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RedHill Biopharma Ltd.

RedHill Biopharma Ltd.RDHL決算レポート

Nasdaq

RedHill Biopharma Ltd. is a specialty biopharmaceutical firm focused on developing and commercializing innovative therapeutics for gastrointestinal disorders, inflammatory conditions, and infectious diseases. It operates mainly in North American and European markets, delivering prescription treatments for unmet clinical needs and partnering with healthcare stakeholders to expand product access.

What changed in RedHill Biopharma Ltd.'s 20-F — 2023 vs 2024

Top changes in RedHill Biopharma Ltd.'s 2024 20-F

835 paragraphs added · 913 removed · 665 edited across 5 sections

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

286 edited+62 added−125 removed366 unchanged
In connection with the clinical trials for our therapeutic candidates and other therapeutic candidates that we may seek to develop in the future, either on our own or through licensing or partnering agreements, we face various risks and uncertainties, including but not limited to: ● delays or failure in securing clinical investigators or trial sites for the clinical trials; ● delays or failure in receiving import or other government approvals to ensure appropriate drug supply; ● delays or failure in obtaining institutional review board (IRB) and other regulatory approvals to commence or continue a clinical trial; ● expiration of clinical trial material before or during our trials as a result of delays, including suspension of a clinical trial, degradation of, or other damage to, the clinical trial material; ● negative or inconclusive results or results that are not sufficiently positive from clinical trials; ● the FDA or other foreign regulatory authorities may disagree with the number, design, size, conduct or implementation of our clinical studies; ● the FDA or other foreign regulatory authorities may require us to conduct additional clinical trials or studies in connection with therapeutic candidates in development, as well as for products that have already been cleared and approved for marketing; ● inability to monitor patients adequately during or after treatment; 31 Table of Contents ● inability to retain patients; ● lack of technology to support clinical trials results; ● problems with investigator or patient compliance with the trial protocols; ● a therapeutic candidate may not prove safe or efficacious; there may be unexpected or even serious adverse events and side effects from the use of a therapeutic candidate; ● the results with respect to any therapeutic candidate may not confirm the positive results from earlier preclinical studies or clinical trials; ● the results may not meet the level of statistical significance required by the FDA or other foreign regulatory authorities; ● the results may justify only limited or restrictive uses, including the inclusion of warnings and contraindications, which could significantly limit the marketability and profitability of a therapeutic candidate; ● the clinical trials may be delayed or not completed due to the failure to recruit suitable candidates or if there is a lower rate of suitable candidates than anticipated or if there is a delay in recruiting suitable candidates; and ● changes to the current regulatory requirements related to clinical trials, which can delay, hinder or lead to unexpected costs in connection with our receiving the applicable regulatory clearances or approvals.
In connection with the clinical trials for our therapeutic candidates and other therapeutic candidates that we may seek to develop in the future, either on our own or through licensing or partnering agreements, we face various risks and uncertainties, including but not limited to: ● delays or failure in securing clinical investigators or trial sites for the clinical trials; ● delays or failure in receiving import or other government approvals to ensure appropriate drug supply; ● delays or failure in obtaining institutional review board (IRB) and other regulatory approvals to commence or continue a clinical trial; ● expiration of clinical trial material before or during our trials as a result of delays, including suspension of a clinical trial, degradation of, or other damage to, the clinical trial material; ● negative or inconclusive results or results that are not sufficiently positive from clinical trials; ● the FDA or other foreign regulatory authorities may disagree with the number, design, size, conduct or implementation of our clinical studies; ● the FDA or other foreign regulatory authorities may require us to conduct additional clinical trials or studies in connection with therapeutic candidates in development, as well as for products that have already been cleared and approved for marketing; 31 Table of Contents ● inability to monitor patients adequately during or after treatment; ● inability to retain patients; ● lack of technology to support clinical trials results; ● problems with investigator or patient compliance with the trial protocols; ● a therapeutic candidate may not prove safe or efficacious; there may be unexpected or even serious adverse events and side effects from the use of a therapeutic candidate; ● the results with respect to any therapeutic candidate may not confirm the positive results from earlier preclinical studies or clinical trials; ● the results may not meet the level of statistical significance required by the FDA or other foreign regulatory authorities; ● the results may justify only limited or restrictive uses, including the inclusion of warnings and contraindications, which could significantly limit the marketability and profitability of a therapeutic candidate; ● the clinical trials may be delayed or not completed due to the failure to recruit suitable candidates or if there is a lower rate of suitable candidates than anticipated or if there is a delay in recruiting suitable candidates; and ● changes to the current regulatory requirements related to clinical trials, which can delay, hinder or lead to unexpected costs in connection with our receiving the applicable regulatory clearances or approvals.
We may not successfully continue the commercialization of Talicia ® or Aemcolo ® and our products may not be, or continue to be, commercially successful for various reasons, including but not limited to: ● difficulty in large-scale manufacturing, including yield and quality, and in shipping product internationally; ● low market acceptance by physicians, healthcare payors, patients and the medical community as a result of lower demonstrated clinical safety or efficacy compared to products, prevalence, and severity of adverse side effects, or other potential disadvantages relative to alternative treatment methods; ● changes to the underlying dynamics of the markets for these products; ● infringement on proprietary rights of others for which we or third parties involved in the development or commercialization of our products or potential future therapeutic candidates have not received licenses; ● incompatibility with other marketed products; ● other potential advantages of alternative treatment methods and competitive forces or advancements that may make it more difficult for us to penetrate a particular market segment, if at all; ● ineffective marketing, sales, and distribution activities and support; ● lack of significant competitive advantages over other products on the market; ● lack of cost-effectiveness or unfavorable pricing compared to other alternatives available on the market; ● pressure from commercial payors and government agencies on gross to net margins; ● inability to generate sufficient revenues to sustain our business operations in accordance with our plan from the sale or marketing of a product; ● changes to product labels, indications or other relevant information that may trigger additional regulatory requirements that may have a direct or indirect impact on the commercialization of our products; ● our inability or unwillingness, for cost or other reasons, to commercialize Talicia ® and Aemcolo ® to the extent any are approved for commercialization at the time of any such collaboration issues; ● timing of market introduction of competitive products, including from generic competitors; and ● changes in any laws, regulations, or other relevant policies related to drug pricing or other marketing conditions and requirements that may directly or indirectly limit, restrict, or otherwise negatively impact our ability or success in marketing or commercializing.
We may not successfully continue the commercialization of Talicia ® and our products may not be, or continue to be, commercially successful for various reasons, including but not limited to: ● difficulty in large-scale manufacturing, including yield and quality, and in shipping product internationally; ● low market acceptance by physicians, healthcare payors, patients and the medical community as a result of lower demonstrated clinical safety or efficacy compared to products, prevalence, and severity of adverse side effects, or other potential disadvantages relative to alternative treatment methods; ● changes to the underlying dynamics of the markets for these products; ● infringement on proprietary rights of others for which we or third parties involved in the development or commercialization of our products or potential future therapeutic candidates have not received licenses; ● incompatibility with other marketed products; ● other potential advantages of alternative treatment methods and competitive forces or advancements that may make it more difficult for us to penetrate a particular market segment, if at all; ● ineffective marketing, sales, and distribution activities and support; ● lack of significant competitive advantages over other products on the market; ● lack of cost-effectiveness or unfavorable pricing compared to other alternatives available on the market; ● pressure from commercial payors and government agencies on gross to net margins; ● inability to generate sufficient revenues to sustain our business operations in accordance with our plan from the sale or marketing of a product; ● changes to product labels, indications or other relevant information that may trigger additional regulatory requirements that may have a direct or indirect impact on the commercialization of our products; ● our inability or unwillingness, for cost or other reasons, to commercialize Talicia ® to the extent any are approved for commercialization at the time of any such collaboration issues; ● timing of market introduction of competitive products, including from generic competitors; and ● changes in any laws, regulations, or other relevant policies related to drug pricing or other marketing conditions and requirements that may directly or indirectly limit, restrict, or otherwise negatively impact our ability or success in marketing or commercializing.
If we or our current or future commercialization partners, suppliers, third-party contractors or clinical investigators are slow to adapt, or are unable to adapt, to changes in existing regulatory requirements or the adoption of new regulatory requirements or policies, we and our development or commercialization partners may lose marketing clearance or approval for any products already cleared or approved for marketing in any jurisdiction, resulting in decreased or lost revenue from such products and could also result in other civil or criminal sanctions, including fines and penalties, and we may lose marketing clearance or approval of any of our therapeutic candidates, if any of our therapeutic candidates are approved for marketing. 30 Table of Contents We may encounter delays in receipt of FDA approval, if any, for our therapeutic candidates due to CMC, clinical, efficacy, safety, or regulatory or other issues.
If we or our current or future development or commercialization partners, suppliers, third-party contractors or clinical investigators are slow to adapt, or are unable to adapt, to changes in existing regulatory requirements or the adoption of new regulatory requirements or policies, we and our development or commercialization partners may lose marketing clearance or approval for any products already cleared or approved for marketing in any jurisdiction, resulting in decreased or lost revenue from such products and could also result in other civil or criminal sanctions, including fines and penalties, and we may lose marketing clearance or approval of any of our therapeutic candidates, if any of our therapeutic candidates are approved for marketing. 30 Table of Contents We may encounter delays in receipt of FDA approval, if any, for our therapeutic candidates due to CMC, clinical studies, efficacy, safety, or regulatory or other issues.
A therapeutic candidate or any product that we may commercialize or promote, may not result in commercial success for various reasons, including but not limited to: ● difficulty in large-scale manufacturing, including yield and quality; 36 Table of Contents ● low market acceptance by physicians, healthcare payors, patients and the medical community as a result of lower demonstrated clinical safety or efficacy compared to products, prevalence, and severity of adverse side effects, or other potential disadvantages relative to alternative treatment methods; ● insufficient or unfavorable levels of reimbursement from government or third-party payors, such as insurance companies, health maintenance organizations and other health plan administrators; ● infringement on proprietary rights of others for which we or our development or commercialization partners have not received licenses; ● incompatibility with other therapeutic candidates or marketed products; ● other potential advantages of alternative treatment methods and competitive forces that may make it more difficult for us to penetrate a particular market segment, if at all; ● ineffective marketing, sales, and distribution activities and support; ● lack of significant competitive advantages over existing products on the market; ● lack of cost-effectiveness or unfavorable pricing compared to other alternatives available on the market; ● inability to generate sufficient revenues to sustain our business operations in accordance with our plan from the sale or marketing of a product in view of the economic arrangements that we have with commercialization or other partners; ● changes to labels, indications or other regulatory requirements as they relate to the commercialization of our products; ● inability to establish collaborations with third-party development or commercialization partners on acceptable terms, or at all, and our inability or unwillingness for cost or other reasons to commercialize the therapeutic candidates or any product we may commercialize or promote on our own; and ● timing of market introduction of competitive products, such as Voquezna.
A therapeutic candidate or any product that we may commercialize or promote, may not result in commercial success for various reasons, including but not limited to: ● difficulty in large-scale manufacturing, including yield and quality; ● low market acceptance by physicians, healthcare payors, patients and the medical community as a result of lower demonstrated clinical safety or efficacy compared to products, prevalence, and severity of adverse side effects, or other potential disadvantages relative to alternative treatment methods; ● insufficient or unfavorable levels of reimbursement from government or third-party payors, such as insurance companies, health maintenance organizations and other health plan administrators; ● infringement on proprietary rights of others for which we or our development or commercialization partners have not received licenses; ● incompatibility with other therapeutic candidates or marketed products; ● other potential advantages of alternative treatment methods and competitive forces that may make it more difficult for us to penetrate a particular market segment, if at all; ● ineffective marketing, sales, and distribution activities and support; ● lack of significant competitive advantages over existing products on the market; ● lack of cost-effectiveness or unfavorable pricing compared to other alternatives available on the market; ● inability to generate sufficient revenues to sustain our business operations in accordance with our plan from the sale or marketing of a product in view of the economic arrangements that we have with commercialization or other partners; ● changes to labels, indications or other regulatory requirements as they relate to the commercialization of our products; ● inability to establish collaborations with third-party development or commercialization partners on acceptable terms, or at all, and our inability or unwillingness for cost or other reasons to commercialize the therapeutic candidates or any product we may commercialize or promote on our own; and ● timing of market introduction of competitive products, such as Voquezna.
In addition, the process of integrating an acquired product, technology, company or business may create operating difficulties and expenditures and pose numerous additional risks to our operations, including: ● difficulty and expense in integrating the acquired product, technology, company or business, and personnel in accordance with our business strategy and existing operations, including the failure to achieve the expected benefits and synergies; ● obligations to further develop and commercialize the acquired product, technology, company or business, in particular in jurisdictions outside of those in which we have experience operating; ● higher than anticipated acquisition costs and expenses; ● failure to manufacture or supply, or procure manufacturers or suppliers for, the acquired product, technology, company or business economically or successfully commercialize or achieve market acceptance of the acquired product; ● exposure to liabilities of the acquired product, technology, company or business, including contract terms and conditions that are less favorable to us than our standard contractual terms, known or unknown risks relating to the validity or enforceability of patents, expiration of patents or exclusivity rights, generic competition, product defects or product liability claims, patent and other litigation and clinical, development or other liabilities; ● disruption of our business and diversion of our management’s and technical personnel’s time and attention from their day-to-day responsibilities; ● adverse effects on our reputation, business, financial condition or results of operations, including due to expenditures or acquisition-related costs, costs of commercialization or amortization or impairment costs for acquired goodwill and other intangible assets; ● impairment of relationships with key suppliers and manufacturers due to changes in management and ownership and difficulty in maintaining existing agreements, licenses and other arrangements or rights on substantially similar terms as existed prior to the acquisition; ● regulatory changes and market dynamics after the acquisition; and ● potential loss of key employees, particularly those of the acquired entity.
In addition, the process of integrating an acquired product, technology, company or business may create operating difficulties and expenditures and pose numerous additional risks to our operations, including: ● difficulty and expense in integrating the acquired product, technology, company or business, and personnel in accordance with our business strategy and existing operations, including the failure to achieve the expected benefits and synergies; ● obligations to further develop and commercialize the acquired product, technology, company or business, in particular in jurisdictions outside of those in which we have experience operating; ● higher than anticipated acquisition costs and expenses; ● failure to manufacture or supply, or procure manufacturers or suppliers for, the acquired product, technology, company or business economically or successfully commercialize or achieve market acceptance of the acquired product; 18 Table of Contents ● exposure to liabilities of the acquired product, technology, company or business, including contract terms and conditions that are less favorable to us than our standard contractual terms, known or unknown risks relating to the validity or enforceability of patents, expiration of patents or exclusivity rights, generic competition, product defects or product liability claims, patent and other litigation and clinical, development or other liabilities; ● disruption of our business and diversion of our management’s and technical personnel’s time and attention from their day-to-day responsibilities; ● adverse effects on our reputation, business, financial condition or results of operations, including due to expenditures or acquisition-related costs, costs of commercialization or amortization or impairment costs for acquired goodwill and other intangible assets; ● impairment of relationships with key suppliers and manufacturers due to changes in management and ownership and difficulty in maintaining existing agreements, licenses and other arrangements or rights on substantially similar terms as existed prior to the acquisition; ● regulatory changes and market dynamics after the acquisition; and ● potential loss of key employees, particularly those of the acquired entity.
This preference for having products covered by such intellectual property be substantially manufactured in the U.S. may limit our ability to contract with non-U.S. product manufacturers or even U.S. product manufacturers whose manufacturing capacity is offshore. The development of opaganib and RHB-107 has relied on support by the National Institutes of Health and the U.S.
This preference for having products covered by such intellectual property be substantially manufactured in the U.S. may limit our ability to contract with non-U.S. product manufacturers or even U.S. product manufacturers whose manufacturing capacity is offshore. The research and development of opaganib and RHB-107 has relied on support by the National Institutes of Health and the U.S.
Relying upon collaborative arrangements to commercialize our current commercial products and other products that we may commercialize or promote in the future and to develop our therapeutic candidates, subjects us to a number of risks, including but not limited to the following: ● we will be responsible for making certain milestones, royalty or other payments under our various in-licenses even if our operating costs exceed the revenues generated from the relevant products; ● our collaborators may default on their obligations to us and we may be forced to either terminate, litigate or renegotiate such arrangements; ● our collaborators may have claims that we breached our obligations to them which may result in termination, renegotiation, litigation or delays in performance of such arrangements; ● we may not be able to control the amount and timing of resources that our collaborators may devote to our current commercial products, products that we may commercialize or promote in the future or our therapeutic candidates; ● our collaborators may fail to comply with applicable laws, rules, or regulations when performing services for us, and we could be held liable for such violations; ● our collaborators may experience financial difficulties, making it difficult for them to fulfill their obligations to us, including payment obligations, or they may experience changes in business focus; ● our collaborators’ partners may fail to secure adequate commercial supplies for our current commercial products or products that we may commercialize or promote; ● our collaborators’ partners may have a shortage of qualified personnel; ● we may be required to relinquish important rights, such as marketing and distribution rights; ● business combinations or significant changes in a collaborator’s business or business strategy may adversely affect a collaborator’s willingness or ability to complete its obligations under any arrangement; ● under certain circumstances, a collaborator could move forward with a competing therapeutic candidate or commercial product developed either independently or in collaboration with others, including our competitors; ● collaborative arrangements are often terminated or allowed to expire, which may limit or terminate our rights to commercialize our current commercial products or products we may commercialize or promote in the future, or could delay the development and may increase the cost of developing our therapeutic candidates; ● our collaborators may not wish to extend the terms of our agreements related to our commercial products or therapeutic candidates beyond the existing terms, in which case, we will not have access to existing rights upon the expiration and will therefore not be able to develop such therapeutic candidates or commercialize or promote such products following the initial terms of our agreements; and 18 Table of Contents ● our collaborators may wish to terminate the collaborative arrangements due to any disagreements or conflicts with us, a change in their assessment that the arrangement is no longer valuable, a change in control or in management or in strategy, changes in product development or business strategies of our collaborators.
Relying upon collaborative arrangements to commercialize Talicia ® and any other products that we may commercialize or promote in the future and to develop our therapeutic candidates, subjects us to a number of risks, including but not limited to the following: ● we will be responsible for making certain milestones, royalty or other payments under our various in-licenses even if our operating costs exceed the revenues generated from the relevant products; ● our collaborators may default on their obligations to us and we may be forced to either terminate, litigate or renegotiate such arrangements; 16 Table of Contents ● our collaborators may have claims that we breached our obligations to them which may result in termination, renegotiation, litigation or delays in performance of such arrangements; ● we may not be able to control the amount and timing of resources that our collaborators may devote to Talicia ® , products that we may commercialize or promote in the future or our therapeutic candidates; ● our collaborators may fail to comply with applicable laws, rules, or regulations when performing services for us, and we could be held liable for such violations; ● our collaborators may experience financial difficulties, making it difficult for them to fulfill their obligations to us, including payment obligations, or they may experience changes in business focus; ● our collaborators’ partners may fail to secure adequate commercial supplies for Talicia ® or products that we may commercialize or promote; ● our collaborators’ partners may have a shortage of qualified personnel; ● we may be required to relinquish important rights, such as marketing and distribution rights; ● business combinations or significant changes in a collaborator’s business or business strategy may adversely affect a collaborator’s willingness or ability to complete its obligations under any arrangement; ● under certain circumstances, a collaborator could move forward with a competing therapeutic candidate or commercial product developed either independently or in collaboration with others, including our competitors; ● collaborative arrangements are often terminated or allowed to expire, which may limit or terminate our rights to commercialize Talicia ® or products we may commercialize or promote in the future, or could delay the development and may increase the cost of developing our therapeutic candidates; ● our collaborators may not wish to extend the terms of our agreements related to Talicia® and any future commercial products or therapeutic candidates beyond the existing terms, in which case, we will not have access to existing rights upon the expiration and will therefore not be able to develop such therapeutic candidates or commercialize or promote such products following the initial terms of our agreements; and ● our collaborators may wish to terminate the collaborative arrangements due to any disagreements or conflicts with us, a change in their assessment that the arrangement is no longer valuable, a change in control or in management or in strategy, changes in product development or business strategies of our collaborators.
Our sales and marketing practices must also comply with federal and state anti-kickback statutes, the violation of which can result in criminal liability and other penalties. In addition to the requirements applicable to approved drug products, we may also be subject to enforcement action in connection with any promotion of an investigational new drug.
Our sales and marketing practices must also comply with federal and state anti-kickback statutes, the violation of which can result in civil and criminal liability and other penalties. In addition to the requirements applicable to approved drug products, we may also be subject to enforcement action in connection with any promotion of an investigational new drug.
Any failure to enter into (or in the case of Gaelen Medical, any failure to maintain) development or commercialization agreements with respect to the development, marketing and commercialization of any therapeutic candidates or products we may commercialize or promote or failure to develop, market and commercialize such commercial products or therapeutic candidates or products we may commercialize or promote independently may have an adverse effect on our reputation, business, financial condition or results of operations.
Any failure to enter into (or in the case of Gaelen Medical and Hyloris, any failure to maintain) development or commercialization agreements with respect to the development, marketing and commercialization of any therapeutic candidates or products we may commercialize or promote or failure to develop, market and commercialize such commercial products or therapeutic candidates or products we may commercialize or promote independently may have an adverse effect on our reputation, business, financial condition or results of operations.
If we are unable to maintain or expand our sales and marketing capabilities, train our sales force or contractors effectively or provide any other capabilities necessary to commercialize products, we may need to contract with third parties to market and sell our products which could have an adverse effect on our financial condition and our results of operations.
If we are unable to maintain or expand our sales and marketing capabilities, train our sales force or contractors effectively or provide any other capabilities necessary to commercialize products, we may need to contract with third parties to market and sell our products, which, if we are able to sell our products, could have an adverse effect on our financial condition and our results of operations.
Part of our strategy is to identify and acquire rights to products that have been cleared or approved for marketing in the U.S. or elsewhere, and in particular, those with a therapeutic focus on GI and infectious diseases or with therapeutic activities which are overlapping or complementary to our existing commercial activities.
Part of our strategy is to identify and acquire rights to products that have been cleared or approved for marketing in the U.S. or elsewhere, and in particular, those with a therapeutic focus on GI, infectious diseases and oncology or with therapeutic activities which are overlapping or complementary to our existing commercial activities.
Our failure to further in-license or acquire therapeutic candidates or products that have been approved or cleared for marketing in the U.S. in the future may materially hinder our ability to grow and could materially harm our reputation, business, financial condition or results of operations. 24 Table of Contents If we or a licensor or a partner of ours cannot meet our or their respective obligations under our acquisition, in-license or other development or commercialization agreements or renegotiate the obligations under such agreements, or if other events occur that are not within our control, such as bankruptcy of a licensor or a partner, we could lose the rights to our therapeutic candidates or products we may commercialize or promote, experience delays in developing or commercializing our therapeutic candidates or products we may commercialize or promote or incur additional costs, which could have a material adverse effect on our reputation, business, financial condition or results of operations.
Our failure to further in-license or acquire therapeutic candidates or products that have been approved or cleared for marketing in the U.S. in the future may materially hinder our ability to grow and could materially harm our reputation, business, financial condition or results of operations. 23 Table of Contents If we or a licensor or a partner of ours cannot meet our or their respective obligations under our acquisition, in-license or other development or commercialization agreements or renegotiate the obligations under such agreements, or if other events occur that are not within our control, such as bankruptcy of a licensor or a partner, we could lose the rights to our therapeutic candidates or products we may commercialize or promote, experience delays in developing or commercializing our therapeutic candidates or products we may commercialize or promote or incur additional costs, which could have a material adverse effect on our reputation, business, financial condition or results of operations.
We experience intense competition for qualified personnel, and the existence of non-competition agreements between prospective employees and their former employers may prevent us from hiring those individuals or subject us to liability from their former employers. Our U.S. subsidiary, RedHill U.S., previously experienced, and continues to experience, high turnover rates.
We experience intense competition for qualified personnel, and the existence of non-competition agreements between prospective employees and their former employers may prevent us from hiring those individuals or subject us to liability from their former employers. Our U.S. subsidiary, RedHill U.S., previously experienced high turnover rates.
However, future regulatory developments may lead to a loss of the right to commercialize Talicia ® or Aemcolo ® or any product we may commercialize or promote in the future. We currently have five therapeutic candidates in development, most of which are in clinical stage development, with the goal of eventually seeking FDA or other foreign regulatory approvals.
However, future regulatory developments may lead to a loss of the right to commercialize Talicia ® or any product we may commercialize or promote in the future. We currently have five therapeutic candidates in development, most of which are in clinical stage development, with the goal of eventually seeking FDA or other foreign regulatory approvals.
If any of these or other issues occur, we may face substantial additional expenses and otherwise experience delays in obtaining FDA approval of the NDAs we may file in the future for our therapeutic candidates, including RHB-104 for Crohn’s disease, or may never obtain the FDA approval for such NDAs.
If any of these or other issues occur, we may face substantial additional expenses and otherwise experience delays in obtaining FDA approval of the NDAs we may file in the future for our therapeutic candidates, including RHB-104/RHB-204 for Crohn’s disease, or may never obtain the FDA approval for such NDAs.
In addition to filing patents, we generally try to protect our trade secrets, know-how, and technology by entering into confidentiality or non-disclosure agreements with parties that have access to them, such as our development or commercialization partners, employees, contractors, and consultants.
In addition to filing patents, we generally try to protect our inventions, trade secrets, know-how, and technology by entering into confidentiality or non-disclosure agreements with parties that have access to them, such as our development or commercialization partners, employees, contractors, and consultants.
As a result, this process may divert internal resources and take a significant amount of time and effort to complete. In addition, we cannot predict the outcome of this process and whether we will need to implement remedial actions in order to implement effective controls over financial reporting.
As a result, this process may continue to divert internal resources and may take a significant amount of time and effort to complete. In addition, we cannot predict the outcome of this process and whether we will need to implement remedial actions in order to implement effective controls over financial reporting.
We plan to fund our future operations through commercialization of Talicia ® and Aemcolo ® , out-licensing of our therapeutic candidates and commercialization of in-licensed or acquired products, and we will also need to raise significant additional capital through equity or debt financing or non-dilutive financing, including government grants.
We plan to fund our future operations through commercialization of Talicia ® , out-licensing of our therapeutic candidates and commercialization of in-licensed or acquired products, and we will also need to raise significant additional capital through equity or debt financing or non-dilutive financing, including government grants.
These structural changes could entail further modifications to the existing system of private payors and government programs (such as Medicare, Medicaid, and the State Children’s Health Insurance Program), creation of government-sponsored healthcare insurance sources, or some combination of both, as well as other changes.
These structural changes could entail further modifications to the existing system of private payors and government programs (such as Medicare, Medicaid, and the Children’s Health Insurance Program), creation of government-sponsored healthcare insurance sources, or some combination of both, as well as other changes.
If there is any conflict, dispute, disagreement or issue of non-performance between us and our third-party partners regarding our rights or obligations under the acquisition, commercialization or license agreements, including any such conflict, dispute or disagreement arising from our failure to satisfy payment obligations under any such agreement or to perform certain activities or to adhere to any contractual obligation, we may be liable to pay damages and incur costs, and it could lead to delays in the research, development, collaboration, and commercialization of our commercial products, products we may promote or commercialize in the future or our therapeutic candidates.
