ENTX

Entera Bio Ltd.

NASDAQ · HEALTH CARE · BIOLOGICAL PRODUCTS, (NO DIAGNOSTIC SUBSTANCES)

2.86

−0.06 −2.05%

USD · close Oct 26

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MKT CAP $495.2MP/E 8.2DIV YIELD —FCF YIELD -2.21%REV TTM $0 −100.0%NET INCOME −$17MNET CASH —52W 1.00 – 3.92SEC XBRL · TTM TO Invalid Date

How ENTX rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

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RISK FACTORS You should carefully consider the risks described below, as well as other information contained in this Annual Report, including the consolidated financial statements and the notes thereto and “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations.” The occurrence of any of the events discussed below could significantly and adversely affect our business, prospects, results of operations, financial condition, and cash flows.
Any investment in our securities involves a high degree of risk.
You should consider carefully the following factors and all other information contained in this Annual Report before you make a decision to invest in our Ordinary Shares.
If any of the negative events referred to below occur, our business, prospects, financial condition and results of operations could be materially and adversely affected.
In any such case, the trading price of our Ordinary Shares could decline, and you could lose all or part of your investment.
Risks Related to Our Financial Position We have incurred significant losses since our inception and anticipate that we will continue to incur substantial losses for the next several years.
We have incurred net losses in each year since our inception, including net losses of $11.4 million in 2025 and $9.5 million in 2024.
As of December 31, 2025, we had an accumulated deficit of $125.4 million.
We expect to continue to incur substantial losses for the next several years, and we expect these losses to increase as we continue our development of and potentially seek regulatory approval for EB613 and EB612, as well as our collaboration with OPKO related to OXM and GLP-2.
We anticipate that our net losses and accumulated deficit for the next several years will be significant as we conduct our planned operations.
Given our current plans, we anticipate that our existing cash and cash equivalents will be sufficient to fund our ongoing operations through the middle of the third quarter of 2026, excluding the initiation of the Phase 3 study for EB613 in osteoporosis.
Our ability to commence the Phase 3 study of EB613 in osteoporosis will require additional funding, which may not be available on reasonable terms, or at all.
The Company regularly evaluates market conditions, its liquidity profile and financing alternatives, including out-licensing arrangements for its products, to enhance its capital structure.
The Company may seek to raise capital through debt or equity financings to or through other strategic initiatives.
Since inception we have not derived any significant income from our activities and incurred an accumulated deficit and negative cash flows from operating activities.
We believe our existing cash resources will be sufficient to meet our projected operating requirements through the middle of the third quarter of 2026 without additional funding; however, as a result of recurring losses, substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least twelve months form the date of this Annual Report.
Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to accurately predict the timing or amount of the development and clinical expenses or when, or if we will be able to achieve, or maintain, profitability.
In addition, our expenses could increase if we are required by the FDA or comparable foreign regulatory authorities to perform preclinical or clinical studies or trials in addition to those currently expected, or if there are any delays in completing our clinical trials or the development and potential commercialization of EB613 or any other product candidates.
The amount of our future net losses will depend, in part, on the amount and timing of our expenses, our ability to enter into strategic partnerships or less dilutive funding agreements or our ability to raise additional capital.
