Entera Bio Ltd. (ENTX): Business Model Canvas [Dec-2025 Updated]

You're trying to map out Entera Bio Ltd.'s business right now, and honestly, as an analyst who's seen this movie before, it all boils down to one thing: successfully navigating that pivotal Phase 3 study for EB613, the oral osteoporosis tablet that could change how patients take their medicine. With cash and equivalents at $16.6 million as of September 30, 2025, the focus is laser-sharp on executing against their proprietary N-Tab™ oral delivery platform, which is the core resource driving value, especially alongside strategic co-development efforts like the one with OPKO Health Inc. This canvas distills exactly how Entera Bio Ltd. plans to convert that groundbreaking technology and pipeline progress-from regulatory agreements to key clinical milestones-into future revenue streams, so dive in to see the nine critical components defining their near-term path.

Entera Bio Ltd. (ENTX) - Canvas Business Model: Key Partnerships

You're looking at how Entera Bio Ltd. structures its development efforts through external alliances, which is critical given its stage. The partnerships are the engine room for advancing its pipeline beyond its core cash reserves.

Strategic co-development with OPKO Health Inc. for Oral OPK-88006.

Entera Bio Ltd. entered a collaboration and license agreement with OPKO Health, Inc. to advance the oral dual agonist GLP-1/glucagon peptide, OPK-88006, into the clinic for obesity and metabolic disorders. This program leverages OPKO's proprietary long-acting oxyntomodulin analog with Entera Bio Ltd.'s N-Tab™ technology. The companies expected to file an Investigational New Drug application with the U.S. Food and Drug Administration (FDA) in late 2025 or early 2026.

40% economic stake in the OPKO dual GLP-1/glucagon program.

The financial structure of this co-development is clearly defined. Entera Bio Ltd. retains a 40% pro-rata ownership interest in the Oral OXM program, while OPKO Health, Inc. holds 60%. Correspondingly, Entera Bio Ltd. is responsible for 40% of the program's development costs, and OPKO Health, Inc. covers 60%. To help fund its portion through Phase 1, OPKO Health, Inc. purchased 3,685,226 ordinary shares of Entera Bio Ltd. at $2.17 per share. Should Entera Bio Ltd. opt out after Phase 1, its ownership interest reduces to 15%, with OPKO Health, Inc. taking 85% and responsibility for subsequent funding.

The key structural terms of this critical alliance are laid out here:

As of June 30, 2025, Entera Bio Ltd. had $18.9 million in cash and cash equivalents, which included $8.0 million restricted cash specifically designated to fund its 40% share of the OPKO collaboration costs through Phase 1 studies. This cash position, including the dedicated funding, was expected to support operations through the middle of the third quarter of 2026.

Collaboration with a third party on a peptide for the EB612 program.

The EB612 program, which is Entera Bio Ltd.'s oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism, is listed as a key pipeline asset. While the search results confirm the existence of this program and its development status, specific financial terms or the identity of a separate third-party collaborator for EB612, distinct from the OPKO Health, Inc. agreements for the GLP-1/glucagon and GLP-2 programs, were not explicitly detailed with 2025 financial figures.

Clinical Research Organizations (CROs) for managing global Phase 3 trials.

Entera Bio Ltd. is preparing for a global Phase 3 registration study for EB613, following the FDA's agreement in July 2025 to accept a single multinational, 24-month Phase 3 study with Bone Mineral Density (BMD) as the primary endpoint. The company's reliance on third parties to conduct clinical trials is a noted factor in its business risk profile. Research and development expenses for the three months ended September 30, 2025, were $1.6 million, an increase of $0.1 million over the prior year, primarily reflecting continued regulatory and Phase 3 preparation activities for EB613. Specific contract values or direct spending allocated to CROs for managing these global trials were not itemized in the reported 2025 financial updates.

• The FDA agreed to a single multinational Phase 3 study for EB613.
• The Phase 3 study for EB613 is planned as a 24-month trial.
• R&D expenses for Q3 2025 were $1.6 million, covering Phase 3 prep.

Entera Bio Ltd. (ENTX) - Canvas Business Model: Key Activities

The Key Activities for Entera Bio Ltd. (ENTX) center on advancing its clinical pipeline, particularly the lead candidate EB613, and leveraging its proprietary N-Tab™ technology across multiple programs.

Initiating the global Phase 3 registration study for EB613 (osteoporosis)

The primary activity involves preparing for and initiating the global Phase 3 registration study for EB613, the oral PTH(1-34) tablet for postmenopausal osteoporosis.

