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In any such case, the trading price of our Ordinary Shares could decline, and you could lose all or part of your investment.
−Removed: Risk Factor Summary
−Removed: Our business is subject to a number of risks, including risks that may prevent us from achieving our business objectives or may adversely affect our business, financial condition, results of operations, cash flows and prospects.
−Removed: These risks are discussed more fully later in this Item 1A, and include, but are not limited to, the following:
−Removed: • We have incurred significant losses since our inception and anticipate that we will continue to incur substantial losses for the next several years;
−Removed: • Management has performed an analysis of our ability to continue as a going concern and our independent registered public accounting firm has raised substantial doubt as to our ability to continue as a going concern;
−Removed: • All of our product candidates, including EB613 and EB612, are in preclinical or clinical development and we have not yet successfully completed the development of any product candidates;
−Removed: • If serious adverse, undesirable or unacceptable side effects are identified during the development of our product candidates, marketing approval may be delayed or we may need to abandon our development of such product candidates, and if such side effects are identified following regulatory approval, any approved product label may be limited or we may be subject to other significant negative consequences;
−Removed: • The commencement and completion of clinical trials can be delayed or prevented for a number of reasons;
−Removed: • The results of previous clinical trials may not be predictive of future results, our progress in trials for one product candidate may not be indicative of progress in trials for other product candidates, and our trials may not be designed so as to support regulatory approval;
−Removed: • Even if regulatory approvals are obtained for our product candidates, we will be subject to ongoing government regulation.
−Removed: If we fail to comply with applicable current and future laws and government regulations, it could delay or prevent the promotion, marketing or sale of our products;
−Removed: • Healthcare legislative changes may harm our business and future prospects;
−Removed: • We are subject to manufacturing risks that could substantially increase our costs and limit supply of our products;
−Removed: • We are highly dependent upon our ability to raise additional capital or enter into agreements with collaborators to develop, commercialize and market our products;
−Removed: • We may fail to establish, maintain, defend and enforce intellectual property rights with respect to our technology;
−Removed: • The price of our Ordinary Shares may be volatile, and holders of our Ordinary Shares could lose all or part of their investment;
−Removed: • Your rights and responsibilities as our shareholder will be governed by Israeli law, which may differ in some respects from the rights and responsibilities of shareholders of U.S.
−Removed: corporations;
−Removed: • Security, political and economic instability in the Middle East may harm our business, including the duration and intensity of the ongoing Israel-Hamas War and its impact on our operations and workforce.
Risks Related to Our Financial Position
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As of December 31, 2024, we had an accumulated deficit of $113.9 million.
−Removed: 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 potentially develop future product candidates, including our GLP-2 and OXM candidates with OPKO.
+Added: 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 anticipate that our net losses and accumulated deficit for the next several years will be significant as we conduct our planned operations.
−Removed: Given our current plans, we anticipate that our existing cash and cash equivalents will be sufficient to fund our operations through the second quarter of 2025.
−Removed: This assumes capital required to fund our ongoing operations, including R&D and the completion of the Phase 1 study related to the new generation platform and the GLP-2/OXM collaborative research we are conducting with OPKO.
−Removed: This does not include the capital required to fund our proposed Phase 3 pivotal study for EB613 in osteoporosis.
−Removed: Delays in securing additional capital or entering into strategic collaborations to capitalize the EB613 Phase 3 program will result in delays in this program.
−Removed: Accordingly, these factors, among others, raise substantial doubt about our ability to continue as a going concern.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Any delay or our inability to secure such funding will delay or prevent the commencement of these studies.
+Added: We believe our existing cash resources will be sufficient to meet our projected operating requirements into the third quarter of 2026 without additional funding.
+Added: Since inception we have not derived any significant income from our activities and incurred an accumulated deficit and negative cash flows from operating activities.
+Added: These factors raise substantial doubt as to the Company's ability to continue as a going concern.
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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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.
−Removed: The amount of our future net losses will depend, in part, on the amount and timing of our expenses, our ability to generate revenue and our ability to raise additional capital.
+Added: 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.
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In addition, our independent registered public accounting firm has raised substantial doubt as to our ability to continue as a going concern.
−Removed: Based on its assessment, management has raised substantial doubt about our ability to continue as a going concern.
+Added: 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.
+Added: These factors raise substantial doubt as to the Company'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.
−Removed: As of March 1, 2024, we had cash and cash equivalents of approximately $9.8 million.
−Removed: Given our current plans, we anticipate that our existing cash and cash equivalents will be sufficient to fund our operations through the second quarter of 2025.
−Removed: This assumes capital required to fund our ongoing operations, including R&D, the completion of the Phase 1 study related to the new generation platform and the GLP-2/OXM collaborative research we are conducting with OPKO.
−Removed: This does not include the capital required to fund our proposed Phase 3 pivotal study for EB613 in osteoporosis.
−Removed: 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.
−Removed: Our ability to continue as a going concern will depend on our ability to obtain additional financing.