If there is any conflict, dispute, disagreement or issue of non-performance between us and our third-party partners regarding our rights or obligations under the acquisition, commercialization or license agreements, including any such conflict, dispute or disagreement arising from our failure to satisfy payment obligations under any such agreement or to perform certain activities or to adhere to any contractual obligation, we may be liable to pay damages and incur costs, and it could lead to delays in the research, development, collaboration, and commercialization of Talicia ® , products we may promote or commercialize in the future or our therapeutic candidates.
We may also have difficulty in integrating into our existing U.S. operations sales and other commercial personnel or contractors that we may hire or engage to support the commercialization of Talicia ® and Aemcolo ® .
We may also have difficulty in integrating into our existing U.S. operations sales and other commercial personnel or contractors that we may hire or engage to support the commercialization of Talicia ® .
Department of Defense and other government bodies. These government bodies can withdraw, reduce or end their support of our products at any time, and this would significantly impair our ability to develop them further.
Department of Defense and other government bodies. These government bodies can withdraw, reduce or end their support of our products at any time, and this would significantly impair our ability to research and develop them further.
In addition, our reliance upon our partners in connection with commercial activities subjects us to a number of additional risks, including but not limited to, the following: ● we do not generally control our partners’ communications with the FDA or other foreign regulatory authorities, and the FDA or other foreign regulatory authorities may determine not to approve or elect to withdraw the products from the market due to various factors including any action or inaction taken by our partners (see “ – Our current commercial products or products which we may commercialize or promote in the future may be subject to recalls or market withdrawal that could have an adverse effect on our reputation, business, financial condition or results of operations .”); ● in many instances, we rely on our partners to take enforcement action to protect the IP and regulatory protections, if any, of some of our commercial products.
In addition, our reliance upon our partners in connection with commercial activities subjects us to a number of additional risks, including but not limited to, the following: ● we do not generally control our partners’ communications with the FDA or other foreign regulatory authorities, and the FDA or other foreign regulatory authorities may determine not to approve or elect to withdraw the products from the market due to various factors including any action or inaction taken by our partners (see “ – Talicia ® or products which we may commercialize or promote in the future may be subject to recalls or market withdrawal that could have an adverse effect on our reputation, business, financial condition or results of operations ”); ● in many instances, we rely on our partners to take enforcement action to protect the IP and regulatory protections, if any, of Talicia® and any future commercial products.
In addition, we are subject to global events beyond our control, including war, public health crises, such as pandemics and epidemics (as described above), trade disputes and other international events.
In addition, we are subject to global events beyond our control, including war, public health crises, such as pandemics and epidemics (as described above), tariffs and trade disputes and other international events.
In addition, the government is under no obligation to continue to support development of our products and can cease such support at any time which could be irreplaceable to the development process of our products.
In addition, the government is under no obligation to continue to support research and development of our products and can cease such support at any time which could be irreplaceable to the research and development process of our products.
We expect our future success will significantly depend upon our ability to successfully commercialize Talicia in the U.S. or to find a commercialization partner ng to do so.
We expect our future success will significantly depend upon our ability to successfully commercialize Talicia ® in the U.S. or to find a commercialization partner to do so.
Consequently, any predictions about our future performance may not be accurate, and we may not be able to fully assess our ability to commercialize our current commercial products or ones we may acquire or develop in the future, complete the development or obtain regulatory approval for our current and future therapeutic candidates or obtain regulatory approvals, reimbursement by third-party payors, achieve market acceptance or competitive pricing of our current commercial products or products that we may commercialize or promote in the future.
Consequently, any predictions about our future performance may not be accurate, and we may not be able to fully assess our ability to commercialize Talicia ® or ones we may acquire or develop in the future, complete the development or obtain regulatory approval for our current and future therapeutic candidates or obtain regulatory approvals, reimbursement by third-party payors, achieve market acceptance or competitive pricing of Talicia ® or products that we may commercialize or promote in the future.
We try to protect our proprietary position by, among other things, filing U.S., European, and other patent applications related to our therapeutic candidates, inventions and improvements that may be important to the continuing development of our commercial products and therapeutic candidates, and we plan to try to do the same with products we may acquire, commercialize or promote in the future, where this is possible.
We try to protect our proprietary position by, among other things, filing U.S., European, and other patent applications related to our therapeutic candidates, inventions and improvements that may be important to the continuing development of Talicia® and any future commercial products and therapeutic candidates, and we plan to try to do the same with products we may acquire, commercialize or promote in the future, where this is possible.
Additionally, if significant deficiencies or other material weaknesses are identified in our internal control over financial reporting that we cannot remediate in a timely manner, investors and others may lose confidence in the reliability of our financial statements and the trading price of our shares and ability to obtain any necessary equity or debt financing could suffer.
Additionally, if significant deficiencies or other material weaknesses are identified in our internal control over financial reporting that we cannot remediate in a timely manner, investors and others may lose confidence in the reliability of our financial statements and the trading price of our securities and ability to obtain any necessary equity or debt financing could suffer.
Any failure by our licensors or commercialization or development partners to properly conduct patent and trademark prosecution, patent and trademark maintenance, patent and trademark enforcement, or patent defense could materially harm our ability to obtain suitable patent protection covering our commercial products or therapeutic candidates or ensure freedom to commercialize the products in view of third-party patent rights, thereby materially reducing our potential profits. 50 Table of Contents If we are unable to protect the confidentiality of our trade secrets or know-how, such proprietary information may be used by others to compete against us.
Any failure by our licensors or commercialization or development partners to properly conduct patent and trademark prosecution, patent and trademark maintenance, patent and trademark enforcement, or patent defense could materially harm our ability to obtain suitable patent protection covering Talicia® and any future commercial products or therapeutic candidates or ensure freedom to commercialize the products in view of third-party patent rights, thereby materially reducing our potential profits. 50 Table of Contents If we are unable to protect the confidentiality of our inventions, trade secrets or know-how, such proprietary information may be used by others to compete against us.
On the legislative front, the American Rescue Plan Act of 2021 was signed into law on March 11, 2021, which, in relevant part, eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source drugs and innovator multiple source drugs, beginning January 1, 2024.
On the legislative front, the American Rescue Plan Act of 2021 was signed into law on March 11, 2021, which, in relevant part, eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source drugs and innovator multiple source drugs, which began on January 1, 2024.
Our commercial products and therapeutic candidates are subject to extensive governmental laws, regulations, and guidelines relating to the development, clinical trials, manufacturing, marketing, promotion, and commercialization of pre- and post-approval prescription drugs. We may not be able to submit for or obtain marketing approval for any of our therapeutic candidates in a timely manner or at all.
Our commercial product and therapeutic candidates are subject to extensive governmental laws, regulations, and guidelines relating to the development, clinical trials, manufacturing, marketing, promotion, and commercialization of pre- and post-approval prescription drugs. We may not be able to submit for or obtain marketing approval for any of our therapeutic candidates in a timely manner or at all.
Additionally, the FDA or other foreign regulatory authorities may change their clearance or approval policies or adopt new laws, regulations or guidelines that materially delay or impair our ability to commercialize our current commercial products and products that we may commercialize or promote in the future, or our ability to obtain the necessary regulatory clearances or approvals for any of our current or future therapeutic candidates.
Additionally, the FDA or other foreign regulatory authorities may change their clearance or approval policies or adopt new laws, regulations or guidelines that materially delay or impair our ability to commercialize Talicia ® and products that we may commercialize or promote in the future, or our ability to obtain the necessary regulatory clearances or approvals for any of our current or future therapeutic candidates.
Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023), and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025).
Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (which was first due in 2023), and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025).
Intellectual property litigation and other proceedings may also absorb significant management time. Consequently, we are unable to guarantee that we will be able to manufacture, use, offer for sale, sell or import any of our commercial products or of our therapeutic candidates in the event of an infringement action.
Intellectual property litigation and other proceedings may also absorb significant management time. Consequently, we are unable to guarantee that we will be able to manufacture, use, offer for sale, sell or import Talicia® and any future commercial products or of our therapeutic candidates in the event of an infringement action.
Physicians, various other healthcare providers, patients, payors or the medical community, in general, may be unwilling to accept, utilize or recommend Talicia ® or Aemcolo ® .
Physicians, various other healthcare providers, patients, payors or the medical community, in general, may be unwilling to accept, utilize or recommend Talicia ® .
If the third-party manufacturers are unable to successfully increase or maintain the manufacturing capacity for a therapeutic candidate, current commercial products or for products that we may commercialize or promote in the future, or if we are unable to secure replacement third-party manufacturers or unable to establish our own manufacturing capabilities, the commercial launch of any approved products may be delayed or there may be a shortage in supply.
If the third-party manufacturers are unable to successfully increase or maintain the manufacturing capacity for a therapeutic candidate, Talicia ® or for products that we may commercialize or promote in the future, or if we are unable to secure replacement third-party manufacturers or unable to establish our own manufacturing capabilities, the commercial launch of any approved products may be delayed or there may be a shortage in supply.
In the event of such an occurrence, we could be held liable for any damages that could result and any such liability could exceed our resources. 44 Table of Contents Security breaches, loss of data, and other disruptions could compromise sensitive information and expose us to liability, which would cause our business and reputation to suffer.
In the event of such an occurrence, we could be held liable for any damages that could result and any such liability could exceed our resources. 46 Table of Contents Security breaches, loss of data, and other disruptions could compromise sensitive information and expose us to liability, which would cause our business and reputation to suffer.
Unauthorized access, loss or dissemination could also disrupt our operations, including our ability to perform tests, provide test results, bill 45 Table of Contents facilities or patients, process claims and appeals, provide customer assistance services, conduct research and development activities, collect, process and prepare Company financial information, provide information about our current and future solutions and other patient and clinician education and outreach efforts through our websites, and manage the administrative aspects of our business and damage our reputation, any of which could adversely affect our reputation, business, financial condition or results of operations.
Unauthorized access, loss or dissemination could also disrupt our operations, including our ability to perform tests, provide test results, bill facilities or patients, process claims and appeals, provide customer assistance services, conduct research and development activities, collect, process and prepare Company financial information, provide information about our current and future solutions and other patient and clinician education and outreach efforts through our websites, and manage the administrative aspects of our business and damage our reputation, any of which could adversely affect our reputation, business, financial condition or results of operations.
In addition, the current armed conflict in Ukraine and the subsequent economic sanctions imposed by some countries on Russia and certain territories in Ukraine may negatively impact the supply chain for our commercial products, our R&D activities and our business development activities. We face risks associated with the lawsuit we initiated against Kukbo.
In addition, the current armed conflict in Ukraine and the subsequent economic sanctions imposed by some countries on Russia and certain territories in Ukraine may negatively impact the supply chain for our commercial product, our R&D activities and our business development activities. We face risks associated with the lawsuit we initiated against Kukbo.
If we fail to establish broad adoption of and reimbursement for our commercial products, or if we are unable to maintain any existing reimbursement from payors, our ability to generate revenue could be harmed and this could have a material adverse effect on our reputation, business, financial condition or results of operations.
If we fail to establish broad adoption of and reimbursement for Talicia® and any future commercial products, or if we are unable to maintain any existing reimbursement from payors, our ability to generate revenue could be harmed and this could have a material adverse effect on our reputation, business, financial condition or results of operations.
If we do not meet our obligations under these agreements in a timely manner or if other events occur that are not within our control, such as the bankruptcy of a licensor, which impact our ability to prosecute certain patent applications and maintain certain issued patents licensed to us, we could lose the rights to our current and future commercial products or our therapeutic candidates which could have a material adverse effect on our reputation, business, financial condition or results of operations.
If we do not meet our obligations under these agreements in a timely manner or if other events occur that are not within our control, such as the bankruptcy of a licensor, which impact our ability to prosecute certain patent applications and maintain certain issued patents licensed to us, we could lose the rights to Talicia® and any future commercial products or our therapeutic candidates which could have a material adverse effect on our reputation, business, financial condition or results of operations.
Such operations could be materially affected by changes in foreign exchange rates, capital and exchange controls, expropriation and other restrictive government actions, changes in intellectual property legal protections and remedies, changes in data privacy laws, trade regulations and procedures and actions affecting approval, production, pricing, and marketing of, reimbursement for and access to, our current commercial products and products we may commercialize or promote, or our therapeutic candidates, as well as by political unrest, unstable governments and legal systems, and inter-governmental disputes.
Such operations could be materially affected by changes in foreign exchange rates, capital and exchange controls, expropriation and other restrictive government actions, changes in intellectual property legal protections and remedies, changes in data privacy laws, trade regulations and procedures and actions affecting approval, production, pricing, and marketing of, reimbursement for and access to, Talicia ® and products we may commercialize or promote, or our therapeutic candidates, as well as by political unrest, unstable governments and legal systems, and inter-governmental disputes.
(“Kukbo”) in the Supreme Court of the State of New York, County of New York, Commercial Division, as a result of Kukbo’s default in delivering to us $5.0 million under the Subscription Agreement, in exchange for the ADSs we were to issue to Kukbo, and in delivering to us the further payment of $1.5 million due under the Exclusive License Agreement.
(“Kukbo”) in the Supreme Court of the State of New York, County of New York, Commercial Division, as a result of Kukbo’s default in delivering to us $5.0 million under the Subscription Agreement (as defined herein), in exchange for the ADSs we were to issue to Kukbo, and in delivering to us the further payment of $1.5 million due under the Exclusive License Agreement.
Complying with these various laws could cause us to incur substantial costs or require us to change our business practices and compliance procedures in a manner adverse to our business. Risks Related to Our COVID-19 Therapeutic Candidates and COVID-19 Impact on Our Business Government involvement may limit the commercial success of our COVID-19 therapeutic candidate.
Complying with these various laws could cause us to incur substantial costs or require us to change our business practices and compliance procedures in a manner adverse to our business. Risks Related to Our COVID-19 Therapeutic Candidates Government involvement may limit the commercial success of our COVID-19 therapeutic candidate.
The development, manufacture, use, offer for sale, sale or importation of any of our commercial products or any of our therapeutic candidates may infringe on the claims of third-party patents or other intellectual property rights. Patentability, invalidity, freedom-to-operate or other opinions may be required to determine the scope and validity of third-party proprietary rights.
The development, manufacture, use, offer for sale, sale or importation of Talicia® and any future commercial products or any of our therapeutic candidates may infringe on the claims of third-party patents or other intellectual property rights. Patentability, invalidity, freedom-to-operate or other opinions may be required to determine the scope and validity of third-party proprietary rights.
It is possible that there will be further 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 55 Table of Contents availability, such as overtime and third-party outsourcing, for example, may have unintended negative effects and adversely impact our results of operations, liquidity or cash flows.
It is possible that there will be further 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, for example, may have unintended negative effects and adversely impact our results of operations, liquidity or cash flows.
Modifications to our current commercial products and any products we may commercialize or promote, or to our therapeutic candidates, after they have been cleared or approved for marketing, if at all, may require new regulatory clearance or approvals, in particular, if we seek or are required to expand our operations to jurisdictions outside of the U.S., and, if necessitated by a problem with a marketed product, may result in the recall or suspension of marketing of the previously approved and marketed product until clearances or approvals of the modified product are obtained.
Modifications to Talicia® and any products we may commercialize or promote, or to our therapeutic candidates, after they have been cleared or approved for marketing, if at all, may require new regulatory clearance or approvals, in particular, if we seek or are required to expand our operations to jurisdictions outside of the U.S., and, if necessitated by a problem with a marketed product, may result in the recall or suspension of marketing of the previously approved and marketed product until clearances or approvals of the modified product are obtained.
Reliance on third-party manufacturers entails risks, including, but not limited to: ● manufacturing delays if our third-party manufacturers give greater priority to the supply of other products over our current or future commercial products, including Talicia ® and Aemcolo ® , or any future therapeutic candidates, if approved, or otherwise do not satisfactorily perform according to the terms of their agreements with us; ● the possible termination or nonrenewal of manufacturing agreements by the third-party manufacturers at a time that is costly or inconvenient for us; ● the possible breach of manufacturing agreements by third-party manufacturers; ● inability to fulfill all or part of our undertakings and commitments to our current or future commercialization partners in the U.S. and other territories, such as our partner Gaelen Medical, due to, among other things, delays or lack of supply by manufacturers of commercial products or the supply of such products in quantity or quality which is inadequate or not in line with the required regulatory standards or our agreements; ● delays in obtaining regulatory approval for any future therapeutic candidates, if our third-party manufacturers fail to satisfy FDA inspection requirements in connection with pre-approval inspections or otherwise fail to comply with regulatory requirements; and ● product loss or serious adverse events due to contamination, equipment failure, or improper installation or operation of equipment or operator error. 23 Table of Contents If we are unable to establish collaborations for our therapeutic candidates or products we may commercialize or promote, or otherwise not be able to raise substantial additional capital, we will likely need to alter or abandon our development and commercialization plans.
Reliance on third-party manufacturers entails risks, including, but not limited to: ● manufacturing delays if our third-party manufacturers give greater priority to the supply of other products over our current or future commercial products, including Talicia ® , or any future therapeutic candidates, if approved, or otherwise do not satisfactorily perform according to the terms of their agreements with us; ● the possible termination or nonrenewal of manufacturing agreements by the third-party manufacturers at a time that is costly or inconvenient for us; ● the possible breach of manufacturing agreements by third-party manufacturers; ● inability to fulfill all or part of our undertakings and commitments to our current or future commercialization partners in the U.S. and other territories, such as our partners, Gaelen Medical and Hyloris, due to, among other things, delays or lack of supply by manufacturers of commercial products or the supply of such products in quantity or quality which is inadequate or not in line with the required regulatory standards or our agreements; ● delays in obtaining regulatory approval for any future therapeutic candidates, if our third-party manufacturers fail to satisfy FDA inspection requirements in connection with pre-approval inspections or otherwise fail to comply with regulatory requirements; and ● product loss or serious adverse events due to contamination, equipment failure, or improper installation or operation of equipment or operator error. 22 Table of Contents If we are unable to establish collaborations for our therapeutic candidates or products we may commercialize or promote, or otherwise not be able to raise significant additional capital, we will likely need to alter or abandon our development and commercialization plans.
Based on the current composition of our gross income and assets and on reasonable assumptions and projections no assurance can be given that we will not be treated as a passive foreign investment company (a “PFIC”), for U.S. federal income tax purposes for 2024.
Based on the current composition of our gross income and assets and on reasonable assumptions and projections no assurance can be given that we will not be treated as a passive foreign investment company (a “PFIC”), for U.S. federal income tax purposes for 2025.
In addition, any current or future collaborative arrangements may place the commercialization of our current commercial products or products that we may commercialize or promote in the future or the development of our therapeutic candidates outside our control and may require us to relinquish important rights or may otherwise be on terms unfavorable to us.
In addition, any current or future collaborative arrangements may place the commercialization of Talicia ® or products that we may commercialize or promote in the future or the development of our therapeutic candidates outside our control and may require us to relinquish important rights or may otherwise be on terms unfavorable to us.
In addition, if we fail to negotiate and maintain suitable development, commercialization or promotion agreements or otherwise raise substantial additional capital to secure our own commercialization capabilities, we may have to limit the size or scope of our activities or we may have to delay or terminate one or more of our development or commercialization programs.
In addition, if we fail to negotiate and maintain suitable development, commercialization or promotion agreements or otherwise raise significant additional capital to secure our own commercialization capabilities, we may have to limit the size or scope of our activities or we may have to delay or terminate one or more of our development or commercialization programs.
If we are unable to maintain or expand such capabilities, either on our own or by entering into agreements with others, or are unable to do so in an efficient manner or on a timely basis, we will not be able to maximize the commercialization of our current commercial products or products that we may commercialize or promote in the future, which would adversely affect our reputation, business, financial condition or results of operations.
If we are unable to maintain or expand such capabilities, either on our own or by entering into agreements with others, or are unable to do so in an efficient manner or on a timely basis, we will not be able to maximize the commercialization of Talicia ® or products that we may commercialize or promote in the future, which would adversely affect our reputation, business, financial condition or results of operations.
As we plan to continue expending funds to commercialize Talicia ® and Aemcolo ® , out-license Talicia ® and our therapeutic candidates and acquire additional products and therapeutic candidates and expand our efforts in research and development, we will need to raise significant additional capital in the future through equity or debt financing, non-dilutive financing or pursuant to development or commercialization agreements with third parties with respect to particular therapeutic candidates and commercial products approved for sale in the U.S.
As we plan to continue expending funds to commercialize Talicia ® , out-license Talicia ® , further develop our therapeutic candidates, acquire additional products and therapeutic candidates and expand our efforts in research and development, we will need to raise significant additional capital in the future through equity or debt financing, non-dilutive financing or pursuant to development or commercialization agreements with third parties with respect to particular therapeutic candidates and commercial products approved for sale in the U.S.
In order to maintain and potentially increase our commercialization capabilities in the U.S. and outside the U.S., we may need to maintain and potentially expand, among others, our development, regulatory, manufacturing, sales and marketing capabilities, and to maintain or potentially increase our personnel to accommodate sales. We may experience difficulties in managing this growth and integrating new personnel.
We may experience difficulties in managing this growth and integrating new personnel. To maintain and potentially increase our own commercialization capabilities in the U.S. and outside the U.S. we may need to expand, among others, our development, regulatory, manufacturing, sales and marketing capabilities, and to maintain or potentially increase our personnel to accommodate sales.
We do not currently own or operate manufacturing facilities. We rely on, and expect to continue to rely on, third parties to manufacture commercial quantities of our current commercial products and products that we may commercialize or promote in the future and clinical quantities of our therapeutic candidates.
We do not currently own or operate manufacturing facilities. We rely on, and expect to continue to rely on, third parties to manufacture commercial quantities of Talicia ® and products that we may commercialize or promote in the future and clinical quantities of our therapeutic candidates.
Our current and anticipated future reliance upon others for the manufacture of our therapeutic candidates and any products that we may commercialize or promote may adversely affect our future operations and our ability to commercialize our current commercial products and any products that we may commercialize or promote on a timely and competitive basis, and to develop therapeutic candidates.
Our current and anticipated future reliance upon others for the manufacture of our therapeutic candidates and any products that we may commercialize or promote may adversely affect our future operations and our ability to commercialize Talicia ® and any products that we may commercialize or promote on a timely and competitive basis, and to develop therapeutic candidates.
The risks and uncertainties described below in this Annual Report for the year ended December 31, 2023, are not the only risks facing us. We may face additional risks and uncertainties not currently known to us or that we currently deem to be immaterial.
The risks and uncertainties described below in this Annual Report for the year ended December 31, 2024, are not the only risks facing us. We may face additional risks and uncertainties not currently known to us or that we currently deem to be immaterial.
Our failure, or the failure of our third-party manufacturers or our partners’ manufacturers, to comply with applicable laws, regulations and guidelines could result in the imposition of sanctions on us, including fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approval of our therapeutic candidates, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of our current and future commercial products and therapeutic candidates, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect regulatory approval and supplies of our current and future commercial products and therapeutic candidates, and materially and adversely affect our reputation, business, financial condition or results of operations.
Our failure, or the failure of our third-party manufacturers or our partners’ manufacturers, to comply with applicable laws, regulations and guidelines could result in the imposition of sanctions on us, including fines, injunctions, civil penalties, delays or suspension of clinical trials, failure of regulatory authorities to grant marketing approval of our therapeutic candidates, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of Talicia® and any future commercial products and therapeutic candidates, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect regulatory approval and supplies of Talicia® and any future commercial products and therapeutic candidates, and materially and adversely affect our reputation, business, financial condition or results of operations.
In the U.S., under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug or biologic intended to treat a rare disease or condition, which is defined as one occurring in a patient population of fewer than 200,000 in the U.S., or a patient population greater than 200,000 in the U.S. where there is no reasonable expectation that the cost of developing 33 Table of Contents the drug or biologic will be recovered from sales in the U.S.
In the U.S., under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug or biologic intended to treat a rare disease or condition, which is defined as one occurring in a patient population of fewer than 200,000 in the U.S., or a patient population greater than 200,000 in the U.S. where there is no reasonable expectation that the cost of developing the drug or biologic will be recovered from sales in the U.S.
Although certain payors may currently provide some form of coverage for our commercial products, payors may suspend or discontinue reimbursement at any time, may require or increase co-payments from patients, may impose restrictions or limitations on coverage, or may reduce reimbursement rates for our products.
Although certain payors may currently provide some form of coverage for Talicia®, payors may suspend or discontinue reimbursement at any time, may require or increase co-payments from patients, may impose restrictions or limitations on coverage, or may reduce reimbursement rates for our products.
Legal proceedings or third-party claims of intellectual property infringement and other challenges may require us to spend substantial time and money and could prevent us from developing or commercializing any of our commercial products and our therapeutic candidates.
Legal proceedings or third-party claims of intellectual property infringement and other challenges may require us to spend substantial time and money and could prevent us from developing or commercializing Talicia® and any future commercial products and our therapeutic candidates.
In addition, our ability to raise capital would be adversely affected if we are not able to maintain compliance with Nasdaq’s continued listing requirements. Any financing may also involve significant dilution to our shareholders.
In addition, our ability to raise capital would be adversely affected if we are not able to regain and maintain compliance with Nasdaq’s continued listing requirements. Any financing may also involve significant dilution to our shareholders.
The material weaknesses will not be considered remediated until we have completed implementing the necessary controls and ensured their applicability. 13 Table of Contents We have made, and will continue to make, changes in these and other areas.
The material weaknesses will not be considered remediated until we have completed implementing the necessary controls and ensured their applicability. 12 Table of Contents We have made, and will continue to make, changes in these and other areas.
In addition, so long as we continue to promote our current commercial products and in the event we promote additional commercial products we may develop, we need to maintain and may need to expand our marketing and sales capabilities and retain key personnel and talented commercial employees including sales representatives.
In addition, so long as we continue to promote Talicia ® and in the event we promote additional commercial products we may develop, we need to maintain and may need to expand our marketing and sales capabilities and retain key personnel and talented commercial employees including sales representatives.
If we or our collaborators do not meet our or their respective obligations under these or future agreements, or if other events occur that are not within our control, such as the bankruptcy of a licensor, we could lose the rights to commercialize our current and future commercial products or to our therapeutic candidates, experience delays in developing our therapeutic candidates or incur additional costs.
If we or our collaborators do not meet our or their respective obligations under these or future agreements, or if other events occur that are not within our control, such as the bankruptcy of a licensor, we could lose the rights to commercialize Talicia ® and any future commercial products or to our therapeutic candidates, experience delays in developing our therapeutic candidates or incur additional costs.
In addition, these breaches and other inappropriate access can be difficult to detect, and any delay in identifying them may lead to increased harm of the type described above. Any such breach or interruption could compromise our networks, and the information stored there could be inaccessible or could be accessed by unauthorized parties, publicly disclosed, lost or stolen.
In addition, these breaches and other inappropriate access can be difficult to detect, and any delay in identifying them may lead to increased harm of the type described above. 47 Table of Contents Any such breach or interruption could compromise our networks, and the information stored there could be inaccessible or could be accessed by unauthorized parties, publicly disclosed, lost or stolen.
Our ability to generate sufficient revenues to sustain our business operations in accordance with our plan and to achieve profitability depends mainly upon our ability, alone and/or with others, to successfully commercialize or promote our current commercial products and products that we may acquire or for which we may acquire commercialization rights in the future, develop our therapeutic candidates, obtain the required regulatory approvals in various territories.
