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What changed in Scinai Immunotherapeutics Ltd.'s 20-F — 2024 vs 2025

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Paragraph-level year-over-year comparison of Scinai Immunotherapeutics Ltd.'s 2024 and 2025 20-F annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+521 added−623 removedSource: 20-F (2026-04-01) vs 20-F (2025-05-07)

Top changes in Scinai Immunotherapeutics Ltd.'s 2025 20-F

521 paragraphs added · 623 removed · 277 edited across 5 sections

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

107 edited+116 added−151 removed323 unchanged
Biggest changeThe degree of market acceptance of these product candidate(s) will depend on a number of factors, including, but not limited to: ● the timing of regulatory approvals in the U.S. and other countries, if any, and the uses for which we intend to pursue regulatory approval for the commercialization of current and future product candidates; 6 ● the competitive environment; ● the demand for our product candidate(s); ● the establishment and demonstration in, and acceptance by, the medical community of the safety and clinical efficacy of our product candidate(s) and its potential advantages over other competitive products; ● our ability to enter into supply agreements with health organizations and governments around the world for the supply of our product candidate(s) or our ability to enter into strategic agreements with pharmaceutical and biopharmaceutical companies with strong marketing and sales capabilities; ● ● the adequacy and success of our distribution, sales and marketing efforts; our ability to conduct large-scale manufacturing, including yield and quality, and in shipping product internationally, on our own and/or through third parties; and ● the pricing, coverage and reimbursement policies of government and third-party payors, such as insurance companies, health maintenance organizations and other plan administrators.
Biggest changeThe degree of market acceptance of any current or future product candidates will depend on a number of factors, including: ● the timing, scope and outcome of regulatory approvals, if any; ● the competitive landscape; ● demand for our product candidates; ● the ability to demonstrate safety, efficacy and clinical differentiation; ● our ability to enter into strategic partnerships for development, commercialization or distribution; ● the effectiveness of our marketing and commercialization capabilities; ● our ability to manufacture at scale with consistent quality; and ● pricing, coverage and reimbursement decisions by governmental and third-party payors.
The market price for the ADSs has been and is likely to remain highly volatile and subject to wide fluctuations in response to numerous factors including the following: ● our failure to obtain the authorizations necessary to commence future clinical trials; ● results of clinical and preclinical studies; ● announcements of regulatory approval or the failure to obtain it, or specific label indications or patient populations for its use, or changes or delays in the regulatory review process; ● announcements of technological innovations, new product candidate(s) or product enhancements by us or others; ● adverse actions taken by regulatory agencies with respect to our clinical trials, manufacturing supply chain or sales and marketing activities; ● changes or developments in laws, regulations, or decisions applicable to our product candidate(s) or patents; ● any adverse changes to our relationship with manufacturers or suppliers; ● announcements concerning our competitors or the pharmaceutical or biotechnology industries in general; ● achievement of expected product sales and profitability or our failure to meet expectations; 44 ● our commencement of or results of, or involvement in, litigation, including, but not limited to, any product liability actions or intellectual property infringement actions; ● any major changes in our board of directors, management or other key personnel; ● legislation in the United States, Europe and other foreign countries relating to the sale or pricing of pharmaceuticals; ● announcements by us of entering into or termination of significant strategic partnerships, out-licensing, in-licensing, joint ventures, acquisitions or capital commitments; ● expiration or terminations of licenses, research contracts or other collaboration agreements; ● public concern as to the safety of therapeutics we, our licensees or others develop; ● success of research and development projects; ● developments concerning intellectual property rights or regulatory approvals; ● variations in our and our competitors’ results of operations; ● changes in earnings estimates or recommendations by securities analysts, if the ADSs are covered by these analysts; ● future issuances of Ordinary Shares, ADSs or other securities; ● general market conditions, including the volatility of market prices for shares of biotechnology companies generally, and other factors, including factors unrelated to our operating performance; and ● the other factors described in this “Risk Factors” section.
The market price for the ADSs has been and is likely to remain highly volatile and subject to wide fluctuations in response to numerous factors including the following: ● our failure to obtain the authorizations necessary to commence future clinical trials; ● results of clinical and preclinical studies; ● announcements of regulatory approval or the failure to obtain it, or specific label indications or patient populations for its use, or changes or delays in the regulatory review process; ● announcements of technological innovations, new product candidate(s) or product enhancements by us or others; ● adverse actions taken by regulatory agencies with respect to our clinical trials, manufacturing supply chain or sales and marketing activities; ● changes or developments in laws, regulations, or decisions applicable to our product candidate(s) or patents; ● any adverse changes to our relationship with manufacturers or suppliers; ● announcements concerning our competitors or the pharmaceutical or biotechnology industries in general; ● achievement of expected product sales and profitability or our failure to meet expectations; 36 ● our commencement of or results of, or involvement in, litigation, including, but not limited to, any product liability actions or intellectual property infringement actions; ● any major changes in our board of directors, management or other key personnel; ● legislation in the United States, Europe and other foreign countries relating to the sale or pricing of pharmaceuticals; ● announcements by us of entering into or termination of significant strategic partnerships, out-licensing, in-licensing, joint ventures, acquisitions or capital commitments; ● expiration or terminations of licenses, research contracts or other collaboration agreements; ● public concern as to the safety of therapeutics we, our licensees or others develop; ● success of research and development projects; ● developments concerning intellectual property rights or regulatory approvals; ● variations in our and our competitors’ results of operations; ● changes in earnings estimates or recommendations by securities analysts, if the ADSs are covered by these analysts; ● future issuances of Ordinary Shares, ADSs or other securities; ● general market conditions, including the volatility of market prices for shares of biotechnology companies generally, and other factors, including factors unrelated to our operating performance; and ● the other factors described in this “Risk Factors” section.