−Removed: The Company constantly evaluates options with respect to various financing alternatives including public or private equity offerings, debt financings and strategic collaborations to finance future clinical trials, including the Phase 3 pivotal study for EB613 in osteoporosis, research and development activities and general and administrative expenses.
+Added: As of March 20, 2025, we had cash and cash equivalents of approximately $21 million, of which $8 million is designated solely to fund our development cost obligations under the collaboration agreement with OPKO.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Any delay or our inability to secure such funding will delay or prevent the commencement of these studies.
+Added: We constantly evaluate options in relation to various financing alternatives including public or private equity offerings, debt financings and strategic collaborations to finance future clinical trials, research and development activities and general and administrative expenses.
A going concern opinion could impair our ability to finance our operations through public or private equity offerings, or debt financings, or a combination of one or more of these funding sources.
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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.
−Removed: As such, we are currently focused on the development of five differentiated, first-in-class oral peptide programs, expected to enter the into various stages of clinical development by 2025, including two programs under the collaboration agreement with OPKO.
−Removed: Our most advanced programs are EB613 and EB612 for the treatment of osteoporosis and hypoparathyroidism, respectively.
+Added: As such, our internal resources are currently focused on the development of EB613 and further development of our N-Tab™ platform.
+Added: We entered into the 2025 Collaboration Agreement with OPKO in relation to our Oral GLP-1/Glucagon .
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Furthermore, the expenses related to collaborative research with a third party for hypoparathyroidism are funded by that collaborator.
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.
−Removed: We are currently advancing our most advanced product candidate, EB613, through clinical development.
+Added: 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.
Developing therapeutics, including conducting preclinical studies and clinical trials, is expensive.
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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.
−Removed: We expect that we would need to raise additional funds to support the execution of our long-term growth strategy, including for a potential Phase 3 trial of EB613, additional non-clinical and clinical studies for EB612, and further development of our N-Tab™ technology platform and pre-clinical product candidates.
+Added: We expect that we would need to raise additional funds to support the execution of our long-term growth strategy.
We can provide no assurance that additional funding will be available on a timely basis, on terms acceptable to us, or at all.
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Many of these factors are outside of our control.
−Removed: Based upon our currently expected level of operating expenditures, we believe that we will be able to fund our operations through the second quarter of 2025.
−Removed: This assumes capital required to fund our ongoing operations, including R&D, the completion of the Phase 1 study related to the new generation platform and the GLP-2/OXM collaborative research we are conducting with OPKO.
−Removed: This does not include the capital required to fund our proposed Phase 3 pivotal study for EB613 in osteoporosis.
−Removed: Delays in securing additional capital or entering into strategic collaborations to capitalize the EB613 Phase 3 program will result in delays in this program.
−Removed: 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.
−Removed: This period could be shortened if there are any unanticipated increases in spending on development programs or other unanticipated increases in spending related to circumstances outside of our control, including, without limitation, costs associated with litigation or other legal proceedings, hiring of additional consultants and personnel or procurement of additional raw materials.
−Removed: Our existing cash and cash equivalents will not be sufficient to obtain regulatory approval for any of our product candidates.
+Added: 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.
+Added: 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.
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If we are unable to raise the requisite funds, we will need to delay the initiation of core activities, curtail or cease operations.
−Removed: Our fundraising efforts in the future to secure additional financing will divert our management from our day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates.
−Removed: In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all.
−Removed: If we are unable to raise additional capital when required or on acceptable terms, we may be required to significantly delay, reduce or discontinue the development or commercialization of one or more of our product candidates or curtail our operations, which will have an adverse effect on our business, operating results and prospects.
We have a limited operating history and no history of late stage clinical studies and commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability and making an investment in our Ordinary Shares unsuitable for many investors.
We began operations in 2010.
−Removed: Our operations to date have been limited to financing and staffing our company, developing our drug delivery technology, N-Tab™, and early clinical development of our product candidates.
−Removed: We have not yet demonstrated an ability successfully to 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.
+Added: 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.
+Added: 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.
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As a public company listed on Nasdaq, we incur significant legal, accounting and other expenses.
−Removed: In addition, changing laws, regulations and standards, in the United States or Israel, relating to corporate governance and public disclosure and other matters, may be implemented in the future, which may increase our legal and financial compliance costs, make some activities more time consuming and divert management’s time and attention from revenue-generating activities to compliance activities.
−Removed: If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to practice, regulatory authorities may initiate legal proceedings against us and our business may be harmed.
−Removed: Furthermore, because we are a publicly traded company in the United States and subject to U.S.
+Added: Because we are a publicly traded company in the United States and subject to U.S.
rules and regulations, it is more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage.
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All of our product candidates are in preclinical or clinical development and we have not yet successfully completed the development of any product candidates.
−Removed: We are a clinical-stage company focused on the development of orally delivered peptide and protein therapeutics to treat unmet medical needs.
+Added: 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.
−Removed: Since inception, we have devoted substantially all of our resources to the development of our N-Tab™ Technology 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.
+Added: 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.