Our ability to generate sufficient revenues to sustain our business operations in accordance with our plan and to achieve profitability depends mainly upon our ability, alone and/or with others, to successfully commercialize or promote Talicia ® and products that we may acquire or for which we may acquire commercialization rights in the future, develop our therapeutic candidates, obtain the required regulatory approvals in various territories.
These laws, regulations, and guidelines cover all aspects of the manufacturing, testing, quality control and recordkeeping relating to our current commercial products and any products we may commercialize or promote, and our therapeutic candidates with varying cGMP rigors depending on what phase each of our respective therapeutic candidates is in with respect to its drug development process.
These laws, regulations, and guidelines cover all aspects of the manufacturing, testing, quality control and recordkeeping relating to Talicia® and any products we may commercialize or promote, and our therapeutic candidates with varying cGMP rigors depending on what phase each of our respective therapeutic candidates is in with respect to its drug development process.
See “– Our business could suffer if we are unable 16 Table of Contents to attract and retain key personnel and additional highly qualified personnel. ” below. In addition, management may have to divert a disproportionate amount of its attention away from running our day-to-day activities and devote a substantial amount of time to managing these growth activities.
See “– Our business could suffer if we are unable to attract and retain key personnel and additional highly qualified personnel ” Below. In addition, management may have to divert a disproportionate amount of its attention away from running our day-to-day activities and devote a substantial amount of time to managing these growth activities.
As such, our strategy includes either selectively partnering or collaborating with multiple pharmaceutical and biotechnology companies to assist us in furthering the development or potential commercialization of our approved products and therapeutic candidates, if approved, promoting or commercializing products, in whole or in part, in some or all jurisdictions or through our own commercialization capabilities, such as our partnership with Gaelan Medical.
As such, our strategy includes either selectively partnering or collaborating with multiple pharmaceutical and biotechnology companies to assist us in furthering the development or potential commercialization of our approved products and therapeutic candidates, if approved, promoting or commercializing products, in whole or in part, in some or all jurisdictions or through our own commercialization capabilities, such as our partnerships with Gaelan Medical and Hyloris.
Later discovery of previously unknown problems with any of our current commercial products and product we may commercialize or promote, or any therapeutic candidate, manufacturer or manufacturing process, or failure to comply with rules and regulatory requirements, may result in actions, including but not limited to the following: ● restrictions on such therapeutic candidate, marketed product, manufacturer or manufacturing process; ● warning letters from the FDA or other foreign regulatory authorities; ● withdrawal of the marketed product from the market; ● withdrawal of the therapeutic candidate from use in a clinical trial; ● suspension or withdrawal of regulatory approvals; ● refusal to approve pending applications or supplements to approved applications that we or our development or commercialization partners submit; ● voluntary or mandatory recall; ● fines; ● refusal to permit the import or export of our current commercial products or products that we may commercialize or promote in the future or our therapeutic candidates; ● product seizure or detentions; ● injunctions or the imposition of civil or criminal penalties; and ● adverse publicity.
Later discovery of previously unknown problems with Talicia® , RHB-102 and products we may develop, commercialize or promote, or any therapeutic candidate, manufacturer or manufacturing process, or failure to comply with rules and regulatory requirements, may result in actions, including but not limited to the following: ● restrictions on such therapeutic candidate, marketed product, manufacturer or manufacturing process; ● warning letters from the FDA or other foreign regulatory authorities; ● withdrawal of the marketed product from the market; ● withdrawal of the therapeutic candidate from use in a clinical trial; ● suspension or withdrawal of regulatory approvals; ● refusal to approve pending applications or supplements to approved applications that we or our development or commercialization partners submit; ● voluntary or mandatory recall; ● fines; ● refusal to permit the import or export of Talicia® , RHB-102 or products that we may develop, commercialize or promote in the future or our therapeutic candidates; ● product seizure or detentions; ● injunctions or the imposition of civil or criminal penalties; and ● adverse publicity.
In addition, our current commercial products and products we may commercialize or promote in the future may compete with products of third parties for market share, and generic drugs or products that treat the same indications as our current commercial products or products we may commercialize or promote in the future, which can have an adverse effect on our revenues by reducing our market share or requiring us to reduce the price of the products we market.
In addition, Talicia® and products we may commercialize or promote in the future may compete with products of third parties for market share, and generic drugs or products that treat the same indications as Talicia® or products we may commercialize or promote in the future, which can have an adverse effect on our revenues by reducing our market share or requiring us to reduce the price of the products we market.
We expect that we will incur additional losses as we continue to focus our resources on advancing the development of our therapeutic candidates, as well as advancing our commercial operations, based on a prioritized plan that may result in negative cash flows from operating activities. Most of our therapeutic candidates are in late-stage clinical development.
We expect that we will incur additional losses as we continue to focus our resources on advancing the development of our therapeutic candidates, as well as advancing our commercial operations, based on a prioritized plan that may result in negative cash flows from operating activities. 13 Table of Contents Most of our therapeutic candidates are in late-stage clinical development.
Modifications to our current commercial products or to any product that we may commercialize or promote in the future, or our therapeutic candidates, may require new regulatory clearances or approvals or may require us or our development or commercialization partners, as applicable, to recall or cease marketing any of our approved products, or delay further studies of our therapeutic candidates in human subjects until clearances or approvals are obtained.
Modifications to Talicia® or to any product that we may commercialize or promote in the future, or our therapeutic candidates, may require new regulatory clearances or approvals or may require us or our development or commercialization partners, as applicable, to recall or cease marketing any of our approved products, or delay further studies of our therapeutic candidates in human subjects until clearances or approvals are obtained.
This attention may result in our current commercial products, products we may commercialize or promote in the future, and our therapeutic candidates, being chosen less frequently or the pricing being substantially lowered. At this stage, it is difficult to estimate the full extent of the direct or indirect impact of the Healthcare Reform Law on us.
This attention may result in Talicia®, products we may commercialize or promote in the future, and our therapeutic candidates, being chosen less frequently or the pricing being substantially lowered. At this stage, it is difficult to estimate the full extent of the direct or indirect impact of the Healthcare Reform Law on us.
We are subject to additional healthcare regulation and enforcement by the U.S. federal government and the states in which we conduct or will conduct our business. Healthcare providers, physicians, and third-party payors play a primary role in the recommendation and prescription of our current commercial products or any products we may commercialize or promote in the future.
We are subject to additional healthcare regulation and enforcement by the U.S. federal government and the states in which we conduct or will conduct our business. Healthcare providers, physicians, and third-party payors play a primary role in the recommendation and prescription of Talicia® or any products we may commercialize or promote in the future.
In addition, the federal district courts of the United States for the District of New York shall be the exclusive forum for any complaint asserting a cause of action arising under the Securities Act of 1933.
In addition, the federal district courts of the United States for the District of New York shall be the exclusive forum for any complaint asserting a cause of action arising under the Securities Act of 1933, as amended.
Cost of care could be reduced further by decreasing the level of reimbursement for medical services or products (including our current commercial products, our development or commercialization partners or any product we may commercialize or promote, or those therapeutic candidates currently being developed by us), or by restricting coverage (and, thereby, utilization) of medical services or products.
Cost of care could be reduced further by decreasing the level of reimbursement for medical services or products (including Talicia®, our development or commercialization partners or any product we may commercialize or promote, or those therapeutic candidates currently being developed by us), or by restricting coverage (and, thereby, utilization) of medical services or products.
The drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential 43 Table of Contents product liability claims. Any of these occurrences may have a material adverse effect on our reputation, business, financial condition or results of operations.
The drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may have a material adverse effect on our reputation, business, financial condition or results of operations.

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Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

180 edited+61 added−59 removed263 unchanged
In September 2023, we announced that the FDA had approved our supplemental new drug application (sNDA) for Talicia ® , allowing a change to a more flexible dosing regimen, enabling patients to take Talicia three times daily, at least 4 hours apart with food.
In September 2023, we announced that the FDA had approved our supplemental new drug application (sNDA) for Talicia ® , allowing a change in dosing to a more flexible regimen, enabling patients to take Talicia ® three times daily, at least 4 hours apart with food.
Army study tested three doses of opaganib (50, 100 and 150 mg/kg BID), against an inactive vehicle control arm.
Army study tested three doses of opaganib (50, 100 and 150 mg/kg BID), against an inactive vehicle control arm.
The in vivo study results showed a statistically significant survival increase in mean (SE) survival time of 11.2 (2.6) days in the 150 mg/kg opaganib group (p=0.0279) compared to a mean (SE) survival time of 5.5 (0.4) days in the inactive vehicle control group.
The in vivo study results showed a statistically significant survival increase in mean (SE) survival time of 11.2 (2.6) days in the 150 mg/kg opaganib group (p=0.0279) compared to a mean (SE) survival time of 5.5 (0.4) days in the inactive vehicle control group.
Ramosetron, another 5-HT3 serotonin receptor inhibitor is marketed for the treatment of IBS in Japan, South Korea, China and India (marketed under the brand name Irribow ® by Astellas Pharma Inc. (in Japan and South Korea) and is available in generic versions marketed by other companies).
Ramosetron, another 5-HT3 serotonin receptor inhibitor is marketed for the treatment of IBS in Japan, South Korea, China and India (marketed under the brand name Irribow ® by Astellas Pharma Inc. in Japan and is available in generic versions marketed by other companies in South Korea, China and India).
We also conducted a sensitivity analysis to account for missing data interpretability: ● Mortality : Opaganib treatment resulted in a statistically significant 62% reduction in mortality (7/117 patients treated with opaganib vs. 21/134 for placebo; nominal p-value=0.019, Relative Risk 2.6) (Sensitivity Analysis: 5/117 vs. 16/134, 64% efficacy benefit; nominal p-value=0.033, Relative Risk - 2.8). 71 Table of Contents A detailed analysis of baseline risk factors and their potential impact on the mortality outcome in the sensitivity analysis group has also been undertaken, showing that the benefit is robustly maintained irrespective of the subgroups/risk factors, confirming that the positive outcome observed is due to opaganib. ● Reaching Room Air by Day 14 (primary endpoint of the study) : 77% of opaganib-treated patients reached room air by Day 14 vs. 63.5% for placebo – an efficacy benefit of 21% with opaganib (nominal p-value=0.033). ● Median time to discharge : Patients treated with opaganib showed median time of 10 days to discharge vs. 14 days for the placebo arm, resulting in a saving of four days hospitalization per opaganib patient and saving a total of 524 cumulative days of hospitalization across the group by Day 42, nominal p-value=0.0195. ● Safety : Overall adverse events were balanced between the opaganib and placebo groups, suggesting good safety, with no new safety signals emerging, further supporting potential use in this patient population and earlier stage populations.
We also conducted a sensitivity analysis to account for missing data interpretability: ● Mortality : Opaganib treatment resulted in a statistically significant 62% reduction in mortality (7/117 patients treated with opaganib vs. 21/134 for placebo; nominal p-value=0.019, Relative Risk 2.6) (Sensitivity Analysis: 5/117 vs. 16/134, 64% efficacy benefit; nominal p-value=0.033, Relative Risk - 2.8). 72 Table of Contents A detailed analysis of baseline risk factors and their potential impact on the mortality outcome in the sensitivity analysis group has also been undertaken, showing that the benefit is robustly maintained irrespective of the subgroups/risk factors, confirming that the positive outcome observed is due to opaganib. ● Reaching Room Air by Day 14 (primary endpoint of the study) : 77% of opaganib-treated patients reached room air by Day 14 vs. 63.5% for placebo – an efficacy benefit of 21% with opaganib (nominal p-value=0.033). ● Median time to discharge : Patients treated with opaganib showed median time of 10 days to discharge vs. 14 days for the placebo arm, resulting in a saving of four days hospitalization per opaganib patient and saving a total of 524 cumulative days of hospitalization across the group by Day 42, nominal p-value=0.0195. ● Safety : Overall adverse events were balanced between the opaganib and placebo groups, suggesting good safety, with no new safety signals emerging, further supporting potential use in this patient population and earlier stage populations.
This enables patients to follow a convenient “breakfast, lunch and dinner” dosing routine, which may support increased patient adherence and optimize the potential for successful H. pylori eradication. In November 2023, we announced that the FDA had officially granted Talicia ® five years of additional market exclusivity via QIDP designation as provided by the GAIN Act.
This enables patients to follow a convenient “breakfast, lunch and dinner” dosing routine, which may support increased patient adherence and further optimize the potential for successful H. pylori eradication. In November 2023, we announced that the FDA had officially granted Talicia ® five years of additional market exclusivity via QIDP designation as provided by the GAIN Act.
In 2011, we obtained FDA “Orphan Drug” status for RHB-104 for the treatment of Crohn’s disease in the pediatric population. See “Item 4. Information on the Company – B. Business Overview – Government Regulations and Funding – Orphan Drug Designation.” The formulation for RHB-104 and manufacturing of the all-in-one capsules for our clinical trials have been completed.
In 2011, we obtained FDA “Orphan Drug” status for RHB-104 for the treatment of Crohn’s disease in the pediatric population. See “Item 4. Information on the Company – B. Business Overview – Government Regulations – Orphan Drug Designation.” The formulation for RHB-104 and manufacturing of the all-in-one capsules for our clinical trials have been completed.
Final results indicate the study drug is well tolerated and can be safely administered to cancer patients ​ Completed 2015 ABC-106 ​ Phase 2 ​ Investigator-Sponsored Safety and Efficacy Study in Patients with Advanced Hepatocellular Carcinoma Who Have Progressed on Sorafenib ​ Medical University of South Carolina, Charleston, U.S. and collaborating sites (Multicenter, U.S.) ​ From 12 to 39 ​ Withdrawn and replaced with ABC-107 in prostate cancer (103193 MUSC Study ID) ​ Withdrawn ABC-104 ​ Phase 1b ​ Safety and efficacy study in the prevention of mucositis in combination with radiotherapy for treatment of squamous head and neck carcinoma ​ Multicenter study across the U.S. ​ Up to 32 ​ TBD ​ TBD ABC-105 ​ Phase 2 ​ A study for the treatment of moderate to severe ulcerative colitis ​ Multicenter study ​ Up to 94 ​ TBD ​ TBD ABC-109 ​ Phase 1 ​ Assessment of the effect of food on the absorption and bioavailability of opaganib; also as a solution via nasogastric (NG) tube under fed conditions ​ ICON Early Phase Services, San-Antonio, TX, U.S. ​ 23 ​ Completed ​ Completed 2018 ​ We cannot predict with certainty our development costs, and such costs may be subject to changes.
Final results indicate the study drug is well tolerated and can be safely administered to cancer patients ​ Completed 2015 ABC-106 ​ Phase 2 ​ Investigator-Sponsored Safety and Efficacy Study in Patients with Advanced Hepatocellular Carcinoma Who Have Progressed on Sorafenib ​ Medical University of South Carolina, Charleston, U.S. and collaborating sites (Multicenter, U.S.) ​ From 12 to 39 ​ Withdrawn and replaced with ABC-107 in prostate cancer (103193 MUSC Study ID) ​ Withdrawn ABC-104 ​ Phase 1b ​ Safety and efficacy study in the prevention of mucositis in combination with radiotherapy for treatment of squamous head and neck carcinoma ​ Multicenter study across the U.S. ​ Up to 32 ​ TBD ​ TBD ABC-105 ​ Phase 2 ​ A study for the treatment of moderate to severe ulcerative colitis ​ Multicenter study ​ Up to 94 ​ TBD ​ TBD ABC-109 ​ Phase 1 ​ Assessment of the effect of food on the absorption and bioavailability of opaganib; also as a solution via nasogastric (NG) tube under fed conditions ​ ICON Early Phase Services, San-Antonio, TX, U.S. ​ 23 ​ Completed ​ Completed 2018 ​ 78 Table of Contents We cannot predict with certainty our development costs, and such costs may be subject to changes.
Business Overview – Acquisition, Commercialization and License Agreements – Acquisition of Talicia ® , RHB-104, and RHB-106.” On December 5, 2021, we entered into an exclusive license agreement with Gaelan Medical for Talicia ® , in the UAE. See “Item 4. Information on the Company – B. Business Overview – Acquisition, Commercialization and License Agreements License Agreement with Gaelan Medical”.
Business Overview – Acquisition, Commercialization and License Agreements – Acquisition of Talicia ® , RHB-104, and RHB-106.” On December 5, 2021, we entered into an exclusive license agreement with Gaelan Medical for Talicia ® , in the UAE. See “Item 4. Information on the Company – B.
Talicia ® is the first product we developed that was approved for marketing in the U.S. We launched Talicia ® in the U.S. in March 2020 with our dedicated sales force. Chronic infection with H. pylori irritates the mucosal lining of the stomach and small intestine.
Talicia ® is the first product we developed that was approved for marketing in the U.S., which we launched in March 2020 with our dedicated sales force. Chronic infection with H. pylori irritates the mucosal lining of the stomach and small intestine.
They may, therefore, bring to market products that are able to compete with our candidates, or other products that we may develop in the future. Our Approved and Commercial Products in the U.S. We have established the headquarters of our U.S. commercial operations in Raleigh, North Carolina.
They may, therefore, bring to market products that are able to compete with our candidates, or other products that we may develop in the future. Our Approved and Commercial Product in the U.S. We have established the headquarters of our U.S. commercial operations in Raleigh, North Carolina.
Additional non-clinical studies indicated that several members of the type II transmembrane serine proteases (TTSPs), some of which are important factors in the spread of infectious diseases, were inhibited by WX-UK1. RHB-107’s safety profile has been demonstrated in approximately 300 participants, including in Phase 2 studies in oncology indications and COVID-19.
Additional non-clinical studies indicated that several members of the type II transmembrane serine proteases (TTSPs), some of which are important factors in the spread of infectious diseases, were inhibited by WX-UK1. RHB-107’s safety profile has been demonstrated in approximately 350 participants, including in Phase 2 studies in oncology indications and COVID-19.
We continue to pursue the acquisition of additional commercial products, including, without limitation, through licensing or promotion transaction, asset purchase, joint venture with, acquisition of, or a merger with or other business combination with, companies with rights to commercial GI and other relevant assets and are continuously working to expand U.S. managed care access and coverage to our commercial products, where appropriate.
We continue to pursue the acquisition of additional commercial products, including, without limitation, through licensing or promotion transaction, asset purchase, joint venture with, acquisition of, or a merger with or other business combination with, companies with rights to commercial GI and other relevant assets and are continuously working to expand U.S. managed care access and coverage to Talicia ® , where appropriate.
See “Item 3. Key Information – D. Risk Factors – Risks Related to Our Financial Condition and Capital Requirements.” 83 Table of Contents Multiple Sclerosis (“MS”) MS is an inflammatory, demyelinating, and neurodegenerative disease of the central nervous system of uncertain etiology that exhibits characteristics of both infectious and autoimmune pathology.
See “Item 3. Key Information – D. Risk Factors – Risks Related to Our Financial Condition and Capital Requirements.” 84 Table of Contents Multiple Sclerosis (“MS”) MS is an inflammatory, demyelinating, and neurodegenerative disease of the central nervous system of uncertain etiology that exhibits characteristics of both infectious and autoimmune pathology.
Our ability to maintain and solidify our proprietary position for our technology will depend on our success in obtaining effective claims and enforcing those claims once granted. Talicia ® The patent portfolio protecting Talicia ® currently includes eight U.S. patents, two pending U.S. patent applications, and over 20 foreign patents and patent applications.
Our ability to maintain and solidify our proprietary position for our technology will depend on our success in obtaining effective claims and enforcing those claims once granted. Talicia ® The patent portfolio protecting Talicia ® currently includes eight U.S. patents, two pending U.S. patent applications, and over 28 foreign patents and patent applications.
Several vaccines for SARS-CoV-2 have also been approved by the FDA and other regulatory agencies to date and multiple additional vaccines and drug therapies are currently under development for COVID-19. Cholangiocarcinoma (bile duct cancer) is a highly lethal malignancy.
Several vaccines for SARS-CoV-2 have also been approved by the FDA and other regulatory agencies to date and multiple additional vaccines and drug therapies are currently in development for COVID-19. Cholangiocarcinoma (bile duct cancer) is a highly lethal malignancy.
The following chart summarizes the clinical trial history and status of opaganib: ​ ​ ​ ​ ​ ​ ​ ​ ​ Planned ​ ​ ​ ​ ​ ​ Development ​ Purpose of ​ ​ ​ number of ​ Nature and ​ ​ Clinical trial ​ phase of the ​ the clinical ​ Clinical ​ subjects of ​ status of ​ ​ name clinical trial trial trial site the trial the trial Schedule ABC-201 ​ Phase 2/3 ​ A study for the treatment of Opaganib in patients with severe COVID-19 pneumonia ​ Multicenter study ​ 464 ​ Completed ​ Results reported in 2022 ABC-110 ​ Phase 2 ​ A study for the treatment of opaganib in patients with severe COVID-19 pneumonia ​ Multicenter study across the U.S. ​ 40 ​ Completed ​ Results reported in 2021 ABC-108 ​ Phase 2a ​ A study for the treatment of advanced, unresectable intrahepatic, perihilar and extrahepatic cholangiocarcinoma with opaganib and co-treatment with opaganib and HCQ ​ Multicenter study across the U.S. ​ 65 ​ Completed ​ Results expected H2/2024 ABC-107 (103193 MUSC Study ID) ​ Phase 2 ​ An add-on study for prostate cancer patients who progressed on enzalutamide or abiraterone.
The following chart summarizes the clinical trial history and status of opaganib: ​ ​ ​ ​ ​ ​ ​ ​ ​ Planned ​ ​ ​ ​ ​ ​ Development ​ Purpose of ​ ​ ​ number of ​ Nature and ​ ​ Clinical trial ​ phase of the ​ the clinical ​ Clinical ​ subjects of ​ status of ​ ​ name clinical trial trial trial site the trial the trial Schedule ABC-201 ​ Phase 2/3 ​ A study for the treatment of Opaganib in patients with severe COVID-19 pneumonia ​ Multicenter study ​ 464 ​ Completed ​ Results reported in 2022 ABC-110 ​ Phase 2 ​ A study for the treatment of opaganib in patients with severe COVID-19 pneumonia ​ Multicenter study across the U.S. ​ 40 ​ Completed ​ Results reported in 2021 ABC-108 ​ Phase 2a ​ A study for the treatment of advanced, unresectable intrahepatic, perihilar and extrahepatic cholangiocarcinoma with opaganib and co-treatment with opaganib and HCQ ​ Multicenter study across the U.S. ​ 65 ​ Completed ​ Ended ABC-107 (103193 MUSC Study ID) ​ Phase 2 ​ An add-on study for prostate cancer patients who progressed on enzalutamide or abiraterone.
Aemcolo ® Aemcolo ® , containing 194mg of rifamycin, is an orally administered, minimally absorbed antibiotic that is delivered to the colon, approved by the FDA in 2018 for the treatment of travelers’ diarrhea caused by non-invasive strains of E. coli in adults (“Travelers’ Diarrhea”).
Aemcolo ® Aemcolo ® , containing 194mg of rifamycin, is an orally administered, minimally absorbed antibiotic that is delivered to the colon, approved by the FDA in 2018 for the treatment of travelers’ diarrhea caused by non-invasive strains of E. coli in adults.
All Obligations under the Credit Agreement (including the loans, all accrued and unpaid interest thereon, the revenue interest, the prepayment premiums and exit fees) terminated as of the Closing, except for those obligations that are expressly intended to survive termination of the Credit Agreement, including certain indemnification obligations.
All Obligations under the Credit Agreement (including the loans, all accrued and unpaid interest thereon, the revenue interest, the prepayment premiums and exit fees) terminated as of the Closing, except for those obligations that were expressly intended to survive termination of the Credit Agreement, including certain indemnification obligations.
The proportion of patients with disease control during treatment with opaganib and enzalutamide or abiraterone will be measured ​ Medical University of South Carolina, Charleston, U.S. and Emory University, Atlanta, Georgia, U.S. ​ 65 ​ Ongoing ​ Results expected H2/2024 ABC-103 ​ Phase 1b/2 ​ Safety and efficacy study in patients with refractory or relapsed multiple myeloma that have previously been treated with proteasome inhibitors and immunomodulatory drugs ​ Duke University, North Carolina, U.S. ​ Ended ​ Ended after Phase 1 ​ Ended ABC-101 ​ Phase 1 ​ Safety, PK and pharmacodynamic study in patients with advanced solid tumors ​ Medical University of South Carolina, Charleston, U.S. ​ 22 ​ Completed.
The proportion of patients with disease control during treatment with opaganib and enzalutamide or abiraterone will be measured ​ Medical University of South Carolina, Charleston, U.S. and Emory University, Atlanta, Georgia, U.S. ​ 65 ​ Ongoing ​ Ended ABC-103 ​ Phase 1b/2 ​ Safety and efficacy study in patients with refractory or relapsed multiple myeloma that have previously been treated with proteasome inhibitors and immunomodulatory drugs ​ Duke University, North Carolina, U.S. ​ Ended ​ Ended after Phase 1 ​ Ended ABC-101 ​ Phase 1 ​ Safety, PK and pharmacodynamic study in patients with advanced solid tumors ​ Medical University of South Carolina, Charleston, U.S. ​ 22 ​ Completed.
Market and Competition According to GlobalData, a provider of market intelligence for the pharmaceutical sector, there were approximately 4 million diagnosed prevalent cases of Crohn’s disease in the sixteen major pharmaceutical markets (the U.S., France, Germany, Italy, Spain, the UK, Japan, Australia, Brazil, Canada, China, India, Mexico, Russia, South Africa and South Korea) in 2023.
Market and Competition According to GlobalData, a provider of market intelligence for the pharmaceutical sector, there were approximately 4.1 million diagnosed prevalent cases of Crohn’s disease in the sixteen major pharmaceutical markets (the U.S., France, Germany, Italy, Spain, the UK, Japan, Australia, Brazil, Canada, China, India, Mexico, Russia, South Africa and South Korea) in 2024.
In connection with the license agreement with Salix (later acquired by Bausch Health), dated February 27, 2014, described below, we amended the asset purchase agreement and related agreements by excluding from the non-compete undertakings of Giaconda Limited and certain of its affiliate products, technology, and related activities in the purgative field and 90 Table of Contents excluded from such non-compete undertakings certain of Giaconda Limited’s affiliates.
In connection with the license agreement with Salix (later acquired by Bausch Health), dated February 27, 2014, described below, we amended the asset purchase agreement and related agreements by excluding from the non-compete undertakings of Giaconda Limited and certain of its affiliate products, technology, and related activities in the purgative field and excluded from such non-compete undertakings certain of Giaconda Limited’s affiliates.
For example, if we change the manufacturer of a product or its API, the FDA may require stability or other data from the new manufacturer, which will take time and is costly to generate, and the delay associated with generating this data may cause interruptions in our ability to meet commercial 97 Table of Contents demand, if any.
For example, if we change the manufacturer of a product or its API, the FDA may require stability or other data from the new manufacturer, which will take time and is costly to generate, and the delay associated with generating this data may cause interruptions in our ability to meet commercial demand, if any.