A number of events, including any of the following, could delay the completion of any such additional clinical trials and negatively impact our ability to obtain regulatory approval for, and to market and sell, a particular product candidate(s): ● conditions imposed on us by the FDA or any applicable foreign regulatory authority regarding the scope or design of our clinical trials; ● delays in recruiting and enrolling participants or volunteers into any potential future clinical trials; ● delays in obtaining, or our inability to obtain, required approvals from institutional review boards (“IRBs”) or other reviewing entities at clinical sites selected for participation in our clinical trials; ● insufficient supply or deficient quality of our product candidate(s) or other materials necessary to conduct our clinical trials; ● lower than anticipated retention rate of subjects and participants in clinical trials; ● negative or inconclusive results from clinical trials, or results that are inconsistent with earlier results, that necessitate additional clinical studies; ● serious and unexpected drug-related side effects experienced by subjects and participants in clinical trials; or ● failure of our third-party contractors to comply with regulatory requirements or otherwise meet their contractual obligations to us in a timely manner. 11 Clinical trials require sufficient participant enrollment, which is a function of many factors, including the size of the participant population, the nature of the trial protocol, the proximity of participants to clinical sites, the availability of effective treatments for the relevant disease and the eligibility criteria for the clinical trial.
A number of events, including any of the following, could delay the completion of any such additional clinical trials and negatively impact our ability to obtain regulatory approval for, and to market and sell, a particular product candidate(s): ● conditions imposed on us by the FDA or any applicable foreign regulatory authority regarding the scope or design of our clinical trials; ● delays in recruiting and enrolling participants or volunteers into any potential future clinical trials; ● delays in obtaining, or our inability to obtain, required approvals from institutional review boards (“IRBs”) or other reviewing entities at clinical sites selected for participation in our clinical trials; ● insufficient supply or deficient quality of our product candidate(s) or other materials necessary to conduct our clinical trials; ● lower than anticipated retention rate of subjects and participants in clinical trials; ● negative or inconclusive results from clinical trials, or results that are inconsistent with earlier results, that necessitate additional clinical studies; ● serious and unexpected drug-related side effects experienced by subjects and participants in clinical trials; or ● failure of our third-party contractors to comply with regulatory requirements or otherwise meet their contractual obligations to us in a timely manner. 9 Clinical trials require sufficient participant enrollment, which is a function of many factors, including the size of the participant population, the nature of the trial protocol, the proximity of participants to clinical sites, the availability of effective treatments for the relevant disease and the eligibility criteria for the clinical trial.
If we fail to establish or maintain collaborations necessary for successful development, commercialization and marketing on acceptable terms, we may not be able to develop, commercialize or market product candidates or generate sufficient revenue to fund further research and development efforts. 7 New or existing collaborations, including our collaboration with MPG and UMG, may never result in the successful development or commercialization of any pipeline candidates for several reasons, including the fact that: ● we may not have the ability to control the activities of our partners and cannot provide assurance that they will fulfill their obligations to us, including with respect to the license, development, manufacture and commercialization of pipeline candidates, in a timely manner or at all; ● such partners may not devote sufficient resources to our pipeline candidates or properly maintain or defend our intellectual property rights (if required); ● such partners may decide to pursue competitive product candidates developed outside of the partnership arrangement; ● any failure on the part of our partners to perform or satisfy their obligations to us could lead to delays in the development or commercialization of our pipeline candidates and affect our ability to realize product revenue; ● disagreements, including disputes over the ownership of technology developed with such collaborators, could result in litigation, which would be time-consuming and expensive, and may delay or terminate research and development efforts, regulatory approvals, and commercialization activities; and ● such partners may decide to terminate or not to renew the collaboration for these or other reasons.
If we fail to establish or maintain collaborations necessary for successful development, commercialization and marketing on acceptable terms, we may not be able to develop, commercialize or market product candidates or generate sufficient revenue to fund further research and development efforts. 5 New or existing collaborations, including our collaboration with MPG and UMG, may never result in the successful development or commercialization of any pipeline candidates for several reasons, including the fact that : ● we may not have the ability to control the activities of our partners and cannot provide assurance that they will fulfill their obligations to us, including with respect to the license, development, manufacture and commercialization of pipeline candidates, in a timely manner or at all; ● such partners may not devote sufficient resources to our pipeline candidates or properly maintain or defend our intellectual property rights (if required); ● such partners may decide to pursue competitive product candidates developed outside of the partnership arrangement; ● any failure on the part of our partners to perform or satisfy their obligations to us could lead to delays in the development or commercialization of our pipeline candidates and affect our ability to realize product revenue; ● disagreements, including disputes over the ownership of technology developed with such collaborators, could result in litigation, which would be time-consuming and expensive, and may delay or terminate research and development efforts, regulatory approvals, and commercialization activities; and ● such partners may decide to terminate or not to renew the collaboration for these or other reasons.
The risks and uncertainties that we face with respect to our intellectual property rights include, but are not limited to, the following: ● the degree and range of protection any patents will afford us against competitors; 31 ● the patents concerning our business activities were not registered in all countries and therefore our patent protection may be lacking in some territories; ● if and when patents will be issued; ● whether or not others will obtain patents claiming aspects similar to those covered by our own or licensed patents and patent applications; ● we may be subject to interference proceedings; ● we may be subject to opposition or post-grant proceedings in foreign countries; ● any patents that are issued may not provide meaningful protection; ● we may not be able to develop additional proprietary technologies that are patentable; ● other companies may challenge patents licensed or issued to us or our customers; ● other companies may independently develop similar or alternative technologies, or duplicate our technologies; ● other companies may design around technologies we have licensed or developed; ● enforcement of patents is complex, uncertain and expensive; and ● we may need to initiate litigation or administrative proceedings that may be costly whether we win or lose.
The risks and uncertainties that we face with respect to our intellectual property rights include, but are not limited to, the following: ● the degree and range of protection any patents will afford us against competitors; 24 ● the patents concerning our business activities were not registered in all countries and therefore our patent protection may be lacking in some territories; ● if and when patents will be issued; ● whether or not others will obtain patents claiming aspects similar to those covered by our own or licensed patents and patent applications; ● we may be subject to interference proceedings; ● we may be subject to opposition or post-grant proceedings in foreign countries; ● any patents that are issued may not provide meaningful protection; ● we may not be able to develop additional proprietary technologies that are patentable; ● other companies may challenge patents licensed or issued to us or our customers; ● other companies may independently develop similar or alternative technologies, or duplicate our technologies; ● other companies may design around technologies we have licensed or developed; ● enforcement of patents is complex, uncertain and expensive; and ● we may need to initiate litigation or administrative proceedings that may be costly whether we win or lose.
Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. We may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could result in litigation and adversely affect our business.
Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. 28 We may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could result in litigation and adversely affect our business.
Any delay or failure to obtain institutional review board approval to conduct a clinical trial at a prospective site could materially impact the costs, timing, or successful completion of a clinical trial. 8 Current and future product candidates would be subject to extensive regulation and may never obtain regulatory approval.
Any delay or failure to obtain institutional review board approval to conduct a clinical trial at a prospective site could materially impact the costs, timing, or successful completion of a clinical trial. Current and future product candidates would be subject to extensive regulation and may never obtain regulatory approval.
Failure to obtain EMA, FDA or any other regulatory approval for current and future product candidates in a timely manner or at all will severely undermine our business by delaying or halting commercialization of our products, imposing costly procedures, diminishing competitive advantages and reducing the number of saleable products and, therefore, corresponding product revenues. 9 Current and future product candidates will remain subject to ongoing regulatory requirements even if we receive regulatory approval to market such product candidate(s), and if we fail to comply with such requirements, we could lose those approvals that have been obtained, and the sales of any approved commercial products could be suspended.
Failure to obtain EMA, FDA or any other regulatory approval for current and future product candidates in a timely manner or at all will severely undermine our business by delaying or halting commercialization of our products, imposing costly procedures, diminishing competitive advantages and reducing the number of saleable products and, therefore, corresponding product revenues. 7 Current and future product candidates will remain subject to ongoing regulatory requirements even if we receive regulatory approval to market such product candidate(s), and if we fail to comply with such requirements, we could lose those approvals that have been obtained, and the sales of any approved commercial products could be suspended.
Pursuant to the terms of the option agreement with Pincell, we have the right to exercise, at our sole discretion, a full sale and transfer of Pincell’s shares by the end of 2025, subject to approval of the Golden Power regulatory clearance by the Italian government and satisfaction of certain closing requirements, which include the requirement to either obtain an award of a grant to our wholly owned Polish subsidiary under the European Funds for a Modern Economy (FENG) program in Poland or secure $3 million by December 31, 2025 to fund the development of PC111.
Pursuant to the terms of the option agreement with Pincell, we had the right to exercise, at our sole discretion, a full sale and transfer of Pincell’s shares by the end of 2025, subject to approval of the Golden Power regulatory clearance by the Italian government and satisfaction of certain closing requirements, which include the requirement to either obtain an award of a grant to our wholly owned Polish subsidiary under the European Funds for a Modern Economy (FENG) program in Poland or secure $3 million by December 31, 2025 to fund the development of PC111.
Our inability to enroll a sufficient number of participants for any clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether. 14 The occurrence of serious complications or side effects in connection with current and future product candidates, either in future clinical trials we may conduct or post-approval, could impede such future clinical trials, if any, and lead to refusal of regulatory authorities to approve our product candidate(s) or, post-approval, revocation of marketing authorizations or refusal to approve new indications, which could severely harm our business, prospects, operating results and financial condition.
Our inability to enroll a sufficient number of participants for any clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether. 11 The occurrence of serious complications or side effects in connection with current and future product candidates, either in future clinical trials we may conduct or post-approval, could impede such future clinical trials, if any, and lead to refusal of regulatory authorities to approve our product candidate(s) or, post-approval, revocation of marketing authorizations or refusal to approve new indications, which could severely harm our business, prospects, operating results and financial condition.
In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow the ADSs to become listed again, stabilize the market price or improve the liquidity of the ADSs, prevent the ADSs from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements. 41 We are a “foreign private issuer” and have disclosure obligations that are different from those of U.S. domestic reporting companies.
In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow the ADSs to become listed again, stabilize the market price or improve the liquidity of the ADSs, prevent the ADSs from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements. 33 We are a “foreign private issuer” and have disclosure obligations that are different from those of U.S. domestic reporting companies.
Regulatory action, including the issuance of Forms FDA 483 and warning letters, can also have an impact. 23 We may be required to ship biological candidates manufactured at our facility to clinical trial facilities at a prescribed temperature range and variations from that temperature range could result in loss of product and could significantly and adversely impact the related drug development program timelines, which could harm our business, financial condition, operating results and cash flows.
Regulatory action, including the issuance of Forms FDA 483 and warning letters, can also have an impact. 17 We may be required to ship biological candidates manufactured at our facility to clinical trial facilities at a prescribed temperature range and variations from that temperature range could result in loss of product and could significantly and adversely impact the related drug development program timelines, which could harm our business, financial condition, operating results and cash flows.
In addition, if the ADSs are delisted from Nasdaq, trading of our securities would most likely take place in an over-the-counter market for unlisted securities.
If the ADSs are delisted from Nasdaq, trading of our securities would most likely take place in an over-the-counter market for unlisted securities.
If we are unsuccessful in accomplishing these objectives, we may not be able to develop any current and future product candidate(s), raise capital, expand our business or continue our operations. 24 We face significant competition. If we cannot successfully compete with new or existing product candidate(s), our marketing and sales will suffer and we may never be profitable.
If we are unsuccessful in accomplishing these objectives, we may not be able to develop any current and future product candidate(s), raise capital, expand our business or continue our operations. 18 We face significant competition. If we cannot successfully compete with new or existing product candidate(s), our marketing and sales will suffer and we may never be profitable.
These rules and regulations could also make it more difficult for us to attract and retain qualified managing directors and supervisory directors. 42 We have not paid, and do not currently intend to pay, dividends on the ADSs and, therefore, unless our traded securities appreciate in value, our investors may not benefit from holding our securities.