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In addition, our Phase 2 clinical trial for EB613 for osteoporosis was the largest clinical trial we have conducted to date, and we have never conducted clinical trials of a size required for regulatory approvals.
−Removed: Furthermore, we have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in rapidly evolving fields, such as the oral delivery of protein therapeutics.
+Added: Furthermore, we have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by biotech companies in rapidly evolving fields.
To become and remain profitable, we must succeed in developing and commercializing products that generate significant revenues.
This will require us to be successful in a range of challenging activities for which we are only in the preliminary stages, including developing product candidates, completing pre-clinical and clinical trials for such product candidates, obtaining regulatory approval for them, and manufacturing, marketing and selling those products for which we may obtain regulatory approval.
−Removed: We may never succeed in these activities and, even if we do, we may never generate revenue from product sales that is significant enough to achieve profitability.
−Removed: Our ability to generate future revenue from product sales depends heavily on our success in many areas, including but not limited to:
+Added: We may never succeed in these activities and, even if we do, we may never generate revenue from product sales or strategic alliances that is significant enough to achieve profitability.
+Added: 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;
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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.
−Removed: Our most advanced programs, EB613 and EB612 may compete with marketed drugs, such as Forteo®, Tymlos®, Evenity®, and osteoanabolic drugs in clinical development for osteoporosis and drugs in clinical development for hypoparathyroidism such as TransCon™ PTH or Eneboparatide.
−Removed: Furthermore, EB612 has orphan drug designation in the United States and in the EU, which means that the potential patient population is limited.
+Added: 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;
+Added: the EB612 program may compete with marketed drugs of hypoparathyroidism such as TransCon™ PTH and those in clinical development such as Eneboparatide and MBX2109.
+Added: 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).
+Added: 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..
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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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.
−Removed: We may not be successful in our efforts to use and expand our drug delivery technology, N-Tab™ , to other product candidates.
−Removed: An element of our strategy is to combine our N-Tab™ technology 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.
+Added: We may not be successful in our efforts to use and expand our N-Tab™ platform, to other product candidates.
+Added: 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.
−Removed: Our initial product candidates combine our oral drug delivery technology, N-Tab™, with PTH, a hormone that has been used in injectable form for many years for the treatment of osteoporosis and hypoparathyroidism.
+Added: 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 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.
−Removed: If we are unable to validate N-Tab™ technology with our PTH product candidates, in particular our lead candidate EB613, we may be unsuccessful in leveraging our N-Tab™ technology for use with other APIs.
In addition, we have modified the formulation of oral PTH to develop new formulations for applications in hypoparathyroidism and other indications.
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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.
−Removed: Even if we are successful in expanding our drug delivery technology to other APIs for other indications, 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.
−Removed: We may never successfully develop or commercialize our technology with other APIs, which could limit our business and prospects.
+Added: 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.
+Added: We may never successfully develop or commercialize our technology with other peptides, which could limit our business and prospects.
If serious adverse, undesirable or unacceptable side effects are identified during the development of our product candidates, marketing approval may be delayed or we may need to abandon our development of such product candidates, and if such side effects are identified following regulatory approval, any approved product label may be limited or we may be subject to other significant negative consequences.
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our reputation may suffer.
−Removed: Any of these events could prevent us or any potential collaborators from achieving or maintaining market acceptance of the affected product or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenue from the sale of our products.
+Added: Any of these events could prevent us or any potential collaborators from achieving or maintaining market acceptance of the affected products or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenue from the sale of our products.
We manage our business and develop our technology with a small number of employees and key advisors with deep functional domain expertise, and, in the event of their loss or unavailability, we may not be able to grow our business or develop and commercialize our products.
−Removed: We are highly dependent on the biopharmaceutical research and development, clinical, regulatory, CMC and strategic expertise of our core executive team and key advisors across these domains, including Miranda Toledano, our Chief Executive Officer, Hillel Galitzer, our Chief Operating Officer and Gregory Bushtein, our Head of Research and Development.
+Added: We are highly dependent on the biopharmaceutical research and development, clinical, regulatory, CMC and strategic expertise of our core executive team and key advisors across these domains, including Miranda Toledano, our Chief Executive Officer, Gregory Burshtein, our Chief of Research and Development and Hillel Galitzer, our Chief Operating Officer.
Our success depends upon the continued contributions of these senior executives, employees and advisors, many of whom have substantial scientific and technical experience with, and have been instrumental to our regulatory, clinical development and technology platform.
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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.
−Removed: 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, which has spurred rising energy costs and exacerbated disruptions to the global supply chain caused by the COVID-19 pandemic and the government and societal responses to the pandemic.
−Removed: Supply chain disruptions could continue to result in delays in our R&D and clinical initiatives.
−Removed: As we have substantial international operations, fluctuations in exchange rates between the currencies in which we operate, which could increase our operating costs and adversely affect our results of operations, and cash flows.
+Added: 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.
+Added: To the extent we experience any supply chain disruptions, we could experience delays in our R&D and clinical initiatives.
+Added: 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.
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Development programs are subject to regulatory requirements, unanticipated delays and we may ultimately not be able to obtain regulatory approvals for the commercialization of our product candidates.