C. Organizational Structure Our wholly-owned and only subsidiary, Redhill Biopharma Inc., was incorporated in Delaware on January 19, 2017. D. Property, Plant and Equipment We lease approximately 826 square meters of office space and eleven parking spaces in the “Platinum” building at 21 Ha’arba’a Street, Tel-Aviv, Israel. The projected yearly gross rental expenses are approximately $470,000 per year.
C. Organizational Structure Our wholly-owned and only subsidiary, Redhill Biopharma Inc., was incorporated in Delaware on January 19, 2017. D. Property, Plant and Equipment We lease approximately 826 square meters of office space and eleven parking spaces in the “Platinum” building at 21 Ha’arba’a Street, Tel-Aviv, Israel. The projected yearly gross rental expenses are approximately $4 2 0,000 per year.
Moreover, the inclusion of rifabutin and clofazimine has shown to mitigate the emergence of resistance to clarithromycin compared to clarithromycin alone or in combination with only rifabutin or clofazimine in a clarithromycin- susceptible 88 Table of Contents M.avium lung infection mouse model as well as exhibiting significant reductions in bacterial counts in the lung after four and eight weeks of treatment.
Moreover, the inclusion of rifabutin and clofazimine has shown to mitigate the emergence of resistance to clarithromycin compared to clarithromycin alone or in combination with only rifabutin or clofazimine in a clarithromycin- susceptible M.avium lung infection mouse model as well as exhibiting significant reductions in bacterial counts in the lung after four and eight weeks of treatment.
The study also evaluated the effect of the administration of a solution of opaganib 76 Table of Contents via nasogastric (NG) tube on the absorption and bioavailability of opaganib. Twenty-three eligible, healthy, male and female adult subjects were randomized to receive opaganib orally in a state of fast, fed or as a solution by NG tube (after tube feeding).
The study also evaluated the effect of the administration of a solution of opaganib via nasogastric (NG) tube on the absorption and bioavailability of opaganib. Twenty-three eligible, healthy, male and female adult subjects were randomized to receive opaganib orally in a state of fast, fed or as a solution by NG tube (after tube feeding).
Our therapeutic candidates, if commercialized, and our approved drugs, compete with existing drugs and therapies. In addition, there are many pharmaceutical companies, biotechnology companies, medical device companies, public and private universities, government agencies and research 63 Table of Contents organizations actively engaged in the research and development of products targeting the same markets as our therapeutic candidates.
Our therapeutic candidates, if commercialized, and our approved drugs, compete with existing drugs and therapies. In addition, there are many pharmaceutical companies, biotechnology companies, medical device companies, public and private universities, government agencies and research organizations actively engaged in the research and development of products targeting the same markets as our therapeutic candidates.
Preliminary data from this cohort indicated that 6 of 39 (of 58 73 Table of Contents total enrolled) patients evaluable for efficacy achieved the primary endpoint of stable disease or better for at least 4 months, with good safety and tolerability heavily pretreated subjects with advanced cholangiocarcinoma.
Preliminary data from this cohort indicated that 6 of 39 (of 58 total enrolled) patients evaluable for efficacy achieved the primary endpoint of stable disease or better for at least 4 months, with good safety and tolerability heavily pretreated subjects with advanced cholangiocarcinoma.
Even if such studies are conducted, the FDA may not approve any change in a timely fashion, or at all. We rely on, and expect to continue to rely on, third parties for the manufacture of clinical and future commercial, quantities of our therapeutic candidates.
Even if such studies are conducted, the FDA may not approve any change in a timely fashion, or at all. 100 Table of Contents We rely on, and expect to continue to rely on, third parties for the manufacture of clinical and future commercial, quantities of our therapeutic candidates.
The value of such liens and security interests are capped at the value of our pre-closing liabilities relating to Movantik ® , and all such liens and security interests will be fully released upon the first to occur of (i) the payment of scheduled pre-closing liabilities related to Movantik ® other than certain specified long-dated liabilities and (ii) the first date 90 days after the Closing on which RedHill Israel has at least $16.9 million in cash and cash equivalents on hand.
The value of such liens and security interests were capped at the value of our pre-closing liabilities relating to Movantik ® , and all such liens and security interests were fully released upon the first to occur of (i) the payment of scheduled pre-closing liabilities related to Movantik ® other than certain specified long-dated liabilities and (ii) the first date 90 days after the Closing on which RedHill Israel has at least $16.9 million in cash and cash equivalents on hand.
The benefit observed with RHB-102 (Bekinda ® ) is evident across the spectrum of severity of nausea at baseline, including in patients with very severe nausea, suggesting that the drug works regardless of the initial severity of gastroenteritis. The lead investigator for the Phase 3 study was Dr. Robert A.
The benefit observed with RHB-102 (Bekinda ® ) is evident across the spectrum of severity of nausea at baseline, including in patients with very severe nausea, suggesting that the drug works regardless of the initial severity of gastroenteritis. 86 Table of Contents The lead investigator for the Phase 3 study was Dr. Robert A.
On September 2, 2022, we filed a lawsuit against Kukbo in the Supreme Court of the State of New York, County of New York, Commercial Division, as a result of Kukbo’s default in delivering to us $5.0 million under a Subscription Agreement, dated October 25, 2021, in exchange for the ADSs we were to issue to Kukbo, and in delivering to us the $1.5 million due under the Kukbo Agreement.
On September 2, 2022, we filed a lawsuit against Kukbo in the Supreme Court of the State of New York, County of New York, Commercial Division, as a result of Kukbo’s default in delivering to us $5.0 million under a subscription agreement, dated October 25, 2021 (the “Subscription Agreement”), in exchange for the ADSs we were to issue to Kukbo, and in delivering to us the $1.5 million due under the Exclusive License Agreement.
Brand names appearing in this annual report are trademarks of RedHill Biopharma Ltd. except for: ● trademarks used or that may be or have been used under license by RedHill or its affiliates, such as Aemcolo ® , a trademark of Cosmo Technologies Ltd. ● trademarks used or that may be or have been used under license by RedHill or its affiliates, such as Movantik ® , a trademark of AstraZeneca AB.
Brand names appearing in this annual report are trademarks of RedHill Biopharma Ltd. except for: ● trademarks used or that may be or have been used under license by RedHill or its affiliates, such as Aemcolo ® , a trademark of Cosmo Technologies Ltd.
In August 2021, the FDA approved Tibsovo ® (ivosidenib, Servier Pharmaceuticals LLC) for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. IDH1 mutations are also found in patients with intrahepatic cholangiocarcinoma, and have a reported incidence rate of 7% to 20% (Prete, 2021).
In August 2021, the FDA approved Tibsovo ® (ivosidenib, Servier Pharmaceuticals LLC) for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation. IDH1 mutations are also found in patients with intrahepatic cholangiocarcinoma and have a reported incidence rate of 7% to 20% (Prete, 2021).
On August 1, 2023, we announced that Gaelan Medical had received marketing approval for Talicia in the UAE and that Gaelan Medical has subsequently placed the first commercial order for Talicia, which was dispatched from the CMO in December 2023.
On August 1, 2023, we announced that Gaelan Medical had received marketing approval for Talicia ® in the UAE and that Gaelan Medical has subsequently placed the first commercial order for Talicia ® , which was dispatched from the CMO in December 2023. In August 2024, we announced the launch of Talicia ® in the UAE.
Subject to the evaluation of eligibility and all other necessary regulatory, reporting and other 92 Table of Contents conditions and approvals required in all relevant jurisdictions, we provide certain patients with access to an investigational new drug under the EAP.
Subject to the evaluation of eligibility and all other necessary regulatory, reporting and other conditions and approvals required in all relevant jurisdictions, we provide certain patients with access to an investigational new drug under the EAP.
Surgery with complete resection is currently known to be the only curative therapy 69 Table of Contents for cholangiocarcinoma; however, only a minority of patients are classified as having a resectable tumor at the time of diagnosis.
Surgery with complete resection is currently known to be the only curative therapy for cholangiocarcinoma; however, only a minority of patients are classified as having a resectable tumor at the time of diagnosis.
The study will compare investigational products (Ips) to control, in standard-risk, non-hospitalized adult SARS-CoV-2 infected participants with at least two moderate-severe symptoms at baseline. RHB-107 is the initial drug being evaluated in the early treatment arm of the study. The primary efficacy assessment in the early treatment indication will be time to sustained alleviation or resolution of COVID-19 symptoms.
The study is comparing investigational products to control, in standard to moderate-risk, non-hospitalized adult SARS-CoV-2 infected participants with at least two moderate-severe symptoms at baseline. RHB-107 is the only drug being evaluated in the early treatment arm of the study. The primary efficacy assessment in the early treatment indication will be time to sustained alleviation or resolution of COVID-19 symptoms.
In November 2022, we announced post hoc analyses of the Phase 3 clinical trials of Talicia ® supporting the efficacy and safety of Talicia ® as empiric first-line treatment for H. pylori infection in patients regardless of obesity, body mass index (BMI) or diabetic status.
In August 2024, we announced the launch of Talicia ® in the UAE. In November 2022, we announced post hoc analyses of the Phase 3 clinical trials of Talicia ® supporting the efficacy and safety of Talicia ® as empiric first-line treatment for H. pylori infection in patients regardless of obesity, body mass index (BMI) or diabetic status.
The clinical testing of a therapeutic drug candidate generally is conducted in three sequential phases prior to approval, but the phases may overlap or be combined. However, safety information should be submitted before the initiation of a subsequent clinical phase. A fourth, or post-approval phase may include additional clinical studies. The phases are generally as follows: Phase 1.
The clinical testing of a therapeutic drug candidate generally is conducted in three sequential phases prior to approval, but the phases may overlap or be combined. However, safety information should be submitted before the initiation of a subsequent clinical phase. A fourth, or post-approval phase may include additional clinical studies.
In the event of sustained operations, our U.S. operations could potentially serve as the platform for potential launch of our proprietary, late-clinical stage therapeutic candidates in the U.S., if approved by the FDA, and potential in-licensed or acquired commercial-stage products in the U.S. Our U.S. commercial operations consisted of 38 employees as of December 31, 2023.
In the event of sustained operations, our U.S. operations could potentially serve as the platform for potential launch of our proprietary, late-clinical stage therapeutic candidates in the U.S., if approved by the FDA, and potential in-licensed or acquired commercial-stage products in the U.S. Our U.S. commercial operations consisted of 11 employees as of December 31, 2024.
Upon Closing, collateral, consisting of (i) the Escrow Account, (ii) Talicia-related assets, (iii) Aemcolo-related assets and (iv) accounts receivable related to Movantik ® accrued as of the Closing, continues to secure “Go-Forward Obligations” consisting of indemnification obligations under the APA and the Credit Agreement and scheduled pre-closing liabilities relating to Movantik ® .
Upon Closing, collateral, consisting of (i) the Escrow Account, (ii) Talicia ® -related assets, (iii) our former Aemcolo ® -related assets and (iv) accounts receivable related to Movantik ® accrued as of the Closing, continued to secure “Go-Forward Obligations” consisting of indemnification obligations under the APA and the Credit Agreement and scheduled pre-closing liabilities relating to Movantik ® .
Information contained on, or that can be accessed through, our website does not constitute a part of this Annual Report. Our capital expenditures for the years ended December 31, 2023, 2022, and 2021, were approximately $9,500, $25,000 and $115,000, respectively. Our current capital expenditures involve basic equipment and leasehold improvements. B.
Information contained on, or that can be accessed through, our website does not constitute a part of this Annual Report. Our capital expenditures for the years ended December 31, 2024, 2023, and 2022, were approximately $8,700, $9,500 and $25,000, respectively. Our current capital expenditures involve basic equipment and leasehold improvements. B.
Regulatory Status On November 1, 2019, Talicia ® was approved by the FDA and is eligible for a total of eight years of U.S. market exclusivity. In November 2014, Talicia ® was granted QIDP designation by the FDA.
Regulatory Status On November 1, 2019, Talicia ® was approved by the FDA and was granted a total of eight years of U.S. market exclusivity. In November 2014, Talicia ® was granted QIDP designation by the FDA.
In May 2023, the FDA approved Rinvoq ® (upadacitinib), a Janus kinase (JAK) inhibitor indicated for the treatment of moderately to severely active Crohn’s disease in adults who have had an inadequate response or intolerance to one or more TNF blockers.
In May 2023, the FDA approved Rinvoq ® (upadacitinib), a Janus kinase (JAK) inhibitor indicated for the treatment of adults with moderately to severely active Crohn’s disease limiting it to patients who have had an inadequate response or intolerance to treatment with one or more TNF blockers.
Both HCRM and its affiliates and RedHill Group provided each other with a broad release of any claims they have against each other arising prior to the Closing. Escrow Agreement.
Both HCRM and its affiliates and RedHill Group provided each other with a broad release of any claims they have against each other arising prior to the Closing. 94 Table of Contents Escrow Agreement.
Sale of Movantik ® to HCRM On February 2, 2023, RedHill US and the Company (together, “RedHill Group”) entered into an Asset Purchase Agreement (the “APA”) and related agreements with HCRM.
Sale of Movantik ® to HCRM On February 2, 2023, RedHill U.S. and the Company (together, “RedHill Group”) entered into an Asset Purchase Agreement (the “APA”) and related agreements with HCRM.
In addition, we may also be exposed to potentially competitive products that may be under development by other companies to treat IBS-D in the U.S. Clinical Development In January 2018, we announced positive final results from the Phase 2 clinical study of RHB-102 (Bekinda ® ) 12 mg for the treatment of IBS-D.
In addition, we may also be exposed to potentially competitive products that may be under development or that have already been approved by other companies to treat IBS-D in the U.S. Clinical Development In January 2018, we announced positive final results from the Phase 2 clinical study of RHB-102 (Bekinda ® ) 12 mg for the treatment of IBS-D.
Talicia ® (omeprazole magnesium, amoxicillin, and rifabutin) delayed-release capsules 10 mg/250 mg/12.5 mg Talicia ® is our proprietary new drug approved for marketing in the U.S. for the treatment of H. pylori infection in adults.
Talicia ® (omeprazole magnesium, amoxicillin, and rifabutin) delayed-release capsules 10.3 mg/250 mg/12.5 mg Talicia ® is our proprietary drug approved by the FDA for marketing in the U.S. for the treatment of H. pylori infection in adults.
Specifically, a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed 99 Table of Contents a violation.
Specifically, a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
We may also be exposed to potential competitive products that may be under development to treat H. pylori infection.
We may also be exposed to potentially competitive products that may be under development to treat H. pylori infection.
See “Item 3. Key Information – D. Risk Factors – Risks Related to Our Financial Condition and Capital Requirements”. 77 Table of Contents RHB-107 (upamostat; formerly Mesupron) As mentioned under “Item 4. Information on the Company – B.
See “Item 3. Key Information – D. Risk Factors – Risks Related to Our Financial Condition and Capital Requirements”. RHB-107 (upamostat; formerly Mesupron) As mentioned under “Item 4. Information on the Company – B.
As of the filing of this report, and to the best of our knowledge, no orally-administered antiviral therapy has been approved by the FDA to date for treatment of hospitalized patients with severe disease.
As of the filing of this report, and to the best of our knowledge, no orally administered antiviral therapy has been approved by the FDA to date for treatment of hospitalized patients with severe COVID-19 pneumonia.
Funds from the Escrow Account can only be used to pay certain scheduled pre-closing liabilities related to Movantik ® that are retained by RedHill U.S. under the terms of the APA.
Funds from the Escrow Account could only be used to pay certain scheduled pre-closing liabilities related to Movantik ® that were retained by RedHill U.S. under the terms of the APA.
Market and Competition RHB-107 is currently being developed for the treatment of non-hospitalized symptomatic COVID-19 and has previously undergone non-clinical and clinical studies in several oncology indications, including metastatic breast cancer and advanced non-metastatic pancreatic cancer.
Market and Competition RHB-107 is currently being developed for the treatment of non-hospitalized symptomatic COVID-19 and Ebola virus disease and has previously undergone non-clinical and clinical studies in several oncological indications, including metastatic breast cancer and advanced non-metastatic pancreatic cancer.
We plan to pursue such opportunities in the U.S. and, if available, in other jurisdictions; however, we intend to focus our commercial activities in the U.S. We currently promote and commercialize three GI products in the U.S.
We plan to pursue such opportunities in the U.S. and, if available, in other jurisdictions; however, we intend to focus our commercial activities in the U.S. We currently promote and commercialize Talicia ® in the U.S.
The ACESO PROTECT study is an adaptive, randomized, double blind, multi-site Phase 2 platform trial, being conducted by researchers from ACESO and partner organizations, and administered by the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF).
The ACESO PROTECT study is funded primarily by the U.S. Department of Defense. The ACESO PROTECT study is an adaptive, randomized, double blind, multi-site Phase 2 platform trial, being conducted by researchers from ACESO and partner organizations, and administered by the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF).
We believe that Talicia ® offers a significant benefit over other marketed drugs in part because of the efficacy, tolerability, and resistance profile demonstrated in our Phase 3 program, which showed no bacterial resistance to rifabutin and high resistance to clarithromycin and metronidazole.
We believe that Talicia ® offers a significant benefit over other marketed drugs in part because of the efficacy, safety and tolerability, and resistance profile demonstrated in our Phase 3 program, which showed minimal to zero resistance to amoxicillin and rifabutin and high resistance to clarithromycin and metronidazole.
We do not know if and when a diagnostic 82 Table of Contents test for MAP would become available. Additional FDA guidance on the potential path to approval of RHB-104 is to be obtained prior to initiation of further clinical studies.
We do not know if and when a validated lab test for MAP would become available. Additional FDA guidance on the potential path to approval of RHB-104 is to be obtained prior to initiation of further clinical studies.
Business Overview We are a specialty biopharmaceutical company, primarily focused on GI and infectious diseases. Our primary goal is to become a leading specialty biopharmaceutical company. We are currently focused primarily on the advancement of our development pipeline of clinical-stage therapeutic candidates. We also commercialize in the U.S.
Business Overview We are a specialty biopharmaceutical company, primarily focused on GI, infectious diseases and oncology. Our primary goal is to become a leading specialty biopharmaceutical company. We are currently focused primarily on the advancement of our development pipeline of clinical-stage therapeutic candidates.
Talicia ® is targeting a significantly broader indication than that of existing H. pylori therapies, as a treatment of H. pylori infection, regardless of ulcer status. We acquired the rights to Talicia ® pursuant to an agreement with Giaconda Limited. See “Item 4. Information on the Company – B.
Talicia ® is targeting a significantly broader indication than most other existing H. pylori therapies, as a treatment for H. pylori infection, regardless of ulcer status. 65 Table of Contents We acquired the rights to Talicia ® pursuant to an agreement with Giaconda Limited. See “Item 4. Information on the Company – B.
The American Cancer Society estimates that approximately 299,010 new cases of prostate cancer will be diagnosed in 2024. Prostate cancer is more likely to develop in older men, African American men and Caribbean men of African ancestry. Treatment options depend on each case and include surgery, radiotherapy, cryotherapy, chemotherapy, hormone therapy, and immunotherapy.
The American Cancer Society estimates that approximately 313,800 new cases of prostate cancer will be diagnosed in the U.S. in 2025. Prostate cancer is more likely to develop in older men, African American men and Caribbean men of African ancestry. Treatment options depend on each case and include surgery, radiotherapy, cryotherapy, chemotherapy, hormone therapy, and immunotherapy.
Talicia ® faces competition in the U.S. from certain branded prescription therapies indicated for the treatment of H. pylori infection including Pylera ® (marketed by Allergan plc) and Voquezna ® (marketed by Phathom Pharmaceuticals) as well as from the generic version of Pylera ® (marketed by Endo International), and individual components of certain therapies which include but are not limited to Pylera and PrevPac.
Talicia ® faces competition in the U.S. from certain branded prescription therapies indicated for the treatment of H. pylori infection including Pylera ® (marketed by Juvisé Pharmaceuticals) and Voquezna ® , DualPak and TriplePak (marketed by Phathom Pharmaceuticals) as well as from the generic version of Pylera ® (first launched by Endo International and Novast Labs), and individual components of certain therapies which include but are not limited to Pylera and PrevPac.
Since 2018, we have been subleasing a portion of the office space to a tenant, and the lease payment is approximately $92,000 per year. The term under our lease agreement will expire on January 31, 2026. These offices have served as our corporate headquarters since April 2011.
Since 2018 until August 2024, we subleased a portion of the office space to a tenant, and the lease payment is approximately $ 70 ,000 per year. The term under our lease agreement will expire on January 31, 2026. These offices have served as our corporate headquarters since April 2011.
Additionally, the individual components of Talicia ® are available in generic form, and while rifabutin is not available in an equivalent dose, there is a risk that some physicians may prescribe the individual components of Talicia ® in doses that are not equivalent to the approved drug and regimen.
Additionally, the individual components of Talicia ® are available in generic form, and while rifabutin is not available in an equivalent dose, there is a risk that some physicians may prescribe the individual components of Talicia ® in doses that are not equivalent to the approved drug and regimen (Howden et al. Aliment Pharmacol Ther. 2023).
We vigorously defend our intellectual property to preserve our rights and gain the benefit of our technological investments. Patents and Patent Applications We have rights, either through assignment, asset purchase or in-licensing, to a total of approximately 239 issued patents and 60 patent applications.
We vigorously defend our intellectual property to preserve our rights and gain the benefit of our technological investments. 95 Table of Contents Patents and Patent Applications We have rights, either through assignment, asset purchase or in-licensing, to a total of approximately 157 issued patents and 46 patent applications.
The related agreements, each dated as of February 2, 2023, included the Sixth Amendment to the Credit Agreement and Collateral Documents (the “Collateral Amendment”), the Escrow Agreement (the “Escrow Agreement”), the Transition Services Agreement (the “TSA”) and the Supply Agreement (the “Supply Agreement”).
The related agreements, each dated as of February 2, 2023, included the Sixth Amendment to the Credit Agreement and Collateral Documents (the “Collateral Amendment”), the Escrow Agreement (the “Escrow Agreement”), the Transition Services Agreement (the “TSA”) and the Supply Agreement (the “Supply Agreement”). The closing of the transaction pursuant to the APA occurred on February 2, 2023 (the “Closing”).
Currently, the portfolio includes four U.S. patents, one foreign patents and five foreign pending patent applications. 94 Table of Contents Trademarks Our principal trademarks, including RedHill, Redhill Biopharma, Talicia, Bekinda, Yeliva ® , and their related logos, are registered or pending with the United States Patent and Trademark Office.
Currently, the portfolio includes four U.S. patents, two foreign patents and three foreign pending patent applications. Trademarks Our principal trademarks, including RedHill, Redhill Biopharma, Talicia ® , Bekinda, Yeliva ® , and their related logos, are registered or pending with the United States Patent and Trademark Office.
We are continuing discussions and work with U.S. and other government agencies and non-governmental organizations to support the ongoing development of opaganib in areas of public health interest, including pandemic preparedness and medical countermeasures. These are currently undergoing pre-clinical evaluation. Discussions are also ongoing with potential partners who are interested in the rights to opaganib in various territories. ABC-110: U.S.
We are continuing discussions and work with U.S. and other government agencies and non-governmental organizations to support the ongoing development of opaganib in areas of public health interest, including pandemic preparedness and medical countermeasures. These are currently undergoing pre-clinical evaluation.
In Phase 1 clinical studies, the therapeutic drug candidate is tested in a small number of healthy volunteers, though in cases where the therapeutic drug candidate may make the volunteer ill, clinical patients with the targeted condition may be used.
The phases are generally as follows: 98 Table of Contents Phase 1. In Phase 1 clinical studies, the therapeutic drug candidate is tested in a small number of healthy volunteers, though in cases where the therapeutic drug candidate may make the volunteer ill, clinical patients with the targeted condition may be used.
Study arms were well balanced with respect to baseline disease severity, risk factors and vaccination status. Patients were also tested for the specific viral strain, with the most common variant being Delta, found in 62.5% of the patients that had next generation sequencing (NGS). In July 2023, we announced that RHB-107 had been accepted for inclusion in the U.S.
Study arms were well balanced with respect to baseline disease severity, risk factors and vaccination status. Patients were also tested for the specific viral strain, with the most common variant being Delta, found in 62.5% of the patients that had next generation sequencing (NGS).
The portfolio currently consists of five issued U.S. patents, three pending U.S. patent applications, one foreign patent and 12 pending foreign patent applications, providing patent protection through 2041. RHB-108 – Combination Cancer Therapy RedHill has also pursued patent protection in cancer therapy for various combination of drugs with different mechanisms of action which achieve synergistic effects.
The portfolio consists of four U.S. patents, one pending U.S. patent application, four foreign patents and one pending foreign patent application providing patent protection through 2035. RHB-108 – Combination Cancer Therapy RedHill has also pursued patent protection in cancer therapy for various combination of drugs with different mechanisms of action which achieve synergistic effects.
In December 2019, we received confirmation from the FDA that it has agreed with our Initial Pediatric Study Plan (iPSP). 87 Table of Contents The following chart summarizes the clinical trial history and status of RHB-102 (Bekinda ® ) for IBS-D: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Planned ​ ​ ​ ​ ​ ​ Development ​ ​ ​ ​ ​ number of ​ Nature and ​ ​ Clinical trial ​ phase of the ​ Purpose of the ​ Clinical ​ subjects ​ status of ​ ​ name clinical trial clinical trial trial site of the trial the trial Schedule - ​ Phase 2 ​ Randomized double-blind placebo-controlled Phase 2 study in IBS-D ​ 16 sites in the U.S. ​ 126 ​ Evaluating the safety and efficacy of RHB-102 (Bekinda ® ) 12 mg in IBS-D ​ Completed 2018 TBD ​ Phase 3 ​ Randomized double-blind placebo-controlled Phase 3 study in IBS-D ​ TBD ​ TBD ​ TBD ​ TBD ​ We cannot predict with certainty our development costs and such costs may be subject to change.
The following chart summarizes the clinical trial history and status of RHB-102 (Bekinda ® ) for IBS-D: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Planned ​ ​ ​ ​ ​ ​ Development ​ ​ ​ ​ ​ number of ​ Nature and ​ ​ Clinical trial ​ phase of the ​ Purpose of the ​ Clinical ​ subjects ​ status of ​ ​ name clinical trial clinical trial trial site of the trial the trial Schedule - ​ Phase 2 ​ Randomized double-blind placebo-controlled Phase 2 study in IBS-D ​ 16 sites in the U.S. ​ 126 ​ Evaluating the safety and efficacy of RHB-102 (Bekinda ® ) 12 mg in IBS-D ​ Completed 2018 TBD ​ Phase 3 ​ Randomized double-blind placebo-controlled Phase 3 study in IBS-D ​ TBD ​ TBD ​ TBD ​ TBD ​ We cannot predict with certainty our development costs and such costs may be subject to change.
RHB-102 (Bekinda ® ) RHB-102 (Bekinda ® ) is an investigational, once-daily, bi-modal release, oral formulation of ondansetron, a leading member of the family of 5-HT3 serotonin receptor inhibitors. We are developing RHB-102 (Bekinda ® ) in multiple dosage strengths.
RHB-102 (Bekinda ® ) RHB-102 (Bekinda ® ) is an investigational, once-daily, bi-modal release, oral formulation of ondansetron, a leading member of the family of 5-HT3 serotonin receptor inhibitors.
