ENTX 10-K & 10-Q changes, risk factors and insider trading

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 and $8.9 million in 2023.2024. As of December 31, 2024,2025, we had an accumulated deficit of $113.9$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,for EB613 and EB612EB612, andas well as our collaboration with OPKO related to GLP-2OXM and OXM.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 intothrough the middle of the third quarter of 2026, excluding the initiation of the Phase 3 study for EB613 in osteoporosis. This includes regulatory expenses and optimization related to the preparation for the planned EB613 phase 3 study, research and development, the completion of an additional Phase 1 PK study related to our new generation platform and the GLP-2/OXM collaborative research we are conducting with OPKO. Our ability to commence the Phase 3 study of EB613 in osteoporosis will depend on finalizing the discussions with the FDA in connection with their anticipated qualification of the SABRE total hip BMD endpoint and will require additional funding, which may not be available on reasonable terms, or at all. Any delay or our inability to secure such funding will delay or prevent the commencement of these studies.

WeThe believeCompany ourregularly existingevaluates cashmarket resourcesconditions, willits beliquidity sufficientprofile and financing alternatives, including out-licensing arrangements for its products, to meetenhance ourits projectedcapital operatingstructure. requirementsThe intoCompany themay thirdseek quarterto ofraise 2026capital withoutthrough additionaldebt funding.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. TheseWe factorsbelieve raiseour 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 asexists toabout the Company'sCompany’s ability to continue as a going concern.concern for a period of at least twelve months form the date of this Annual Report. Our expectations are based on management’s current assumptions, clinical development plans and regulatory submission timelines, which may prove to be wrong, and we could spend our available financial resources much faster than we currently expect. 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 workingoperating capital.assets and liabilities.

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 since inception.activities. These factors raise substantial doubt as to the Company'sCompany’s ability to continue as a going concern. 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 20,23, 2025,2026, we had cash and cash equivalents of approximately $21$12.6 million, of which $8$7.8 million is designated solely to fund our development cost obligations under the collaboration agreement with OPKO. Given our current plans, we anticipate that our existing cash and cash equivalents will be sufficient to fund our ongoing operations intothrough the middle of the third quarter of 2026, excluding the initiation of the Phase 3 study for EB613 in osteoporosis. This assumes capital required to fund our ongoing operations, including our ongoing operations, including regulatory expenses and optimization related to the preparation for the planned EB613 phase 3 study, research and development, the completion of an additional Phase 1 PK study related to our new generation platform and the GLP-2/OXM collaborative research we are conducting with OPKO. Our ability to commence the Phase 3 study of EB613 in osteoporosis will depend on finalizing discussions with the FDA in connection with their anticipated qualification of the total hip BMD endpoint and will require additional funding, which may not be available on reasonable terms, or at all. Any delay or our inability to secure such funding will delay or prevent the commencement of these studies.

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 .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. Furthermore,In February 2026, we entered into the expensesA&R relatedCollaboration Agreement, which amends and restates the 2025 Collaboration Agreement to collaborativeexpand researchthe scope of the agreement to include the collaboration with respect to the preclinical and clinical development of a thirddaily partylong acting PTH tablet (“LA-PTH”) for the treatment of hypoparathyroidism areand fundedother indications. Development costs incurred by thatthe collaborator.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. Similarly, our current or potential decisions to delay, terminate or collaborate with third parties with respect to certain product development programs may also be sub-optimal and could cause us to miss valuable opportunities. If we make incorrect determinations regarding the market potential of our product candidates or misread trends in the biopharmaceutical industry, our business, financial condition and results of operations could be materially adversely affected.

We are currently planning and preparing to initiate a phase 3 study for our most advanced product candidate, EB613, pendingfollowing the FDA’s qualificationfeedback ofon theour SABREphase BMD3 endpoint.protocol submission. Developing therapeutics, including conducting preclinical studies and clinical trials, is expensive. We will require substantial additional capital in order to complete research and development, clinical trials, file with the regulatory agencies, including the FDA and EMA, secure commercial manufacturing supply for and commercialize our product candidates. If the FDA or comparable foreign regulatory authorities require that we perform additional preclinical studies or clinical trials at any point, our expenses would further increase beyond what we currently expect, and the anticipated timing of any future clinical development activities and potential regulatory approvals may be delayed depending upon our allocation of resources and available funding. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. If adequate funds are not available to us on a timely basis, or on acceptable terms, we may be required to delay, limit, reduce or terminate preclinical studies, clinical trials or other development activities for one or more of our product candidates or delay, limit, reduce or terminate our establishment of manufacturing, sales and marketing capabilities or other activities that may be necessary to commercialize our product candidates.

Many of these factors are outside of our control. Given our current plans, we believe that we will be able to fund our ongoing operations intothrough the middle of the third quarter of 2026, excluding the initiation of the Phase 3 study for EB613 in osteoporosis. This assumes capital required to fund our ongoing operations, including regulatory expenses and optimization related to the preparation for the planned EB613 phase 3 study, research and development, the completion of an additional Phase 1 PK Our existing cash and cash equivalents will not be sufficient to obtain regulatory approval for any of our product candidates. Accordingly, we continue to require substantial additional capital. In order to fund our future capital needs, we may seek additional funding through equity or debt financings, development partnering arrangements, lines of credit or other sources. These conditions raise substantial doubt about our ability to continue as a going concern, and we will be required to raise additional funds, seek alternative means of financial support, including strategic partnerships, or both, in order to continue operations. The accompanying financial statements have been prepared assuming that we will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty. If we are unable to raise the requisite funds, we will need to delay the initiation of core activities, curtail or cease operations.

We began operations in 2010. Our operations to date have been limited to developing our N-Tab™® platform, pre-clinical and early clinical development of our product candidates, expanding our intellectual property portfolio, financing and staffing our company. . We have not yet demonstrated an ability to successfully complete a large-scale, pivotal clinical trial, obtain marketing approval, manufacture a commercial scale product or conduct sales and marketing activities necessary for successful product commercialization. Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a history of successfully developing and commercializing pharmaceutical products.

We are a clinical-stage company focused on the development of oral peptide and protein replacement therapies to treat unmet medical needs. We commenced operations in 2010 and have a limited operating history. Since inception, we have devoted substantially all of our resources to the development of our N-Tab™® platform, the clinical and preclinical advancement of our product candidates, the creation, licensing and protection of related intellectual property rights and the provision of general and administrative support for these operations. We have not yet obtained regulatory approval for any product candidates in any jurisdiction or generated any revenues from any product sales. If any of our current or future product candidates fails in clinical trials or preclinical development, or does not gain regulatory approval, or if our product candidates following regulatory approval, if any, do not achieve market acceptance, we may never become profitable or sustain profitability.

