What changed in this filing

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Item 1A. Risk Factors

2026-03-27 compared with 2025-03-28 · 93 added, 97 removed, 1020 unchanged (16% of the section changed)

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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 and our collaboration with OPKO related to GLP-2 and OXM.

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 operations into 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.

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.

Any delay or our inability to secure such funding will delay or prevent the commencement of these studies.

We believe our existing cash resources will be sufficient to meet our projected operating requirements into the third quarter of 2026 without additional funding.

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.

These factors raise substantial doubt as to the Company's ability to continue as a going concern.

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.

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.

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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 working 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 and negative cash flows from operating activities since inception.

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.

These factors raise substantial doubt as to the Company’s ability to continue as a going concern.

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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.

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.

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.

Any delay or our inability to secure such funding will delay or prevent the commencement of these studies.

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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 ongoing development activities and funding of the program.

Furthermore, the expenses related to collaborative research with a third party for hypoparathyroidism are funded by that collaborator.

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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We will require substantial additional funding, which may not be available to us on acceptable terms, or at all, and, if not available, may require us to delay, reduce or cease our product development activities and operations.

We are currently planning and preparing to initiate a phase 3 study for our most advanced product candidate, EB613, pending FDA’s qualification of the SABRE BMD endpoint.

We are currently planning and preparing to initiate a phase 3 study for our most advanced product candidate, EB613, following the FDA’s feedback on our phase 3 protocol submission.

Developing therapeutics, including conducting preclinical studies and clinical trials, is expensive.

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Many of these factors are outside of our control.

Given our current plans, we believe that we will be able to fund our operations into 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.

Given our current plans, we believe that we will be able 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 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.

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Our ability to generate future revenue and value from product sales depends heavily on our success in many areas, including but not limited to:

the completion of future development efforts for EB613, EB612 or other product candidates;

• the completion of future development efforts for EB613 for osteoporosis and EB612 for hypoparathyroidism, other oral peptides for obesity, metabolic disorders and gastrointestinal rare diseases, or any other product candidates;

• securing additional funding as may be needed to continue the development of EB613 or any other product candidates;

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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, EB613 may compete with marketed drugs, such as Prolia®, bisphosphonates, Forteo®, Tymlos®, Evenity®, and osteoanabolic drugs in clinical development for osteoporosis;

Our most advanced 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 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 (Submitted 01/025).

Our Oral GLP-1/Glucagon program may compete with approved GLP-1 injectables, Rybelsus and experimental incretin targeted injectables and oral small molecules and potential oral peptide candidates in the metabolic indications we pursue..

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 (FDA has required another phase 3 trial 04/25)).

Our Oral GLP-1/Glucagon program may compete with approved GLP-1 injectables, Wegovy pill, and experimental incretin targeted injectables and oral small molecules and potential oral peptide candidates in the metabolic indications we 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.

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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, 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.

Our initial product candidates combine our oral 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.

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 obtain 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 drug delivery technology to other peptides for other indications as we have to GLP-2 and GLP-1/Glucagon , 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.

If we are not successful in obtaining regulatory approval for them or successfully commercialize them, our business and prospects may be severely limited.

Even if we are successful in expanding our technology platform to other peptides for other indications as we have to 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.

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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, the 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.

The 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.

Additionally, the FDA and foreign regulatory agency regulations require that we report certain information about adverse medical events if our products may have caused or contributed to those adverse events.

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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 with many innovations, artificial intelligence (or “AI”) presents risks, challenges, and unintended consequences that could affect its adoption, and therefore our business.

AI algorithms and training methodologies may be flawed, ineffective or inadequate.

The rapid evolution of AI, particularly the anticipated government regulation of AI, could require significant resources for compliance, whether in the development, testing or maintenance of such systems or software.

AI development or deployment practices by us or third-party providers could increase vulnerability to cybersecurity risks and require additional resources to implement heightened cybersecurity measures to protect the security of our data.

These deficiencies and other failures of any potential AI systems could subject us to competitive harm, regulatory action, legal liability, and brand or reputational harm.

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.

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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-Hamas War, which may contribute to rising energy costs and disruptions to the global supply chain.

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 regional 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.

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• the approval policies or regulations of such authorities may significantly change in a manner rendering our or any of our future development partners’ clinical data insufficient for approval.