These net losses have had, and will continue to have, an adverse effect on our stockholders’ equity and operating assets and liabilities.
Management has performed an analysis of our ability to continue as a going concern.
In addition, our independent registered public accounting firm has raised substantial doubt as to our ability to continue as a going concern.
The Company is engaged in research and development activities, and it has not derived significant income from its activities and has incurred an accumulated deficit in the amount of $125.4 million as of December 31, 2025 and negative cash flows from operating activities.
In addition, our independent registered public accounting firm expressed substantial doubt as to our ability to continue as a going concern in their report accompanying our audited consolidated financial statements.
As of March 23, 2026, we had cash and cash equivalents of approximately $12.6 million, of which $7.8 million is designated solely to fund our development cost obligations under the collaboration agreement with OPKO.
We constantly evaluate options in relation to various financing alternatives including public or private equity offerings, debt financings and strategic collaborations to finance future clinical trials, research and development activities and general and administrative expenses.
A going concern opinion could impair our ability to finance our operations through public or private equity offerings, or debt financings, or a combination of one or more of these funding sources.
Any additional equity or debt financing could be extremely dilutive to our current shareholders.
Additional capital may not be available on reasonable terms, or at all, and we may be required to delay, terminate or significantly curtail our operations, or enter into arrangements with collaborative partners or others that may require us to relinquish rights to certain aspects of our product candidates, or potential markets that we would not otherwise relinquish.
If we are unable to obtain capital, our business, including our ability to conduct studies and develop our product candidates, would be jeopardized and we may not be able to continue operations.
Due to our limited resources and access to capital, we must and have in the past decided to prioritize development of certain product candidates; these decisions may prove to have been wrong and may adversely affect our current and any potential future revenues.
Because we have limited resources and access to capital to fund our operations, we must decide which product candidates to pursue and the amount of resources to allocate to each product candidate.
As such, our internal resources are currently focused on the development of EB613 and further development of our N-Tab ® platform.
We entered into the 2025 Collaboration Agreement with OPKO in relation to our Oral GLP-1/Glucagon.
Under the terms of the agreement, OPKO and Entera will hold 60% and 40% pro-rata ownership interests, respectively, in the program and be responsible for 60% and 40% of the program’s development costs, respectively.
Following the completion of the Phase 1 stage, we have the option to continue to fund our 40% share to maintain our pro-rata ownership interest of the program, or we may opt-out.
Should we opt-out, we will retain a 15% ownership interest in the Oral OXM program, while OPKO would retain 85% and be responsible for all ongoing development activities and funding of the program.
In February 2026, we entered into the A&R Collaboration Agreement, which amends and restates the 2025 Collaboration Agreement to expand the scope of the agreement to include the collaboration with respect to the preclinical and clinical development of a daily long acting PTH tablet (“LA-PTH”) for the treatment of hypoparathyroidism and other indications.
Development costs incurred by the parties with respect to the development of the LA-PTH program will be shared equally between the Company and OPKO.
Our decisions concerning the allocation of research, collaboration, management and financial resources toward particular compounds, product candidates or therapeutic areas may not lead to the development of viable commercial products and may divert resources away from better opportunities.