Successful and timely completion of clinical trials will require that we enroll enough volunteers in early studies, or patients with a specific disease in later trials. Trials may be subject to delays as a result of enrollment taking longer than anticipated or subject withdrawal. Enrollment depends on many factors, including the size and nature of the patient population, eligibility criteria for the trial, the proximity of patients to clinical sites, the design of the clinical protocol, the number of competing clinical trials, the availability of drugs approved for the indication the clinical trial is investigating, and clinicians’ and patients’ perceptions as to the potential advantages of the product being studied in relation to other available therapies. Our most advanced programs,program, EB613 may compete with marketed drugs, such as Prolia®, bisphosphonates, Forteo®, Tymlos®, Evenity®, and osteoanabolic drugs in clinical development for osteoporosis such as Angitia’s AGA2118; the EB612 program may compete with marketed drugs of hypoparathyroidism such as TransCon™ PTH and those in clinical development such as Eneboparatide and MBX2109. Our Oral GLP-2 Programprogram will compete with Gattex™, the only approved GLP-2 treatment for short bowel syndrome and experimental GLP-2 injectables such as Zealand’s glepaglutide (FDA CRL 12/24) and Vectiv/ Ironwood’s apraglutide (SubmittedFDA 01has required another phase 3 trial 04/02525)). Our Oral GLP-1/Glucagon program may compete with approved GLP-1 injectables, RybelsusWegovy pill, and experimental incretin targeted injectables and oral small molecules and potential oral peptide candidates in the metabolic indications we pursue..pursue. These factors may make it difficult for us to enroll enough subjects to complete our clinical trials in a timely and cost-effective manner. Delays in the completion of any clinical trial of our product candidates will increase our costs, slow down development of our product candidates and any potential approvals and delay or potentially jeopardize our ability to commence product sales and generate revenue. In addition, some of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.

We may not be successful in our efforts to use and expand our N-Tab™® platform, to other product candidates.

An element of our strategy is to combine our N-Tab™® platform with a variety of peptides and therapeutic proteins to build a pipeline of product candidates and progress these product candidates through clinical development for the treatment of a variety of different types of diseases. We intend to use N-Tab™ technology in combination with known APIs, to validate our platform and potentially minimize risk and development timelines.

Our initial product candidates combine our oral drug delivery technology,platform, N-Tab™®, with PTH(1-34), a hormone that has been used in injectable form for over 20 years for the treatment of osteoporosis and hypoparathyroidism.osteoporosis. Our business is substantially dependent on our ability to complete the development of, obtain regulatory approval for, and successfully commercialize our oral PTH product candidates in a timely manner. In addition, we have modified the formulation of oral PTH to develop new formulations for applications in hypoparathyroidism and other indications. If we are not successful in optimizing the formation of our PTH product candidates for additional indications, or if we are not otherwise able to obtainobtaining regulatory approval for them or successfully commercialize them, our business and prospects may be severely limited.

In addition, our technology makes use of synthetically bioengineered ingredients. Although our product candidates utilize a synthesized PTH molecule with a known mechanism of action, they may cause patients to exhibit safety or immune responses that do not match the biological effect of a human protein produced by the parathyroid gland. Such responses could result in increased regulatory scrutiny, delays or other impediments to our planned development or the public acceptance and commercialization of our products. Even if we are successful in expanding our drugtechnology delivery technologyplatform to other peptides for other indications as we have to GLP-2 and GLP-1/Glucagon ,and GLP-2, the potential product candidates that we identify may not be suitable for clinical development, to the extent they are shown to have harmful side effects or other characteristics that indicate that they are unlikely to be products that will receive marketing approval and achieve market acceptance. We may never successfully develop or commercialize our technology with other peptides, which could limit our business and prospects.

All of our product candidates are still in clinical or non-clinical development and although our product candidates have undergone or will undergo safety testing, not all adverse effects of drugs can be predicted or anticipated. Unforeseen side effects from any of our product candidates could be recognized either during clinical development or, if such side effects are rare, after our product candidates have been approved by regulatory authorities and the approved product has been marketed, resulting in the exposure of additional patients. While our oral PTH programs have exhibited no serious drug related adverse events in our clinical trials to date, theThe results of future clinical trials may show that our product candidates cause undesirable or unacceptable side effects, which could interrupt, delay or halt clinical trials, and result in delay of, or failure to obtain, marketing approval from the FDA, the EMA and other regulatory authorities, or result in marketing approval from the FDA, the EMA and other regulatory authorities with restrictive label warnings or potential product liability claims.

In conjunction with the addition of these employees and senior members of management, we intend to grow our company. Due to our limited financial resources and the limited size of our management team, it is possible that our management, finance, development personnel, systemssystems, and facilities currently in place may not be adequate to support this future growth. We may not be able to effectively manage the expansion of our operations, which may result in weaknesses in our infrastructure, give rise to operational errors, loss of business opportunities, loss of employees and reduced productivity among remaining employees. Our expected growth could require significant expenditures and may divert financial resources from other projects, such as the development of existing and additional product candidates. If we are unable to effectively manage our expected growth, our expenses may increase more than expected, our ability to generate or grow revenue could be reduced and we may not be able to implement our strategy. Our future financial performance and our ability to develop our product candidates and compete effectively with others in our industry will depend, in part, on our ability to effectively manage any future growth. In addition, pursuant to both Israeli law and Nasdaq rules, we have appointed independent directors, which may result in a change in the company’s direction over time.

To date, we have regularly engaged consultants to assess our internal cybersecurity programs and compliance, and, in connection with such assessment, have implemented various cybersecurity defense measures we believe are appropriate. However, we may be required to expend significant capital and other resources to protect against, respond to, and recover from any potential, attempted, or existing cybersecurity incidents. As cybersecurity incidents continue to evolve, we may be required to expend significant additional resources to continue to modify or enhance our protective measures or to investigate and remediate any information security vulnerabilities. In addition, our remediation efforts may not be successful. Moreover, there could be public announcements regarding any cybersecurity incidents and any steps we take to respond to or remediate such incidents, and if securities analysts or investors perceive these announcements to be negative, it could, among other things, have a substantial adverse effect on the price of our Ordinary Shares. There can be no assurance that our efforts will prevent service interruptions, or identify breaches in our systems, that could adversely affect our business and operations and/or result in the loss of critical or sensitive information or the illegal transfer of funds to unknown persons, which could result in financial, legal, business or reputational harm, and may harm our relationships with third parties.