• The Phase 2 study supporting this involved 161 post-menopausal women (Cite: 7, 8, 19).
• The Phase 2 study demonstrated rapid onset of action with increases in BMD at both cortical and cancellous bone after 6 months of treatment (Cite: 16).
• Research and development expenses for the three months ended June 30, 2025, were $1.5 million, with the increase from the prior year primarily due to regulatory activities and Phase 3 planning for EB613 (Cite: 15, 10).

The planned Phase 3 study is designed as a single multinational, randomized, double-blind, placebo-controlled trial spanning 24 months (Cite: 1, 2, 6). The company is planning to initiate this study following the July 2025 regulatory alignment (Cite: 7, 16, 19).

Advancing the proprietary N-Tab™ oral delivery platform technology

Advancing the N-Tab™ platform is key, demonstrated by its application in the Next-Gen EB613 candidate.

Pre-IND and Phase 1 activities for Next-Gen EB613 and Oral OPK-88006

Activities include finalizing regulatory submissions and initiating early-stage clinical trials for pipeline assets.

• Pre-IND activities for Next Gen EB613 were in final stages as of May 9, 2025 (Cite: 9).
• Oral OPK-88006 (GLP1/Glucagon) abstract submitted to ENDO2025 (Cite: 9, 18).
• Entera Bio retains a 40% stake in the economics of the Oral OPK-88006 asset (Cite: 9).
• The company is fully funded to co-develop Oral OPK-88006 through SAD/MAD Phase 1 studies (Cite: 9).

As of June 30, 2025, $8.0 million of the company's cash was restricted to fund the OPKO collaboration through Phase 1 studies of OPK-88006 (Cite: 15, 10).

Securing regulatory milestones, like the July 2025 FDA BMD primary endpoint agreement

This was a critical activity that streamlined the path to Phase 3.

• The U.S. Food and Drug Administration (FDA) agreed to the proposal on July 28, 2025 (Cite: 1, 4).
• The agreement accepts change in total hip BMD as the primary endpoint for the NDA marketing application filing (Cite: 1, 2, 6).
• The incidence of new or worsening vertebral fractures is the key secondary endpoint (Cite: 1, 2, 6).
• The FDA also waived requirements for additional safety studies (Cite: 15).
• The company's cash position of $18.9 million as of June 30, 2025, provides runway through mid-Q3 2026 (Cite: 10, 15).

Presenting clinical data at major medical conferences (e.g., NAMS 2025, ASBMR 2025)

Disseminating data from the Phase 2 study and presenting on pipeline advancements is a core activity.

Data presented at ASBMR 2025 included an oral presentation on Friday, September 5, 2025, at 11:45 AM (Cite: 3, 12).

The ASBMR presentation covered Phase 2 results showing EB613 2.5 mg demonstrated significant increases in BMD after 6 months of treatment (Cite: 7).

Entera Bio Ltd. will present its first data at the NAMS 2025 Annual Meeting, taking place October 21-25, 2025 (Cite: 11).

The company reported a net loss of $2.7 million for the three months ended June 30, 2025 (Cite: 15).

Entera Bio Ltd. (ENTX) - Canvas Business Model: Key Resources

You're looking at the core assets Entera Bio Ltd. (ENTX) is relying on right now to drive its pipeline forward, especially with the pivotal Phase 3 study for EB613 on the horizon. These aren't just abstract concepts; they are concrete financial and technological pillars supporting their operations as of late 2025.

The most immediate, tangible resource is the capital base. As of September 30, 2025, Entera Bio Ltd. held $16.6 million in cash and cash equivalents. This figure is critical because it dictates the operational runway. Honestly, management projected that the cash on hand was expected to support operations through the middle of the third quarter of 2026 under current plans.

A significant portion of that cash is earmarked specifically for a key partnership. Specifically, $8.0 million of that cash was reported as restricted cash, designated solely to fund the collaboration activity with OPKO Health through the Phase 1 studies of the oral GLP-1/glucagon candidate, OPK-88006.

Here's a quick look at the financial position as of that reporting date:

The technology platform itself is arguably the most valuable, non-financial asset. This is the proprietary N-Tab™ oral drug delivery platform technology. This platform is what allows Entera Bio Ltd. to pursue oral peptide and protein replacement therapies, aiming to transform treatments like PTH(1-34) for osteoporosis (EB613) from injections to tablets. The next-generation version of this platform is key, with the next-generation EB613 candidate expected to enter a Phase 1 Safety and PK Study in November 2025.