These rules and regulations could also make it more difficult for us to attract and retain qualified managing directors and supervisory directors. 34 We have not paid, and do not currently intend to pay, dividends on the ADSs and, therefore, unless our traded securities appreciate in value, our investors may not benefit from holding our securities.
An adverse outcome in an interference proceeding could require us to cease using the technology or to license rights from prevailing third parties. 33 The cost to us of any patent litigation or other proceeding relating to our licensed patents or patent applications, even if resolved in our favor, could be substantial and could divert management’s resources and attention.
An adverse outcome in an interference proceeding could require us to cease using the technology or to license rights from prevailing third parties. 26 The cost to us of any patent litigation or other proceeding relating to our licensed patents or patent applications, even if resolved in our favor, could be substantial and could divert management’s resources and attention.
The following examples are illustrative: ● others may be able to make compounds that are the same as or similar to current and future product candidates but that are not covered by the claims of the patents that we own or have exclusively licensed; ● we or our licensors or any future strategic partners might not have been the first to make the inventions covered by the issued patent or pending patent application that we own or have exclusively licensed; ● we or our licensors or any future strategic partners might not have been the first to file patent applications covering certain of our inventions; ● others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; ● it is possible that our pending patent applications will not lead to issued patents; ● issued patents that we own or have exclusively licensed may not provide us with any competitive advantages, or may be held invalid or unenforceable, as a result of legal challenges by our competitors; ● our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; ● we may not develop additional proprietary technologies that are patentable; and ● the patents of others may have an adverse effect on our business. 35 We may be subject to claims challenging the inventorship of our patents and other intellectual property.
The following examples are illustrative: ● others may be able to make compounds that are the same as or similar to current and future product candidates but that are not covered by the claims of the patents that we own or have exclusively licensed; ● we or our licensors or any future strategic partners might not have been the first to make the inventions covered by the issued patent or pending patent application that we own or have exclusively licensed; ● we or our licensors or any future strategic partners might not have been the first to file patent applications covering certain of our inventions; ● others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; ● it is possible that our pending patent applications will not lead to issued patents; ● issued patents that we own or have exclusively licensed may not provide us with any competitive advantages, or may be held invalid or unenforceable, as a result of legal challenges by our competitors; ● our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; ● we may not develop additional proprietary technologies that are patentable; and ● the patents of others may have an adverse effect on our business.
If any of these adverse events occur, they may render current and future product candidates ineffective or harmful in some participants, and any future sales would suffer, materially adversely affecting our business, financial condition and results of operations. 25 In addition, potential adverse events caused by current and future product candidates could lead to product liability lawsuits.
If any of these adverse events occur, they may render current and future product candidates ineffective or harmful in some participants, and any future sales would suffer, materially adversely affecting our business, financial condition and results of operations. 19 In addition, potential adverse events caused by current and future product candidates could lead to product liability lawsuits.
If reimbursement of our product candidate(s) is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be harmed, possibly materially. 27 Our internal computer systems, or those used by our contractors or consultants, may fail or experience security breaches or other unauthorized or improper access.
If reimbursement of our product candidate(s) is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be harmed, possibly materially. 21 Our internal computer systems, or those used by our contractors or consultants, may fail or experience security breaches or other unauthorized or improper access.
In addition, since publication of discoveries in the scientific or patent literature often lags behind actual discoveries, we cannot be certain that we were the first to make our inventions or to file patent applications covering those inventions. 32 Moreover, some of our owned or in-licensed patents and patent applications may in the future be co-owned with third parties.
In addition, since publication of discoveries in the scientific or patent literature often lags behind actual discoveries, we cannot be certain that we were the first to make our inventions or to file patent applications covering those inventions. 25 Moreover, some of our owned or in-licensed patents and patent applications may in the future be co-owned with third parties.
These provisions may be interpreted to impose additional obligations and liabilities on our shareholders that are not typically imposed on shareholders of U.S. corporations. 39 Changes in Israeli tax laws and examinations by the Israeli Tax Authorities could increase our overall tax liabilities. We are subject to various taxes and tax compliance obligations in Israel.
These provisions may be interpreted to impose additional obligations and liabilities on our shareholders that are not typically imposed on shareholders of U.S. corporations. 31 Changes in Israeli tax laws and examinations by the Israeli Tax Authorities could increase our overall tax liabilities. We are subject to various taxes and tax compliance obligations in Israel.
If we are unable to manage our growth effectively, it will have a material adverse effect on our business, results of operations and financial condition. 26 If we are unable to obtain adequate insurance, our financial condition could be adversely affected in the event of uninsured or inadequately insured loss or damage.
If we are unable to manage our growth effectively, it will have a material adverse effect on our business, results of operations and financial condition. 20 If we are unable to obtain adequate insurance, our financial condition could be adversely affected in the event of uninsured or inadequately insured loss or damage.
Despite the protective measures we employ, we still face the risk that: ● these agreements may be breached; 34 ● these agreements may not provide adequate remedies for the applicable type of breach; ● our proprietary know-how will otherwise become known; or ● our competitors will independently develop similar technology or proprietary information.
Despite the protective measures we employ, we still face the risk that: ● these agreements may be breached; 27 ● these agreements may not provide adequate remedies for the applicable type of breach; ● our proprietary know-how will otherwise become known; or ● our competitors will independently develop similar technology or proprietary information.
These measures, however, may not adequately protect us from adverse effects. 40 Risks Related to our Securities Our failure to meet the continued listing requirements of Nasdaq could result in a delisting of the ADSs. The delisting could adversely affect the market liquidity of our shares and the market price of our shares could decrease significantly.
These measures, however, may not adequately protect us from adverse effects. 32 Risks Related to our Securities Our failure to meet the continued listing requirements of Nasdaq could result in a delisting of the ADSs. The delisting could adversely affect the market liquidity of our shares and the market price of our shares could decrease significantly.
In addition, in the capacity as a holder of ADSs, they will not be able to call a shareholders’ meeting. 43 You may be subject to limitations on transfer of the ADSs. The ADSs are transferable on the books of the depositary.