During 2023, record levels of inflation resulted in significant volatility and disruptions in the global economy. In response to rising inflation, central banks in the markets in which we operate, including the United States Federal Reserve, have tightened their monetary policies and raised interest rates, and such measures may continue if there is a period of sustained heightened inflation. Higher interest rates and volatility in financial markets could lead to additional economic uncertainty or recession. Increased inflation rates have increased our and our suppliers’ operating costs, including labor costs, raw materials costs, manufacturing costs, freight costs and R&D costs. In addition to rising inflation, the global economy has also been impacted by fluctuating foreign exchange rates and geopolitical tensions, such as the ongoing conflict between Russia and Ukraine and the Israel-Hamasregional War,conflicts throughout the Middle East, which may contribute to rising energy costs and disruptions to the global supply chain. To the extent we experience any supply chain disruptions, we could experience delays in our R&D and clinical initiatives. As we have substantial international operations, fluctuations in exchange rates between the currencies in which we operate could increase our operating costs and adversely affect our results of operations and cash flows. The duration and extent of such macroeconomic developments are uncertain and we cannot accurately predict whether we will be able to effectively and timely mitigate their impact on our business.

Each of our oral peptide candidates, including EB613 and EB612,EB612 for hypoparathyroidism or other oral peptides for obesity, metabolic disorders and gastrointestinal rare diseases, are still in clinical development and face a variety of risks and uncertainties, including the following:

If we are unsuccessful in dealing with any of these risks, or if we or a potential partner are unable to successfully commercialize our oral PTH, LA-PTH, GLP-1/Glucagon , GLP-2 or any other product candidate we may develop in the future, it would likely have a material adverse effect on our business, prospects, financial condition and results of operations.

EB613 completed a six-month placebo-controlled Phase 2 double-blind, dose-ranging trial in 2021. In December 2021, we held an end-of-Phase 2 meeting with the FDA to review the six-month phase 2 results and a proposed Head-to-Head Non-Inferiority Phase 3 study protocol vs. Forteo®, our nonclinical and clinical development plan and the use of BMD, rather than fracture incidence, as the primary endpoint to support an NDA. Following our End of Phase 2 Meeting with the FDA and pursuant to the FDA’s concern that a Head-to-Head study phase 3 design may not be favorable to support an NDA for EB613, we redesigned the pivotal phase 3 study for EB613 based on the FDA’s suggestion to explore a placebo-controlled trial. A Type C meeting with the FDA in relation to Entera’s proposed Phase 3 registrational study was held in the second half of 2022 and in October 2022, the Company concluded its Type C meeting and the FDA agreed that a single Phase 3 placebo-controlled study could support an NDA submission of EB613. The FDA also agreed that Total BMD could serve as the primary endpoint of the registrational study in post-menopausal osteoporosis patients. In February 2023, we announced that a Type D meeting protocol review had been accepted by the FDA. The objective of the Type D meeting review was to confirm that the protocol fully meets FDA’s expectations, including the analysis of the primary endpoint and the population PK evaluations,evaluations to serve as the Scientific Bridge to Forteo, ahead of potential initiation of the Phase 3 study. On April 3, 2023, we reported that the FDA would not be opposed to Entera initiating the Phase 3 study under the proposed FNIH BQP SABRE BMD pathway and that the Company’s proposed PK sampling scheme seemed reasonable. On the same day, we announced that we planplanned to continue our dialogue with the FDA and await the final qualification of the SABRE qualification and FDA’s guidance on the statistical evaluation of our BMD endpoint before initiating a Phase 3 study for EB613.EB613 which has since been obtained in December 2025.

There have been changes and modifications to certain aspects of the ACA, and we expect such changes and modifications to continue. In 2017, the U.S. Congress enacted the Tax Cuts and Jobs Act, or the 2017 Tax Act, which eliminated the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate”. The Bipartisan Budget Act of 2018, or the BBA, among other things, amended the ACA, effective January 1, 2019,ACA to close the coverage gap in most Medicare drug plans. In July 2018, CMS, published a final rule permitting further collections and payments to and from certain ACA qualified health plans and health insurance issuers under the ACA risk adjustment program in response to the outcome of federal district court litigation, regarding the method CMS uses to determine this risk adjustment. Changes and modifications to the ACA are likely to continue, with unpredictable and uncertain results.

Recently, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their commercial products. There have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the cost of drugs under Medicare, and reform government program reimbursement methodologies for drugs. On September 24, 2020, the FDA released a final rule providing guidance for states to build and submit importation plans for drugs from Canada. In 2025, HHS began implementation of “Most Favored Nation” drug pricing by setting the Medicare price of single-source brand drugs without generic or biosimilar competition to the lowest price available in wealthy countries with aper capita GDP of at least 60% of that in the United States. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

On November 20, 2020, the HHS Office of Inspector General finalized further modifications to the federal Anti-Kickback Statute. Under the final rules, the HHS Office of Inspector General added safe harbor protections under the Anti-Kickback Statute for certain coordinated care and value-based arrangements among clinicians, providers, and others, yet removed safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. CMS issued a final rule, effective on July 9, 2019, that requires direct-to-consumer advertisements of prescription drugs and biological products, for which payment is available through or under Medicare or Medicaid, to include in the advertisement the Wholesale Acquisition Cost, or list price, of that drug or biological product if it is equal to or greater than $35 for a monthly supply or usual course of treatment. Prescription drugs and biological products that are in violation of these requirements will be included on a public list. On September 9, 2025, the FDA began requiring pharmaceutical advertisements to include full safety warnings during direct-to-consumer advertisements, instead of footnoting such information. Additionally, the FDA expanded its oversight on social medial promotional activities, including influencer partnerships, algorithm-driven targeted advertising, and AI-generated health content, to ensure compliance with the FDA’s advertisement requirements. The FDA has indicated it will begin enforcement actions for any advertisement violations. Any adopted health reform measure could reduce the ultimate demand for our products, if approved, or put pressure on our product pricing. Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. We expect that additional state and federal healthcare reform measures will be adopted in the future.

Our industry is highly competitive and subject to rapid and significant technological change. While we believe that our technology, drug candidates, knowledge, experience and scientific resources provide us with competitive advantages, we face competition from many different sources, including large pharmaceutical, specialty pharmaceutical, biotechnology and generic drug companies and academic and government institutions. These organizations may have significantly greater resources than we do and conduct similar research, seek and obtain patent protection that may impact our freedom to operate and establish collaborative arrangements for research, development, manufacturing and marketing of products that compete with our product candidates. We believe that the key competitive factors that will affect the development and commercial success of our oral PTH product candidates, and any other product candidates that we develop, are efficacy, safety and tolerability profile, convenience in dosing, product labeling, price and availability of reimbursement from the government and other third-parties. Our commercial opportunity could be reduced or eliminated if our competitors have products that are better in one or more of these categories. Furthermore, our competitors may, among other things, develop and commercialize products that are safer, more effective, less expensive, or more convenient or easier to administer, obtain quicker regulatory approval, establish superior proprietary positions, have access to more manufacturing capacity, implement more effective approaches to sales and marketing, or form more advantageous strategic alliances.