−Removed: Our most advanced product candidates are orally delivered tablet formulations of the synthetic form of the first 34 amino acids of human PTH, teriparatide.
−Removed: We are developing EB613 to treat osteoporosis and EB612 to treat hypoparathyroidism.
−Removed: These product candidates have not yet reached late-stage clinical development and are subject to the risks of failure inherent in regulatory assessments and drug development.
+Added: Our most advanced product has not yet reached late-stage clinical development and are subject to the risks of failure inherent in regulatory assessments and drug development.
The clinical development, manufacturing, quality assurance, labeling, storage, record-keeping, advertising, promotion, pharmacovigilance, import, export, marketing and distribution of our product candidates is subject to extensive regulation by the FDA in the United States and by comparable authorities in foreign markets.
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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.
−Removed: Each of our oral PTH product candidates, including EB613 and EB612, are still in clinical development and face a variety of risks and uncertainties, including the following:
−Removed: • future clinical trial results may show that our oral PTH is not effective, including if our drug delivery technology 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;
+Added: 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:
+Added: 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;
our product candidates may not be well tolerated or may cause negative side effects;
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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.
−Removed: 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 or any other product candidates we may develop in the future, it would likely have a material adverse effect on our business, prospects, financial condition and results of operations.
+Added: 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.
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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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.
−Removed: 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 (oral hPTH (1-34), teriparatide tablets).
+Added: 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.
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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.
−Removed: 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 pathway and that the Company’s proposed PK sampling scheme seemed reasonable.
−Removed: On the same day, we announced that we plan to continue our dialogue with the FDA and await the final qualification of the FNIH-BQP criteria and their guidance on the statistical evaluation of our BMD endpoint before initiating a Phase 3 study for EB613.
+Added: 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.
+Added: 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.
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Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services.
−Removed: Under certain circumstances, including the Physician Payments Sunshine Act, we are required to report some of these relationships to the FDA and other regulatory authorities.
+Added: Under certain circumstances, including the Physician Payments Sunshine Act, we are required to report some of these relationships to the FDA, CMS and other regulatory authorities.
The FDA and other regulatory authorities may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected the investigator’s conduct of the trial.
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These limitations could in turn reduce the revenue that we will be able to generate in the future from sales of our products and licenses of our technology.
−Removed: In the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or MMA, changed the way Medicare covers and pays for pharmaceutical products.
−Removed: The MMA expanded Medicare coverage for outpatient drug purchases by those covered by Medicare under a new Part D and introduced a new reimbursement methodology based on average sales prices for Medicare Part B physician-administered drugs.
−Removed: In addition, the MMA authorized Medicare Part D prescription drug plans to limit the number of drugs that will be covered in any therapeutic class.
−Removed: As a result of this legislation and the expansion of federal coverage of drug products, we expect that there will be additional pressure to contain and reduce costs.
−Removed: These cost reduction initiatives and other provisions of the MMA could decrease the coverage and price that we receive for any approved products and could seriously harm our future business prospects.
−Removed: While this law applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates, and any reduction in reimbursement that results from this law may result in a similar reduction in payments from private payors.
−Removed: In March 2010,the Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for health care and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms.
+Added: In the United States, in March 2010, the Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for health care and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms.
The ACA, among other things, increased rebates a manufacturer must pay to the Medicaid program, addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, established a new Medicare Part D coverage gap discount program, in which manufacturers must provide 75% point-of-sale discounts on products covered under Part D and implemented payment system reforms including a national pilot program on payment bundling to encourage hospitals, physicians and other providers to improve the coordination, quality and efficiency of certain healthcare services through bundled payment models.
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The Budget Control Act resulted in the imposition of 2% reductions in Medicare payments to providers beginning in 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2027 absent additional congressional action.
−Removed: However, pursuant to the CARES Act, and subsequent legislation, these reductions were suspended from May 1, 2020 through March 31, 2022 due to the COVID-19 pandemic.
In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, reduced Medicare payments to several providers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
+Added: Further, on August 16, 2022, Congress enacted the Inflation Reduction Act allowing CMS to negotiate directly with drug manufacturers to lower the price of some of the costliest drugs under the Medicare program, as well as requiring drug manufacturers to provide Medicare with a rebate if the price of drugs increases faster than the rate of inflation.
These new laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on customers for our drugs, if approved, and accordingly, our financial operations.
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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.
−Removed: Further, on November 20, 2020, the U.S.
−Removed: Department of Health and Human Services, or HHS, finalized a regulation removing 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.
−Removed: The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers.
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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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.
−Removed: The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers.
−Removed: This rule (with exceptions) became effective on January 19, 2021.
−Removed: We continue to evaluate what effect, if any, these rules will have on our business.
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.
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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.
−Removed: Our primary innovation is our development of an oral drug delivery technology, N-Tab™, for peptides, therapeutic protein replacement therapies in small tablet form.
+Added: 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.
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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.
