, which addresses a massive, defintely unmet need in the pharmaceutical world: oral delivery of large molecules. This is the holy grail of drug development, and Entera Bio has a clear, functional platform.

• Proprietary N-Tab™ Platform: This technology uses a dual-mechanism approach, combining a synthetic absorption enhancer with chemical and biological protection to overcome the GI tract's natural barriers against large molecules.
• Regulatory De-risking: The FDA's agreement in July 2025 to accept Bone Mineral Density (BMD) as the primary endpoint for the EB613 Phase 3 study, instead of waiting for fracture data, significantly accelerates and de-risks the path to a New Drug Application (NDA).
• Patient-Centric Value Proposition: Replacing daily or weekly injections with a simple pill dramatically increases patient compliance and comfort, which is a major commercial advantage in chronic conditions like osteoporosis, which affects over 200 million women globally.
• Pipeline Breadth: The platform is validated across multiple therapeutic areas, including bone health (PTH), hypoparathyroidism, obesity (GLP-1/Glucagon), and rare malabsorption (GLP-2), allowing for diversified revenue streams through internal development and external partnerships like the one with OPKO Health.

For a deeper dive into the company's long-term vision, you should review their core principles: Mission Statement, Vision, & Core Values of Entera Bio Ltd. (ENTX).

Entera Bio Ltd. (ENTX) How It Makes Money

Entera Bio Ltd. is a clinical-stage biopharmaceutical company, meaning it does not yet generate revenue from commercial product sales; its financial engine is fueled almost entirely by strategic collaboration agreements and licensing deals tied to its proprietary oral drug delivery technology (N-Tab™).

The company receives funding through upfront payments, milestone achievements, and potential future royalties from partners like OPKO Health, which help finance the costly research and development (R&D) of its oral peptide programs, such as EB613 for osteoporosis and the dual GLP-1/Glucagon tablet for metabolic diseases.

Entera Bio Ltd.'s Revenue Breakdown

As a pre-commercial business, Entera Bio's revenue is minimal and highly volatile, hinging on the timing of non-recurring milestone payments or grants, rather than steady product sales. For the third quarter of 2025, the company reported a very small amount of revenue, reflecting its deep focus on R&D for its pipeline candidates.

The revenue reported for the three months ended September 30, 2025, was only $42 thousand, a figure so small it underscores that the company's financial health is not measured by its current top-line but by its cash position and pipeline progress. This revenue is primarily classified as 'Oral Tablet Formats of Peptides' in their reporting, which essentially represents the non-product revenue from their ongoing partnerships and technology platform.

Business Economics

The economic reality for Entera Bio is typical of a clinical-stage biotech: a high cash burn rate driven by R&D, with no near-term product revenue to offset it. Their core value is in their N-Tab™ platform, which is designed to convert injectable peptide drugs into daily oral tablets, a massive market opportunity if successful.

• Core Cost Structure: The business is dominated by operating expenses, which totaled $3.3 million for Q3 2025. Here's the quick math: R&D expenses were $1.6 million, and General and Administrative (G&A) expenses were $1.6 million for the quarter.
• The R&D Focus: The R&D investment is defintely the most critical expenditure, primarily funding the pivotal Phase 3 preparation activities for EB613, their lead candidate for osteoporosis. This is an investment in future revenue, not a cost of current revenue.
• Partnership Funding: The collaboration with OPKO Health is a crucial economic lever. As of September 30, 2025, $8.0 million of the company's total cash was restricted and designated to fund the Phase 1 studies for the oral GLP-1/glucagon candidate (OPK-88006). This dedicated funding stream significantly de-risks that specific program and preserves Entera's general operating cash.

The entire economic model is a high-stakes bet on clinical success and regulatory approval; if EB613 is approved, the revenue model shifts entirely to product sales and substantial royalties, but until then, it's a pure R&D cost center.

Entera Bio Ltd.'s Financial Performance

Financial performance for Entera Bio is best gauged by its cash position and its ability to manage its operating loss while advancing its pipeline, not by its current revenue. This is a capital-intensive business, so cash is king.