Our primary innovation is our development of our N-Tab™® platform which enables us to develop peptides and therapeutic protein replacement therapies in tablet form. If another company develops an alternative technology for oral delivery of such molecules in small tablet form that is equal to or better than our technology, we may be unable to compete.

The osteoporosis market is already served by a variety of competing products. Many of these existing products have achieved widespread acceptance among physicians, patients and payors for the treatment of osteoporosis. We anticipate that our product candidate EB613, if approved, will compete with other osteoanabolic drugs such as daily subcutaneous Forteo®, generic teriparatide daily subcutaneous injections, daily subcutaneous injectable Tymlos® and EVENITY® which requires monthly injections, and the rest of the pharmacological treatments for osteoporosis which include anti-resorptive agents such as the bisphosphonates and Prolia®. Many of these products are available on a generic basis, and EB613 may not demonstrate sufficient additional clinical benefits to physicians and patients or be priced adequately to support reimbursement. In many cases, insurers or other third-party payors, particularly Medicare, seek to encourage the use of generic products. Furthermore, our competitors in this market are large pharmaceutical companies and the alternatives have been on the market for many years and have widespread market acceptance. We anticipate our EB612 program to compete with marketed drugs for the treatment of hypoparathyroidism such as TransCon™ PTH and those in clinical development for hypoparathyroidism such as Eneboparatide and MBX2109. Our Oral GLP-2 Program will compete with Gattex™, the only approved GLP-2 treatment for short bowel syndrome and experimental GLP-2 injectables such as Zealand’s glepaglutide (FDA CRL 12/24) and Vectiv/ Ironwood’s apraglutide (SubmittedFDA 01demanded another phase 3 trial 04/02525). Our Oral GLP-1/Glucagon program may compete with approved GLP-1 injectables, RybelsusWegovy pill and many experimental incretin targeted injectables, oral peptide candidates and oral small molecules developed for metabolic indications.

We are exposed to potential product liability and professional indemnity risks that are inherent in the research, development, manufacturing, marketing and use of pharmaceutical products. Currently we have no products that have been approved for commercial sale ; however, the current and future use of product candidates by us in clinical trials, and the sale of any approved products in the future, may expose us to liability claims. These claims might be made by patients that use the product, healthcare providers, pharmaceutical companies, our collaborators or others selling such products. Any claims against us, regardless of their merit, could be difficult and costly to defend and could materially adversely affect the market for our product candidates or any prospects for commercialization of our product candidates. Regardless of the merits or eventual outcome, liability claims may result in:

We anticipate continuing our engagement of third parties to provide our clinical supply as we advance our product candidates into and through clinical development. We expect in the future to use third parties for the manufacture of our product candidates for clinical testing, as well as for commercial manufacture. We are in process of enteringentered into long-term supply agreements with several manufacturers for commercial supplies. We may be unable to reach agreement on satisfactory terms with contract manufacturers to manufacture our product candidates. Additionally, the facilities to manufacture our product candidates must be the subject of a satisfactory inspection before the FDA, the EMA or other regulatory authorities approve an NDA or grant a marketing authorization for the product candidate manufactured at that facility. We will depend on these third-party manufacturers for compliance with the FDA’s and EMA’s requirements for the manufacture of our finished products. We do not control the manufacturing process of, and are completely dependent on, our contract manufacturers for compliance with cGMPs. If our manufacturers cannot successfully manufacture material that conforms to our specifications and the FDA, European Commission and other regulatory authorities’ cGMP requirements, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities. In addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for, or market our product candidates, if approved, and may subject us to recalls or enforcement action for products already on the market.

We maintain our cash at financial institutions, often in balances that exceed federally insured limits.]

Our success depends in large part on our ability to obtain and maintain protection with respect to our intellectual property and proprietary technology. Our product candidates utilize our proprietary N-Tab™® technologyplatform and know-how relating to the development of oral peptides and oral protein replacement therapies in tablet form. We seek to protect our proprietary position by filing patent applications in the United States and certain foreign jurisdictions relating to our product candidates and technologies that are important to our business. This process is expensive, complex and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. If we do not adequately obtain, maintain, protect and enforce our proprietary rights in our technologies, competitors may be able to use our technologies and erode or negate any competitive advantage we may have, which could have a material adverse effect on our business and our ability to achieve profitability.

We have limited patent protection with respect to our product candidates and technologies. Our global patent portfolio includes issued patents and patent applications. We believe that the granted patents as well as certain of the pending claims contained in our patent applications, if issued in substantially the same form, would cover our proprietary technology platform (N-Tab™®) and the formulations used in various pipeline programs through 20442046 not including patent term extensions.extensions and patent term adjustments. However, we cannot be certain that patents will be issued or granted with respect to any of our pending or future patent applications, or that issued or granted patents will not later be found to be invalid or unenforceable. The patent position of pharmaceutical companies is generally uncertain because it involves complex legal and factual considerations. The standards applied by the USPTO and foreign patent offices in granting patents are not always applied uniformly or predictably, and can change. For example, there is no uniform worldwide policy regarding patentable subject matter or the scope of claims allowable in pharmaceutical or biotechnology patents. Even if our pending patent applications issue as patents, such patents may not cover our product candidates in the United States or in other countries. Accordingly, we cannot predict whether additional patents protecting our technology will issue in the United States or in non-U.S. jurisdictions, or whether any patents that do issue will have claims of adequate scope to provide us with a competitive advantage.

Competitors or other third parties may infringe or otherwise violate our patents, trademarks, copyrights or other intellectual property rights. To counter infringement or other violations, we may be required to file claims, which can be expensive and time consuming. Any such claims could provoke these parties to assert counterclaims against us, including claims alleging that we infringe their patents or other intellectual property rights. In addition, in a patent infringement proceeding, a court may decide that one or more of the patents we assert is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to prevent the other party from using the technology at issue on the grounds that our patents do not cover the technology. In any intellectual property litigation, even if we are successful, any award of monetary damages or other remedy we receive may not be commercially valuable. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. Third parties may also raise challenges to the validity of our patent claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post-grant review and inter partes review proceedings and equivalent proceedings in foreign jurisdictions such as opposition proceedings. If third parties have prepared and filed patent applications in the United States that also claim technology to which we have rights, we may have to participate in interference proceedings in the USPTO, to determine priority of invention for patent applications filed with an effective filing date, or claiming priority to an application with a filing date, before March 16, 2013, or in derivation proceedings to determine inventorship for patent applications filedclaiming priority to an application with a filing date after such date. Such proceedings could result in the revocation of, cancellation of, or amendment to our patents in such a way that they no longer cover our product candidates or provide us with any competitive advantage.