The net revenues for the fiscal years ended December 31, 2023 and December 31, 2022 from the commercial products were approximately $6.5 million and $59.8 million, respectively.
The net revenues for the fiscal years ended December 31, 2024 and December 31, 2023 from the commercial products were approximately $7.0 million and $6.5 million, respectively.
Inflammatory conditions and solid tumors are additional areas of focus for opaganib. Furthermore, we are investigating RHB-107 (upamostat) as a potential treatment for COVID-19 and other viruses as part of pandemic preparedness, including the Ebola virus. Our current pipeline consists of five therapeutic candidates, most of which are in clinical development.
Furthermore, we are investigating RHB-107 (upamostat) as a potential treatment for COVID-19 and other viruses as part of pandemic preparedness, including the Ebola virus. Our current pipeline consists of five therapeutic candidates, part of which are in late stage clinical development.
Results from the study demonstrated strong inhibition of SARS-CoV-2 viral replication. In October 2022, we announced study results showing preliminary evidence of in vitro efficacy against the Omicron COVID-19 sub-variant BA.5 by opaganib and RHB-107.
The study was designed to evaluate the in vitro efficacy of RHB-107 in inhibiting SARS-CoV-2 infection and included a positive control of camostat. Results from the study demonstrated strong inhibition of SARS-CoV-2 viral replication. In October 2022, we announced study results showing preliminary evidence of in vitro efficacy against the Omicron COVID-19 sub-variant BA.5 by opaganib and RHB-107.
Information on the Company – B. Business Overview – Acquisition, Commercialization and License Agreements – Acquisition of Talicia ® , RHB-104, and RHB-106.” 80 Table of Contents We continue to require a companion diagnostic for the detection of MAP bacteria in Crohn’s disease patients.
Information on the Company – B. Business Overview – Acquisition, Commercialization and License Agreements – Acquisition of Talicia ® , RHB-104, and RHB-106.” 81 Table of Contents We are likely to require a validated lab test for the detection of MAP bacteria in Crohn’s disease patients.
To the best of our knowledge, there is currently no clinical development of ramosetron for marketing approval in the U.S. for any indication. 86 Table of Contents If approved, RHB-102 (Bekinda ® ) will compete with several prescription drugs indicated for IBS-D, including but not limited to Xifaxan ® (rifaximin), marketed in the U.S. by Salix Pharmaceuticals, and Viberzi ® (eluxadoline), marketed in the U.S. by Allergan plc., now AbbVie Inc, as well as additional prescription drugs, generic drugs, and over-the-counter products indicated for IBS-D or for symptomatic relief of diarrhea and pain.
If approved, RHB-102 (Bekinda ® ) will compete with several prescription drugs indicated for IBS-D, including but not limited to Xifaxan ® (rifaximin), marketed in the U.S. by Salix Pharmaceuticals, and Viberzi ® (eluxadoline), marketed in the U.S. by Allergan plc., now AbbVie Inc, as well as additional prescription drugs, generic drugs, and over-the-counter products indicated for IBS-D or for symptomatic relief of diarrhea and pain.
Business Overview – Government Regulations and Funding – Section 505(b)(2) New Drug Applications”; ● Cooperate with third parties to develop or commercialize therapeutic candidates in order to share costs and leverage the expertise of others; and ● Consider potential acquisitions of other companies with or without commercial products. The pharmaceutical and biotechnology industries are intensely competitive.
Business Overview – Government Regulations – Section 505(b)(2) New Drug Applications”; ● Cooperate with third parties to develop or commercialize therapeutic candidates in order to share costs and leverage the expertise of others; and ● Consider potential acquisitions of other companies with or without commercial products, including combinations or strategic partnerships with companies that may have complementary assets, capabilities, or financial resources. 64 Table of Contents The pharmaceutical and biotechnology industries are intensely competitive.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Under the prospectus supplement relating to the ATM program and the accompanying base prospectus, we offered and were permitted to sell ADSs having an aggregate offering price of up to $100.0 million from time to time through SVB and Cantor, acting as our agents, in accordance with the Sales Agreement.
Under the prospectus supplement relating to the ATM program and the accompanying base prospectus, we offered and were permitted to sell ADSs having an aggregate offering price of up to $100.0 million from time to time through SVB and Cantor, acting as our agents, in accordance with the Cantor – SVB Sales Agreement.
On November 3, 2022, we received notice from SVB notifying us and Cantor of SVB’s termination of the Sales Agreement with respect to itself. On April 4, 2024, we delivered written notice to Cantor and terminated the Sales Agreement.
On November 3, 2022, we received notice from SVB notifying us and Cantor of SVB’s termination of the Cantor – SVB Sales Agreement with respect to itself. On April 4, 2024, we delivered written notice to Cantor and terminated the Cantor – SVB Sales Agreement.
Net Cash Provided by Financing Activities Net Cash Provided by Financing Activities for the year ended December 31, 2023, was $21.4 million, comprised primarily of proceeds from equity offerings and exercise of certain warrants in transactions consummated in each of April 2023, July 2023, September 2023 and November 2023, and from decrease in restricted cash, partially offset by repayment of payables in respect of intangible asset purchases.
Net Cash Provided by Financing Activities for the year ended December 31, 2023, was $21.4 million, comprised primarily of proceeds from equity offerings and exercise of certain warrants in transactions consummated in each of April 2023, July 2023, September 2023 and November 2023, and from decrease in restricted cash, partially offset by repayment of payables in respect of intangible asset purchases.
Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Annual Report, particularly those in “Item 3. Key Information – D. Risk Factors.” Company Overview We are a specialty biopharmaceutical company, primarily focused on GI and infectious diseases.
Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Annual Report, particularly those in “Item 3. Key Information – D. Risk Factors.” Company Overview We are a specialty biopharmaceutical company, primarily focused on GI, infectious diseases and oncology.
In addition, following the sale of our rights to Movantik ® in 2023, we have lost our primary revenue source and our ability to operate as a financially viable commercial business has been significantly more difficult.
In addition, following the sale of our rights to Movantik ® in 2023, we lost our primary revenue source and our ability to operate as a financially viable commercial business has been significantly more difficult.
Opaganib is an investigational new drug that is proprietary, first-in-class, orally administered SK2 selective inhibitor, with anti-viral, anti-inflammatory and anti-cancer activities, targeting multiple oncology, inflammatory and GI indications.
Opaganib is an investigational new drug that is proprietary, first-in-class, orally administered SK2 selective inhibitor, with anti-viral, anti-inflammatory and anti-cancer activities, targeting multiple potential oncology, inflammatory, viral and GI indications.
Between November 27, 2023, and November 29, 2023, the September 2023 Reload Warrants (as defined below) were exercised for a total of approximately $4 million gross proceeds to the Company.
Between November 27, 2023, and November 29, 2023, the September 2023 Reload Warrants (as defined below) were exercised for a total of approximately $4.0 million gross proceeds to the Company.
We did not have any material commitments for capital expenditures, including any anticipated material acquisition of plant and equipment or interests in other companies, as of December 31, 2023. C. Research and Development, Patents and Licenses Our research and development expenses consist primarily of costs of clinical trials, professional services, share-based payments and payroll, and related expenses.
We did not have any material commitments for capital expenditures, including any anticipated material acquisition of plant and equipment or interests in other companies, as of December 31, 2024. C. Research and Development, Patents and Licenses Our research and development expenses consist primarily of costs of clinical trials, professional services, share-based payments and payroll, and related expenses.
The other income was comprised of (i) $35.5 million from the divestiture of Movantik, calculated as the difference between the fair value of the rights and the carrying amount of this asset and (ii) $8.6 million from transitional services provided to the buyer of Movantik.
The other income in 2023 was comprised of (i) $35.5 million from the divestiture of Movantik®, calculated as the difference between the fair value of the rights and the carrying amount of this asset and (ii) $8.6 million from transitional services provided to the buyer of Movantik®.
In connection with the April 2023 offering, we reduced the exercise price of the May 2022 Warrants (defined below) to $4.75 per ADS and amended the termination date to April 3, 2028 (subsequently amended in July 2023 as described above).
In connection with the April 2023 offering, we reduced the exercise price of the May 2022 Warrants (defined below) to $118.75 per ADS and amended the termination date to April 3, 2028 (subsequently amended in July 2023 as described above).
However, additional financing may not be available on acceptable terms, if at all, including due to the difficult conditions in the capital markets, particularly with respect to securities of biopharmaceutical companies on the U.S. stock exchanges, including the ADSs, and due to the very low market capitalization which makes it more difficult to raise significant 111 Table of Contents amounts of capital.
However, additional financing may not be available on acceptable terms, if at all, including due to the difficult conditions in the capital markets, particularly with respect to securities of biopharmaceutical companies on the U.S. stock exchanges, including the ADSs, and due to the very low market capitalization which makes it more difficult to raise significant amounts of capital.
On June 30, 2014, we acquired from Heidelberg the exclusive development and commercialization rights to RHB-107, excluding China, Hong Kong, Taiwan, and Macao, for all indications. We made an upfront payment to Heidelberg of $1.0 million with potential tiered royalties on net revenues, ranging from mid-teens up to 30%.
On June 30, 2014, we acquired from Heidelberg the exclusive development and commercialization rights to RHB-107, excluding China, Hong Kong, Taiwan, and Macao, for all indications. We made an upfront payment to Heidelberg of $1.0 million with potential tiered royalties on net revenues, ranging from mid-teens up to 30%. We are responsible for all development, regulatory and commercialization of RHB-107.
The income recognized in the year ended December 31, 2023, was primarily attributable to gain resulting from the extinguishment of the HCRM debt in exchange for the transfer of rights 105 Table of Contents to Movantik, calculated as the difference between the carrying amount of the financial liability and the fair value of the rights transferred partially offset by financial expenses related to the financial instruments and other financial expenses.
The income recognized in the year ended December 31, 2023, was primarily attributable to gain resulting from the extinguishment of the HCRM debt in exchange for the transfer of rights to Movantik®, calculated as the difference between the carrying amount of the financial liability and the fair value of the rights transferred partially offset by financial expenses related to the financial instruments and other financial expenses.
The gross proceeds were approximately $8 million, before fees and expenses. The January 2024 Warrants are exercisable immediately after the issuance date and have a term of five years.
The gross proceeds were approximately $8.0 million, before fees and expenses. The January 2024 Warrants are exercisable immediately after the issuance date and have a term of five years following the issuance date.
Impairment Reviews of Intangible Research and Development Assets We review annually or when events or changes in circumstances indicate the carrying value of the research and development assets may not be recoverable. 113 Table of Contents When and if necessary, an impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount.
Impairment Reviews of Intangible Research and Development Assets We review annually or when events or changes in circumstances indicate the carrying value of the research and development assets may not be recoverable. When and if necessary, an impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount.
Concurrently, we are actively engaged in discussions to explore potential divestment of certain Company assets. Going Concern Our consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
Concurrently, we are actively engaged in discussions to explore strategic business transactions, including potential divestment of certain Company assets. Going Concern Our consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
Risk Factors – Risks Related to Regulatory Matters.” We expect our research and development expenses to stay material as we continue the advancement of our clinical trials and therapeutic candidates’ development. The lengthy process of completing clinical trials and seeking regulatory approvals for our therapeutic candidates requires substantial expenditures.
Risk Factors – Risks Related to Regulatory Matters.” We expect our research and development expenses to stay material as we continue the advancement of our clinical trials and therapeutic candidates’ development. The lengthy process of completing clinical trials and seeking regulatory approvals for our therapeutic candidates requires substantial expenditures or government support.
The main estimates used in calculating the recoverable amount include: outcome of the therapeutic candidates research and development activities; probability of success in gaining regulatory approval, size of the potential market and our asset’s specific share in it and amount and timing of projected future cash flows. ​
The main estimates used in calculating the recoverable amount include: outcome of the therapeutic candidates research and development activities; probability of success in gaining regulatory approval, size of the potential market and our asset’s specific share in it and amount and timing of projected future cash flows. ​ 116 Table of Contents
As of the filing date of this Form 20-F, we became subject to the limitations of General Instruction I.B.5 of Form F-3, which limits the amount of funds we can raise through primary public offerings of securities in any twelve-calendar month period using a registration statement on Form F-3 to one-third of the aggregate market value of our ordinary shares held by non-affiliates.
As of the filing date of this Annual Report, we are subject to the limitations of General Instruction I.B.5 of Form F-3, which limits the amount of funds we can raise through primary public offerings of securities in any twelve-calendar month period using a registration statement on Form F-3 to one-third of the aggregate market value of our ordinary shares held by non-affiliates.
The warrants have an exercise price of $0.75 per ADS, immediately exercisable upon issuance and have a term of five years following the issuance date. The April 2024 Offering closed on April 3, 2034. The gross proceeds to us were approximately $1.25 million, before deducting offering expenses payable by us.
The warrants have an exercise price of $18.75 per ADS, are immediately exercisable upon issuance and have a term of five years following the issuance date. The April 2024 Offering closed on April 3, 2024. The gross proceeds to us were approximately $1.25 million, before deducting offering expenses payable by us.
The recoverable amount is determined using discounted cash flow calculations where the asset’s expected post-tax cash flows are risk-adjusted over their estimated remaining useful economic life. The risk-adjusted cash flows are discounted using our estimated post-tax weighted average cost of capital which was 17.8 % as of December 31, 2023.
The recoverable amount is determined using discounted cash flow calculations where the asset’s expected post-tax cash flows are risk-adjusted over their estimated remaining useful economic life. The risk-adjusted cash flows are discounted using our estimated post-tax weighted average cost of capital which was 1 8.1% as of December 31, 2024.
Financial Income and Expenses Financial income and expenses consist of non-cash financing expenses in connection with changes in the fair value of derivative financial instruments, interest earned on our cash, cash equivalents, and short-term bank deposits, bank fees, interest, and finance changes for lease liabilities and other transactional costs and expense or income resulting from fluctuations of the U.S. dollar against other currencies, in which a portion of our assets and liabilities are denominated like NIS, for example.
Financial Income and Expenses Financial income and expenses consist of non-cash financing expenses in connection with changes in the fair value of derivative financial instruments, interest earned on our cash, cash equivalents, and short-term bank deposits, bank fees, interest, and finance changes for lease liabilities and other transactional costs and expense or income resulting from fluctuations of the U.S. dollar against other currencies, in which a portion of our assets and liabilities are denominated like NIS, for example, as well as losses from the Global Termination Agreement.
On September 28, 2023, we entered into a warrant reprice and reload letter with holders of (i) the May 2022 Warrants (as defined below), as amended as described below, (ii) the December 2022 Warrants (as defined below), as amended as described below, (iii) warrants issued on April 3, 2023 (as amended, the “Class B Warrants”), and (iv) warrants issued on July 25, 2023 (the “July 2023 Warrants”, and together with the May 2022 Warrants, the December 2022 Warrants and the Class B Warrants, the “Existing Warrants”) to purchase up to an aggregate of 4,301,923 ADSs, pursuant to which such investors agreed to exercise their Existing Warrants in full at a reduced exercise price of $0.47 per ADS for aggregate gross proceeds of approximately $2.0 million, before deducting the fees and expenses.
On September 28, 2023, we entered into a warrant reprice and reload letter with holders of (i) the May 2022 Warrants (as defined below), as amended as described below, (ii) the December 2022 Warrants (as defined below), as amended as described below, (iii) warrants issued on April 3, 2023 (as amended, the “Class B Warrants”), and (iv) warrants issued on July 25, 2023 (the “July 2023 Warrants”, and together with the May 2022 Warrants, the December 2022 Warrants and the Class B Warrants, the “Existing Warrants”) to purchase up to an aggregate of 172,076 ADSs, pursuant to which such holders agreed to exercise their Existing Warrants in full at a reduced exercise price of $11.75 per ADS for aggregate gross proceeds of approximately $2.0 million, before deducting the fees and expenses.
Management has substantial doubt about our ability to continue as a going concern. 101 Table of Contents Description of our Products The following is a description of our two current commercial products and five therapeutic candidates, most of which are in late-stage clinical development: Commercial Products Talicia ® is a proprietary new drug approved for marketing in the U.S. for the treatment of H. pylori bacterial infection in adults.
Management has substantial doubt about our ability to continue as a going concern. 104 Table of Contents Description of our Products The following is a description of our current commercial product and five therapeutic candidates, most of which are in late-stage clinical development: Commercial Product Talicia ® is our proprietary drug approved by the FDA for marketing in the U.S. for the treatment of H. pylori bacterial infection in adults.
In connection with the offering, on July 21, 2023, we entered into a warrant reprice and reload letter (the “Reload Agreement”) with a certain holder of Series A Warrants to purchase up to an aggregate of 1,500,000 ADSs and Series B Warrants to purchase up to an aggregate of 1,500,000 ADSs, each issued in April 2023, pursuant to which: (i) such holder exercised its Series A Warrants in full at a reduced exercise price of $1.35 per ADS (the “Series A Warrant Exercise”) in exchange for new unregistered warrants to purchase up to an aggregate of 1,500,000 ADSs at an exercise price of $1.80 per ADS exercisable until April 3, 2028 (the “Reload Warrant”), and (ii) the exercise price of the Series B Warrants was reduced to $1.80 per ADS.
In connection with the offering, on July 21, 2023, we entered into a warrant reprice and reload letter (the “Reload Agreement”) with a certain holder of Series A Warrants to purchase up to an aggregate of 60,000 ADSs and Series B Warrants to purchase up to an aggregate of 60,000 ADSs, each issued in April 2023, pursuant to which: (i) such holder exercised its Series A Warrants in full at a reduced exercise price of $33.75 per ADS (the “Series A Warrant Exercise”) in exchange for new unregistered warrants to purchase up to an aggregate of 60,000 ADSs at an exercise price of $45.00 per ADS exercisable until April 3, 2028 (the “Reload Warrant”), and (ii) the exercise price of the Series B Warrants was reduced to $45.00 per ADS.
In addition, in connection with the sale of Movantik ® , the obligation to pay indemnification obligations and scheduled pre-closing liabilities of Movantik ® are secured by a lien on Talicia ® and Aemcolo ® -related assets.
In addition, in connection with the sale of Movantik ® , the obligation to pay indemnification obligations and scheduled pre-closing liabilities of Movantik ® were secured by a lien on Talicia ® - related assets and our former Aemcolo ® -related assets.
We will need to raise significant additional capital to finance our losses and negative cash flows from operations, and if we were to fail to raise sufficient capital or on favorable terms, we may need to cease operations.
We will need to raise significant additional capital to finance our losses and negative cash flows from operations, and if we were to fail to raise sufficient capital or on favorable terms and/or divest assets on favorable terms or at all, we may need to cease operations.
Due to the factors set forth above, we are not able to estimate with any high certainty if and when we would recognize any substantial revenues from our projects. D.
Due to the factors set forth above, we are not able to estimate with any high certainty if and when we would recognize any substantial revenues from our projects. 115 Table of Contents D.
Business Overview – Acquisition, Commercialization and License Agreements – License Agreement for RHB-107.” RHB-104 is an investigational new drug intended to treat Crohn's disease, which is a serious inflammatory disease of the GI system that may cause severe abdominal pain and bloody diarrhea, malnutrition and potentially life-threatening complications.
See “Item 4. Information on the Company – B. Business Overview – Acquisition, Commercialization and License Agreements – License Agreement for RHB-107.” RHB-104 is an investigational new drug intended to treat Crohn’s disease, which is a serious inflammatory disease of the GI system that may cause severe abdominal pain and bloody diarrhea, malnutrition and potentially life-threatening complications.
The Series B Warrants had an initial exercise price of $4.00 per ADS (subsequently reduced to $1.80 as described above), were exercisable immediately and had a term of nine months following issuance. The gross proceeds were approximately $6 million, before fees and expenses.
The Series B Warrants had an initial exercise price of $100.00 per ADS (subsequently reduced to $45.00 as described above), were exercisable immediately and had a term of nine months following issuance. The gross proceeds were approximately $6.0 million, before fees and expenses.
As of December 31, 2023, we had approximately $6.5 million of cash, cash equivalents, short-term investments and restricted cash. Through our U.S. subsidiary, we currently commercialize Talicia ® and Aemcolo ® . However, our ability to generate profits from the commercialization of our commercial products still remains uncertain. To date, our commercial operations are still generating operational losses.
As of December 31, 2024, we had approximately $4.8 million of cash, cash equivalents, short-term investments and restricted cash. Through our U.S. subsidiary, we currently commercialize Talicia ® . However, our ability to generate profits from the commercialization of commercial products still remains uncertain. To date, our commercial operations are still generating operational losses.
The Series A Warrants had an initial exercise price of $4.75 per ADS (subsequently reduced to $1.35 per ADS as described above), were exercisable immediately and had a term of five years following issuance.
The Series A Warrants had an initial exercise price of $118.75 per ADS (subsequently reduced to $33.75 per ADS as described above), were exercisable immediately and had a term of five years following issuance.
Cash Flow Net Cash Used in Operating Activities Net Cash Used in Operating Activities for the year ended December 31, 2023, was $35.8 million, compared to $29.2 million for the year ended December 31, 2022. The cash used in operating activities was primarily directed towards settling pre-closing liabilities related to Movantik and other operational activities.
Cash Flow Net Cash Used in Operating Activities Net Cash Used in Operating Activities for the year ended December 31, 2024, was $9.4 million, compared to $35.8 million for the year ended December 31, 2023. The cash used in operating activities was primarily directed towards settling pre-closing liabilities related to Movantik ® and other operational activities.
These placement agent warrants have exercise prices ranging from $0.5875 per ADS to $5 per ADS and expire between April 3, 2028, and January 25, 2029. These warrants were issued to the placement agent as part of the compensation for the offerings conducted in April, July, and September 2023, as well as January 2024 .
These placement agent warrants have exercise prices ranging from $14.6875 per ADS to $125.00 per ADS and expire between April 3, 2028, and January 25, 2029. These warrants were issued to the placement agent as part of the compensation for the offerings conducted in April, July, and September 2023, as well as January 2024.
Financing Activities On March 29, 2024, we entered into a securities purchase agreement with certain investors, pursuant to which we agreed to issue and sell, in a registered direct offering directly to such investors, (i) 2,144,487 ADSs and (ii) warrants to purchase up to an aggregate of 2,144,487 ADSs, at a combined purchase price of $0.58289 per ADS and accompanying warrant (the “April 2024 Offering”).
Financing Activities On March 29, 2024, we entered into a securities purchase agreement with certain investors, pursuant to which we agreed to issue and sell, in a registered direct offering directly to such investors, (i) 85,779 ADSs and (ii) warrants to purchase up to an aggregate of 85,779 ADSs, at a combined purchase price of $14.57 per ADS and accompanying warrant (the “April 2024 Offering”).
Because we do not have sufficient resources to fund our operations for the next twelve months from the date of this filing, management has substantial doubt of our ability to continue as a going concern.
Because we do not have sufficient resources to fund our operations for the next twelve months from the date of this filing, management has substantial doubt of our ability to continue as a going concern. See “– B. Operating Results – Going Concern”.
On January 26, 2024, we issued (i) in a registered direct offering 10,000,000 ADSs at a purchase price of $0.80 per ADS and (ii) in a concurrent private offering, warrants (the “January 2024 Warrants”) to acquire 10,000,000 ADSs in the aggregate at an exercise price of $1.00 per ADS (the “January 2024 Offering”).
On January 26, 2024, we issued (i) in a registered direct offering 400,000 ADSs at a purchase price of $20.00 per ADS and (ii) in a concurrent private offering, warrants (the “January 2024 Warrants”) to acquire 400,000 ADSs in the aggregate at an exercise price of $25.00 per ADS (the “January 2024 Offering”).
During the year ended December 31, 2023, we sold 2,625 ADSs under the at-the-market program (the “ATM program”) for total gross proceeds of approximately $20,000. We terminated the ATM program effective as of April 4, 2024. During the year ended December 31, 2022, we sold 30,582 ADSs under the ATM program for total gross proceeds of approximately $2.0 million.
During the year ended December 31, 2023, we sold 105 ADSs under an at-the-market program (the “ATM program”) for total gross proceeds of approximately $20,000. During the year ended December 31, 2022, we sold 1,223 ADSs under the ATM program for total gross proceeds of approximately $2.0 million. We terminated the ATM program effective as of April 4, 2024.
In addition, we have future obligations to purchase API, bulk tables and finished goods with respect to Talicia ® for an aggregate purchase price of approximately $12.8 million until the end of 2025 in the ordinary course of business.
In addition, we have future obligations to purchase API, bulk tables and finished goods with respect to Talicia ® for an aggregate purchase price of approximately $6.2 million until the end of 2026 in the ordinary course of business.
In addition, as it relates to the extinguishment of all debt obligations of RedHill Inc. under the Credit Agreement in exchange for the transfer of its rights in Movantik ® , the portion of the gain from the debt extinguishment, resulting from the difference between the carrying amount (the amortized cost) of the financial liability to HCRM and the fair value of the assets transferred, is included within financial income. 103 Table of Contents Other income Incorporates the portion of the gain from the sale of Movantik ® resulting from the difference between the carrying value and fair value of the assets transferred to HCRM.
In addition, as it relates to the extinguishment of all debt obligations of RedHill U.S. under the Credit Agreement in exchange for the transfer of its rights in Movantik ® , the portion of the gain from the debt extinguishment, resulting from the difference between the carrying amount (the amortized cost) of the financial liability to HCRM and the fair value of the assets transferred, is included within financial income.
See “ATM Program with Cantor”, below. On December 6, 2022, we consummated an underwritten offering of 544,375 ADSs and pre-funded warrants to purchase 255,625 ADSs for gross proceeds of approximately $8 million after deducting the underwriting discounts and commissions and estimated offering expenses payable by us in connection with the offering.
See “ATM Program with Cantor”, below. On December 6, 2022, we consummated an underwritten offering of 21,775 ADSs and pre-funded warrants to purchase 10,225 ADSs for gross proceeds of approximately $8.0 million after deducting the underwriting discounts and commissions and estimated offering expenses payable by us in connection with the offering.
We also entered into a Security Agreement, a Pledge Agreement, an Israeli-law governed Fixed Charge Debenture and an Israeli-law governed Floating Charge Debenture in favor of HCRM, pursuant to which our obligations under the Credit Agreement (and those of RedHill U.S.) are secured by a pledge of all of our holdings of the capital stock of RedHill U.S., substantially all of the assets of RedHill U.S., and all of our assets relating in any material respect to Talicia ® .
Business Overview – Sale of Movantik ® to HCRM. ” 112 Table of Contents We also entered into a Security Agreement, a Pledge Agreement, an Israeli-law governed Fixed Charge Debenture and an Israeli-law governed Floating Charge Debenture in favor of HCRM, pursuant to which our obligations under the Credit Agreement (and those of RedHill U.S.) were secured by a pledge of all of our holdings of the capital stock of RedHill U.S., substantially all of the assets of RedHill U.S., and all of our assets relating in any material respect to Talicia ® .
We also agreed to reduce the exercise price of (i) the May 2022 Warrants (as defined below), as amended as described below, and (ii) the December 2022 Warrants (defined below) to purchase up to an aggregate of 971,817 ADSs, at an exercise price of $1.80 per ADS (the “Warrant Amendment”).
We also agreed to reduce the exercise price of (i) the May 2022 Warrants (as defined below), as amended as described below, and (ii) the December 2022 Warrants (defined below) to purchase up to an aggregate of 38,873 ADSs, at an exercise price of $45.00 per ADS (the “Warrant Amendment”).