This technology is protected by an intellectual property portfolio. This portfolio is designed to safeguard the company's ability to create oral peptide formulations, which is central to their entire pipeline, including assets like EB613 and the collaboration programs.

Finally, the human capital is a definite resource, especially given the near-term clinical milestones. The specialized R&D and clinical operations team is actively engaged in advancing these programs. For instance, the company is preparing for the EB613 Phase 3 program and advancing the OPKO collaboration on oral OXM. Key personnel additions to strengthen this operational capacity included Ms. Leslie Gautam as Chief Business Officer and Ms. Cherin Smith as Head of Clinical Operations, both noted for their extensive experience in strategic and operational execution as of Q1 2025.

You can see the focus is clearly on leveraging the platform and the cash to push the pipeline through critical next steps.

Entera Bio Ltd. (ENTX) - Canvas Business Model: Value Propositions

You're looking at the core advantages Entera Bio Ltd. (ENTX) brings to the table, which is really about transforming how patients get critical peptide and protein therapies. It's about moving away from needles to pills, which is a massive shift in patient convenience and access.

EB613: Oral Anabolic Therapy for Osteoporosis

The primary value proposition centers on EB613, which is being developed as the first oral, once-daily anabolic (bone-building) tablet for postmenopausal osteoporosis. This is a significant departure from the current standard, where all available anabolic agents require subcutaneous (SC) injection. The clinical data from the Phase 2 trial supports this claim.

• - EB613 is an oral PTH(1-34) tablet, designed for once-daily dosing.
• - Phase 2 study involved 161 postmenopausal women over six months.
• - Demonstrated significant bone mineral density (BMD) gains at key sites using the 2.5 mg dose.

Here's a quick look at the efficacy shown in the Phase 2 post-hoc analysis:

Replacing Inconvenient Injectable Therapies

The core value is the oral delivery mechanism, which directly addresses a major barrier to treatment adoption. Anabolic agents offer superior benefits for lowering fracture risk, but their injectable administration leads to significant underutilization. Entera Bio Ltd. is targeting this gap.

The company secured pivotal agreement with the FDA in July 2025 to use BMD as the primary endpoint for the Phase 3 registration study, clearing a streamlined pathway for this first oral anabolic treatment. This regulatory milestone positions the company to potentially address a market where less than 25% of the world's 200 million osteoporotic women currently have access to safe, effective, and affordable anabolic options. Also, the company is advancing a Next-Generation EB613 tablet, with plans to initiate a Phase 1 study in November 2025.

Expanding Patient Access

By offering an oral tablet, Entera Bio Ltd. has the potential to move treatment earlier in the care continuum. The data presented at NAMS 2025 showed consistent BMD improvements in women within 10 years post-menopause, a critical population for fracture prevention where injectable options remain underutilized. The goal is to broaden access for the over 200 million women worldwide living with osteoporosis.

Developing First-in-Class Oral Metabolic Disease Treatment (OPK-88006)

Beyond bone health, Entera Bio Ltd. is leveraging its N-Tab technology in collaboration with OPKO Health, Inc. to develop OPK-88006, a first-in-class oral dual GLP-1/glucagon agonist for metabolic diseases like obesity. This is a novel modality, as most current dual agonists are injectable. The partners expect to file an Investigational New Drug application with the FDA later this year (2025) to begin Phase 1 clinical studies.

The financial structure of this collaboration also provides a value proposition for Entera Bio Ltd. itself. Under the agreement, Entera shoulders 40% of the development costs and holds a 40% ownership stake, which is funded in part by an $8-million equity investment from OPKO Health. As of the second quarter of 2025, the company reported a cash position of $18.9 million, which, including dedicated collaboration funding, provides a runway through mid-Q3 2026. This funding stability supports the execution of milestones across the pipeline, including the planned Phase 1 study for Next-Gen EB613 in late 2025.

Entera Bio Ltd. (ENTX) - Canvas Business Model: Customer Relationships

You're hiring before product-market fit, so every interaction with a key stakeholder is critical for advancing the pipeline. Entera Bio Ltd. focuses its customer relationship strategy on high-value, high-impact engagements with scientific and regulatory authorities, given its clinical-stage focus.

High-touch, collaborative relationships with key opinion leaders (KOLs) and clinical investigators

Entera Bio Ltd. actively engages with the clinical and scientific community to validate its data and platform. This relationship building is evident through presentations at major medical congresses throughout 2025, showcasing data from its pipeline candidates.