The pharmaceutical and biotechnology industries have produced a significant number of patents, and it may not always be clear to industry participants, including us, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform or predictable. There is a substantial amount of litigation involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries generally, and these lawsuits can be very time consuming and costly. If we are sued for patent infringement,infringement weby a patent owner, the patent owner would need to demonstrate that our products or methods either do not infringe the patent claims of the relevant patentpatent. We may need to defend ourselves against such an infringement action, and/or demonstrate that the patent claims are invalid, and we may not be successful in doing so. Proving invalidity is difficult. For example, in the United States, proving invalidity requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Even if we are successful in these proceedings, we may incur substantial costs and divert management’s time and attention in defending these proceedings, which could have a material adverse effect on our business.

As is the case with other pharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the pharmaceutical industry involve both technological and legal complexity. Therefore, obtaining and enforcing pharmaceutical patents is costly, time-consuming and inherently uncertain. In addition, in 2013, the United States has recently enacted wide-ranging patent reform legislation, which includes provisions that affect the way patent applications are prosecuted, redefine prior art, may affect patent litigation, and switch the U.S. patent system from a “first to invent” system to a “first inventor to file” system. The United States may enact other patent reforms in the future. It is not clear what, if any, impact such past or potential future legislation will have on the operation of our business. Additionally, the United States Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisionslegislation by the U.S. Congress,government, decisions by the federal courts, and interpretations/implementation by the USPTO, the laws and regulations governing patents could change in unpredictable ways that could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of any U.S. patents that may issue to us in the future, all of which could have a material adverse effect on our business and financial condition.

We currently have relationships with different consultants who perform research and development activities for us and who are not employed by us,us , and we may enter into additional relationships of such nature in the future. We have limited control over the activities of these consultants and can expect only limited amounts of their time to be dedicated to our activities. These persons may have consulting, employment or advisory arrangements with other entities that may conflict with or compete with their obligations to us. We typically require our consultants to sign agreements that require such consultants to treat our proprietary information and results of studies as confidential. However, in connection with each such relationship, we may not be able to maintain the confidentiality of our technology, the dissemination of which could hurt our competitive position and results of operations. To the extent that our scientific consultants develop inventions or processes independently that may be applicable to our product candidates, disputes may arise as to the ownership of the proprietary rights to such information, and we may expend significant resources in such disputes and we may not win those disputes.

We are currently in the process of registering the trademark N-Tab™® for our oral platform technology,platform, globally. As of March 15,23, 20252026, N-Tab™® is registered in Israel and pending in the United States, Europe, Japan, Great Britain, Canada, Brazil, Norway, China, Australia,China and Switzerland.Australia. In the future, our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition by potential collaborators or customers in our markets of interest. Any unauthorized use of these trademarks could harm our reputation or commercial interests. In addition, our enforcement against third-party infringers or violators may be unduly expensive and time-consuming, and the outcome may be an inadequate remedy. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected.

We qualify as a “smaller reporting company,” and we expectare to taketaking advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not smaller reporting companies, including reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements. In addition, we qualify as a “non-accelerated filer,” and we expect to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not non-accelerated filers, including the auditor attestation requirements of Section 404.

We are required to disclose changes made in our internal controls and procedures and our management is required to assess the effectiveness of these controls annually. However, for as long as we are a non-accelerated filer, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal controls over financial reporting pursuant to Section 404. An independent assessment of the effectiveness of our internal controls could detect problems that our management’s assessment might not. Undetected material weaknesses in our internal controls could lead to financial statement restatements and require us to incur the expense of remediation.

These restrictions may impair our ability to sell our technology assets or to perform or outsource manufacturing outside of Israel, engage in change of control transactions or otherwise transfer our IIA-related know-how outside of Israel and may require us to obtain the approval of the IIA for certain actions and transactions and pay additional royalties and other amounts to the IIA. In addition, any change of control and any change of ownership of our Ordinary Shares that would make a non-Israeli citizen or resident an interested party, as defined in the Israeli Securities Law, 5728-1968, as amended, requires written notice to the IIA, and our failure to comply with this requirement could result in monetary fines. Such non-Israeli interested parties, which include 5% shareholders and shareholders who have the right to appoint a director to the Board, are required to sign an undertaking towards the IIA in which they would undertake to comply with the Research Law. Notice or undertaking to the IIA may not be required in respect of purchase of Ordinary Shares in standard acquisition or tradingmarket in the stock exchangepurchases following to an IPO that was approved by the IIA.

Our principal research facilities are located in Israel. In addition, most of our key employees, officers and two directors are residents of Israel. Accordingly, political, economic and military conditions in the Middle East may affect our business directly. Since the establishment of the State of Israel in 1948, a number of armed conflicts have occurred between Israel and its neighboring countries, Hamas (an Islamist militia and political group in the Gaza Strip), Hezbollah (an Islamist militia and political group in Lebanon), and Iran.

In addition, since April 2024, Israel has experienced direct attacks from Iran, involving hundreds of drones and ballistic missiles launched towards mostly densely populated civilian towns across Israel and some military bases, threatening continued aggression while also exerting considerable influence over regional militia groups encouraging them to launch attacks against Israel. The Israeli defense systems, aided by international allies, successfully intercepted the majority of the ballistic missile attacks, minimizing physical damage and casualties. Additionally, since October 2023, the Houthis, a military organization based in Yemen, have launched a series of attacks on global shipping routes in the Red Sea, as well as direct attacks on various parts of Israel. Such incidents contribute to regional instability and could potentially escalate into broader conflicts with Iran and its proxies in the Middle East, affecting Israel'sIsrael’s political and trade relations, especially with neighboring countries and global allies. The situation remains fluid, and the potential for further escalation exists. In October 2024, Israel initiated both air and ground operations against Hezbollah in Lebanon, culminating in a ceasefire agreement between Israel and Lebanon on November 27, 2024, the results of which areremain uncertain. In response to ongoing Iranian aggression and support of proxy attacks against Israel, on June 12, 2025, Israel conducted a series of preemptive defensive air strikes in Iran targeting Iran’s nuclear program and military commanders. On June 21, 2025, U.S. President Donald Trump announced that the United States had conducted air strikes against three nuclear sites within Iran. On October 9, 2025, a ceasefire had been reached. Israel, Hamas, the United States and other countries in the region agreed to a framework for a ceasefire in Gaza between Israel and Hamas.