In addition, the investors in this financing received warrants to purchase 1,727,678 ADSs with an exercise price of $4.6305 per ADS (following a reset on March 31, 2023, in connection with the ratio change of the ADSs to the Company’s ordinary shares) (the “December 2022 Warrants”).
In addition, the investors in this financing received warrants to purchase 69,107 ADSs with an exercise price of $115.7625 per ADS (following a reset on March 31, 2023, in connection with the ratio change of the ADSs to the Company’s ordinary shares) (the “December 2022 Warrants”).
RHB-102 (Bekinda ® ) is an investigational once-daily bi-modal extended-release oral formulation of ondansetron, a leading member of the family of 5-HT3 serotonin receptor inhibitors, intended to treat nausea, vomiting and diarrhea symptoms experienced in some people suffering from acute gastroenteritis, gastritis, and IBS-D.
The compound was developed to treat Crohn’s disease through the targeting of MAP infection. 105 Table of Contents RHB-102 (Bekinda ® ) is an investigational once-daily bi-modal extended-release oral formulation of ondansetron, a leading member of the family of 5-HT3 serotonin receptor inhibitors, intended to treat nausea, vomiting and diarrhea symptoms experienced in some people suffering from acute gastroenteritis, gastritis, and IBS-D.
On April 3, 2023, we issued in a registered direct offering (i) 270,000 ADSs and pre-funded warrants to purchase 1,230,000 ADSs, (ii) Series A Warrants to purchase up to an aggregate of 1,500,000 ADSs, and (iii) Series B Warrants to purchase up to an aggregate of 1,500,000 ADSs at a combined offering price of $4.00 per ADS (or pre-funded warrant) and accompanying Series A Warrant and Series B Warrant.
On April 3, 2023, we issued in a registered direct offering (i) 10,800 ADSs and pre-funded warrants to purchase 49,200 ADSs, (ii) Series A Warrants to purchase up to an aggregate of 60,000 ADSs, and (iii) Series B Warrants to purchase up to an aggregate of 60,000 ADSs at a combined offering price of $100.00 per ADS (or pre-funded warrant) and accompanying Series A Warrant and Series B Warrant.
Prior to termination, we sold 34,453 ADSs at a weighted average offering price of $74.87 per ADS for approximate aggregate net proceeds of approximately $2.5 million pursuant to the Sales Agreement and related prospectus supplement and accompanying base prospectus since the launch of the ATM program in July 2021.
Prior to termination, we sold 1,378 ADSs at a weighted average offering price of $1,871.07 per ADS for approximate aggregate net proceeds of approximately $2.5 million pursuant to the Cantor – SVB Sales Agreement and related prospectus supplement and accompanying base prospectus since the launch of the ATM program in July 2021. ATM Program with H.C.
We expect to purchase the inventory in the regular course of business as part of our ongoing commercialization of Talicia ® . We continue to have negative cash flows from operations, and our ability to generate sufficient revenues for our operations is significantly limited unless we are successful in replacing Movantik ® with another commercial product.
We expect to purchase the inventory in the regular course of business as part of our ongoing commercialization of Talicia ® . We continue to have negative cash flows from operations, and our ability to generate sufficient revenues for our operations is significantly limited after the sale of the rights to Movantik ® .
If we are unsuccessful in achieving sufficient commercial sales of our products, including replacing Movantik ® with another commercial product on a timely basis, or in raising sufficient capital, we will need to reduce activities and curtail or cease operations. 104 Table of Contents Comparison of the Year Ended December 31, 2023, to the Year Ended December 31, 2022 Net Revenues Net Revenues for the year ended December 31, 2023, were $6.5 million, compared to $61.8 million for the year ended December 31, 2022.
If we are unsuccessful in achieving sufficient commercial sales of our products, or in raising sufficient capital, we will need to reduce activities and curtail or cease operations. 107 Table of Contents Comparison of the Year Ended December 31, 2024, to the Year Ended December 31, 2023 Net Revenues Net Revenues for the year ended December 31, 2024, were $8.0 million, compared to $6.5 million for the year ended December 31, 2023.
Inflammatory conditions and solid tumors are additional areas of focus for opaganib. Furthermore, we are investigating RHB-107 (upamostat) as a potential treatment for COVID-19 and other viruses as part of pandemic preparedness, including the Ebola virus. Our current pipeline consists of five therapeutic candidates, most of which are in clinical development.
Furthermore, we are investigating RHB-107 (upamostat) as a potential treatment for COVID-19 and other viruses as part of pandemic preparedness, including the Ebola virus. 103 Table of Contents Our current pipeline consists of five therapeutic candidates, part of which are in late stage clinical development.
On February 2, 2023, we reached an agreement with HCRM for the extinguishment of all our debt obligations (including all principal, interest, revenue interest, prepayment premiums and exit fees) under the Credit Agreement in exchange for the transfer of our rights in Movantik ® to Movantik Acquisition Co., an affiliate of HCRM.
On February 2, 2023, we reached an agreement with HCRM for the extinguishment of all our debt obligations under the Credit Agreement in connection with the transfer of our rights in Movantik ® to Movantik Acquisition Co., an affiliate of HCRM.
On May 11, 2022, we issued (i) in a registered direct offering a total of 126,492 ADSs and pre-funded warrants to purchase 137,592 ADSs and (ii) in a concurrent private placement, warrants to acquire 330,106 ADSs at a purchase price of $59.20 per ADS (“May 2022 Warrants”). The gross proceeds were approximately $15 million, before fees and expenses.
On May 11, 2022, we issued (i) in a registered direct offering a total of 5,059 ADSs and pre-funded warrants to purchase 5,503 ADSs and (ii) in a concurrent private placement, warrants to acquire 13,204 ADSs at a purchase price of $1,480.00 per ADS (“May 2022 Warrants”). The gross proceeds were approximately $15.0 million, before fees and expenses.
After the mentioned offerings and the November 2023 warrants’ exercise described below, as of January 31, 2024, the Company’s share capital included 29,703,027 ADSs, the January 2024 Warrants, December 2022 Warrants to purchase 755,861 ADSs (as defined below), and placement agent warrants to purchase 1,116,230 ADSs.
After the mentioned offerings and the November 2023 warrants’ exercise described below, as of January 31, 2024, the Company’s share capital included 1,188,121 ADSs, the January 2024 Warrants, December 2022 Warrants to purchase 30,234 ADSs (as defined below), and placement agent warrants to purchase 44,649 ADSs.
We have determined that the Company’s available cash at December 31, 2023, together with proceeds raised in the January 2024 Offering and the April 2024 Offering (each as defined herein), will not be sufficient to fund current liabilities and capital expenditure requirements for a period exceeding one year from the date of this Annual Report.
We have determined that the Company’s available cash on December 31, 2024, together with proceeds raised pursuant to the Wainwright Sales Agreement (as defined below) during the first quarter of 2025, will not be sufficient to fund current liabilities and capital expenditure requirements for a period exceeding one year from the date of this Annual Report.
Talicia ® is a combination of three approved drugs, omeprazole, which is a proton pump inhibitor (prevents the secretion of hydrogen ions necessary for the digestion of food in the stomach), amoxicillin and rifabutin, which are antibiotics. Talicia ® is administered to patients orally.
Talicia ® is a combination of three approved drugs, omeprazole, which is a proton pump inhibitor (it prevents the secretion of hydrogen ions increasing the PH of the stomach), amoxicillin and rifabutin, which are antibiotics. Talicia ® is administered to patients orally in the form of a fixed-dose, all-in-one capsule.
Investors are encouraged to review the related IFRS financial measure, Consolidated Comprehensive Income (Loss), and the reconciliations of Adjusted EBITDA provided below to Consolidated Comprehensive Income (Loss) and to not rely on any single financial measure to evaluate our business. 106 Table of Contents The following table sets forth our Adjusted EBITDA for the years ended December 31, 2023, 2022 and 2021: ​ Year Ended December 31, ​ 2023 2022 2021 ​ ​ U.S. dollars in thousands Adjusted EBITDA ​ (28,338) ​ (29,015) ​ (52,774) ​ The following table provides a reconciliation of adjusted EBITDA to Consolidated Comprehensive Income (Loss) for the periods indicated: ​ Year Ended December 31, ​ 2023 2022 2021 ​ ​ U.S. dollars in thousands Consolidated Comprehensive Income (Loss) ​ 23,916 ​ (71,669) ​ (97,744) Depreciation ​ 1,445 ​ 2,136 ​ 1,914 Amortization and impairment of intangible assets ​ 545 ​ 6,018 ​ 16,235 Share-based compensation to employees and service providers ​ 1,647 ​ 5,675 ​ 10,212 Gain from early termination of lease, net ​ (543) ​ — ​ — Other income ​ (44,064) ​ — ​ — Financial (income) expenses, net ​ (11,284) ​ 28,825 ​ 16,609 Adjusted EBITDA ​ (28,338) ​ (29,015) ​ (52,774) ​ B.
The following table sets forth our Adjusted EBITDA for the years ended December 31, 2024, 2023 and 2022: ​ Year Ended December 31, ​ 2024 2023 2022 ​ ​ U.S. dollars in thousands Adjusted EBITDA ​ (10,993) ​ (28,338) ​ (29,015) ​ The following table provides a reconciliation of adjusted EBITDA to Consolidated Comprehensive Income (Loss) for the periods indicated: ​ Year Ended December 31, ​ 2024 2023 2022 ​ ​ U.S. dollars in thousands Consolidated Comprehensive Income (Loss) ​ (8,268) ​ 23,916 ​ (71,669) Depreciation ​ 588 ​ 1,445 ​ 2,136 Amortization and impairment of intangible assets ​ 31 ​ 545 ​ 6,018 Share-based compensation to employees and service providers ​ 665 ​ 1,647 ​ 5,675 Gain from early termination of lease, net ​ (22) ​ (543) ​ — Other income ​ 2,359 ​ (44,064) ​ — Financial (income) expenses, net ​ (6,346) ​ (11,284) ​ 28,825 Adjusted EBITDA ​ (10,993) ​ (28,338) ​ (29,015) ​ B.
Due to the inherently unpredictable nature of clinical development processes, we are unable to estimate with any certainty the costs we will incur in the continued development of the therapeutic candidates in our pipeline for potential commercialization.
The research and development of certain of our product candidates, including RHB-107, have been supported by government-funded programs. Due to the inherently unpredictable nature of clinical development processes, we are unable to estimate with any certainty the costs we will incur in the continued development of the therapeutic candidates in our pipeline for potential commercialization.
Total Assets Total Assets as of December 31, 2023, were $23 million, as compared to $158.9 million as of December 31, 2022.
Total Assets Total Assets as of December 31, 2024, were $18.0 million, as compared to $23.0 million as of December 31, 2023.
Remaining pre-closing liabilities related to Movantik as of December 2023, are estimated at $4.8 million. Comparison of the Year Ended December 31, 2022, to the Year Ended December 31, 2021 This analysis can be found in Item 5 of the Annual Report on Form 20-F for the year ended December 31, 2022, filed with the SEC on April 28, 2023.
Comparison of the Year Ended December 31, 2023, to the Year Ended December 31, 2022 This analysis can be found in Item 5 of the Annual Report on Form 20-F for the year ended December 31, 2023, filed with the SEC on April 8, 2024.
ATM Program with Cantor On July 29, 2021, we entered into the sales agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”) and SVB Leerink LLC (“SVB”), for the sale of ADSs, pursuant to which we may offer and sell, from time to time, ADSs through our ATM program, with SVB and Cantor acting as our agents.
(“Cantor”) and SVB Leerink LLC (“SVB”), for the sale of ADSs, pursuant to which we were able to offer and sell, from time to time, ADSs through our ATM program, with SVB and Cantor acting as our agents.
Adjusted EBITDA We define Adjusted EBITDA as Consolidated Comprehensive Income (Loss) plus depreciation, Amortization and impairment of intangible assets, share based compensation, financial (income) expenses, minus gains from early termination of leases, and other income, which includes income from service provided to HCRM and gain from the sale of Movantik®.
See tables below for a discussion regarding our use of Adjusted EBITDA, including its limitations, and a reconciliation to the most directly comparable IFRS financial measure. 109 Table of Contents Adjusted EBITDA We define Adjusted EBITDA as Consolidated Comprehensive Income (Loss) plus depreciation, amortization and impairment of intangible assets, share based compensation, financial (income) expenses, minus gains from early termination of leases, and other income, which includes income from service provided to HCRM and gain from the sale of Movantik®.
Non-IFRS Financial Measures In addition to our financial results reported in accordance with IFRS, we believe that Adjusted EBITDA, which is a non-IFRS financial measure, is useful in evaluating the performance of our business. See tables below for a discussion regarding our use of Adjusted EBITDA, including its limitations, and a reconciliation to the most directly comparable IFRS financial measure.
Non-IFRS Financial Measures In addition to our financial results reported in accordance with IFRS, we believe that Adjusted EBITDA, which is a non-IFRS financial measure, is useful in evaluating the performance of our business.
An additional $50 million tranche was used to fund the acquisition of rights to Movantik ® from AstraZeneca. See “Item 4. Information on the Company – B.
Pursuant to the terms of the Credit Agreement, RedHill U.S. received a $30 million loan following the signing of the Credit Agreement. An additional $50 million tranche was used to fund the acquisition of rights to Movantik ® from AstraZeneca. See “Item 4. Information on the Company – B.
Term Loan Facility On February 23, 2020, we, through our wholly-owned subsidiary, RedHill U.S., entered into the Credit Agreement with HCRM, as Administrative Agent, and the lenders from time to time party thereto. Pursuant to the terms of the Credit Agreement, RedHill U.S. received a $30 million loan following the signing of the Credit Agreement.
The warrants were exercisable six months after the issuance date and had a term of five and one-half years. Term Loan Facility On February 23, 2020, we, through our wholly-owned subsidiary, RedHill U.S., entered into the Credit Agreement with HCRM, as Administrative Agent, and the lenders from time to time party thereto.
We are working to replace Movantik ® with another commercial product, either internal or external, but this may not occur, and we may never achieve levels of revenue we have achieved through Movantik. We also lost economies of scale in our commercial operations that we were able to benefit from by having Movantik ® as a core commercial product.
We are working to replace Movantik ® with another commercial product, either internal or external, but this may not occur, and we may never achieve levels of revenue we have achieved through Movantik ® .
Because we do not have sufficient resources to fund our operations for the next twelve months from the date of this filing, management has substantial doubt of our ability to continue as a going concern.
During the year ended December 31, 2024, our net cash used in operating activities was $9.4 million leaving a cash balance of $4.8 million. Because we do not have sufficient resources to fund our operations for the next twelve months from the date of this filing, management has substantial doubt of our ability to continue as a going concern.
See “Term Loan Facility” and “Additional Cash Requirements”, below. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should we be unable to continue as a going concern.
The consolidated financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should we be unable to continue as a going concern. We will need to raise significant additional capital to finance our losses and negative cash flows from operations.
We have one product that we primarily developed internally which has been approved for marketing and, to date, none of our other therapeutic candidates has generated revenues.
We have one product, Talicia ® , that we primarily developed internally which has been approved for marketing and, to date, none of our other therapeutic candidates has generated revenues. We have out-licensed our commercial product, Talicia ® , for specific territories outside the U.S., and one of our therapeutic candidates, RHB-102, worldwide (except for the U.S., Canada, and Mexico).
Our primary goal is to become a leading specialty biopharmaceutical company. 100 Table of Contents We are currently focused primarily on the advancement of our development pipeline of clinical-stage therapeutic candidates. We also commercialize in the U.S.
Our primary goal is to become a leading specialty biopharmaceutical company. We are currently focused primarily on the advancement of our development pipeline of clinical-stage therapeutic candidates. We also commercialize in the U.S. our GI-related product, Talicia ® (omeprazole, amoxicillin, and rifabutin), and continue to explore our strategic plans for other potential products and activities.
Risk Factors – Risks 112 Table of Contents Related to Regulatory Matters – If we or our development or commercialization partners are unable to obtain or maintain FDA or other foreign regulatory clearance and approval for our therapeutic candidates or products we may commercialize or promote, we or our commercialization partners will be unable to commercialize our therapeutic candidates, upon approval, if any, or products we may commercialize or promote.” As we obtain results from clinical trials, we may elect to discontinue or delay the development and clinical trials for certain therapeutic candidates in order to focus our resources on more promising therapeutic candidates or projects.
Risk Factors – Risks Related to Regulatory Matters - Talicia ® or any product for which we may obtain regulatory approval or acquire commercialization rights may not become or continue to be commercially viable products.” As we obtain results from clinical trials, we may elect to discontinue or delay the development and clinical trials for certain therapeutic candidates in order to focus our resources on more promising therapeutic candidates or projects.
RHB-104 is a patented combination of clarithromycin, clofazimine, and rifabutin, three generic antibiotic ingredients, in a single capsule. The compound was developed to treat Crohn's disease through the targeting of MAP infection.
RHB-104 is a patented combination of clarithromycin, clofazimine, and rifabutin, three generic antibiotic ingredients, in a single capsule.
Upon closing of the sale of Movantik ® to an affiliate of HCRM and the simultaneous extinguishment of debt obligations under the Credit Agreement, these collateral documents continued in effect were amended to provide HCRM with security interests in (i) the Escrow Account, (ii) Talicia-related assets, (iii) Aemcolo-related assets and (iv) accounts receivable related to Movantik ® accrued as of the Closing (as defined in the APA) to secure “Go-Forward Obligations” consisting of indemnification obligations under the APA and the Credit Agreement and scheduled pre-closing liabilities relating to Movantik ® .
These collateral documents were amended to provide HCRM with security interests in (i) an escrow account (“Escrow Account”) established to pay pre-closing liabilities related to Movantik ® that were retained by RedHill U.S. under the terms of the asset purchase agreement, (ii) Talicia ® -related assets, (iii) our former Aemcolo ® -related assets and (iv) accounts receivable related to Movantik ® accrued as of the Closing (as defined in the APA) to secure “Go-Forward Obligations” consisting of indemnification obligations under the APA and the Credit Agreement and scheduled pre-closing liabilities relating to Movantik ® until substantially all pre-closing liabilities relating to Movantik ® were paid or other specific conditions were met.
Operating Income (Loss) Operating Income for the year ended December 31, 2023, was $12.6 million, compared to operating loss of $42.8 million for the year ended December 31, 2022. The difference is primarily attributable to the changes resulting from the divestiture of Movantik, as detailed above.
The difference is primarily attributable to the changes resulting from the divestiture of Movantik® partially offset by the decrease in operating expenses as detailed above. 108 Table of Contents Financial Income (Expenses), net Financial Income, net for the year ended December 31, 2024, was $6.3 million, compared to Financial Income, net of $11.3 million for the year ended December 31, 2023.
Other Income Other Income for the for the year ended December 31, 2023, was $44.1 million, as compared to no other income recognized for the year ended December 31, 2022.
Other Income/Expenses Other Expense for the year ended December 31, 2024 was $2.3 million, recognized as part of the Global Termination Agreement, as compared to Other Income of $44.1 million for the year ended December 31, 2023.
Additional Cash Requirements We are obligated to make various payments upon the achievement of agreed-upon milestones or make certain royalty payments under our in-license agreements with Apogee with respect to opaganib and with Heidelberg with respect to RHB-107, under our asset purchase agreement with Giaconda Limited with respect to Talicia ® , RHB-104, and RHB-106 and under our agreement with UCF or the University of Minnesota, pursuant to which we are obligated to make various payments upon the achievement of agreed-upon milestones or make certain royalty payments.
To date, we have sold 453,345 ADSs at a weighted average offering price of $4.96 per ADS for aggregate net proceeds of approximately $2.2 million pursuant to the Wainwright Sales Agreement and related prospectus supplement and accompanying base prospectus. 113 Table of Contents Additional Cash Requirements We are obligated to make various payments upon the achievement of agreed-upon milestones or make certain royalty payments under our in-license agreements with Apogee with respect to opaganib and with Heidelberg with respect to RHB-107, under our asset purchase agreement with Giaconda Limited with respect to Talicia ® , RHB-104, and RHB-106 and under our agreement with UCF or the University of Minnesota, pursuant to which we are obligated to make various payments upon the achievement of agreed-upon milestones or make certain royalty payments.
Additionally, includes service fees relating to transition services provided as part of the sale of Movantik ® . A. Operating Results History of Losses Since inception in 2009, we have generated significant losses in connection with the research and development of our therapeutic candidates and from our commercial operations.
Operating Results History of Losses Since inception in 2009, we have generated significant losses in connection with the research and development of our therapeutic candidates and from our commercial operations. We may continue to incur additional losses as we continue our commercial activities and expand our research and development activities over time.
Net Income (Loss) Net Income of $23.9 million for the year ended December 31, 2023, as compared to Net Loss of $71.7 million for the year ended December 31, 2022, primarily attributed to the changes resulting from the sale of Movantik and to the ongoing cost-reduction measures, as detailed above.
Net Income (Loss) Net Loss was $8.3 million for the year ended December 31, 2024, as compared to Net Income of $23.9 million for the year ended December 31, 2023. The change was primarily attributable to the impact of the Movantik® divestiture in 2023, partially offset by reduction in operating expenses resulting from ongoing cost-reduction measures, as detailed above.
We have out-licensed one of our commercial products, Talicia ® for specific territories outside the U.S. and we plan to commercialize our therapeutic candidates, upon approval, if any, through licensing and other commercialization arrangements with pharmaceutical companies on a global and territorial basis or independently with a dedicated commercial operations or in potential partnership with other commercial-stage companies.
Furthermore, we plan to commercialize our therapeutic candidates, upon approval, if any, through licensing and other commercialization arrangements with pharmaceutical companies on a global and territorial basis or independently with a dedicated commercial operation or in potential partnership with other commercial-stage companies. We also evaluate, on a case-by-case basis, co-development, co-promotion, licensing, acquisitions and similar arrangements.
In December 2019, we commenced the commercialization of Aemcolo ® in certain territories in the U.S. Therapeutic Candidates RHB-204 is a patented fixed-dose combination product of three antibiotics that will simplify administration and optimize compliance.
Talicia ® is the first therapeutic candidate we developed to be approved by the FDA. Therapeutic Candidates RHB-204 is a patented fixed-dose combination product of three antibiotics that will simplify administration and optimize compliance.
Other than Talicia ® , our therapeutic candidates are in research and development stage, and therefore do not yet generate revenues. Until our sale to HCRM on February 2, 2023, we also commercialized Movantik ® (naloxegol). Following this sale, we have lost our primary revenue source which will make it more difficult for us to satisfy our payment obligations.
Other than Talicia ® , our therapeutic candidates are in research and development stage, and therefore do not yet generate revenues. 110 Table of Contents Until our sale to HCRM on February 2, 2023, we also commercialized Movantik ® (naloxegol), and until October 8, 2024, we also commercialized Aemcolo ® .

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Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

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A “change in control” is defined under the change in control employee retention plan (the “CIC Plan”) as follows: (1) the consummation of any merger, consolidation, reorganization, or similar transaction or series of related transactions of the Company with another entity, other than a merger, consolidation, reorganization, or similar transaction or series of related transactions which would result in the shareholders of the Company immediately preceding the transaction beneficially owning, immediately after the transaction, at least 50% of the combined voting power of the outstanding securities of the surviving or resulting entity (or its parent); (2) any “person” (as such term is used in Sections 13(d) and 14(d) of the Exchange Act or “group” (two or more persons acting as a partnership, limited partnership, syndicate or other group for the purpose of acquiring, holding, or disposing of the applicable securities referred to herein) becomes the “beneficial owner” (as defined in Rule 13d-3 of the Exchange Act), directly or indirectly, of securities of the Company representing fifty percent (50%) or more of the total voting power represented by the Company’s then-outstanding voting securities; (3) the election of a board of directors over a three-year period or less, the majority of which is not supported by at least a majority of the then existing board of directors of the Company; or (4) any sale, lease, exchange, or other transfer (in one transaction or a series of related transactions) of all or substantially all of the assets of the Company (other than to an entity controlled by the Company). 117 Table of Contents (6) Mr.
A “change in control” is defined under the change in control employee retention plan (the “CIC Plan”) as follows: (1) the consummation of any merger, consolidation, reorganization, or similar transaction or series of related transactions of the Company with another entity, other than a merger, consolidation, reorganization, or similar transaction or series of related transactions which would result in the shareholders of the Company immediately preceding the transaction beneficially owning, immediately after the transaction, at least 50% of the combined voting power of the outstanding securities of the surviving or resulting entity (or its parent); (2) any “person” (as such term is used in Sections 13(d) and 14(d) of the Exchange Act or “group” (two or more persons acting as a partnership, limited partnership, syndicate or other group for the purpose of acquiring, holding, or disposing of the applicable securities referred to herein) becomes the “beneficial owner” (as defined in Rule 13d-3 of the Exchange Act), directly or indirectly, of securities of the Company representing fifty percent (50%) or more of the total voting power represented by the Company’s then-outstanding voting securities; (3) the election of a board of directors over a three-year period or less, the majority of which is not supported by at least a majority of the then existing board of directors of the Company; or (4) any sale, lease, exchange, or other transfer (in one transaction or a series of related transactions) of all or substantially all of the assets of the Company (other than to an entity controlled by the Company). 120 Table of Contents (6) Mr.
Such undertaking must specify the events that, in the board of directors’ opinion, are foreseeable in view of the company’s actual business at the time of the undertaking and the amount or the standards that the board of directors deemed reasonable at the time; ● a provision authorizing the company to indemnify an officer or director for future events with respect to reasonable litigation expenses, including counsel fees, incurred by an officer or director in which he is ordered to pay by a court, in proceedings that the company institutes against him or instituted on behalf of the company or by another person, or in a criminal charge of which he was acquitted, or a criminal charge in which he was convicted of a criminal offense that does not require proof of criminal intent; ● a provision authorizing the company to indemnify an officer or director for future events with respect to reasonable litigation fees, including attorney’s fees, incurred by an officer or director due to an investigation or proceeding filed against him by an authority that is authorized to conduct such investigation or proceeding, and that resulted without filing an indictment against him and without imposing on him financial obligation in lieu of a criminal proceeding, or that resulted without filing an indictment against him but with imposing on him a financial obligation as an alternative to a criminal proceeding in respect of an offense that does not require the proof of criminal intent or in connection with a monetary sanction; 129 Table of Contents ● a provision authorizing the company to indemnify an officer or director for future events with respect to a Party Harmed by the Breach; ● a provision authorizing the company to indemnify an officer or director for future events with respect to expenses incurred by such officer or director in connection with an administrative proceeding, including reasonable litigation expenses, including legal fees; and ● a provision authorizing the company to indemnify an officer or director retroactively.