In addition, in the capacity as a holder of ADSs, they will not be able to call a shareholders’ meeting. 35 You may be subject to limitations on transfer of the ADSs. The ADSs are transferable on the books of the depositary.
Risks Related to Our R&D Business Unit The members of our management team and certain consultants are important to the efficient and effective operation of our business, and we may need to attract and retain additional management and experts.
Risks Related to Our R&D Business Unit The members of our management team are important to the efficient and effective operation of our business, and we may need to attract and retain additional management and experts.
In general, the institutional review board will consider, among other matters, ethical factors, the safety of human subjects and the possibility of liability of the institution conducting the trial.
In general, the institutional review board will consider, among other matters, ethicastil factors, the safety of human subjects and the possibility of liability of the institution conducting the trial.
We appealed the delisting determination and requested a hearing before the Hearing Panel, which automatically stayed any suspension. Our board of directors also approved a ratio change of the ADSs to our non-traded Ordinary Shares, increasing the number of Ordinary Shares represented by each ADS from 400 to 4,000, which was equivalent to a reverse split of 1 for 10.
We appealed this determination and requested a hearing before the Hearing Panel, which stayed the suspension. Our board of directors also approved a ratio change of the ADSs to our non-traded Ordinary Shares, increasing the number of Ordinary Shares represented by each ADS from 400 to 4,000, which was equivalent to a reverse split of 1 for 10.
We may be subject to claims that employees, partners or other third parties who were involved in the development of intellectual property for the Company have an interest in our patents or other intellectual property as an inventor or co-inventor.
We may be subject to claims challenging the inventorship of our patents and other intellectual property. We may be subject to claims that employees, partners or other third parties who were involved in the development of intellectual property for the Company have an interest in our patents or other intellectual property as an inventor or co-inventor.
If we fail to satisfy Nasdaq’s continued listing requirements, Nasdaq may take steps to delist the ADSs. On November 1, 2023, we received a notice of non-compliance from Nasdaq that we are not in compliance with the requirement to maintain a minimum bid price of $1.00 per share as required by Nasdaq Listing Rule 5550(a)(2) (the “Minimum Price Rule”).
If we fail to satisfy Nasdaq’s continued listing requirements, Nasdaq may take steps to delist the ADSs. On March 12, 2026, we received a notice of non-compliance from Nasdaq that we are not in compliance with the requirement to maintain a minimum bid price of $1.00 per share as required by Nasdaq Listing Rule 5550(a)(2) (the “Minimum Price Rule”).
Our GMP biologics manufacturing facility in Jerusalem is capable of manufacturing an annual supply of current and future product candidate(s) suitable for regulatory or other similar uses. However, we may also rely on a third party CMO for commercial supply of current and future product candidates.
Our GMP biologics manufacturing facility in Jerusalem and our cGMP manufacturing facility in Yavne, Israel are capable of manufacturing an annual supply of current and future product candidate(s) suitable for regulatory or other similar uses. However, we may also rely on a third party CMO for commercial supply of current and future product candidates.
Our failure, or the failure of our third-party manufacturers to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidate(s), operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our product candidate(s). countries around the world that we may conduct.
Our failure, or the failure of our third-party manufacturers to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidate(s), operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our product candidate(s).
Our current and future arrangements with third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we conduct research and would market, sell and distribute our product candidate(s).
Our current and future arrangements with customers, third-party payors and healthcare providers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we conduct research and, if approved, market, sell and distribute our product candidates.
We are incorporated in Israel. Most of our current executive officers and directors reside in Israel and most of our assets reside outside of the United States.
Most of our current executive officers and directors reside in Israel and most of our assets reside outside of the United States.
Certain Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively, the Affordable Care Act marketplace and other private payor plans are required to include coverage for certain preventative services, including vaccinations recommended by the U.S.
Therefore, coverage and reimbursement for pharmaceutical products can differ significantly from payor to payor. Certain Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively, the Affordable Care Act marketplace and other private payor plans are required to include coverage for certain preventative services, including vaccinations recommended by the U.S.
If regulatory approval is not obtained or if we are not successful in either obtaining the grant under the FENG program or securing $3 million by December 31, 2025 to fund the development of PC111, we will be unable to exercise the option. If we are unable to exercise the option, our future prospects will be affected.
If we are not successful in either obtaining the grant under the FENG program or securing $3 million by August 31, 2026 to fund the development of PC111, we will be unable to exercise the option. If we are unable to exercise the option, our future prospects will be affected.
The processes and requirements imposed by the U.S. Food and Drug Administration (the “FDA”) or other applicable health authorities may cause delays and additional costs in obtaining approvals for marketing authorization for our products.
Food and Drug Administration (the “FDA”) or other applicable health authorities may cause delays and additional costs in obtaining approvals for marketing authorization for our products.
Current and future product candidates we may develop, which will be tested and marketed abroad, will be subject to extensive regulation by foreign governments, whether or not we have obtained EMA, the Israeli Ministry of Health’s approval and/or FDA approval.
Current and future product candidates we may develop, which will be tested and marketed abroad, will be subject to extensive regulation by foreign governments, whether or not we have obtained EMA, the Israeli Ministry of Health’s approval and/or FDA approval. Such foreign regulation may be equally or more demanding than corresponding European, Israeli or U.S. regulation.
Our executive officers, management team and technical personnel, as well as certain consultants, are important to the efficient and effective operation of our business, particularly Mr. Amir Reichman, our Chief Executive Officer, Dr. Tamar Ben-Yedidia, our Chief Scientific Officer, Mr. Elad Mark, our Chief Operating Officer and Dr. Dalit Fischer our Chief Technology Officer.
Our executive officers, management team and technical personnel, as well as certain consultants, are important to the efficient and effective operation of our business, particularly Mr. Amir Reichman, our Chief Executive Officer, and Mr. Elad Mark, our Chief Operating Officer.
If we have difficulty in funding the development of PC111, including if we exercise our option to acquire Pincell but do not receive the grant from the FENG program in Poland, or if for any other reason we do not file an IND application for PC111 to the FDA, or any similar dossier application in a country other than the U.S., by December 31, 2028, we will be required to resell our shares in Pincell to the previous shareholders of Pincell, which will affect our future prospects.