Additionally, political uprisings, social unrest and violence in various other countries in the Middle East, including Israel’s neighboring countries Syria, Lebanon, Egypt and Jordan, are affecting the political stability of those countries. This instability may lead to deterioration of the political relationships that exist between Israel and certain countries and have raised concerns regarding security in the region and the potential for a broader regional armed conflict. Since February 2026, there has been a significant escalation in hostilities involving the U.S., Israel, Iran and several other countries in the middle east, including direct military exchanges. These developments have increased regional instability and may further escalate into more severe and prolonged hostilities, which could affect Israel and us. Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading partners could have a material adverse effect on our business. Although such hostilities did not have a material adverse impact on our business in the past, we cannot guarantee that hostilities will not be renewed and have such an effect in the future. These or other Israeli political or economic factors could harm our operations and product development. Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading partners could adversely affect our operations. In light of the intensity of the ongoing Israel-Hamas War, the escalation of Hezbollah'sHezbollah’s and Iran’s attack of Israeli civilian and military sites, in September 2024, the international rating agency Moody'sMoody’s downgraded Israel'sIsrael’s credit rating from A2‘A2’ to Baa1,‘Baa1’, reflecting heightened geopolitical risks. In July 2025, this downgrade was affirmed by Moody's. On November 7, 2025, S&P Global Ratings affirmed Israel’s credit ratings as ‘A’ after lowering from ‘A+’ on October 1, 2025, and updated the outlook from negative to stable. In January 2026, Moody's affirmed Israel’s sovereign rating at “Baa1” but changed the outlook from “negative” to “stable”. This lowered credit rating, as well as the ongoing war and conflicts described above, could make it more difficult for us to raise capital, if needed, and negatively influence the market price of our Ordinary Shares. We could experience disruptions if acts associated with such conflicts result in any serious damage to our facilities.

Our employees in Israel, including executive officers, generally, may be called upon to perform military reserve duty until they generally reach the age of 40 or 45 (or older in some casescases, depending on rank, the nature of the service, and other factors). In response to the Hamas attack on October 7, 2023, and the following hostilities, the Israeli government declared that the country was at war and the Israeli military began to call-up reservists for active duty. To date, several employees were called for duty, and it is possible that there will be further or longer military reserve duty call-ups in the future, which may affect our business due to a shortage of skilled labor and loss of institutional knowledge, and necessary mitigation measures we may take to respond to a decrease in labor availability, such as overtime and third-party outsourcing, which may materially adversely affect our operations, business and results of operations. Our operations could also be disrupted by the absence of a significant number of our employees related to military service or the absence for extended periods of one or more of our key employees for military service in connection with other military and security matters.

The U.S. dollar is both our functional and reporting currency. As a result, our results of operations may be adversely affected by exchange rate fluctuations between the U.S. dollar and the NIS. A significant portion of the expenses associated with our Israeli operations, including personnel and facilities related expenses, are incurred in NIS. Consequently, inflation in Israel will have the effect of increasing the cost of our operations in Israel unless it is offset on a timely basis by a devaluation of the NIS relative to the U.S. dollar. In addition, if the value of the U.S. dollar decreases against the NIS, our earnings may be negatively impacted. Moreover, exchange rate fluctuations in currency exchange rates in countries other than Israel where we operate, perform our clinical trials or conduct business may also negatively affect our earnings and results of operations. We cannot predict any future trends in the rate of inflation or deflation in Israel or the rate of devaluation or appreciation of the NIS against the U.S. dollar. If the dollar cost of our operations in Israel increases, our dollar-measured results of operations will be adversely affected. For example, in 2025, the value of the NIS increased against the U.S dollar by 14%, which was potentially computed by inflation in Israel of 2.6%. In 2024, the value of the NIS increased against the U.SU.S. dollar by 0.55%, which was potentially computed by inflation in Israel of 3.5%. In 2023, the value of the NIS depreciated against the U.S. dollar by 3.1%, which was potentially computed by inflation in Israel of 3%. As a result of these fluctuations, our NIS denominated expenses were affected.

Business 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/Glucagon 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.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 peptides and 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.stream. We leverage our N-Tab™® platformplatform, which is designed to simultaneously stabilize thelarge peptide(4kD+) hydrophilic peptides in the gastrointestinal tract and promote itstheir absorption into the bloodstream.

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 progressiondisease of the disease,progression, and its associateddecrease 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 phasePhase 2 data was published in the Journal of Bone and Mineral Research (JBMR).

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.Biologics. 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.platform.

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.program.. 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.

In 2011, we entered into a patent transfer agreement with Oramed Ltd. (“Oramed”), which we refer to as the Patent Transfer Agreement with Oramed,Agreement, pursuant to which Oramed assigned to us all of its rights, title and interest in the patent rights that Oramed licensed to us when we were originally organized, subject to a worldwide, royalty-free, exclusive, irrevocable, perpetual and sub-licensable license granted to Oramed under the assigned patent rights to develop, manufacture and commercialize products or otherwise exploit such patent rights in the fields of diabetes and influenza. Additionally, we agreed not to engage, directly or indirectly, in any activities in the fields of diabetes and influenza that involve the use of, or utilize, the patents underlying the Patent Transfer Agreement. Under the terms of the Patent Transfer Agreement, we agreed to pay Oramed royalties equal to 3% of our net revenues generated, directly or indirectly, from our exploitation of the assigned patent rights, including the sale, lease or transfer of the assigned patent rights or sales of products or services covered by the assigned patent rights. On March 27, 2025, we entered into a Novation Agreement with Oramed, and Oramed NewCo Inc. ("Oramed NewCo") pursuant to which Oramed NewCo replaced Oramed as a party to the Patent Transfer Agreement. Under the Novation Agreement, Oramed NewCo assumed all of Oramed's rights and obligations under the Patent Transfer Agreement accruing on or after the effective date, Oramed was released from any obligations and liabilities owed to us under the Patent Transfer Agreement accruing or arising after such date, and we were released from any obligations and liabilities owed to Oramed accruing or arising after such date. All other provisions of the Patent Transfer Agreement remain in full force and effect.