Each of our oral peptide candidates, including EB613 and EB612, are still in clinical development and face a variety of risks and uncertainties, including the following:

Each of our oral peptide candidates, including EB613 and 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:

• future clinical trial results may show that our oral PTH is not effective, including if our platform is not effective, our product candidates are not effective, our clinical trial designs are flawed, or clinical trial investigators or subjects do not comply with trial protocols;

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• our competitors may develop therapeutics or other treatments that are superior to or less costly than our own with the result that our products, even if they are successfully developed, manufactured and approved, may not generate significant revenues.

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, 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.

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.

In addition, before we can submit an application for regulatory approval in the United States, we must conduct a pivotal trial that will be substantially broader than our completed Phase 2 trials in osteoporosis and hypoparathyroidism (with the earlier formulation of EB612).

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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, ahead of potential initiation of the Phase 3 study.

In February 2023, we announced that a Type D meeting 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 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 plan 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.

In addition, with respect to EB612, we have since developed what we believe could be an improved formulation of EB612 based on new intellectual property, tailored to optimize its PK profile and the potential for reduced daily dosing.

We initiated a PK study in May 2023, which is testing various potential drug candidates based on our new platform, including several which could be developed for the treatment of hypoparathyroidism.

We are also collaborating on an undisclosed peptide for this indication using our N-Tab™ Technology.

On the same day, we announced that we planned 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 which has since been obtained in December 2025.

On July 28, 2025, we announced that in a written response to a Type A meeting request, the FDA agreed with our proposal that the NDA filing for EB613 would be supported by a single multinational, randomized, double-blind, placebo-controlled, 24-month 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.

In December 2025, the FDA broad qualification of total hip bone mineral density (BMD) as a validated efficacy regulatory endpoint for novel drugs in development for post-menopausal women at risk for osteoporotic fracture.

In February 2026, we submitted a clinical amendment to the FDA providing a streamlined Phase 3 protocol, statistical analysis plan (SAP), and open-label extension synopsis to the IND 505(b)(2) submission.

We anticipate FDA feedback within 60 days.

In addition, with respect to EB612, in December 2025, we announced new in vivo PK/PD data supporting the development of a proprietary long-acting PTH (LA-PTH) analog utilizing our N-Tab ® platform.

These data support the development of a once-daily oral PTH tablet for patients with hypoparathyroidism.

Following the results, we expanded our collaboration with OPKO to jointly advance this LA-PTH program.

We intend to accelerate development and currently expect to submit an IND application to the FDA in late 2026.

Drug development is a long, expensive and uncertain process, and delay or failure can occur at any stage of any of our clinical trials for a number of reasons including:

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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, to close the coverage gap in most Medicare drug plans.

The Bipartisan Budget Act of 2018, or the BBA, among other things, amended the 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.

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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.

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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.

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• the federal False Claims Act imposes civil penalties, and provides for civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

• the Civil Monetary Penalty Act of 1981 imposes penalties against any person or entity that, among other things, is determined to have presented or caused to be presented a claim to a federal health care program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent, or offering or transferring remuneration to a federal health care beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier.

These penalties include monetary fines ranging from $2,670 and $127,973 per violation and exclusion from participation in a federal health care program such as Medicare and Medicaid, meaning that items and services provided by excluded entities are not directly or separately billable to federal health care programs;

• HIPAA imposes criminal and civil liability for executing a scheme to defraud any health care benefit program or making false statements relating to health care matters.

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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.

We believe that the key competitive factors that will affect the development and commercial success of our product candidates, 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.

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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-1/Glucagon program may compete with approved GLP-1 injectables, Rybelsus and many experimental incretin targeted injectables, oral peptide candidates and oral small molecules developed for metabolic indications.

Our Oral GLP-1/Glucagon program may compete with approved GLP-1 injectables, Wegovy pill and many experimental incretin targeted injectables, oral peptide candidates and oral small molecules developed for metabolic indications.

We are subject to manufacturing risks that could substantially increase our costs and limit supply of our products.

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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 entering 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.

We entered into long-term supply agreements with several manufacturers for commercial supplies.

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.

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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™ technology and know-how relating to the development of oral peptides and oral protein replacement therapies in tablet form.

Our product candidates utilize our proprietary N-Tab ® platform 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.

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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 2044 not including patent term extensions.

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 2046 not including patent term 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.