Key scientific engagements in 2025 included:

• - Presentation of EB613 Phase 2 data at the 2025 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases Congress.
• - Oral presentation of EB613 effects on trabecular and cortical bone at the American Society for Bone and Mineral Research (ASBMR) 2025 Annual Meeting on Friday, September 5, 2025.
• - Presentation of new Phase 2 data for EB613 at the North American Menopause Society (NAMS) 2025 Annual Meeting, taking place October 21-25, 2025.
• - Presentation of pharmacokinetic data for the oral GLP-2 tablet candidate at the 2025 ESPEN Congress.

The Phase 2 study for the lead candidate, EB613, involved 161 patients.

The company also presented pharmacokinetic data for its oral GLP-1/glucagon dual agonist program with OPKO at ENDO2025.

Direct engagement with regulatory bodies (FDA) for streamlined development pathways

Direct interaction with the U.S. Food and Drug Administration (FDA) has been a pivotal relationship for de-risking the lead asset. This engagement focused on establishing a clear path to market for EB613, the oral PTH(1-34) tablet for osteoporosis.

A significant milestone was achieved in July 2025 when the FDA provided written concurrence following a Type A meeting. This agreement allows the New Drug Application (NDA) filing for EB613 to be supported by a single multinational, randomized, double-blind, placebo-controlled, 24 month Phase 3 study, with the change in total hip Bone Mineral Density (BMD) evaluated as the primary endpoint.

For the oral OPK-88006 program with OPKO, the companies expect to file an Investigational New Drug (IND) application with the FDA in the late first half of 2026.

Investor relations and public disclosures for capital market confidence

Maintaining confidence in the capital markets is crucial for a clinical-stage company funding its development through equity and partnerships. Entera Bio Ltd. provided regular updates and engaged with analysts and investors throughout the year.

Financial and market metrics as of late 2025 include:

The CEO, Miranda Toledano, was scheduled to participate in a fireside chat at the 8th Annual Evercore ISI Healthcare Conference on December 3, 2025.

Future: Sales force and medical science liaisons (MSLs) post-commercialization

Entera Bio Ltd. is planning for commercialization activities post-potential regulatory approval for EB613. This future relationship structure will involve building out a commercial team to interact with healthcare providers.

The company is preparing for the initiation of a global registrational Phase 3 study for EB613, with plans to initiate a Phase 1 study for Next-Gen EB613 in late 2025.

Entera Bio Ltd. (ENTX) - Canvas Business Model: Channels

You're looking at how Entera Bio Ltd. (ENTX) gets its science and its financing in front of the right people. For a clinical-stage company, the channels are less about retail shelves and more about regulatory bodies, scientific peers, and capital markets. It's a focused approach, which makes sense given their pipeline.

Direct regulatory submissions (IND, NDA) to the FDA and international agencies serve as the primary gate to commercialization. This channel is about direct, formal communication with the U.S. Food and Drug Administration (FDA) to gain approval for clinical trials or market access. A major recent win here was the FDA's written concurrence on July 28, 2025, agreeing that a single multinational, randomized, double-blind, placebo-controlled, 24-month Phase 3 study for EB613, using change in total hip Bone Mineral Density (BMD) as the primary endpoint, would support an NDA (New Drug Application) filing. This streamlined pathway is critical for getting their first oral anabolic osteoporosis treatment to market. Looking ahead, the IND (Investigational New Drug) filing for the next-generation EB613 tablet candidate is planned for H1 2026. For the OPKO collaboration on OPK-88006, the IND filing window is set for later 2025 or early 2026.

Disseminating clinical data through scientific and medical conferences is how Entera Bio Ltd. builds credibility and informs the medical community. This is where the science gets peer-reviewed in real-time. For instance, data on EB613 from the Phase 2 study was significant enough to be selected for oral presentation out of 1,680 abstracts submitted to the 2025 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases Congress. Furthermore, abstracts were submitted for presentation at the 2025 American Society for Bone and Mineral Research (ASBMR) and the North American Menopause Society (NAMS) conferences. The oral GLP-2 analog also saw its data presented at the 47th European Society for Clinical Nutrition & Metabolism ('ESPEN') Congress in June 2025.