−Removed: Ascendis Pharma developed a long-acting, oral prodrug formulation of PTH for the treatment of hypoparathyroidism, which was approved in the European Union in November 2023 and has a PDUFA date of May 14, 2024 from the FDA.
−Removed: We believe that our key competitors in hypoparathyroidism treatment include TransCon™ PTH and eneboparotide, a peptide in Phase 3 development, both of which require daily subcutaneous injections.
−Removed: If we obtain regulatory approval for EB612, it may compete with TransCon™ PTH and eneboparotide which by that time may have been marketed for several years and may have wide-spread market acceptance that may be difficult to overcome.
−Removed: Moreover, although we have obtained orphan drug designation for EB612 for the treatment of hypoparathyroidism, we may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.
+Added: 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.
+Added: 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).
+Added: 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.
We are subject to manufacturing risks that could substantially increase our costs and limit supply of our products.
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Difficulties in achieving commercial-scale production or the need for additional regulatory approvals as a result of scaling up could delay the development and regulatory approval of our product candidates and ultimately affect our success.
−Removed: Contract manufacturers may not have sufficient expertise to manufacture a dry oral formulation with a large molecule API, in which case we may have to establish our own commercial manufacturing capabilities, which could be expensive and delay launch of product candidates.
The manufacturing process for large molecules is more complex and subject to greater regulation than that of other drugs.
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If microbial, viral or other contaminations are discovered in our product candidates or in the manufacturing facilities in which our product candidates are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination.
−Removed: • The manufacturing facilities in which our product candidates are made could be adversely affected by equipment failures, labor shortages, natural disasters, power failures, outbreaks of an infectious disease such as the duration and intensity of the ongoing Israel-Hamas War, other geopolitical tensions such as the ongoing conflict between Russia and Ukraine, and numerous other factors.
+Added: The manufacturing facilities in which our product candidates are made could be adversely affected by equipment failures, labor shortages, natural disasters, power failures, outbreaks of an infectious disease such as the duration and intensity of the ongoing war in Israel, other geopolitical tensions such as the ongoing conflict between Russia and Ukraine, and numerous other factors.
We and our contract manufacturing organizations, or CMOs, must comply with applicable cGMP regulations and guidelines.
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If we enter into collaborations to market and sell any approved products, our revenue may be lower and we will be dependent on the efforts of a third party.
−Removed: We have no established sales, marketing or distribution operations.
−Removed: If our product candidates are approved and we were to commercialize these products, such activities would be expensive and time consuming.
−Removed: If we elect to fund and undertake commercialization activities on our own, we may need to obtain additional expertise and additional capital, which may not be available to us on acceptable terms or at all.
−Removed: In addition, the costs of establishing sales and marketing operations may be incurred in advance of any approval of our product candidates.
−Removed: Moreover, we may not be able to hire a sales force that is sufficient in size or has adequate expertise in the medical markets that we intend to target.
−Removed: Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely affect the commercialization of our products.
−Removed: Alternatively, we may consider entering into a collaboration to commercialize our oral PTH candidates globally or in selected regions.
−Removed: Any such collaborator could be responsible for, or substantially support, late stage clinical trials of our oral PTH product candidates, as well as regulatory approvals and registrations.
+Added: We may consider entering into a collaboration to commercialize our oral peptides candidates globally or in selected regions.
+Added: Any such collaborator could be responsible for, or substantially support, late stage clinical trials of our oral peptide candidates, as well as regulatory approvals and registrations.
These arrangements are typically complex and time consuming to negotiate.
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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.
−Removed: We plan to enter into long-term supply agreements with several manufacturers for commercial supplies.
+Added: 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.
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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.
−Removed: Our product candidates utilize our proprietary technology and know-how relating to the oral delivery of large molecules for the treatment of certain conditions with oral PTH and other targeted peptides.
+Added: 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.
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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We have limited patent protection with respect to our product candidates and technologies.
−Removed: We have been issued a patent with claims generally directed to compositions comprising a protein, an absorption enhancer and a protease inhibitor, as well as methods for oral administration of a protein with an enzymatic activity in each of the United States, Australia, Canada, Japan, New Zealand, China, Israel and Russia.
−Removed: Related patent applications are pending in the United States, the EU, Hong Kong, Brazil and India.
−Removed: We have also filed patent applications derived from six patent families in various jurisdictions that currently contain claims directed to oral administration technologies, including compositions and drug delivery devices utilizing an absorption enhancer and methods of treating osteoporosis, hypoparathyroidism and bone fractures and related conditions with orally administered parathyroid hormone.
−Removed: Certain of these patent applications have already matured into patents in the United States, Israel, India, China, Canada, New Zealand, Brazil and Japan.
−Removed: Other applications are in prosecution.
−Removed: We have also recently filed seven additional international patent applications (patent families) with claims pertaining to a novel oral delivery platform, with claims directed at compositions comprising a protein, an absorption enhancer and an alkaline polymer, and methods of oral administration these compositions.
−Removed: 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.
+Added: Our global patent portfolio includes issued patents and patent applications.
+Added: 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.
+Added: 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.