The amount that must be repaid may be increased up to six times the amount of the grant received and the interest. The rate of royalties may be accelerated and the royalty liability may increase (up to three times the amount of the grant amount and the interest), if manufacturing of the products developed with the grant money is transferred outside of the State of Israel. Moreover, a payment of up to 600% of the grant received may be required upon the transfer of any IIA-related know-how to a non-Israeli entity. We signed a contract with a U.K.-based contract manufacturing organization to produce and supply pills for trials performed worldwide. We believe that, because this production is not for commercial purposes, it will not affect the royalty rates to be paid to the IIA. Should the IIA successfully take a contrary position, the maximum royalties to be paid to the IIA will be approximately $1.5 million, which is three times the amount of the original grant (plus interest on the entire increased amount). Under a collaboration agreement that was previously mutually terminated in May 2023, from 2019 through March 31, 2023, we recognized an aggregate amount of $1.7 million of revenue in accordance with ASC 606, “Revenues from Contracts with Customers” With respect to revenue generated from the collaboration agreement. Prior to its termination, we had been required to pay to the IIA 5.38% of each payment made to us under such collaboration agreement with an ultimately liability of up to 600% of the grant received plus interest. As of December 31, 2024,2025, we had paid royalties to the IIA in the amount of $96 thousand.

Israel-Hamas War and Regional Conflicts

Research and development expenses consist of costs incurred for the development of our N-Tab™ technology® platform technology and our product candidates,candidates. including:We expense both internal and external research and development expenses to operations for the periods in which they are incurred. We mapped the majority of external research and development costs incurred for our product candidates and development programs.

Research and development activities are theour primary focus of our business.focus. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses will increase significantly in future periods as we advance our clinical candidates into later stages of clinical development and invest in additional preclinical candidates.

Our research and development expenses may vary substantially from period to period based on the timing of our research and development activities, including due to the timing of initiation of clinical trials and the enrollmentenrolment of patients in clinical trials. For the years ended December 31, 20242025 and 2023,2024, our research and development expenses were $4.5$6.0 million and $4.5 million, respectively. Research and development expenses for the yearsyear ended December 31, 2024 and 20232025 were primarily for the development of EB613 and next-generation of EB613, EB612 and our collaboration with OPKO related to GLP-2 and OXM. The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing and estimated costs of the efforts that will be necessary to complete the development of, or the period, if any, in which material net cash inflows may commence from,from any of our product candidates. This is due to numerous risks and uncertainties associated with developing drugs, including:

On April 16, 2026, following direct talks between Israeli and Lebanese officials in Washington, D.C., a 10-day cessation of hostilities between Israel and Lebanon was announced, brokered by the United States. TheOn partiesJune have26, requested2026, thatfollowing further U.S.-brokered negotiations, Israel, Lebanon and the United States facilitatesigned furthera directtrilateral negotiationsframework withagreement providing for the objectivedisarmament of achievingHezbollah by the Lebanese Armed Forces, beginning in designated pilot zones, and a comprehensivephased agreementwithdrawal forof lastingIsraeli securityforces andfrom peace.southern Lebanon. Implementation has been limited to date, Israeli forces remain stationed in southern Lebanon and Hezbollah has not accepted the terms as binding, stating that its fighters will remain deployed and will respond to any violations. The ceasefirearrangement remains fragile, with reports of continued military operations by both sides in southern Lebanon.

Additionally, political uprisings, social unrest and violence in various other countries in the Middle East, including Israel’s neighboring countries Syria, Lebanon, Egypt and Jordan, are affecting the political stability of those countries. This instability may lead to deterioration of the political relationships that exist between Israel and certain countries and have raised concerns regarding security in the region and the potential for a broader regional armed conflict. Since February 2026, there has been a significant escalation in hostilities involving the U.S., Israel, Iran and several other countries in the middleMiddle east,East, including direct military exchanges.exchanges, which resumed in July 2026 following the breakdown of the June 2026 ceasefire. In addition, the ceasefire framework in Gaza remains in place but implementation of its later phases has stalled, and the Houthis have renewed threats against commercial shipping in the Red Sea. These developments have increased regional instability and may further escalate into more severe and prolonged hostilities, which could affect Israel and us.

Entera is a clinical stage company focused on developing first-in-class oral tablet formats of peptides or protein replacement therapies.peptides. 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 differentiated, first-in-class oral peptide programs targeting PTH(1-34), GLP-1/Glucagon and GLP-2.

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 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 diseaseprogression progression,of the disease, and decreaseits 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 (bone mineral density (“BMD”)). In April 2024, the Phase 2 data was published in the Journal of Bone and Mineral Research (JBMR).

In July 2025, we announced thatthat, in a written response to a Type A meeting request, the FDA agreed that aan new drug application (“NDA”) filing for EB613 could be supported by a phase 3 study in women with postmenopausal osteoporosis, where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures is evaluated as the key secondary endpoint at 24 months.

In December 2025, the FDA released the Determination for Qualification of BMD qualifying total hip BMD as a surrogate efficacy endpoint for fracture that could be used in future studies of new anti-osteoporosis therapies. The FDA’s suggested a context of use (COU): “The percentage change from baseline at 24 months in total hip bone mineral density (BMD) assessed by dual-energy X-ray absorptiometry (DXA) can be used as a validated surrogate endpoint for the assessment of investigational therapies for postmenopausal women with osteoporosis at risk for fracture.”

In February 2026, we submitted to the FDA a clinical amendment that included thea streamlined EB613 Phase 3 protocol,protocol to evaluate the percentage change in total hip BMD from baseline to month 12 as the primary endpoint, statistical analysis plan and open-label extension synopsis. Subject to regulatory feedback, we are planning to initiate the Phase 3 study in the second half of 2026.

In February 2026, we announced the expansion of our collaboration with OPKO Biologics, Inc. (“OPKO Biologics”), a subsidiary of OPKO Health, Inc. (“OPKO”), and OPKO to jointly advance this LA-PTH program. Under the expanded collaboration, Entera and OPKO each hold a 50% pro-rata ownership interest in the LA-PTH hypoparathyroidism program, and each is responsible for 50% of development costs. We intend to accelerate development and currently expect to submit an IND application to the FDA in late 2026.

The EB618 program focuses on developing the first oral dual agonist GLP-1/Glucagon (OXM) peptide as a potential once-daily tablet treatment for patients with obesity and metabolic disorders using the N-Tab® platform. Currently,Oxyntomodulin there(OXM) areis noa approvednaturally occurring dual GLP-1/Glucagonglucagon agonistsreceptor available.agonist hormone that regulates appetite and glucose metabolism and promotes weight loss, with additional cardioprotective and anti-fibrotic properties; its therapeutic potential as a native hormone is limited by a short plasma half-life. Currently, there are no approved dual GLP-1/Glucagon agonists available.

OPKO is planning to initiate a single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1 clinical study with the subcutaneous injection formulation in 2027. We plan to filedetermine annext INDsteps of the clinical development plan for the oral OXM tabletbased formulationon thereafter.the outcomes of that study.