The channel of strategic pharmaceutical partners, most notably OPKO Health Inc., is vital for co-development and sharing the financial burden. This partnership is structured with clear financial and ownership splits for the oral GLP-1/glucagon dual agonist program (OPK-88006). You need to know these numbers because they directly impact Entera Bio Ltd.'s future economics. The agreement dictates that OPKO shoulders 60% of the development costs and holds 60% ownership, while Entera Bio Ltd. is responsible for 40% of costs and retains 40% ownership through the Phase 1 studies. Should Entera Bio Ltd. opt out post-Phase 1, its interest drops to 15%, with OPKO taking the remaining 85% and assuming full funding responsibility. As part of this, OPKO purchased 3,685,226 ordinary shares of Entera Bio Ltd. at $2.17 per share, amounting to approximately $8 million.

Investor communications are the lifeline for a clinical-stage company, directly feeding the capital required to fund these channels. The company communicates progress through press releases and investor relations sections on their website. The financial health as of the end of Q2 2025 reflects this reliance on capital events. Here's a quick look at the financial context that drives these communications:

The extension of the cash runway into late 2026 in Q1 2025 was achieved via direct investment from 'marquis investors' and OPKO, showing the success of these investor-facing channels. Still, management notes that the current cash position raises substantial doubt about the ability to continue as a going concern without additional financing, specifically for the EB613 Phase 3 study funding gap.

The dissemination of data at conferences also acts as an investor communication channel, as seen by the planned presentations in September 2025 and October 2025. For example, the CEO is scheduled for a fireside chat on November 18, 2025, which is a direct engagement with the financial community.

Entera Bio Ltd. (ENTX) - Canvas Business Model: Customer Segments

You're looking at the core patient groups Entera Bio Ltd. (ENTX) is targeting with its oral peptide platform, starting with the most advanced asset, EB613. The focus is on transforming the standard of care by offering an oral anabolic tablet where only injections exist today.

The primary customer segment is postmenopausal women with low bone mass or high-risk osteoporosis. This is a massive, underserved population globally. For context, the global postmenopausal osteoporosis treatment market was calculated at USD 13.48 billion in 2025. In the US alone, about 71 million Americans are projected to have osteoporosis or reduced bone mass by 2030. To be precise, one in three women over age 50 develops osteoporosis. Entera Bio Ltd. (ENTX) is developing EB613, an oral PTH(1-34) tablet, specifically for this group, aiming to close the treatment gap. The Phase 2 study for EB613 involved n=161 participants.

The secondary, but critical, customer segment involves the prescribing physicians who manage these conditions. These are the specialists you need to convince about the value of an oral anabolic over established injectables. This group primarily includes:

• Endocrinologists.
• Rheumatologists.
• OB/GYNs.

The value proposition for these prescribers centers on the convenience and compliance benefits of an oral tablet, which could dramatically expand patient access to bone-building therapy.

Looking ahead, Entera Bio Ltd. (ENTX) has two distinct future customer segments tied to its collaboration with OPKO Health Inc. These programs leverage the same N-Tab™ platform technology to address rare and prevalent metabolic conditions.

For the Short Bowel Syndrome (SBS) program, the customer is the patient population suffering from rare malabsorption conditions requiring GLP-2 analog therapy. The oral GLP-2 tablet candidate is showing significant promise; preclinical data demonstrated a plasma half-life of approximately 15 hours, which is an 18-fold improvement over teduglutide (Gattex®), the only approved therapy requiring a daily injection.

The second future segment is patients with Obesity and metabolic disorders, targeted by the Oral OPK-88006 program, a dual-acting GLP1/glucagon single tablet. Entera Bio Ltd. (ENTX) retains a 40% stake in the economics of this asset.

Here's a quick look at the scale of the primary osteoporosis market Entera Bio Ltd. (ENTX) is initially addressing:

The company's financial position as of late 2025 supports this pipeline development; cash and cash equivalents stood at $16.6 million as of September 30, 2025. The net loss for the quarter ending September 30, 2025, was $3.2 million. This cash position is expected to support operations through the middle of the third quarter of 2026.

The specialists you need to target-Endocrinologists, rheumatologists, and OB/GYNs-are the gatekeepers to the high-risk osteoporosis patient pool, which is currently managed with treatments that require subcutaneous injection, a major barrier to adherence.

Finance: draft 13-week cash view by Friday.

Entera Bio Ltd. (ENTX) - Canvas Business Model: Cost Structure

You're looking at the core expenditures driving Entera Bio Ltd.'s operations as of late 2025. For a clinical-stage biotech, the cost structure is heavily weighted toward discovery, development, and protecting the science. Here's a breakdown of the key financial commitments based on the latest figures.

The most immediate, recurring costs are reflected in the quarterly operating expenses. For the three months ended September 30, 2025, the company reported significant spending:

The Research and Development (R&D) expenses of $1.6 million for Q3 2025 reflect the ongoing push, primarily the continued regulatory and Phase 3 preparation activities for EB613. To be fair, this figure is higher than the $1.5 million reported for the same period in 2024.