If we have difficulty in funding the development of PC111, including if we exercise our option to acquire Pincell but do not receive the grant from the FENG program in Poland, or if for any other reason we do not file an IND application for PC111 to the FDA, or any similar dossier application in a country other than the U.S., by December 31, 2028, we will be required to resell our shares in Pincell to the previous shareholders of Pincell, which will affect our future prospects. 6 Development of sufficient and appropriate clinical protocols to demonstrate safety and efficacy are required, and we may not adequately develop such protocols to support approval.
Our board of directors has the authority, in most cases without action or vote of our shareholders, to issue all or any part of our authorized but unissued shares, including Ordinary Shares and ADSs issuable upon the exercise of outstanding options. Issuances of additional shares and ADSs would reduce your influence over matters on which our shareholders vote.
Our board of directors has the authority, in most cases without action or vote of our shareholders, to issue all or any part of our authorized but unissued shares, including Ordinary Shares and ADSs issuable upon the exercise of outstanding options.
As of December 31, 2024 and December 31, 2023, we had $1.9 million and $4.9 million, respectively, in cash and cash equivalents and short-term deposits, working capital of $0.59 million and $3.6 million, respectively, and an accumulated deficit of $117.6 million and $122.3 million, respectively.
As of December 31, 2025 and December 31, 2024, we had approximately $1.6 million and $1.9 million, respectively, in cash and cash equivalents and short-term deposits, working capital of $0.46 million and $0.59 million, respectively, and an accumulated deficit of $125.8 million and $117.6 million, respectively.
If we are unable to identify suitable compounds for preclinical and clinical development, we may not be able to obtain sufficient product revenues in future periods, which likely would result in significant harm to our financial position and adversely impact the price of the ADSs.
If we are unable to identify suitable compounds for preclinical and clinical development, we may not be able to obtain sufficient product revenues in future periods, which likely would result in significant harm to our financial position and adversely impact the price of the ADSs. 12 Inadequate funding, resource constraints or shifting priorities at regulatory authorities may delay the development and approval of our product candidates.
The commencement and completion of clinical trials may be delayed by several factors, including: ● unforeseen safety issues; ● determination of proper dosing; ● lack of effectiveness or efficacy during clinical trials; ● failure of our contract manufacturers or inability of our in-house facility to manufacture our product candidate(s) in sufficient quantities and in accordance with current good manufacturing practices, or cGMP; ● our failure or the failure of third party suppliers to perform final manufacturing steps for the drug substance; ● slower than expected rates of participant recruitment and enrollment; ● lack of healthy volunteers and participants to conduct trials; ● inability to monitor participants adequately during or after treatment; ● Failure or delay in reaching an agreement with a third party contract research organization or clinical trial site(s), and failure of third party contract research organizations to properly implement or monitor the clinical trial protocols; 12 ● failure of the FDA, Institutional Review Boards (“IRBs”), or other regulatory bodies to authorize our clinical trial protocols, or a decision by a regulatory body to place one or more of our trials on hold; ● inability or unwillingness of medical investigators and Contract Research Organizations to follow our clinical trial protocols and applicable regulatory requirements; and ● lack of sufficient funding to finance the clinical trials.
The commencement and completion of clinical trials may be delayed by several factors, including: ● unforeseen safety issues; ● determination of proper dosing; ● lack of effectiveness or efficacy during clinical trials; ● failure of our contract manufacturers or inability of our in-house facility to manufacture our product candidate(s) in sufficient quantities and in accordance with current good manufacturing practices, or cGMP; ● our failure or the failure of third party suppliers to perform final manufacturing steps for the drug substance; ● slower than expected rates of participant recruitment and enrollment; ● lack of healthy volunteers and participants to conduct trials; ● inability to monitor participants adequately during or after treatment; ● failure or delay in reaching an agreement with a third party contract research organization or clinical trial site(s), and failure of third party contract research organizations to properly implement or monitor the clinical trial protocols; ● failure of the FDA, Institutional Review Boards (“IRBs”), or other regulatory bodies to authorize our clinical trial protocols, or a decision by a regulatory body to place one or more of our trials on hold; ● inability or unwillingness of medical investigators and Contract Research Organizations to follow our clinical trial protocols and applicable regulatory requirements; and ● lack of sufficient funding to finance the clinical trials. 10 In addition, we or regulatory authorities may suspend or terminate our clinical trials at any time if it appears that we are exposing participants to unacceptable health risks, if the regulatory authorities find deficiencies in our regulatory submissions or the conduct of these trials, if inspection of the clinical trial operations or trial site by a regulatory authority results in the imposition of a clinical hold, or if there is a failure to demonstrate a benefit from using the product candidate(s), or changes in governmental regulations or administrative actions.
Our failure to comply with these regulations could result in, by way of example, significant fines, criminal and civil liability, product seizures, recalls, withdrawals, withdrawals of approvals, and exclusion and debarment from government programs.
Government regulation substantially increases the cost and risk of researching, developing, manufacturing, and selling products. Our failure to comply with these regulations could result in, by way of example, significant fines, criminal and civil liability, product seizures, recalls, withdrawals, withdrawals of approvals, and exclusion and debarment from government programs.
We are a developmental stage biopharmaceutical company with a limited operating history. We have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in rapidly evolving fields, particularly in the pharmaceutical area.
We have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in rapidly evolving fields, particularly in the pharmaceutical area.
On April 30, 2024, we received a staff determination letter from Nasdaq notifying us that, due to our continued non-compliance with the minimum $1.00 bid price requirement, the ADSs would be scheduled for delisting from Nasdaq and would be suspended for trading at the opening of business on May 7, 2024 unless we timely request a hearing before an independent Nasdaq Hearings Panel (the “Hearing Panel”).