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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 before March 16, 2013, or in derivation proceedings to determine inventorship for patent applications filed after such date.

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 claiming 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.

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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, we would need to demonstrate that our products or methods either do not infringe the patent claims of the relevant patent or that the patent claims are invalid, and we may not be successful in doing so.

If we are sued for patent infringement by a patent owner, the patent owner would need to demonstrate that our products or methods infringe the patent claims of the relevant patent.

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.

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Therefore, obtaining and enforcing pharmaceutical patents is costly, time-consuming and inherently uncertain.

In addition, 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.

In addition, in 2013, the United States 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.

It is not clear what, if any, impact such legislation will have on the operation of our business.

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 decisions by the U.S.

Congress, the federal courts, and 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.

Depending on legislation by the U.S.

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.

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If trademarks and trade names related to our product candidates are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

We are currently in the process of registering the trademark N-Tab™ for our oral platform technology, globally.

As of March 15, 2025 N-Tab™ is registered in Israel and pending in the United States, Europe, Japan, Great Britain, Canada, Brazil, Norway, China, Australia, and Switzerland.

We are currently in the process of registering the trademark N-Tab ® for our oral platform, globally.

As of March 23, 2026, N-Tab ® is registered in Israel and pending in the United States, Europe, Great Britain, Norway, China and 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.

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the success or failure of our licensees to develop, obtain approval for and commercialize our licensed products, for which we are entitled to contingent payments and royalties;

the publication of the results of preclinical or clinical trials for EB613, EB612 or any other oral peptide product candidates we may develop, including the oral GLP-2 and OXM programs we are developing with OPKO;

the publication of the results of preclinical or clinical trials for EB613, EB612 or any other oral peptide product candidates we may develop, including the programs we are developing with OPKO;

the failure by us to achieve a publicly announced milestone;

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the limited trading volume of our Ordinary Shares;

general economic and market conditions, including factors unrelated to our industry or operating performance, such as the duration and intensity of the ongoing Israel-Hamas War, and other geopolitical tensions.

general economic and market conditions, including factors unrelated to our industry or operating performance, such as political and economic instability in the Middle East.

In addition, broad market and industry factors may materially affect the market price of companies’ stocks, including ours, regardless of actual operating performance.

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We are a smaller reporting company and non-accelerated filer, and our compliance with the reduced reporting and disclosure requirements applicable to smaller reporting companies and non-accelerated filers could make our Ordinary Shares less attractive to investors and may make it more difficult to raise capital as and when we need it.

We qualify as a “smaller reporting company,” and we expect to take 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.

We qualify as a “smaller reporting company,” and we are taking 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.

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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.

However, 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.

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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 trading in the stock exchange following to an IPO that was approved by the IIA.

Notice or undertaking to the IIA may not be required in respect of purchase of Ordinary Shares in standard acquisition or market purchases following an IPO that was approved by the IIA.

These restrictions will continue to apply even after we have repaid the full amount of the grants and the interest.

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Our principal research facilities are located in Israel.

In addition, most of our key employees, officers and directors are residents of 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.

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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 are 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.

On February 28, 2026, following the breakdown of diplomatic efforts and heightened regional tensions, the United States and Israel conducted a series of preemptive strikes targeting Iranian military infrastructure and strategic assets.

Immediately thereafter, Iran launched extensive retaliatory ballistic missile and drone attacks against multiple locations across Israel, including central and southern population centers, critical infrastructure facilities and military installations.

On March 2, 2026, Hezbollah resumed hostilities, ending the November 2024 ceasefire, by launching projectiles into northern Israel, prompting Israeli airstrikes in Lebanon targeting Hezbollah operatives and assets.

Since the outbreak of these hostilities, Israel has implemented nationwide emergency measures, including restrictions on public gatherings and large-scale reserve duty call-ups affecting the civilian workforce.

How long and how severe the current conflicts in Gaza, Northern Israel, Lebanon, Iran or the broader region become is unknown at this time and any continued clash among Israel, Hamas, Hezbollah, Iran or other countries or militant groups in the region may escalate in the future into a greater regional conflict.

While we have a few employees who are in active military service, the ongoing war, the escalation of Hezbollah’s attacks on Northern Israel, and the direct offensives from Iran and its proxies have not, to date, materially impacted our business or operations.