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We may also grant licenses under our intellectual property that may limit our ability to exploit such intellectual property.
−Removed: For example, we are party to the Patent Transfer Agreement with Oramed, pursuant to which we have granted Oramed an exclusive, worldwide, royalty-free, irrevocable and perpetual license, with the right to sublicense, under certain of our patent rights to develop, manufacture and commercialize covered products or otherwise exploit such patent rights in the fields of diabetes and influenza and we have agreed not to, directly or indirectly, engage in any activities within the fields of diabetes and influenza.
−Removed: Even if such agreement were to be terminated, Oramed would retain its exclusive license under such patent rights.
In the future, we may enter into additional collaborative agreements or license agreements with third parties which may subject us to obligations that must be fulfilled and require us to manage complex relationships with third parties.
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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.
−Removed: We are currently in the process of registering the trademark N-Tab™ for our oral drug delivery platform technology, globally.
+Added: We are currently in the process of registering the trademark N-Tab™ for our oral platform technology, globally.
+Added: 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.
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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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.
−Removed: In addition, the stock market in general has recently experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of individual companies.
−Removed: Broad market and industry factors may materially affect the market price of companies’ stocks, including ours, regardless of actual operating performance.
+Added: In addition, broad market and industry factors may materially affect the market price of companies’ stocks, including ours, regardless of actual operating performance.
We do not know whether a market for our Ordinary Shares will be sustained and as a result, it may be difficult for holders of our Ordinary Shares to sell their securities.
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The price of our Ordinary Shares must trade at or above $1.00 to comply with the minimum bid requirement for continued listing on the Nasdaq Capital Market.
−Removed: On November 21, 2022, the Company received a notice (the “Notice”) from the Nasdaq Stock Market LLC (“Nasdaq”), stating that the Company’s Ordinary Shares fail to comply with the $1.00 minimum bid price requirement for continued listing on Nasdaq in accordance with Nasdaq Listing Rule 5550(a)(2) based upon the closing bid price of the ordinary shares for the 30 consecutive business days prior to the date of the Notice.
−Removed: Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided an initial compliance period of 180 calendar days, or until May 22, 2023, to regain compliance with the minimum bid price requirement.
−Removed: On March 23, 2023, Nasdaq notified us that we had regained compliance with the minimum bid price requirement given that the closing bid price for our Ordinary Shares had been at or above $1.00 for 14 consecutive trading days, from March 3, 2023 through March 22, 2023.
−Removed: On June 29, 2023 , the Company received an additional notice (the “Additional Notice”) from Nasdaq, stating that the Company’s Ordinary Shares fail to comply with the minimum bid price requirement based upon the closing bid price of the ordinary shares for the 30 consecutive business days prior to the date of the Additional Notice.
−Removed: Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided an initial compliance period of 180 calendar days to regain compliance with the minimum bid price requirement.
−Removed: On December 27, 2023, we received an extension of 180 calendar days, or until June 24, 2024, from Nasdaq, to regain compliance with the minimum bid price requirement.
−Removed: On March 1, 2024, Nasdaq notified us that we had regained compliance with the minimum bid price requirement given that the closing bid price for our Ordinary Shares had been at or above $1.00 for 10 consecutive trading days, from February 15, 2024 through February 29, 2024.
+Added: In the past, the Company has received notices from Nasdaq stating that the Company’s Ordinary Shares failed to comply with the $1.00 minimum bid price requirement for continued listing on Nasdaq in accordance with Nasdaq Listing Rule 5550(a)(2) based upon the closing bid price of the ordinary shares for the 30 consecutive business days prior to the date of such notices.
+Added: In each case, the Company was able to regain compliance with the Nasdaq continued listing requirements within the compliance periods provided to the Company by Nasdaq.
However, there can be no assurance that we will maintain compliance with the $1.00 minimum bid price requirement or comply with Nasdaq’s other continued listing standards in the future.
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If we fail to satisfy these conditions, we may be required to refund grants previously received together with interest and penalties or to pay other amounts according to the formulas set out in the relevant laws.
−Removed: Our research and development efforts have been financed, in part, through the grants that we have received from the IIA.
+Added: Our PTH research and development efforts in relation to osteoporosis have been financed, in part, through the grants that we have received from the IIA in total amount of $460 thousand.
Pursuant to these grants, we must comply with the requirements of the Research Law.
−Removed: Until the grants are repaid with interest, royalties are payable to the IIA in the amount of 3% on revenues derived from sales of products or services developed in whole or in part using the IIA grants, including EB612, EB613 and any other oral PTH product candidates we may develop.
+Added: Until the grants are repaid with interest, royalties are payable to the IIA in the amount of 3% on revenues derived from sales of products or services developed in whole or in part using the IIA grants.
The royalty rate may increase to 5%, with respect to approved applications filed following any year in which we achieve sales of over $70 million.
−Removed: Under the Research Law, we are prohibited from manufacturing products developed using these grants outside of the State of Israel without special approvals.
−Removed: We may not receive the required approvals for any proposed transfer of manufacturing activities.