Such undertaking must specify the events that, in the board of directors’ opinion, are foreseeable in view of the company’s actual business at the time of the undertaking and the amount or the standards that the board of directors deemed reasonable at the time; 132 Table of Contents ● a provision authorizing the company to indemnify an officer or director for future events with respect to reasonable litigation expenses, including counsel fees, incurred by an officer or director in which he is ordered to pay by a court, in proceedings that the company institutes against him or instituted on behalf of the company or by another person, or in a criminal charge of which he was acquitted, or a criminal charge in which he was convicted of a criminal offense that does not require proof of criminal intent; ● a provision authorizing the company to indemnify an officer or director for future events with respect to reasonable litigation fees, including attorney’s fees, incurred by an officer or director due to an investigation or proceeding filed against him by an authority that is authorized to conduct such investigation or proceeding, and that resulted without filing an indictment against him and without imposing on him financial obligation in lieu of a criminal proceeding, or that resulted without filing an indictment against him but with imposing on him a financial obligation as an alternative to a criminal proceeding in respect of an offense that does not require the proof of criminal intent or in connection with a monetary sanction; ● a provision authorizing the company to indemnify an officer or director for future events with respect to a Party Harmed by the Breach; ● a provision authorizing the company to indemnify an officer or director for future events with respect to expenses incurred by such officer or director in connection with an administrative proceeding, including reasonable litigation expenses, including legal fees; and ● a provision authorizing the company to indemnify an officer or director retroactively.
Directors’ and Officers’ Insurance The Israeli Companies Law and our articles of association provide that, subject to the provisions of the Israeli Companies Law, we may obtain insurance for our directors and officers for any liability stemming from any act performed by an officer or director in his capacity as an officer or director, as the case may be with respect to any of the following: ● a breach of such officer’s or director’s duty of care to us or to another person; 128 Table of Contents ● a breach of such officer’s or director’s duty of loyalty to us, provided that such officer or director acted in good faith and had reasonable cause to assume that his act would not prejudice our interests; ● a financial liability imposed upon such officer or director in favor of another person; ● financial liability imposed on the officer or director for payment to persons or entities harmed as a result of violations in administrative proceedings as described in Section 52(54)(a)(1)(a) of the Israeli Securities Law (“Party Harmed by the Breach”); ● expenses incurred by such officer or director in connection with an administrative proceeding conducted in this matter, including reasonable litigation expenses, including legal fees; or ● a breach of any duty or any other obligation, to the extent insurance may be permitted by law.
Our articles of association provide for this exemption from liability for our directors and officers. 131 Table of Contents Directors’ and Officers’ Insurance The Israeli Companies Law and our articles of association provide that, subject to the provisions of the Israeli Companies Law, we may obtain insurance for our directors and officers for any liability stemming from any act performed by an officer or director in his capacity as an officer or director, as the case may be with respect to any of the following: ● a breach of such officer’s or director’s duty of care to us or to another person; ● a breach of such officer’s or director’s duty of loyalty to us, provided that such officer or director acted in good faith and had reasonable cause to assume that his act would not prejudice our interests; ● a financial liability imposed upon such officer or director in favor of another person; ● financial liability imposed on the officer or director for payment to persons or entities harmed as a result of violations in administrative proceedings as described in Section 52(54)(a)(1)(a) of the Israeli Securities Law (“Party Harmed by the Breach”); ● expenses incurred by such officer or director in connection with an administrative proceeding conducted in this matter, including reasonable litigation expenses, including legal fees; or ● a breach of any duty or any other obligation, to the extent insurance may be permitted by law.
Mr. Tsimchi received his BA in Economics and Agriculture from the Hebrew University of Jerusalem, Israel. The board of directors has determined that Mr. Tsimchi is a financial and accounting expert under Israeli law.
Mr. Tsimchi received his BA in Economics and Agriculture from the Hebrew University of Jerusalem, Israel. The board of directors has determined that Mr. Tsimchi is a financial and accounting expert under Israeli law. Dr.
See “Management - Share Ownership” for further information regarding the RSUs. (4) “All Other Compensation” includes, among other things, car-related expenses (including tax gross-up), communication expenses, and basic health insurance. (5) Mr. Ben-Asher’s employment terms as the Company’s Chief Executive Officer provide that Mr. Ben-Asher is currently entitled to a monthly base gross salary of NIS 124,740 (approximately $34,186). Mr.
See “Management - Share Ownership” for further information regarding the RSUs. (4) “All Other Compensation” includes, among other things, car-related expenses (including tax gross-up), communication expenses, and basic health insurance. (5) Mr. Ben-Asher’s employment terms as the Company’s Chief Executive Officer provide that Mr. Ben-Asher is currently entitled to a monthly base gross salary of NIS 124,740 (approximately $34,203). Mr.
Our board of directors currently has three directors with such “accounting and financial expertise.” External directors are to be elected by a majority vote at a shareholders’ meeting, provided that either (1) the majority of shares voted at the meeting, including at least a majority of the votes of the shareholders who are not controlling shareholders (as defined in the Israeli Companies Law), do not have a personal interest in the appointment (excluding a personal interest which did not result from the shareholder’s relationship with the controlling shareholder), vote in favor of the election of the director without taking abstentions into account; or (2) the total number of shares of the above-mentioned shareholders who voted against the election of the external director does not exceed two percent of the aggregate voting rights in the company.
Our board of directors currently has three directors with such “accounting and financial expertise.” 125 Table of Contents External directors are to be elected by a majority vote at a shareholders’ meeting, provided that either (1) the majority of shares voted at the meeting, including at least a majority of the votes of the shareholders who are not controlling shareholders (as defined in the Israeli Companies Law), do not have a personal interest in the appointment (excluding a personal interest which did not result from the shareholder’s relationship with the controlling shareholder), vote in favor of the election of the director without taking abstentions into account; or (2) the total number of shares of the above-mentioned shareholders who voted against the election of the external director does not exceed two percent of the aggregate voting rights in the company.
(3) Consists of the fair value of the equity-based compensation granted during the year ended December 31, 2023, in exchange for the directors and officers services recognized as an expense in profit or loss and is carried to the accumulated deficit under equity. The total amount is recognized as an expense over the vesting period of the RSUs.
(3) Consists of the fair value of the equity-based compensation granted during the year ended December 31, 2024, in exchange for the directors and officers services recognized as an expense in profit or loss and is carried to the accumulated deficit under equity. The total amount is recognized as an expense over the vesting period of the RSUs.
An “interested party” is defined in the Securities Law and includes, among others: ● a holder of 5% or more of the outstanding shares or voting rights of an entity; ● a person entitled to appoint one or more of the directors or chief executive officer of an entity; ● a director of an entity or its chief executive officer; 133 Table of Contents ● an entity, in which an individual referred to above holds 25% or more of its outstanding shares or voting rights, or is entitled to appoint 25% or more of its directors; or ● a person who initiated the establishment of the entity.
An “interested party” is defined in the Securities Law and includes, among others: ● a holder of 5% or more of the outstanding shares or voting rights of an entity; ● a person entitled to appoint one or more of the directors or chief executive officer of an entity; ● a director of an entity or its chief executive officer; ● an entity, in which an individual referred to above holds 25% or more of its outstanding shares or voting rights, or is entitled to appoint 25% or more of its directors; or ● a person who initiated the establishment of the entity.
Reza Fathi, Ph.D ., has served as our Senior Vice President Research and Development since May 2010. From 2005 to 2009, Dr. Fathi served as a Director of Research in XTL Biopharmaceuticals Inc., a biotechnology company engaged in 114 Table of Contents developing small molecule clinical candidates for infectious diseases. Prior to that, from 2000-2005, Dr.
Reza Fathi, Ph.D ., has served as our Senior Vice President Research and Development since May 2010. From 2005 to 2009, Dr. Fathi served as a Director of Research in XTL Biopharmaceuticals Inc., a biotechnology company engaged in developing small molecule clinical candidates for infectious diseases. Prior to that, from 2000-2005, Dr.
The letter also exempts an officer or director from any liability for any damage incurred by him, either directly or indirectly, due to the breach of the officer or director’s duty of care vis-à-vis us, by his acts in his capacity as an officer or director prior to the letter of exemption and indemnification becoming effective. 130 Table of Contents D.
The letter also exempts an officer or director from any liability for any damage incurred by him, either directly or indirectly, due to the breach of the officer or director’s duty of care vis-à-vis us, by his acts in his capacity as an officer or director prior to the letter of exemption and indemnification becoming effective. D.
A personal interest also includes a personal interest of a person who votes according to a proxy of another person, even if the other person has no personal interest, 126 Table of Contents and a personal interest of a person who gave a proxy to another person to vote on his behalf – in each case, regardless whether discretion with respect to how to vote lies with the person voting or not.
A personal interest also includes a personal interest of a person who votes according to a proxy of another person, even if the other person has no personal interest, and a personal interest of a person who gave a proxy to another person to vote on his behalf – in each case, regardless whether discretion with respect to how to vote lies with the person voting or not.
Major Shareholders – B. Related Party Transactions.” The Israeli Companies Law requires that every shareholder that participates, either by proxy or in person, in a vote regarding a transaction with a controlling shareholder indicate whether or not that shareholder has a personal interest in the vote in question, the failure of which results in the invalidation of that shareholder’s vote.
Related Party Transactions.” The Israeli Companies Law requires that every shareholder that participates, either by proxy or in person, in a vote regarding a transaction with a controlling shareholder indicate whether or not that shareholder has a personal interest in the vote in question, the failure of which results in the invalidation of that shareholder’s vote.
However, if the shareholders of the company do not approve a compensation arrangement with an officer inconsistent with the company’s compensation policy, in special situations the compensation committee and the board of directors may override the shareholders’ decision if each of the compensation 119 Table of Contents committee and the board of directors provide detailed reasons for their decision.
However, if the shareholders of the company do not approve a compensation arrangement with an officer inconsistent with the company’s compensation policy, in special situations the compensation committee and the board of directors may override the shareholders’ decision if each of the compensation committee and the board of directors provide detailed reasons for their decision.
Compensation The aggregate compensation paid, and benefits-in-kind granted to or accrued on behalf of all of our directors and executive officers for their services, in all capacities, to us during the year ended December 31, 2023, was approximately $2.3 million.
Compensation The aggregate compensation paid, and benefits-in-kind granted to or accrued on behalf of all of our directors and executive officers for their services, in all capacities, to us during the year ended December 31, 2024, was approximately $2.2 million.
Raday was a partner in Charles Street Securities Europe, LLP, an investment banking firm, where he was responsible for the field of life sciences. Mr. Raday previously served on the boards of Sepal Pharma Plc., ViDAC Limited, Morria Biopharmaceuticals Plc., Vaccine Research International Plc., Tksignal Plc., and Miras Medical Imaging Plc.
From 2004 to 2008, Mr. Raday was a partner in Charles Street Securities Europe, LLP, an investment banking firm, where he was responsible for the field of life sciences. Mr. Raday previously served on the boards of Sepal Pharma Plc., ViDAC Limited, Morria Biopharmaceuticals Plc., Vaccine Research International Plc., Tksignal Plc., and Miras Medical Imaging Plc.
On November 16, 2023, our board of directors adopted the Policy for Recovery of Erroneously Awarded Compensation (the “Compensation Recovery Policy”), effective as of December 1, 2023, which provides for certain incentive-based compensation awarded to our officers to be recovered in the event that we are required to prepare an accounting restatement to correct material noncompliance with any financial reporting requirement to which we are subject.
On November 16, 2023, our board of directors adopted the Policy for Recovery of Erroneously Awarded Compensation (the “Compensation Recovery Policy”), effective as of December 1, 2023, which provides for certain incentive-based compensation (including cash bonuses and equity-based compensation) awarded to our officers to be recovered in the event that we are required to prepare an accounting restatement to correct material noncompliance with any financial reporting requirement to which we are subject.
In addition, the approval of the audit committee is required to effect specified actions and related party transactions. 123 Table of Contents Additional functions to be performed by the audit committee include, among others, the following: ● the determination whether certain related party actions and transactions are “material” or “extraordinary” for purposes of the requisite approval procedures; ● to determine whether to approve actions and transactions that require audit committee approval under the Israel Companies Law; ● to assess the scope of work and compensation of the company’s independent accountant; ● to assess the company’s internal audit system and the performance of its internal auditor and if the necessary resources have been made available to the internal auditor considering the company’s needs and size; and ● to determine arrangements for handling complaints of employees in relation to suspected flaws in the business management of the company and the protection of the rights of such employees.
Additional functions to be performed by the audit committee include, among others, the following: ● the determination whether certain related party actions and transactions are “material” or “extraordinary” for purposes of the requisite approval procedures; ● to determine whether to approve actions and transactions that require audit committee approval under the Israel Companies Law; ● to assess the scope of work and compensation of the company’s independent accountant; ● to assess the company’s internal audit system and the performance of its internal auditor and if the necessary resources have been made available to the internal auditor considering the company’s needs and size; and ● to determine arrangements for handling complaints of employees in relation to suspected flaws in the business management of the company and the protection of the rights of such employees.
Under these rules, a person is deemed to be a beneficial owner of a security if that person has or shares voting power, which includes the power to vote or to direct the voting of the security, or investment power, which includes the power to dispose of or to direct the disposition of the 131 Table of Contents security.
Under these rules, a person is deemed to be a beneficial owner of a security if that person has or shares voting power, which includes the power to vote or to direct the voting of the security, or investment power, which includes the power to dispose of or to direct the disposition of the security.
However, under regulations, promulgated pursuant to the Israeli Companies Law, certain transactions between a company and its controlling shareholders, or the controlling shareholder’s relative, do not require shareholder approval. 127 Table of Contents For information concerning the direct and indirect personal interests of certain of our directors or officers and principal shareholders in certain transactions with us, see “Item 7.
However, under regulations, promulgated pursuant to the Israeli Companies Law, certain transactions between a company and its controlling shareholders, or the controlling shareholder’s relative, do not require shareholder approval. For information concerning the direct and indirect personal interests of certain of our directors or officers and principal shareholders in certain transactions with us, see “Item 7. Major Shareholders – B.
In addition, we also receive services from 8 consultants, of which two are in the U.S., four in Canada and two in Israel. ​ ​ As of December 31, ​ ​ 2023 ​ 2022 ​ 2021 ​ ​ Company ​ ​ ​ Company ​ ​ ​ Company ​ ​ ​ ​ Employees Consultants Employees Consultants Employees Consultants Management and administration 14 — 15 — 17 — Research and development 1 8 2 10 2 10 Commercial operations 38 — 96 — 182 — ​ While none of our employees are party to a collective bargaining agreement, certain provisions of the collective bargaining agreements between the Histadrut (General Federation of Labor in Israel) and the Coordination Bureau of Economic Organizations (including the Industrialists’ Associations) are applicable to our employees by order of the Israel Ministry of Labor.
In addition, we also receive services from 10 consultants, of which three are in the U.S., four are in Canada and four are in Israel. ​ ​ As of December 31, ​ ​ 2024 ​ 2023 ​ 2022 ​ ​ Company ​ ​ ​ Company ​ ​ ​ Company ​ ​ ​ ​ Employees Consultants Employees Consultants Employees Consultants Management and administration 12 — 14 — 15 — Research and development 1 10 1 8 2 10 Commercial operations 11 — 38 — 96 — ​ While none of our employees are party to a collective bargaining agreement, certain provisions of the collective bargaining agreements between the Histadrut (General Federation of Labor in Israel) and the Coordination Bureau of Economic Organizations (including the Industrialists’ Associations) are applicable to our employees by order of the Israel Ministry of Labor.
Share Ownership The following table sets forth information regarding the beneficial ownership of our outstanding Ordinary Shares as of April 4, 2024, of each of our directors and executive officers individually and as a group based on information provided to us by our directors and executive officers.
Share Ownership The following table sets forth information regarding the beneficial ownership of our outstanding Ordinary Shares as of April 6, 2025, of each of our directors and executive officers individually and as a group based on information provided to us by our directors and executive officers.
Board Practices – Exemption, Insurance and Indemnification of Directors and Officers.” Director Compensation We currently pay our non-executive directors (i) an annual cash fee retainer of $32,000, (ii) a committee membership annual cash fee retainer of (a) $10,000 to each Audit Committee member, (b) $6,400 to each Compensation Committee member, and (c) $1,200 to each Investment Committee member, and (iii) a committee chairperson annual cash fee retainer in an amount that is higher than the annual cash fee payable to other members of that committee (as described in clause (ii) above) by 50% to each of the Audit Committee and Compensation Committee chairs and by 10% to the Investment Committee chair (without duplication of the fees paid under clause (ii)).
Board Practices – Exemption, Insurance and Indemnification of Directors and Officers.” Director Compensation We currently pay our non-executive directors (i) an annual cash fee retainer of $26,000, (ii) a committee membership annual cash fee retainer of (a) $6,500 to each Audit Committee member and (b) $6,000 to each Compensation Committee member and (iii) a committee chairperson annual cash fee retainer in an amount that is higher than the annual cash fee payable to other members of that committee (as described in clause (ii) above) by 50% to each of the Audit Committee and Compensation Committee chairs (without duplication of the fees paid under clause (ii)).
Scruggs’s employment is terminated in connection with a “change in control” he will be entitled to a special one-time payment equal to his then-current monthly salary and retirement benefits, including payments to an advanced study fund and pension arrangement, multiplied by 12. A “change in control” is defined in the same manner as defined for Mr.
Additionally, in the event Mr. Scruggs’s employment is terminated in connection with a “change in control” he will be entitled to a special one-time payment equal to his then-current monthly salary and retirement benefits, including payments to an advanced study fund and pension arrangement, multiplied by 12.
The number of Ordinary Shares beneficially owned by a person includes Ordinary Shares subject to RSUs that due to vest within 60 days of April 4, 2024, and to options held by that person that were currently exercisable at, or exercisable within 60 days of April 4, 2024.
The number of Ordinary Shares beneficially owned by a person includes Ordinary Shares subject to RSUs that are due to vest within 60 days of April 6, 2025, and to options held by that person that were currently exercisable at, or exercisable within 60 days of April 6, 2025.
The audit committee also oversees our major financial risk exposures and policies for managing such potential risks, discusses with management and our independent auditor significant risks or exposure and assesses the steps management has taken to minimize such risk. As noted above, the members of our audit committee include Alla Felder, Ofer Tsimchi Eric Swenden and Dr.
The audit committee also oversees our major financial risk exposures and policies for managing such potential risks, discusses with management and our independent auditor significant risks or exposure and assesses the steps management has taken to minimize such risk. As noted above, the members of our audit committee include Mr. Ofer Tsimchi, Dr. Roni Mamluk and Dr.
The compensation committee chairman must be an external director and any persons not qualified from serving as a member of the compensation committee may not be present at the compensation committee meetings during the discussion and at the time decisions are made, unless the chairman of the compensation committee determines that the presence of such person is required to present a matter to the meeting or if such person qualifies under an available exemption in the Israeli Companies Law.
The compensation committee chairman must be an external director and any persons not qualified from serving as a member of the compensation committee may not be present at the compensation committee meetings during the discussion and at the time decisions are made, unless the chairman of the compensation committee determines that the presence of such person is required to present a matter to the meeting or if such person qualifies under an available exemption in the Israeli Companies Law. 127 Table of Contents Our compensation committee, which consists of Ofer Tsimchi (Chairman), Dr.
Senior management of the Company includes members of the Company’s administrative, supervisory or management bodies, or nominees for such positions. ​ ​ ​ ​ ​ ​ Name Age Position(s) Executive Officers ​ ​ ​ ​ Dror Ben-Asher 58 Chief Executive Officer and Chairman of the Board of Directors Razi Ingber 40 Chief Financial Officer Reza Fathi, Ph.D. 69 Senior Vice President Research and Development Gilead Raday 49 Chief Operating Officer Adi Frish 54 Chief Corporate and Business Development Officer Guy Goldberg 48 Chief Business Officer Rick D.
Senior management of the Company includes members of the Company’s administrative, supervisory or management bodies, or nominees for such positions. ​ ​ ​ ​ ​ ​ Name Age Position(s) Executive Officers ​ ​ ​ ​ Dror Ben-Asher 59 Chief Executive Officer and Chairman of the Board of Directors Razi Ingber 41 Chief Financial Officer Reza Fathi, Ph.D. 70 Senior Vice President Research and Development Gilead Raday 50 Chief Operating Officer Adi Frish 55 Chief Corporate and Business Development Officer Guy Goldberg 49 Chief Business Officer Rick D.
The exercise price of these options ranges between $264.8 and $280 per share and the options expire between 2029 and 2031. ​ 132 Table of Contents Award Plans Amended and Restated Award Plan Our Award Plan provides for the granting of Ordinary Shares, ADSs, stock options under various tax regimes in Israel and the U.S., RSUs, restricted shares, and other share-based awards to our directors, officers, employees, consultants and service providers and individuals who are their employees, and to the directors, officers, employees, consultants and service providers of our subsidiaries and affiliates.
The exercise price of these options ranges between $6,620 and $7,000 per share and the options expire between 2029 and 2031. ​ Award Plans Amended and Restated Award Plan Our Award Plan provides for the granting of Ordinary Shares, ADSs, stock options under various tax regimes in Israel and the U.S., RSUs, restricted shares, and other share-based awards to our directors, officers, employees, consultants and service providers and individuals who are their employees, and to the directors, officers, employees, consultants and service providers of our subsidiaries and affiliates.
Between 1998-2000, he served as a Manager of Chemical Biology Research at the Institute of Chemistry and Chemical Biology (ICCB) at Harvard Medical School, pioneering chemical genetics to identify small molecules in cancer biology, and from 1991-1998 headed the Discovery Group at PharmaGenics, Inc. Dr. Fathi holds a Postdoctoral and Ph.D. in Chemistry from Rutgers University.
Between 1998-2000, he served as a Manager of Chemical Biology Research at the Institute of Chemistry and Chemical Biology (ICCB) at Harvard Medical School, pioneering chemical genetics to identify small molecules in cancer biology, and from 1991-1998 headed the Discovery Group at PharmaGenics, Inc. Dr.
Out of that amount, approximately $1.9 million was paid as salary, approximately $0.04 million was attributed to the value of the RSUs granted to senior management and the directors during the year ended December 31, 2023, approximately $0.3 million was attributed to retirement plans and approximately $0.1 million was attributed to other long-term benefits.
Out of that amount, approximately $1.7 million was paid as salary, approximately $0.2 million was attributed to the value of the RSUs granted to senior management and the directors during the year ended December 31, 2024, approximately $0.3 million was attributed to retirement plans and approximately $0.05 million was attributed to other long-term benefits.
Kenneth Reed, with Ms. Felder serving as chairperson. All members of our audit committee meet the requirements for financial literacy under the Nasdaq Listing Rules. Our board of directors has determined that each of Ms. Alla Felder, Mr. Ofer Tsimchi, Mr. Eric Swenden and Dr.
Kenneth Reed, with Mr. Tsimchi serving as Chairman. All members of our audit committee meet the requirements for financial literacy under the Nasdaq Listing Rules. Our board of directors has determined that each of Mr. Ofer Tsimchi and Dr.
We have never experienced any employment-related work stoppages and believe our relationship with our employees is good. E.
We have never experienced any employment-related work stoppages and believe our relationship with our employees is good. 134 Table of Contents E.
Under the Israeli Companies Law, the internal auditor may not be an interested party, an officer or a director, a relative of an interested party, or a relative of an officer or a director, nor may the internal auditor be our independent accountant or its representative. In January 2018, Ms.
Under the Israeli Companies Law, the internal auditor may not be an interested party, an officer or a director, a relative of an interested party, or a relative of an officer or a director, nor may the internal auditor be our independent accountant or its representative. In December 2024, Mr.
As of the date of this Annual Report, there is no executive officer or director that beneficially own 5.0% or more of our outstanding Ordinary Shares. The information in this table is based on 12,746,797,800 Ordinary Shares outstanding as of such date.
As of the date of this Annual Report, there is no executive officer or director that beneficially own 5.0% or more of our outstanding Ordinary Shares. The information in this table is based on 17,691,201,000 Ordinary Shares outstanding as of such date.
This process continues indefinitely. A simple majority shareholder vote may elect directors for a term of less than three years in order to ensure that the three groups of directors have as equal a number of directors as possible as provided above.
This process continues indefinitely. A simple majority shareholder vote may elect directors for a term of less than three years in order to ensure that the three groups of directors have as equal a number of directors as possible as provided above. The directors of the first class, currently consisting of Mr. Ofer Tsimchi and Dr.
Raday served as Interim Chief Executive Officer of Sepal Pharma Plc., an oncology drug development company, and from January 2009 to December 2009, he was an independent consultant, specializing in business development and project management in the field of life sciences. From 2004 to 2008, Mr.
Raday served as our Vice President Corporate and Product Development. From January 2010 until October 2010, Mr. Raday served as Interim Chief Executive Officer of Sepal Pharma Plc., an oncology drug development company, and from January 2009 to December 2009, he was an independent consultant, specializing in business development and project management in the field of life sciences.
Compensation.” In June 2022, our directors and officers voluntarily deferred 20% of their fees or salary (as the case may be), which amounts may be fully or partially paid at a later date, subject to several conditions.
For more information, see “Item 6. Directors, Senior Management and Employees – B. Compensation.” In June 2022, our directors and officers voluntarily deferred 20% of their fees or salary (as the case may be), which amounts may be fully or partially paid at a later date, subject to several conditions.
The Israeli Companies Law requires that a director or an officer of a company promptly and, in any event, not later than the first board meeting at which the transaction is discussed, disclose any personal interest that he may have, and all related material facts or document known to such person, in connection with any existing or proposed transaction by the company.
Under the Israeli Companies Law, subject to certain exceptions, directors’ compensation arrangements require the approval of the compensation committee, the board of directors and the shareholders. 129 Table of Contents The Israeli Companies Law requires that a director or an officer of a company promptly and, in any event, not later than the first board meeting at which the transaction is discussed, disclose any personal interest that he may have, and all related material facts or document known to such person, in connection with any existing or proposed transaction by the company.
In June 2023 (only the officers) and October 2023, our directors and officers voluntarily deferred an additional sum of the cash compensation due to them under their respective employment agreements or compensation arrangements, as the case may be.
In June 2023 (only the officers) and October 2023, our directors and officers voluntarily deferred an additional sum of the cash compensation due to them under their respective employment agreements or compensation arrangements, as the case may be. Independent and External Directors – Israeli Companies Law Requirements We are subject to the provisions of the Israeli Companies Law.
Nevertheless, regulations under the Israeli Companies Law provide that companies, whose 122 Table of Contents shares are listed for trading the Nasdaq Stock Market, may appoint an external director for additional three-year terms, under certain circumstances and conditions.
The initial term of an external director is three years and may be extended for two additional three-year terms under certain circumstances and conditions. Nevertheless, regulations under the Israeli Companies Law provide that companies, whose shares are listed for trading the Nasdaq Stock Market, may appoint an external director for additional three-year terms, under certain circumstances and conditions.
Reed is also a co-founder of Early Cell, a prenatal diagnostics company, Prescient Pharma and Lispiro. Ofer Tsimchi has served as a director on our board of directors, a member of our audit committee and as the Chairman of our compensation committee since May 2011. From 2008 to 2012, Mr.
Reed is also a co-founder of Early Cell, a prenatal diagnostics company, Prescient Pharma and Lispiro. 118 Table of Contents Ofer Tsimchi has served as a director on our board of directors, as Chairman of our compensation committee and as a member in our audit committee since May 2011. Since June 2024, Mr.
Under our Award Plan, as amended, in the event any person, entity or group that was not an interested party at the time of our initial public offering on the TASE becoming a controlling shareholder, all options granted by us under the plan will be accelerated, so that the grantee will be entitled to exercise all of those options.