Similarly, on November 1, 2023, we received a notice of non-compliance from Nasdaq that we are not in compliance with the Minimum Price Rule, and on April 30, 2024, we received a staff determination letter from Nasdaq notifying us that, due to our continued non-compliance with the Minimum Price Rule, the ADSs would be scheduled for delisting from Nasdaq and suspended for trading4 unless we timely request a hearing before an independent Nasdaq Hearings Panel (the “Hearing Panel”).
If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they adversely change their recommendations or publish negative reports regarding our business or our traded securities, the market price for the ADSs and trading volume could be negatively impacted.
Issuances of additional shares and ADSs would reduce your influence over matters on which our shareholders vote. 37 If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they adversely change their recommendations or publish negative reports regarding our business or our traded securities, the market price for the ADSs and trading volume could be negatively impacted.
If we raise additional funds through strategic partnerships, alliances and licensing arrangements with third parties, we may have to relinquish Risks Related to Development, Clinical Testing and Regulatory Approval of NanoAbs and any Other Current and Future Product Candidate(s) We have not yet commercialized any product candidate(s), and we may never become profitable.
If we raise additional funds through strategic partnerships, alliances and licensing arrangements with third parties, we may have to relinquish Risks Related to Development, Clinical Testing and Regulatory Approval of NanoAbs and any Other Current and Future Product Candidate(s) Our IL-17 program is subject to significant contractual, development and strategic uncertainties Our IL-17 development program is subject to significant development, strategic and contractual uncertainties.
Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement rates, but also have their own methods and approval process apart from Medicare determinations. Therefore, coverage and reimbursement for pharmaceutical products can differ significantly from payor to payor.
In the United States, no uniform policy of coverage and reimbursement for pharmaceutical products exists among third-party payors. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement rates, but also have their own methods and approval process apart from Medicare determinations.
Before making an investment decision, you should carefully consider the factors described below, together with all other information included in this annual report, including our financial statements and the related notes included elsewhere in this annual report. We may face additional risks and uncertainties not currently known to us or that we currently deem to be immaterial.
Before making an investment decision, you should carefully consider the factors described below, together with all other information included in this annual report, including our financial statements and the related notes included elsewhere in this annual report.
Clinical trials we may conduct in the future may involve obtaining materials and information that may not currently be in our possession and that we rely on suppliers and manufacturers to provide.
We may not obtain the necessary materials for the performance of any future clinical trials in the U.S. or other countries around the world that we may conduct. Clinical trials we may conduct in the future may involve obtaining materials and information that may not currently be in our possession and that we rely on suppliers and manufacturers to provide.
These market fluctuations may also have a material adverse effect on the market price of the ADSs. Your percentage ownership in us may be diluted by future issuances of share capital, which could reduce your influence over matters on which shareholders vote.
Your percentage ownership in us may be diluted by future issuances of share capital, which could reduce your influence over matters on which shareholders vote.
CDMO services are highly complex and failure to provide quality and timely services to our CDMO clients could adversely impact our business. The CDMO services we offer can be highly complex, due in part to strict regulatory requirements and the inherent complexity of the services provided.
The CDMO services we offer can be highly complex, due in part to strict regulatory requirements and the inherent complexity of the services provided.
Market acceptance and sales of current and future product candidates will depend on coverage and reimbursement policies. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which products they will pay for and establish reimbursement levels.
Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which products they will pay for and establish reimbursement levels. We cannot be sure that coverage and reimbursement will be available for current and future product candidates we may develop.
Any disruptions or delays at our facility or its failure to meet regulatory compliance would significantly impair our ability to advance our NanoAbs program and other product candidates and deliver our CDMO services, which would result in increased costs and losses and adversely affect our business and results of operations. 30 Use of third parties to manufacture current and future product candidate(s) may increase the risk that we will not have sufficient quantities of such product candidate(s) at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
Any such disruptions could result in delays, increased costs, loss of customers or impairment of our development programs, and could materially adversely affect our business, financial condition and results of operations. 23 Use of third parties to manufacture current and future product candidate(s) may increase the risk that we will not have sufficient quantities of such product candidate(s) at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
As a biopharmaceutical company, even though we do not and will not control referrals of healthcare services or bill directly to Medicare, Medicaid or other third-party payors, federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and will be applicable to our business.
Although we do not currently control referrals of healthcare services or bill directly to Medicare, Medicaid or other third-party payors, federal and state healthcare laws and regulations pertaining to fraud and abuse and patient rights may apply to our business.
Our relationships with customers, third-party payors, physicians and healthcare providers will be subject to applicable anti-kickback, fraud and abuse, and other laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, and diminished profits.
Our relationships with customers, third-party payors, physicians and healthcare providers will be subject to applicable anti-kickback, fraud and abuse, and other healthcare laws and regulations, which could expose us to significant liability and adversely affect our business.
We cannot be sure that coverage and reimbursement will be available for current and future product candidates we may develop. Even if coverage is provided, we cannot be sure that the amount of reimbursement available, if any, will not reduce the demand for, or the price of, our product candidate(s).
Even if coverage is provided, we cannot be sure that the amount of reimbursement available, if any, will not reduce the demand for, or the price of, our product candidate(s). If reimbursement is not available or is available only at limited levels, we may not be able to successfully compete through sales of our proposed product candidate(s).
These restrictive laws and policies may have an adverse impact on our operating results, financial condition or the expansion of our business. 38 Investors may have difficulties enforcing a U.S. judgment, including judgments based upon the civil liability provisions of the U.S. federal securities laws, against us, or our executive officers and directors or asserting U.S. securities laws claims in Israel.
Any such developments could materially adversely affect our business, financial condition and results of operations 30 Investors may have difficulties enforcing a U.S. judgment, including judgments based upon the civil liability provisions of the U.S. federal securities laws, against us, or our executive officers and directors or asserting U.S. securities laws claims in Israel. We are incorporated in Israel.
Healthcare providers, physicians and third-party payors will play a primary role in the recommendation and prescription of current and future product candidates.
Healthcare providers, physicians and third-party payors will play a primary role in the recommendation and use of any product candidates for which we obtain marketing approval.