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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 armed conflict Iran is also believed to have a strong influence over various proxy militias across the Middle East, and among the Hamas and Hezbollah, in addition to its readiness to engage in conflict with Israel directly.

These situations may potentially escalate in the future into more violent events which may affect Israel and us.

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.

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In light of the intensity of the ongoing Israel-Hamas War, the escalation of Hezbollah’s and Iran’s attack of Israeli civilian and military sites, in September 2024, the international rating agency Moody’s downgraded Israel’s credit rating from ‘A2’ to ‘Baa1’, reflecting heightened geopolitical risks.

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.

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 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 operations may be disrupted by the obligations of personnel to perform military service.

Our employees in Israel, including executive officers, generally, may be called upon to perform military reserve duty until they generally reach the age of 45 (or older in some cases).

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 cases, 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.

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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 2023, the value of the NIS depreciated against the U.S.

In 2024, the value of the NIS increased against the U.S.

dollar by 0.55%, which was potentially computed by inflation in Israel of 3.5%.

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The perceived uncertainties as to our future direction also could affect the market price and volatility of our securities.

UNRESOLVED STAFF COMMENTS.

CYBERSECURITY.

We recognize the importance of assessing, identifying, and managing material risks associated with cybersecurity threats, as such term is defined in Item 106(a) of Regulation S-K.

These risks include, among other things:

operational risks, intellectual property theft, fraud, extortion, harm to employees or customers and violation of data privacy or security laws.

Identifying and assessing cybersecurity risk is integrated into our overall risk management systems and processes.

Cybersecurity risks related to our business, technical operations, privacy and compliance issues are identified and addressed through a multi-faceted approach including third party assessments, internal IT Audit, IT security, governance, risk and compliance reviews.

Our IT policies, processes and practices are based on recognized frameworks established by our external IT service provider and other applicable industry standards.

In general, we seek to address cybersecurity risks through a comprehensive, cross-functional approach that is focused on preserving the confidentiality, security and availability of the information that we collect and store by identifying, preventing and mitigating cybersecurity threats and effectively responding to cybersecurity incidents when they occur.

As part of the above processes, we regularly engage consultants to assess our internal cybersecurity programs and compliance with applicable practices and standards.

As part of our cybersecurity defense measures, we enforce the use of the following security systems:

EDR System (Endpoint Detection & Response)

Two-factor authentication for email (Office 365) and cloud-stored information

We protect our mail system against spam, phishing, spoofing, and malware using a (Mail Relay system).

Additionally, we enforce a real-time threat notification mechanism and activate alerts and reports for failures in our backup system.

We do not believe that there are currently any known risks from cybersecurity threats that are reasonably likely to materially affect us or our business strategy, results of operations or financial condition.

We also describe whether and how risks from identified cybersecurity threats, including as a result of any previous cybersecurity incidents, have materially affected or are reasonably likely to materially affect us, including our business strategy, results of operations, or financial condition, under the heading “We are increasingly dependent on information technology systems, infrastructure and data, and our internal computer systems, or those of our collaborators, third-party clinical research organizations or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs.” included as part of our risk factor disclosures at Item 1A of this Annual Report.

Our Audit Committee of the Board of Directors (“the Audit Committee”), is responsible for overseeing cybersecurity risk and periodically updates our Board of Directors on such matters.

The Audit Committee receives periodic updates from management regarding cybersecurity matters and is notified between such updates regarding any significant new cybersecurity threats or incidents.

Management is responsible for the operational oversight of company-wide cybersecurity strategy, policy, and standards across relevant departments to assess and help prepare us to address cybersecurity risks.

Our facilities in Israel, which house our research and development and certain production and management functions, are in Jerusalem, Israel.

Most of our clinical development, clinical operations and regulatory functions are located in the United States.

Under a lease agreement with Unihead Biopark Ltd., we lease approximately 622 square meters of office and laboratory space.

This lease has a term that extends through 2028, but we have the option to terminate the lease in June 2026.

The average rent over the current term is $180,000 per year.

We believe that our current office and laboratory space in Israel is sufficient to meet our anticipated needs for the foreseeable future and is suitable for the conduct of our business.

We believe that suitable additional space would be available if required in the future on commercially reasonable terms.

LEGAL PROCEEDINGS

We are not currently a party to any material legal proceedings.

MINE SAFETY DISCLOSURES.

Not applicable.

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What changed 10-K

Item 1A. Risk Factors