Upon termination in the event of a merger or other change in control approved by the board of directors, the grantee will be entitled at the time of termination to full acceleration of all the options granted prior to the event. 136 Table of Contents Under our Award Plan, as amended, in the event any person, entity or group that was not an interested party at the time of our initial public offering on the TASE becoming a controlling shareholder, all options granted by us under the plan will be accelerated, so that the grantee will be entitled to exercise all of those options.
The engagement with a public company’s chief executive officer need not be approved by the shareholders of the company with respect to the period from the commencement of the engagement until the next shareholder meeting convened by the company, if the terms and conditions of such engagement were approved by the compensation committee and the board of directors of the company, the terms and conditions of such engagement are in accordance with the company’s compensation policy approved in accordance with the Israeli Companies Law, and if the terms and conditions of such engagement are no more beneficial than the terms and conditions of the person previously serving in such role or there is no substantial difference in the terms and conditions of the previous engagement versus the new one under the circumstances, including the scope of engagement.
The engagement with a public company’s chief executive officer need not be approved by the shareholders of the company with respect to the period from the commencement of the engagement until the next shareholder meeting convened by the company, if the terms and conditions of such engagement were approved by the compensation committee and the board of directors of the company, the terms and conditions of such engagement are in accordance with the company’s compensation policy approved in accordance with the Israeli Companies Law, and if the terms and conditions of such engagement are no more beneficial than the terms and conditions of the person previously serving in such role or there is no substantial difference in the terms and conditions of the previous engagement versus the new one under the circumstances, including the scope of engagement. 123 Table of Contents We have service contracts with two of our directors, Dror Ben-Asher and Rick Scruggs, that provide for benefits upon termination of their employment.
Under the Israeli Companies Law, entry by a public company into a contract with a non-controlling director as to the terms of his office, including exculpation, indemnification or insurance, requires the approval of the compensation committee, the board of directors and the shareholders of the company.
Under the Israeli Companies Law, entry by a public company into a contract with a non-controlling director as to the terms of his office, including exculpation, indemnification or insurance, requires the approval of the compensation committee, the board of directors and the shareholders of the company. 122 Table of Contents The Israeli Companies Law requires that the terms of service and engagement of the chief executive officer, directors or controlling shareholders (or a relative thereof) receive the approval of the compensation committee, board of directors, and shareholders, subject to limited exceptions.
The Award Plan provides for awards to be issued at the determination of our board of directors in accordance with applicable laws. As of April 4, 2024, there were 89,714,000 Ordinary Shares issuable upon the exercise or vesting of outstanding awards under the Award Plan and 2,811,935,600 Ordinary Shares available for future issuance under the Award Plan.
The Award Plan provides for awards to be issued at the determination of our board of directors in accordance with applicable laws. As of April 6, 2025, there were 1,010,200,000 Ordinary Shares issuable upon the exercise or vesting of outstanding awards under the Award Plan and 3,001,613,300 Ordinary Shares available for future issuance under the Award Plan.
Ben-Asher is further entitled to vacation days, sick days and convalescence pay in accordance with the market practice and applicable law, monthly remuneration for a study fund, contribution by the Company to an insurance policy and pension fund, and additional benefits, including communication expenses. In addition, Mr. Ben-Asher is entitled to reimbursement of car-related expenses from the Company. Mr.
Ben-Asher is further entitled to vacation days, sick days and convalescence pay in accordance with the market practice and applicable law, monthly remuneration for a study fund, contribution by the Company to an insurance policy and pension fund, and additional benefits, including communication expenses reimbursement of up to NIS 3,500 per year for private medical insurance, and coverage of one annual comprehensive medical check-up.
Ben-Asher as described in footnote (5) above. Employment Agreements We have entered into employment or consultant agreements with each of our executive officers. All of these agreements contain customary provisions regarding non-competition, confidentiality of information and assignment of inventions. However, the enforceability of the non-competition provisions may be limited under applicable laws.
A “change in control” is defined in the same manner as defined for Mr. Ben-Asher as described in footnote (5) above. Employment Agreements We have entered into employment or consultant agreements with each of our executive officers. All of these agreements contain customary provisions regarding non-competition, confidentiality of information and assignment of inventions.
Committees Israeli Companies Law Requirements Our board of directors has established three standing committees, the audit committee, the compensation committee, and the investment committee. Audit Committee Under the Israeli Companies Law, the board of directors of a public company must appoint an audit committee.
Committees Israeli Companies Law Requirements Our board of directors has established two standing committees, the audit committee and the compensation committee. To streamline oversight functions, the responsibilities of the investment committee were assigned in December 2024 to the audit committee. Audit Committee Under the Israeli Companies Law, the board of directors of a public company must appoint an audit committee.
(7) Includes options to purchase 2,215,600 Ordinary Shares exercisable within 60 days of April 4, 2024. The exercise price of these options ranges between $194.8 and $283.2 per share, and the options expire between 2025 and 2031. (8) Includes options to purchase 2,037,600 Ordinary Shares exercisable within 60 days of April 4, 2024.
(6) Includes options to purchase 2,220,000 Ordinary Shares exercisable within 60 days of April 6, 2025. The exercise price of these options ranges between $4,870 and $7,080 per share and the options expire between 2025 and 2031. (7) Includes options to purchase 2,260,000 Ordinary Shares exercisable within 60 days of April 6, 2025.
Cabilly holds a B.Sc. in Biology from the Ben Gurion University of Beer Sheva, Israel, an M.Sc. in Immunology and Microbiology from the Hebrew University of Jerusalem, Israel, and a Ph.D. in Immunology and Microbiology from the Hebrew University of Jerusalem, Israel. 115 Table of Contents Eric Swenden has served as a member of our board of directors since May 2010 and has served on our investment committee since May 2011.
Cabilly holds a B.Sc. in Biology from the Ben Gurion University of Beer Sheva, Israel, an M.Sc. in Immunology and Microbiology from the Hebrew University of Jerusalem, Israel, and a Ph.D. in Immunology and Microbiology from the Hebrew University of Jerusalem, Israel. Dr. Kenneth Reed has served as a member of our board of directors since December 2009. Dr.
However, a person may not serve as an external director if the person or the person’s relative, partner, employer, someone to whom he is subordinated directly or indirectly or any entity under the person’s control has a business or professional relationship with an entity which has an affiliation with is prohibited as detailed above, even if such relationship is not on a regular basis (excluding negligible relationship).
Under the Israeli Companies Law, an “officer” is defined as a general manager, chief business manager, deputy general manager, vice general manager, any person filing any of these positions in a company even if he holds a different title, director or any manager directly subordinate to the general manager. 124 Table of Contents However, a person may not serve as an external director if the person or the person’s relative, partner, employer, someone to whom he is subordinated directly or indirectly or any entity under the person’s control has a business or professional relationship with an entity which has an affiliation with is prohibited as detailed above, even if such relationship is not on a regular basis (excluding negligible relationship).
Our audit committee also serves as our financial statements committee. The members of our audit committee are Alla Felder (chairperson), Ofer Tsimchi, Eric Swenden and Dr. Kenneth Reed.
Our audit committee also serves as our financial statements committee. The members of our audit committee are Mr. Ofer Tsimchi (Chairman), Dr. Kenneth Reed and Dr. Roni Mamluk.
Employees As of December 31, 2023, we had 53 employees, of which 15 provide services in Israel and 38 which provide services in the U.S.
Employees As of December 31, 2024, we had 35 employees, of which 13 provide services in Israel and 11 provide services in the U.S.
Part of the rationale is that our Compensation Policy should 118 Table of Contents encourage our officers to identify with our objectives, and an increase in officer satisfaction and motivation should retain the employment of high-quality officers in our service over the long term. C.
Part of the rationale is that our Compensation Policy should encourage our officers to identify with our objectives, and an increase in officer satisfaction and motivation should retain the employment of high-quality officers in our service over the long term. 121 Table of Contents On March 23, 2025, our board of directors approved certain amendments to the Compensation Policy to align it with the Compensation Recovery Policy adopted in 2023.
The exercise price of these options ranges between $194.8 and $283.2 per share and the options expire between 2030 and 2031. (3) Includes options to purchase 374,800 Ordinary Shares exercisable within 60 days of April 4, 2024. The exercise price of these options ranges between $194.8 and $283.2 per share and the options expire between 2029 and 2031.
The exercise price of these options ranges between $4,870 and $7,000 per share and the options expire between 2029 and 2031. (2) Includes options to purchase 270,000 Ordinary Shares exercisable within 60 days of April 6, 2025. The exercise price of these options ranges between $4,870 and $7,080 per share and the options expire between 2030 and 2031.
The exercise price of these options ranges between $194.8 and $283.2 per share and the options expire between 2029 and 2031. (6) Includes options to purchase 2,974,800 Ordinary Shares exercisable within 60 days of April 4, 2024. The exercise price of these options ranges between $194.8 and $283.2 per share and the options expire between 2028 and 2031.
The exercise price of these options ranges between $4,870 and $7,080 per share and the options expire between 2028 and 2031. (5) Includes options to purchase 2,470,000 Ordinary Shares exercisable within 60 days of April 6, 2025. The exercise price of these options ranges between $4,870 and $7,080 per share, and the options expire between 2025 and 2031.
At each annual general meeting, which is required to be held annually, but not more than fifteen months after the prior annual general meeting, the term of one class of directors expires, and the directors of such class are re-nominated to serve an additional three-year term that expires at the annual general meeting held in the third year following such election (other than any director nominated for election by Cosmo pursuant to the Company’s subscription agreement with Cosmo, whose term of office may expire earlier depending on the beneficial ownership by the Cosmo investor of the Cosmo shares).
At each annual general meeting, which is required to be held annually, but not more than fifteen months after the prior annual general meeting, the term of one class of directors expires, and the directors of such class are re-nominated to serve an additional three-year term that expires at the annual general meeting held in the third year following such election.
Regulations under the Israeli Companies Law provide for various instances and kinds of relationships in which an external director will not be deemed to have “affiliation” with the public company for which he serves or is a candidate for serving as an external director. 121 Table of Contents No person can serve as an external director if the person’s positions or other businesses create, or may create, a conflict of interests with the person’s responsibilities as a director or may impair his ability to serve as a director.
Regulations under the Israeli Companies Law provide for various instances and kinds of relationships in which an external director will not be deemed to have “affiliation” with the public company for which he serves or is a candidate for serving as an external director.
As such, when reviewing and assessing the qualifications of possible nominees to the Board, our Board is guided by the following considerations: ● the competencies and skills necessary for the Board as a whole should possess; ● the experience and skill each new nominee will bring to the Board; ● the diversity of the Board as a whole and whether the new nominee would enhance such diversity; and ● whether the nominees can devote sufficient time and resources to his or her duties as a Board member. 125 Table of Contents Due to the size of the Company and Board, our activities, and our current number of employees across two geographies, we have not yet set measurable objectives or adopted a formal policy for achieving gender diversity on the Board.
As such, when reviewing and assessing the qualifications of possible nominees to the Board, our Board is guided by the following considerations: ● the competencies and skills necessary for the Board as a whole should possess; ● the experience and skill each new nominee will bring to the Board; ● the diversity of the Board as a whole and whether the new nominee would enhance such diversity; and ● whether the nominees can devote sufficient time and resources to his or her duties as a Board member.
The directors of the first class, currently consisting of Eric Swenden and Ofer Tsimchi, will hold office until our annual general meeting to be held in the year 2024. The directors of the second class, currently consisting of Dror Ben-Asher, Dr.
Roni Mamluk will hold office until our annual general meeting to be held in the year 2027. The directors of the second class, currently consisting of Mr. Dror Ben-Asher and Dr. Kenneth Reed, will hold office until our annual general meeting to be held in the year 2025. The directors of the third class, currently consisting of Dr.
Gilead Raday has served as our Chief Operating Officer since April 2016. From December 2012 until March 2016, Mr. Raday served as Senior Vice President Corporate and Product Development. From November 2010 to December 2012, Mr. Raday served as our Vice President Corporate and Product Development. From January 2010 until October 2010, Mr.
Fathi holds a Postdoctoral and Ph.D. in Chemistry from Rutgers University. 117 Table of Contents Gilead Raday has served as our Chief Operating Officer since April 2016. From December 2012 until March 2016, Mr. Raday served as Senior Vice President Corporate and Product Development. From November 2010 to December 2012, Mr.
The exercise price of these options ranges between $194.8 and $283.2 per share and the options expire between 2025 and 2031. (9) Includes options to purchase 2,082,400 Ordinary Shares exercisable within 60 days of April 4, 2024. The exercise price of these options ranges between $194.8 and $283.2 per share and the options expire between 2025 and 2031.
The exercise price of these options ranges between $4,870 and $7,080 per share and the options expire between 2025 and 2031. (9) Includes options to purchase 450,000 Ordinary Shares exercisable within 60 days of April 6, 2025. The exercise price of these options ranges between $5,000 and $7,080 per share and the options expire between 2028 and 2031.
As part of the indemnification letters, we exempted our directors and officers, in advance, to the extent permitted by law, from any liability for any damage incurred by them, either directly or indirectly, due to the breach of an officer’s or director’s duty of care vis-à-vis us, within his acts in his capacity as an officer or director.
As approved by our shareholders on May 13, 2022, the amount of the advance indemnity is limited to the higher of 25% of our then shareholders’ equity, per our most recent annual financial statements, or $10 million. 133 Table of Contents As part of the indemnification letters, we exempted our directors and officers, in advance, to the extent permitted by law, from any liability for any damage incurred by them, either directly or indirectly, due to the breach of an officer’s or director’s duty of care vis-à-vis us, within his acts in his capacity as an officer or director.
The Compensation Policy is in effect for three years from the 2022 annual general meeting. Pursuant to the foregoing approvals, we carry directors’ and officers’ liability insurance. This insurance is renewed on an annual basis.
Pursuant to the foregoing approvals, we carry directors’ and officers’ liability insurance. This insurance is renewed on an annual basis.
Ben-Asher’s employment terms include an advance notice period of 12 months by the Company and 90 days by Mr. Ben-Asher. During such an advance notice period, Mr. Ben-Asher will be entitled to all of the compensation elements, and to the continuation of vesting of any options or restricted shares granted to him. Additionally, in the event Mr.
Scruggs’ employment is terminated without cause by the Company. Mr. Scruggs’s employment terms also include an advance notice period of 60 days by either party. During such an advance notice period, Mr. Scruggs will be entitled to all of the compensation elements, and to the continuation of vesting of any options or restricted shares granted to him.
An “independent director” is defined as an external director or a director who meets the following conditions: (i) satisfies certain conditions for appointment as an external director (as described above) and the audit committee has determined that such conditions have been met and (ii) has not served as a director of the company for more than nine consecutive years, with any interruption of up to two years in service not being deemed a disruption in the continuity of such service.
Any persons not qualified from serving as a member of the audit committee may not be present at the audit committee meetings during the discussion and at the time decisions are made, unless the chairman of the audit committee determines that the presence of such person is required to present a matter to the meeting or if such person qualifies under an available exemption in the Israeli Companies Law. 126 Table of Contents An “independent director” is defined as an external director or a director who meets the following conditions: (i) satisfies certain conditions for appointment as an external director (as described above) and the audit committee has determined that such conditions have been met and (ii) has not served as a director of the company for more than nine consecutive years, with any interruption of up to two years in service not being deemed a disruption in the continuity of such service.
Reed received his B.A. from Brown University in the U.S. and an M.D from the University of Medicine and Dentistry of New Jersey in the U.S. Dr. Reed is a board-certified dermatologist with over 25 years of clinical experience since completing the Harvard Medical School Residency Program in Dermatology. Dr.
Reed is a board-certified dermatologist with over 25 years of clinical experience since completing the Harvard Medical School Residency Program in Dermatology. Dr.
(10) Includes options to purchase 1,775,200 Ordinary Shares exercisable within 60 days of April 4, 2024. The exercise price of these options ranges between $194.8 and $283.2 per share, and the options expire between 2025 and 2031. (11) Includes options to purchase 375,200 Ordinary Shares exercisable within 60 days of April 4, 2024.
The exercise price of these options ranges between $4,870 and $7,080 per share and the options expire between 2025 and 2031. 135 Table of Contents (8) Includes options to purchase 1,920,000 Ordinary Shares exercisable within 60 days of April 6, 2025.
(4) Includes options to purchase 374,800 Ordinary Shares exercisable within 60 days of April 4, 2024. The exercise price of these options ranges between $194.8 and $283.2 per share and the options expire between 2029 and 2031. (5) Includes options to purchase 374,800 Ordinary Shares exercisable within 60 days of April 4, 2024.
(3) Includes options to purchase 420,000 Ordinary Shares exercisable within 60 days of April 6, 2025. The exercise price of these options ranges between $4,870 and $7,080 per share and the options expire between 2029 and 2031. (4) Includes options to purchase 3,250,000 Ordinary Shares exercisable within 60 days of April 6, 2025.
The shareholders’ approval must include either: ● a majority of the shareholders who have no personal interest in the transaction and who are participating in the voting, in person, by proxy or by written ballot, at the meeting (votes abstaining not being taken into account); or ● the total number of shares voted against the proposal by shareholders without a personal interest does not exceed 2% of the aggregate voting rights in the Company.
The shareholders’ approval must include either: ● a majority of the shareholders who have no personal interest in the transaction and who are participating in the voting, in person, by proxy or by written ballot, at the meeting (votes abstaining not being taken into account); or ● the total number of shares voted against the proposal by shareholders without a personal interest does not exceed 2% of the aggregate voting rights in the Company. 130 Table of Contents In addition, any such transaction whose term is more than three years requires the above-mentioned approval every three years, unless, with respect to transactions not involving the receipt of services or compensation, the audit committee approves a longer term as reasonable under the circumstances.
Until the next annual general meeting, the board of directors may elect new directors to fill vacancies or increase the number of members of the board of directors up to the maximum number provided in our articles of association. Any director so appointed may hold office until the first general shareholders’ meeting convened after the appointment.
Shmuel Cabilly and Mr. Rick Scruggs, will hold office until our annual general meeting to be held in the year 2026. Until the next annual general meeting, the board of directors may elect new directors to fill vacancies or increase the number of members of the board of directors up to the maximum number provided in our articles of association.
Executive officers Dror Ben-Asher has served as our Chief Executive Officer and as a director since August 2009. Since May 2011, Mr. Ben-Asher has also served as Chairman of our board of directors. From January 2002 to November 2010, Mr. Ben-Asher served as a manager at P.C.M.I. Ltd., an affiliate of ProSeed Capital Holdings CVA. Mr.
Ben-Asher has also served as Chairman of our board of directors. From January 2002 to November 2010, Mr. Ben-Asher served as a manager at P.C.M.I. Ltd., an affiliate of ProSeed Capital Holdings CVA. Mr. Ben-Asher holds an LLB from the University of Leicester, U.K., an MJur from Oxford University, U.K. and completed LLM studies at Harvard University.
For information on exemption and indemnification letters granted to our directors and officers, please see “Item 6 – C.
However, the enforceability of the non-competition provisions may be limited under applicable laws. For information on exemption and indemnification letters granted to our directors and officers, please see “Item 6 – C.
Our compensation committee, which consists of Ofer Tsimchi (chairman), Dr. Kenneth Reed and Alla Felder, administers issues relating to our global compensation plan with respect to our employees, directors, and consultants.
Shmuel Cabilly, Dr. Kenneth Reed and Dr. Roni Mamluk, administers issues relating to our global compensation plan with respect to our employees, directors, and consultants.
It is also authorized to approve certain financial transactions and review risk factors associated with management of our finances and the mitigation of such risks, as well as financial controls and reporting and various other finance-related matters. 124 Table of Contents Nasdaq Stock Market Requirements Under the Nasdaq Listing Rules, we are required to maintain an audit committee consisting of at least three members, all of whom are independent and are financially literate and one of whom has accounting or related financial management expertise.
Nasdaq Stock Market Requirements Under the Nasdaq Listing Rules, we are required to maintain an audit committee consisting of at least three members, all of whom are independent and are financially literate and one of whom has accounting or related financial management expertise.
The policy was previously approved by our board of directors, upon the recommendation of our compensation committee. The Compensation Policy is in effect for three years from the 2022 annual general meeting. Our Compensation Policy principles were designed to grant proper, fair and well-considered remuneration to our officers, in alignment with our long-term best interests and overall organizational strategy.
Our Compensation Policy principles were designed to grant proper, fair and well-considered remuneration to our officers, in alignment with our long-term best interests and overall organizational strategy.
By bringing together individuals with varying backgrounds, expertise, and perspectives into an inclusive and collaborative work environment, we believe we can better achieve our corporate objectives and deliver long-term, sustained value for our shareholders.
By bringing together individuals with varying backgrounds, expertise, and perspectives into an inclusive and collaborative work environment, we believe we can better achieve our corporate objectives and deliver long-term, sustained value for our shareholders. 128 Table of Contents We recognize that gender diversity is a significant aspect of diversity and acknowledge the important role that women with appropriate and relevant skills and experience can play in contributing to the diversity of thought on the Board.
Scruggs 64 Chief Commercial Officer and Director ​ ​ ​ ​ ​ Non-Employee Directors ​ ​ ​ ​ Dr. Shmuel Cabilly (3) 74 Director Eric Swenden (1), (3) 80 Director Dr.
Scruggs 65 Chief Commercial Officer and Director ​ ​ ​ ​ ​ Non-Employee Directors ​ ​ ​ ​ Dr. Shmuel Cabilly (2), (3) 75 Director Dr. Kenneth Reed (1), (2), (3) 71 Director Ofer Tsimchi (1), (2), (3) 65 Director Dr.
As of the date of this Annual Report, we have not elected to have one committee acting as both the audit and the compensation committees. Compensation Committee According to the Israeli Companies Law, the board of directors of a public company must establish a compensation committee.
Compensation Committee According to the Israeli Companies Law, the board of directors of a public company must establish a compensation committee.
Scruggs is further entitled to vacation days, sick days and convalescence pay in accordance with the market practice and applicable law, monthly remuneration for a study fund, contribution by the Company to an insurance policy and pension fund, and additional benefits, including communication expenses. Mr.
Scruggs is further entitled to vacation days and sick days in accordance with the market practice and applicable law, contribution by the Company to welfare benefits insurance policies, and additional benefits, including communication expenses. Mr. Scruggs will be entitled to payment of severance in the amount of 12 months’ base salary at the time of termination in the event Mr.

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Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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We deem ordinary shares issuable pursuant to options or warrants that are currently exercisable or exercisable within 60 days of April 4, 2024, and ordinary shares underlying RSUs that vest within 60 days of April 4, 2024, if any, to be outstanding and to be beneficially owned by the person holding the options warrants or RSUs for the purposes of computing the percentage ownership of that person, but we do not treat them as outstanding for the purpose of computing the percentage ownership of any other person.
We deem ordinary shares issuable pursuant to options or warrants that are currently exercisable or exercisable within 60 days of April 6, 2025, and ordinary shares underlying RSUs that vest within 60 days of April 6, 2025, if any, to be outstanding and to be beneficially owned by the person holding the options, warrants or RSUs for the purposes of computing the percentage ownership of that person, but we do not treat them as outstanding for the purpose of computing the percentage ownership of any other person.
Avi Polischuk, as the President of R&S United Services, may be deemed to beneficially own the ordinary shares held by the R&S United Services. The number of ordinary shares beneficially owned in the table above includes 686,236,000 ordinary shares (represented by 1,715,590 ADSs) issuable upon the exercise of a certain warrant issued to R&S United Services on April 3, 2024.
Avi Polischuk, as the President of R&S United Services, may be deemed to beneficially own the ordinary shares held by the R&S United Services. The number of ordinary shares beneficially owned in the table above includes 686,236,000 ordinary shares (represented by 68,623 ADSs) issuable upon the exercise of a certain warrant issued to R&S United Services on April 3, 2024.
All other ADSs are held by Cede & Co., the nominee of the Depositary Trust Company, which is a United States registered holder. The number of record holders is not at all representative of the number of beneficial holders of the ADSs Shares 134 Table of Contents because many of the ADSs are held by brokers or other nominees.
All other ADSs are held by Cede & Co., the nominee of the Depositary Trust Company, which is a United States registered holder. The number of record holders is not at all representative of the number of beneficial holders of the ADSs because many of the ADSs are held by brokers or other nominees.
(1) 2,030,472,000 15.12 % (1) To the best of our knowledge, R&S United Services Inc. is the direct holder of the ordinary shares in the table above, exercises voting and investment power over the ordinary shares, and thus may be deemed to beneficially own the ordinary shares.
(1) 3,029,016,000 16.48 % (1) To the best of our knowledge, R&S United Services Inc. is the direct holder of the ordinary shares in the table above, exercises voting and investment power over the ordinary shares, and thus may be deemed to beneficially own the ordinary shares.
The calculation of beneficial ownership is based on 12,746,797,800 ordinary shares outstanding as of April 4, 2024. None of the holders of the ordinary shares listed in this table have voting rights different from other holders of ordinary shares. ​ ​ ​ ​ ​ ​ ​ Name Number of Ordinary Shares Beneficially Held Percent of Class R&S United Services Inc.
The calculation of beneficial ownership is based on 17,691,201,000 ordinary shares outstanding as of April 6, 2025. None of the holders of the ordinary shares listed in this table have voting rights different from other holders of ordinary shares. ​ ​ ​ ​ ​ ​ ​ Name Number of Ordinary Shares Beneficially Held Percent of Class R&S United Services Inc.
The address of R&S United Services is 15 Ranick Drive West, Amityville, NY 11701. ​ To the best of our knowledge, we are not owned or controlled, directly or indirectly, by another corporation or by any foreign government. We are not aware of any arrangement that may, at a subsequent date, result in a change of control of our company.
The address of R&S United Services is 15 Ranick Drive West, Amityville, NY 11701. ​ To the best of our knowledge, we are not owned or controlled, directly or indirectly, by another corporation or by any foreign government.
Record Holders On April 4, 2024, 10,197 ADSs (equivalent to 4,078,800 Ordinary Shares, or approximately 0.03% of our total issued and outstanding Ordinary Shares), were held of record by four record holders, of which two holders have a U.S. address.
We are not aware of any arrangement that may, at a subsequent date, result in a change of control of our company. 137 Table of Contents Record Holders On April 6, 2025, 407 ADSs (equivalent to 4,078,800 Ordinary Shares, or approximately 0.02% of our total issued and outstanding Ordinary Shares) were held of record by four record holders, of which two holders have a U.S. address.
As of April 4, 2024, there was one shareholder of record of our Ordinary Shares. B. Related Party Transactions See “Item 4. Information on the Company - B. Business Overview - Acquisition, Commercialization and License Agreements - Licensing and Manufacturing Terms with Cosmo Pharmaceuticals.” Additionally, the Company is party to ordinary course employment arrangements with its officers.
As of April 6, 2025, there was one shareholder of record of our Ordinary Shares. B. Related Party Transactions The Company is party to ordinary course employment arrangements with its officers. See “Management - Compensation - Employment Agreements” and See “Management - Compensation - Change in Control Retention Plan and Agreements; Severance Arrangements.” C.
Removed
See “Management - Compensation - Employment Agreements” and See “Management - Compensation - Change in Control Retention Plan and Agreements; Severance Arrangements.” C. Interests of Experts and Counsel Not applicable. ​
Added
Interests of Experts and Counsel Not applicable. ​

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