+Added: Under the Research Law, we are prohibited from manufacturing products for commercial use developed using these grants outside of the State of Israel without special approvals.
+Added: We may not receive the required approvals for any proposed transfer of manufacturing activities for such IIA-related products or technologies.
Even if we do receive approval to manufacture products developed with government grants outside of Israel, the royalty rate may be increased and we may be required to pay up to three times the grant amounts and the interest, depending on the manufacturing volume that is performed outside of Israel.
−Removed: This restriction may impair our ability to outsource manufacturing or engage in our own manufacturing operations for those products or technologies.
+Added: This restriction may impair our ability to outsource manufacturing or engage in our own manufacturing operations for IIA-related products or technologies.
For additional information, see “Item 1-Business—The Israeli Innovation Authority (IIA) Grant.”
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The scope of the IIA support received, the royalties that we have already paid to the IIA, the amount of time that has elapsed between the date on which the know-how or other intellectual property rights were transferred and the date on which the IIA grants were received and the sale price and the form of transaction will be taken into account in order to calculate the amount of the payment to the IIA.
−Removed: Approval to transfer the technology to residents of the State of Israel is also required, and may be granted in specific circumstances only if the recipient abides by the provisions of applicable laws, including the restrictions on the transfer of know-how and the obligation to pay royalties.
+Added: Approval to transfer the technology to residents of the State of Israel is also required, and may be granted in specific circumstances only if the recipient abides by the provisions of applicable laws, including the restrictions on the transfer of IIA-related know-how and the obligation to pay royalties.
No assurance can be made that approval to any such transfer, if requested, will be granted.
−Removed: Transfer of know-how or rights outside of the state of Israel without IIA approval is a criminal offense.
−Removed: 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 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.
+Added: Transfer of IIA-related know-how or rights outside of the state of Israel without IIA approval is a criminal offense.
+Added: 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.
−Removed: Shareholders that purchased Ordinary Shares in our IPO would not be required to sign such an undertaking.
+Added: 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.
These restrictions will continue to apply even after we have repaid the full amount of the grants and the interest.
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In response to the foregoing developments, certain leading international financial institutions, including investment banks, investors and key economists, have indicated several causes for concern, including that such proposed changes, if adopted, may cause a downgrade to Israel’s sovereign credit rating and Israel’s international standing, which would adversely affect the macroeconomic condition in which we operate, and also potentially deter foreign investment into Israel or Israeli companies, which may hinder our ability to raise additional funds, if deemed necessary by our management and the Board.
−Removed: Security, political and economic instability in the Middle East may harm our business, including the duration and intensity of the ongoing Israel-Hamas War and its impact on our operations and workforce.
−Removed: Our principal research and development facilities are located in Israel.
−Removed: In addition, some of our key employees, officers and directors are residents of Israel.
+Added: Security, political and economic instability in the Middle East may harm our business .
+Added: Our principal research facilities are located in Israel.
+Added: In addition, most of our key employees, officers and directors are residents of Israel.
Accordingly, political, economic and military conditions in the Middle East may affect our business directly.
−Removed: 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) and Hezbollah (an Islamist militia and political group in Lebanon).
−Removed: In October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets.
−Removed: Hamas also launched extensive rocket attacks on the Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel.
−Removed: These attacks resulted in thousands of deaths and injuries, and Hamas additionally kidnapped many Israeli civilians and soldiers.
−Removed: Following the attack, Israel’s security cabinet declared war against Hamas and commenced a military campaign against Hamas.
−Removed: While we have a few employees who are in active military service, the ongoing war with Hamas has not, since its inception, materially impacted our business or operations.
−Removed: Furthermore, we do not expect any delays to any of our programs as a result of the situation.
−Removed: However, we cannot currently predict the intensity or duration of Israel’s war against Hamas, nor can we predict how this war will ultimately affect our business and operations or Israel’s economy in general.
−Removed: Additionally, political uprisings, social unrest and violence in various other countries in the Middle East, including Israel’s neighbor Syria, are affecting the political stability of those countries.
−Removed: 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.
−Removed: In addition, Iran has threatened to attack Israel.
−Removed: Iran is also believed to have a strong influence among the Syrian government, Hamas and Hezbollah.
+Added: 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.
+Added: On October 7, 2023, thousands of Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of lethal attacks on Israeli civilians and some military targets.
+Added: Hamas also launched extensive rocket attacks on the Israeli civilian population and industrial centers located along Israel’s border with the Gaza Strip and across the State of Israel.
+Added: These attacks resulted in thousands of deaths and injuries, and Hamas additionally kidnapped over 250 Israeli civilians and soldiers.
+Added: Following the attack, Israel’s security cabinet commenced a counter-offense military campaign against Hamas in Gaza.
+Added: Since the onset of these events, hostilities have persisted across Israel, along Israel's northern border with Lebanon, primarily involving the Hezbollah terror organization, as well as other extremist groups in the region, including the Houthis in Yemen and various militia groups in Syria and Iraq.
+Added: Israel has conducted multiple targeted strikes against these terror organizations.