• Net Loss: The company reported a net loss of $3.2 million for the three months ended September 30, 2025, which is slightly larger than the $3.0 million loss in the prior-year quarter. This widening loss is a direct result of increased R&D and G&A spending to push EB613 toward Phase 3.
• Cash Runway: As of September 30, 2025, Entera Bio held $16.6 million in cash and cash equivalents. This cash position is expected to support operations through the middle of Q3 2026. This runway is a key metric for investors, indicating no immediate need for dilutive financing.
• Pipeline Milestones: The most important non-financial performance indicator is the regulatory progress of EB613. The FDA agreeing to a single 24-month Phase 3 study with Bone Mineral Density (BMD) as the primary endpoint is a massive de-risking event that streamlines the path to a New Drug Application (NDA). This regulatory clarity is worth more than any small revenue figure.

To truly understand the sustainability and growth potential, Breaking Down Entera Bio Ltd. (ENTX) Financial Health: Key Insights for Investors is the concrete next step. We need to watch the burn rate against the cash balance to ensure the company doesn't run out of capital before their next major milestone payment or financing event.

Entera Bio Ltd. (ENTX) Market Position & Future Outlook

Entera Bio Ltd. (ENTX) is positioned as a disruptive, clinical-stage biopharmaceutical company aiming to transform the treatment of chronic conditions like osteoporosis by replacing inconvenient injectable therapies with oral tablets through its proprietary N-Tab™ platform. The company's future hinges on the successful, capital-efficient advancement of its lead candidate, EB613-a potential first-in-class oral anabolic (bone-building) treatment for osteoporosis-and the continued progress of its strategic collaboration with OPKO Health.

The FDA's agreement in mid-2025 to use Bone Mineral Density (BMD) as the primary endpoint for the EB613 Phase 3 study significantly de-risks the regulatory pathway, but the company's limited cash runway, expected through mid-Q3 2026, makes near-term financing or partnership deals defintely crucial for funding the large multinational trial.

Competitive Landscape

Entera Bio's competitive advantage is not in current market share, which is 0% as a clinical-stage entity, but in its ability to offer an oral alternative to the highly effective, yet injection-based, anabolic therapies.

The overall osteoporosis drugs market size is substantial, valued at approximately $16.88 billion in 2025, but the oral segment is currently dominated by lower-efficacy anti-resorptive agents like Bisphosphonates, which held a 37.40% market share in 2024. Entera Bio is targeting the high-value anabolic segment, which is currently limited by the burden of daily or monthly injections.

Opportunities & Challenges

The company's strategic focus on oral delivery of large molecules (peptides and proteins) addresses a major patient adherence issue across multiple chronic diseases, which is a massive opportunity. The ability to deliver an anabolic agent in a simple tablet form-EB613-could fundamentally change the standard of care for high-risk osteoporosis patients who are reluctant to use injections.

Industry Position

Entera Bio holds a unique industry position not as a market leader by revenue, but as a technology leader in oral peptide delivery (N-Tab™). The company is a pure-play bet on solving the biopharma industry's adherence problem for large-molecule drugs. Their pipeline extends beyond bone health, leveraging the same platform for metabolic diseases and rare conditions.

• Technology Validation: The N-Tab™ platform is validated by the promising pharmacokinetic (PK) data in the oral GLP-2 program and the positive Phase 2 data for EB613, showing early and significant bone density gains.
• Pipeline Breadth: The collaboration with OPKO Health on the oral GLP-1/glucagon dual agonist gives Entera Bio a stake in the massive, high-growth obesity market, diversifying risk beyond the EB613 program.
• Valuation Driver: The primary near-term value driver is the successful initiation and enrollment pace of the EB613 Phase 3 trial, coupled with securing the necessary financing before the cash runway expires. Exploring Entera Bio Ltd. (ENTX) Investor Profile: Who's Buying and Why?

The company's total operating expenses for Q3 2025 were $3.3 million, reflecting the ongoing investment in regulatory and Phase 3 preparation activities. This burn rate means execution speed is paramount.