In connection with the 2023 Collaboration AgreementAgreement, we and OPKO completed proof-of-concept pharmacokinetic studies in rodents and minipigs. Oral GLP-2 tablets exhibited significant systemic exposure with plasma levels about 10-fold higher than therapeutic plasma concentrations reported for subcutaneously administered teduglutide (Gattex® label). Rodent repeat-dose PK/PD studies showed clear pharmacologic activity in intestinal tissue. Systemic exposure was maintained for more than 24 hours with relatively low variability, supporting once-daily oral dosing.

In September 2023, we entered into the 2023 Collaboration Agreement with OPKO Biologics. 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® platform. 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 feasibilityfeasibility.

The amount that must be repaid may be increased up to six times the amount of the grant received and the interest. The rate of royalties may be accelerated and the royalty liability may increase (up to three times the amount of the grant amount and the interest), if manufacturing of the products developed with the grant money is transferred outside of the State of Israel. Moreover, a payment of up to 600% of the grant received may be required upon the transfer of any IIA-related know-how to a non-Israeli entity. We signed a contract with a U.K.-based contract manufacturing organization to produce and supply pills for trials performed worldwide. We believe that, because this production is not for commercial purposes, it will not affect the royalty rates to be paid to the IIA. Should the IIA successfully take a contrary position, the maximum royalties to be paid to the IIA will be approximately $1.5 million, which is three times the amount of the original grant (plus interest on the entire increased amount). Under a collaboration agreement that was previously mutually terminated in May 2023, from 2019 through March 31, 2023, we recognized an aggregate amount of $1.7 million of revenue in accordance with ASC 606, “Revenues from Contracts with Customers” with respect to revenue generated from the collaboration agreement. Prior to its termination, we had been required to pay to the IIA 5.38% of each payment made to us under such collaboration agreement with an ultimately liability of up to 600% of the grant received plus interest. As of MarchJune 31,30, 2026, we had paid royalties to the IIA in the amount of $96 thousand.

AprilJuly 2026 Private Placement

On AprilJuly 1,26, 2026, we entered into a securities purchase agreement (the “July 2026 Purchase Agreement”) with certain institutional and accredited investors, including funds affiliated with BVF Partners LPL.P. (collectively, the “PurchaserBVF”), providing for the private placement (the “AprilJuly 2026 Private Placement”) to the Purchaser of an aggregate of 7,916,879 units (the “2026 Units”), each 2026 Unit consisting of (i) one134,803,910 Ordinary ShareShares, (or, in lieu thereof, one pre-funded warrantwarrants to purchase one Ordinary Share (the “2026 Pre-Funded Warrants”)) and (ii) one warrant to purchase one and one-half Ordinary Shares (the “July 2026 Ordinary SharePre-Funded Warrants”), at a purchase price of $2.04 per Ordinary Share, for aggregate gross proceeds of approximately $10.0$275.0 millionmillion, (orbefore $1.2775deducting perplacement 2026agent Unit).fees and other related offering expenses. On AprilJuly 2,28, 2026 (the “Closing Date”), the Companywe issued 2,425,000122,961,215 Ordinary Shares,Shares 5,402,789and July 2026 Pre-Funded Warrants,Warrants andto 11,741,683purchase 202611,842,695 Ordinary Share Warrants in connection with the April 2026 Private Placement.Shares.

Israel-Hamas War and Regional ConflictsConflict

The Company’s research personnel and management personnel are located in Israel, however other core activities including clinical, regulatory and supply chain are located outside of Israel. Currently, such activities in Israel remain largely unaffected. During the three and six months ended MarchJune 31,30, 2026 and MarchJune 31,30, 2025, the impact of this war on the Company’s results of operations and financial condition was immaterial. See Item 1.A. “Risk Factors—Security, political and economic instability in the Middle East may harm our business.”

From our inception through MarchJune 31,30, 2026, we have raisedfinanced aour totaloperations ofprimarily $111.8 million fromthrough a combination of public and private equity offerings, grants from the IIA grants and the issuance of Ordinary Shares upon the exercise of options and warrants. SinceThrough inception,June 30, 2026, we havehad incurredraised significantan losses.aggregate Forof theapproximately three months ended March 31, 2026 and 2025, our operating losses were $3.5$121.8 million andfrom $2.6these million, respectively, and we expect to continue to incur significant expenses and losses for the foreseeable future.sources.

As of MarchJune 31,30, 2026, we had an accumulated deficit of $128.9$136.2 million. Our lossesoperating results may fluctuateincrease significantly from quarterperiod to quarter and year to year,period depending onon, among other things, the timing and progress of our clinical trials, our expenditures on research and development activitiesactivities, manufacturing activities, regulatory interactions, strategic collaborations and any third-party collaborations into which we may enter.

As of MarchJune 31,30, 2026, we had a total of 22 employees, of whom 20 are full-time employees, and all are based in Israel. In addition, we employ a number of specialized clinical, non-clinical, statistical, regulatory and development advisors based in the United States, the United Kingdom and Europe. Our operations are located in Jerusalem, Israel.

Our research and development expenses may vary substantially from period to period based on the timing of our research and development activities, including due to the timing of initiation of clinical trials and the enrolment of patients in clinical trials. For the three months ended MarchJune 31,30, 2026 and 2025, our research and development expenses were $2.3$3.2 million and $1.1$1.5 million, respectively. For the six months ended June 30, 2026 and 2025, our research and development expenses were $5.5 million and $2.6 million, respectively. Research and development expenses for the three and six months ended MarchJune 31,30, 2026 were primarily for the development of the EB613 and the next-generation of EB613program and our collaboration with OPKO related to the EB612 (LA-PTH) and EB618 (OXM) and EB612 (LA-PTH) programs. The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing and estimated costs of the efforts that will be necessary to complete the development of, or the period, if any, in which material net cash inflows may commence from any of our product candidates. This is due to numerous risks and uncertainties associated with developing drugs, including:

Our research and development expenses for the three and six months ended MarchJune 31,30, 2026 and MarchJune 31,30, 2025 are summarized as follows:

Financial Income,Expenses (Income), Net

Financial income,expenses (income), net is composed primarily of changes in fair value of the April 2026 Pre-Funded Warrants classified as a financial liability, interest income from bank deposits and exchange rate differences of certain currencies against our functional currency, which is the U.S. Dollar.

We have not generated taxable income since our inception, and, as of MarchJune 31,30, 2026, we had carryforward tax losses of $93.9$96.4 million.

The Company’s subsidiary, Entera Bio, Inc., is taxed separately under U.S. tax laws. As of MarchJune 31,30, 2026, Entera Bio Inc. had tax loss carryforwards of $0.2 million.

Comparison of Three Months Ended MarchJune 31,30, 2026 and 2025