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Item 1A—Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” of this Annual Report.
Our forward-looking statements reflect our views only as of the date they are made.
We do not undertake any obligation to update forward-looking statements except as required by applicable law.
We intend that all forward-looking statements be subject to the safe harbor provisions of PSLRA.
Overview Entera is a clinical stage company focused on developing first-in-class oral tablet formats of peptides or protein replacement therapies.
We focus on underserved, chronic medical conditions for which oral administration of a protein therapy has the potential to significantly shift a treatment paradigm.
Our pipeline includes five differentiated, first-in-class oral peptide programs targeting PTH(1-34), GLP-1 and GLP-2.Currently, most protein therapies are administered via frequent intravenous, subcutaneous, or intramuscular injections.
In chronic diseases where patients require persistent management, these cumbersome, often painful and high-priced injections can create a major treatment gap.
From a technical standpoint, oral delivery of therapeutic proteins is challenging due to the enzymatic degradation within the gastrointestinal tract and poor absorption into the blood stream due to the proteins’ polarity and molecular weight.
We leverage our N-Tab™ platform which is designed to simultaneously stabilize the peptide in the gastrointestinal tract and promote its absorption into the bloodstream.
EB613 Program Our most advanced product candidate, EB613, oral PTH(1-34), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low bone mineral density (“BMD”) and high-risk osteoporosis.
EB613 is intended to provide an oral anabolic treatment earlier in an osteoporosis patient’s journey to increase skeletal mass, reduce the risk of fracture and consequently limit the progression of the disease, and its associated disability and mortality.
A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (pharmacodynamic/bone turnover biomarker) and secondary endpoints (BMD).
In April 2024, the phase 2 data was published in the Journal of Bone and Mineral Research (JBMR).
Following Type C and Type D meetings with the FDA, we announced in 2023 the FDA’s concurrence that a 2-year, placebo-controlled phase 3 (registrational) study with Total Hip BMD as primary endpoint could support a new drug application (“NDA”) for EB613, however the SABRE BMD endpoint remained unqualified as a surrogate endpoint by FDA.
In November 2023, the ASBMR announced that the SABRE project team had submitted its full qualification plan to the FDA for the use of BMD as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs.
In March 2024, the ASBMR announced that the FDA had communicated to the SABRE project team that a ruling to qualify the treatment-related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs would be provided within 10 months.
The EB613 osteoporosis clinical program has been developed under the auspices of this new approach to osteoporosis drug development.
We believe EB613 stands as the first program to potentially avail itself of the ASBMR-SABRE BMD endpoint.
SABRE is expected to provide an update on its FDA interactions and the qualification of the BMD endpoint in 2025.
EB612 Program Our product candidate, EB612, is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for patients with hypoparathyroidism.
With respect to our EB612 program, we are currently testing new generations of our N-Tab™ Technology with the naked PTH(1-34) peptide to assess the effectiveness of once or twice a day dosing regimens, as well as collaborating with a third party on another peptide in this field.
In June 2024, Phase 1 clinical data for EB612 was presented at the Endocrine Society ENDO 2024 Annual Meeting.
To date, Entera’s proprietary PTH tablets have been safely administered to a total of 102 healthy subjects in Phase 1 studies and 153 patients in Phase 2 studies in osteoporosis and hypoparathyroidism, two diseases that remain underserved with the current standard of care and which disproportionately affect women.
We believe these product candidates, if approved, hold the potential to become standards of care for patients with osteoporosis and hypoparathyroidism.
Our ability to deliver our oral PTH(1-34) peptide in a simple mini tablet format with reproduceable, dose dependent pharmacokinetics and rapid biological responses across gender, age, and health status was highlighted as part of two poster sessions at the ASBMR 2023 Annual Meeting.
We believe our work to date has built the foundation for our oral PTH (1-34) tablets to potentially treat diverse patient populations, including younger men and women athletes at risk of stress fractures.
Oral GLP-2 and Oral GLP-1/Glucagon Programs in Collaboration with OPKO Biologics In September 2023, we entered into the 2023 Collaboration Agreement with OPKO Biologics, Inc., a subsidiary of OPKO.
Under the terms of this agreement, OPKO has agreed to supply its proprietary long-acting GLP-2 peptide and certain OXM analogs for the development of oral tablet candidates using our proprietary N-Tab™ technology.
Under this agreement, we and OPKO have each agreed to be responsible for specific phases of development of the two oral peptides to the point of demonstrated in vivo feasibility.
In March 2024, we announced positive in vivo pharmacokinetic (PK) results from our collaborative research, combining a proprietary long acting GLP-2 agonist developed by OPKO with Entera’s proprietary N-Tab™ technology.
The program is focused on developing the first and only GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and additional disorders involving mucosal inflammation and nutrient malabsorption.
OXM is a naturally occurring peptide hormone found in the colon, with glucagon-like-peptide 1 (GLP-1) and glucagon dual agonist activity that suppresses appetite and induces weight loss.
OPKO has developed several proprietary, modified OXM analogs as potential candidates for treating obesity, including an injectable pegylated peptide which demonstrated safety in over 430 subjects and significant reductions in weight loss and decreased plasma triglyceride levels in over 110 subjects in completed phase 2 studies.
In September 2024, we jointly announced with OPKO topline pharmacokinetic/pharmacodynamic (PK/PD) results for the OXM program.
The program is focused on developing the first oral dual agonist GLP-1/Glucagon peptide as a potential once-daily tablet treatment for patients with obesity and metabolic disorders using the N-Tab™ platform.
Oral OXM exhibited significant systemic exposure across two in vivo models, a favorable PK profile and bioavailability.
The high plasma concentrations with prolonged systemic exposure were consistent with the reported half-life for semaglutide (Rybelsus®), the only approved oral GLP-1 analog.
Oral OXM showed a statistically significant reduction in plasma glucose levels compared with placebo.
Financial Overview We are primarily engaged in research and development activities, and we have not derived significant income from our activities.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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