Similarly, General and Administrative (G&A) expenses were $1.6 million for the third quarter of 2025, up from $1.5 million in the prior-year quarter. These costs cover the overhead required to manage the company's pipeline and corporate functions.

The most substantial, lumpy cost on the horizon is clinical trial expenses, specifically for the upcoming global Phase 3 study of EB613. While the FDA agreed in July 2025 that a single 24-month multinational Phase 3 study can support an NDA filing, the capital required to initiate this study is a major factor. Management has explicitly stated that the current cash position, which was $16.6 million as of September 30, 2025, excludes the capital required to initiate the EB613 Phase 3 study, raising substantial doubt about the company's ability to continue as a going concern without additional financing.

Entera Bio Ltd. also incurs necessary, though less variable, costs related to protecting its platform technology. These include:

• - Intellectual property maintenance and patent prosecution costs, which are essential for securing the exclusivity of the N-Tab platform and pipeline assets.
• - Ongoing costs associated with internal programs and regulatory consulting, which contributed to the R&D spend increase.

A significant portion of development spending is managed through partnerships, which shifts some of the financial burden. For the Oral OPK-88006 program, a collaboration with OPKO Health dictates a clear cost-sharing mechanism:

• - Entera Bio Ltd. is responsible for 40% of the development costs for OPK-88006.
• - OPKO shoulders the remaining 60% of the development costs.
• - The initial $8.0 million received from OPKO in 2025 was specifically designated to fund Entera's 40% share through the Phase 1 studies of OPK-88006.

Here's the quick math on that specific cost allocation:

The cash on hand as of September 30, 2025, was $16.6 million, including $8.0 million in restricted cash for the OPKO collaboration, and this is expected to support operations through the middle of the third quarter of 2026, assuming the Phase 3 funding gap is addressed.

Entera Bio Ltd. (ENTX) - Canvas Business Model: Revenue Streams

You're looking at the financial reality of a clinical-stage company; revenue right now is not the main story, but the funding mechanism to reach the next stage is. Entera Bio Ltd. operates on a capital-intensive model typical for its stage, where operational funding is derived from non-sales sources until a product gains approval.

The current revenue generation is minimal, reflecting its pre-commercial status. For the first quarter ended March 31, 2025, Entera Bio Ltd. reported revenue of $\text{0.04 million}$. More recently, as of September 30, 2025, the trailing twelve-month (TTM) revenue stood at $\text{124.00K}$.

The core of the business model's financial future rests on two distinct, non-current revenue pillars: eventual product sales and upfront/milestone payments from partnerships.

Future product sales revenue depends entirely on the success of the pipeline assets moving through clinical development and regulatory approval. These assets represent the potential for significant top-line growth:

• - EB613: Oral PTH(1-34) tablet for Osteoporosis; FDA agreement secured in July 2025 for a single 24-month Phase 3 study with Bone Mineral Density (BMD) as the primary endpoint.
• - Next Gen EB613: Tablet candidate planned to initiate Phase 1 study in the second half of 2025.
• - EB612: Oral PTH(1-34) tablet for Hypoparathyroidism; currently in development with a third party on another peptide in this field.
• - Oral GLP-2: Tablet candidate for Short Bowel Syndrome (SBS), developed in collaboration with OPKO Biologics.

Milestone payments and royalties are already being realized through strategic alliances. The most significant is the collaboration with OPKO Health Inc. for the Oral OPK-88006 program (dual GLP-1/Glucagon agonist). Under the March 2025 agreement, Entera Bio Ltd. retains a $\text{40\%}$ pro-rata ownership interest and is responsible for $\text{40\%}$ of development costs through the SAD/MAD Phase 1 studies. Should Entera Bio Ltd. opt out after Phase 1, its ownership interest reduces to $\text{15\%}$, with OPKO retaining $\text{85\%}$ and funding subsequent development.

To bridge the gap until product sales commence, Entera Bio Ltd. relies on capital markets and direct strategic investment. This funding is critical for covering operating expenses, which included $\text{R\&D}$ expenses of $\text{1.6 million}$ for the quarter ended September 30, 2025. Here is a snapshot of the cash position and funding events near the end of 2025:

The company's current financial structure is heavily weighted toward equity financing and partner funding to sustain its $\text{R\&D}$ burn rate. Finance: draft 13-week cash view by Friday.