+Added: 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.
+Added: The Israeli defense systems, aided by international allies, successfully intercepted the majority of the ballistic missile attacks, minimizing physical damage and casualties.
+Added: 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.
+Added: Such incidents contribute to regional instability and could potentially escalate into broader conflicts with Iran and its proxies in the Middle East, affecting Israel's political and trade relations, especially with neighboring countries and global allies.
+Added: The situation remains fluid, and the potential for further escalation exists.
+Added: 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.
+Added: 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.
+Added: Furthermore, we do not expect any delays to any of our programs as a result of such conflicts.
+Added: While research and some management are located in Israel, other core activities including clinical, regulatory and our supply chain are not.
+Added: However, we cannot currently predict the intensity or duration of Israel’s war against Hamas, Hezbollah and Iran, and its proxies, nor can we predict how such conflicts will ultimately affect our business and operations or Israel’s economy in general.
+Added: 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.
+Added: 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.
−Removed: These situations, including conflicts which involved missile strikes against civilian targets in various parts of Israel, have, in the past, negatively affected business conditions in Israel.
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.
−Removed: The political and security situation in Israel may result in parties with whom we have contracts claiming that they are not obligated to perform their commitments under those agreements pursuant to force majeure provisions.
These or other Israeli political or economic factors could harm our operations and product development.
−Removed: Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading partners could adversely affect our operations and could make it more difficult for us to raise capital.
+Added: Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading partners could adversely affect our operations.
+Added: 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.
+Added: 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.
−Removed: Furthermore, several countries, as well as certain companies and organizations, continue to restrict business with Israel and Israeli companies, which could have an adverse effect on our business and financial condition in the future.
−Removed: Our business interruption insurance may not adequately compensate us for losses, if at all, that may occur as a result of an event associated with a security situation in the Middle East, and any losses or damages incurred by us could have a material adverse effect on our business.
Our operations may be disrupted by the obligations of personnel to perform military service.
−Removed: Our employees in Israel, including executive officers, generally, may be called upon to perform up to 42 days (and in some cases more) of annual military reserve duty until they generally reach the age of 45 (or older in some cases) and, in emergency circumstances, could be called to active duty.
−Removed: In response to increased tension and hostilities, since September 2000 there have been occasional call-ups of military reservists, including in connection with the mid-2006 war in Lebanon and the December 2008, November 2012 and July 2014 conflicts with Hamas.
−Removed: In October 2023, Hamas terrorists invaded southern Israel and launched thousands of rockets in a widespread terrorist attack on Israel.
−Removed: As a result, the Israeli government declared that the country was at war and the Israeli military began to call-up reservists for active duty.
−Removed: To date, several employees were called for duty, but 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.
+Added: 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).
+Added: 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.
+Added: 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.
11 unchanged sentences
If the dollar cost of our operations in Israel increases, our dollar-measured results of operations will be adversely affected.
−Removed: For example, in 2023, the value of the NIS depreciated against the U.S.
−Removed: dollar by 3.1%, which was potentially computed by inflation in Israel of 3%.
+Added: For example, 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%.
In 2023, the value of the NIS depreciated against the U.S.
52 unchanged sentences
The perceived uncertainties as to our future direction also could affect the market price and volatility of our securities.
+Added: UNRESOLVED STAFF COMMENTS.
+Added: CYBERSECURITY.
+Added: 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.
+Added: These risks include, among other things:
+Added: operational risks, intellectual property theft, fraud, extortion, harm to employees or customers and violation of data privacy or security laws.
+Added: Identifying and assessing cybersecurity risk is integrated into our overall risk management systems and processes.
+Added: 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.
+Added: Our IT policies, processes and practices are based on recognized frameworks established by our external IT service provider and other applicable industry standards.
+Added: 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.
+Added: As part of the above processes, we regularly engage consultants to assess our internal cybersecurity programs and compliance with applicable practices and standards.
+Added: As part of our cybersecurity defense measures, we enforce the use of the following security systems:
+Added: EDR System (Endpoint Detection & Response)
+Added: Two-factor authentication for email (Office 365) and cloud-stored information
+Added: We protect our mail system against spam, phishing, spoofing, and malware using a (Mail Relay system).
+Added: Additionally, we enforce a real-time threat notification mechanism and activate alerts and reports for failures in our backup system.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Our facilities in Israel, which house our research and development and certain production and management functions, are in Jerusalem, Israel.
+Added: Most of our clinical development, clinical operations and regulatory functions are located in the United States.
+Added: Under a lease agreement with Unihead Biopark Ltd., we lease approximately 622 square meters of office and laboratory space.
+Added: This lease has a term that extends through 2028, but we have the option to terminate the lease in June 2026.
+Added: The average rent over the current term is $180,000 per year.
+Added: 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.
+Added: We believe that suitable additional space would be available if required in the future on commercially reasonable terms.
+Added: LEGAL PROCEEDINGS
+Added: We are not currently a party to any material legal proceedings.
+Added: MINE SAFETY DISCLOSURES.
+Added: Not applicable.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.