Any or all of these hostilities may escalate in the future into more violent events which may adversely affect our ability to continue carrying out various administrative, research, operational and commercial functions and activities both in Israel and globally. 37 Our R&D business unit is currently focused on advancing a novel VHH antibody for the treatment of psoriasis and related diseases.
Some, or all of these hostilities may escalate in the future into more violent events which may adversely affect our ability to continue carrying out various administrative, research, operational and commercial functions and activities both in Israel and globally.
Research programs designed to identify current and future product candidates may require substantial technical, financial and human resources, whether or not such efforts are successful.
If we are not successful in discovering, developing and commercializing current and future product candidates, our ability to expand our business and achieve our strategic objectives may be impaired. Research programs designed to identify current and future product candidates may require substantial technical, financial and human resources, whether or not such efforts are successful.
We were given 180 days to regain compliance.
We were given 180 days, or until September 8, 2026, to regain compliance.
A number of companies in the pharmaceutical and biopharmaceutical industries have suffered significant setbacks in late-stage clinical trials even after achieving promising results in early-stage development.
A number of companies in the pharmaceutical and biopharmaceutical industries have suffered significant setbacks in late-stage clinical trials even after achieving promising results in early-stage development. Accordingly, the results from preclinical studies and clinical trials for current and future product candidates may not be predictive of the results we may obtain in later stage trials.
Any of these events could prevent us from achieving or maintaining market acceptance of current and future product candidates, if approved, and could significantly harm our business, results of operations and prospects. 15 If we are not successful in discovering, developing and commercializing current and future product candidates, our ability to expand our business and achieve our strategic objectives may be impaired.
Any of these events could prevent us from achieving or maintaining market acceptance of current and future product candidates, if approved, and could significantly harm our business, results of operations and prospects.
If we are unable to successfully demonstrate our competitive advantages, we may not be able to compete against other CDMOs and generate significant revenues. 22 Our CDMO business is dependent upon attracting and maintaining customers and upon the demand for our services by our customers.
If we are unable to successfully demonstrate our competitive advantages, we may not be able to compete against other CDMOs and generate significant revenues. Our CDMO business depends on our ability to attract and retain customers and on the level of spending by those customers on development and manufacturing services.
Hamas also launched extensive rocket attacks on Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel. These attacks resulted in extensive deaths, injuries and kidnapping of civilians and soldiers.
In October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Hamas also launched extensive rocket attacks on Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel.
If our operations, including any arrangements with physicians and other healthcare providers, are found to be in violation of any such laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, reputational harm, exclusion from government-funded healthcare programs, such as Medicare and Medicaid, disgorgement, additional reporting requirements, and/or the curtailment or restructuring of our operations, as well as additional reporting obligations oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws.
If our operations or arrangements are found to be in violation of any applicable laws, we may be subject to significant civil, criminal and administrative penalties, including fines, damages, disgorgement, exclusion from participation in government healthcare programs such as Medicare and Medicaid, reputational harm, and the curtailment or restructuring of our operations.
Our current cash and cash equivalents position is not sufficient to fund our planned operations for at least a year beyond the date of the filing date of the financial statements. Those factors raise substantial doubt about our ability to continue as a going concern.
Our current cash position is not sufficient to fund our planned operations for at least one year from the date of the issuance of our financial statements. Accordingly, there is substantial doubt about our ability to continue as a going concern. While we generate revenues from our CDMO activities, these revenues are not currently sufficient to fund our operations.
Given the amount of time required for the development, testing and regulatory review of new product candidate(s), patents protecting such product candidate(s) might expire before or shortly after such product candidate(s) are commercialized.
Given the time required for the development, testing and regulatory review of our product candidates, any patents protecting such product candidates may expire before or shortly after commercialization, if at all.
The early stage of our NanoAbs program creates uncertainty about our prospects and may make it more difficult to attract and retain qualified executives and other key personnel. We are a developmental stage biopharmaceutical company with no product candidate(s) approved for marketing by regulatory agencies such as FDA, which makes it difficult to assess our future viability.
We are a developmental stage biopharmaceutical company with no product candidate(s) approved for marketing by regulatory agencies such as FDA, which makes it difficult to assess our future viability. We are a developmental stage biopharmaceutical company with a limited operating history.
Compliance with U.S. and foreign data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions.
In addition, we may be required to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, and in some cases impact our ability to operate in certain jurisdictions.
Failure by us or our partners and third-party providers to comply with U.S. and foreign data protection laws and regulations could result in government enforcement actions (which could include civil or criminal penalties), private litigation and/or adverse publicity and could negatively affect our operating results and business.
Any failure by us or our partners and third-party service providers to comply with applicable data protection laws and regulations could result in government enforcement actions (which could include civil or criminal penalties, private litigation and/or adverse publicity and could negatively affect our operating results and business. 22 Risks Related to Dependence on Third Parties Our NanoAb development programs depend on exclusive license agreements with MPG and UMG, and the loss or limitation of these rights could materially adversely affect our business.
Restrictions under applicable federal and state healthcare laws and regulations that may affect our ability to operate include the following: ● the federal healthcare Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving, paying or providing remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order, arrangement, or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under a federal healthcare program such as the Medicare and Medicaid programs.
These laws and regulations include, among others: ● the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving any remuneration, directly or indirectly, to induce or reward referrals of, or the purchase, lease, order or recommendation of, any item or service reimbursable under a federal healthcare program such as Medicare or Medicaid.
Manufacturers can be held liable under the False Claims Act even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims.
Manufacturers may be held liable even if they do not submit claims directly if they are deemed to have “caused” the submission of false claims. In addition, violations of the Anti-Kickback Statute may form the basis for liability under the False Claims Act.
We are now focused on the development of NanoAbs targeting Interleukin-17 (IL-17), which we licensed in June 2023, as treatments for all potential indications where IL-17 plays a meaningful role, starting with plaque psoriasis and psoriatic arthritis.
Our current development focus is on NanoAbs targeting Interleukin-17 (IL-17), which we licensed in June 2023, initially for indications such as plaque psoriasis and psoriatic arthritis.
NanoAbs represent a relatively new approach to treating diseases, and we must overcome significant challenges in order to successfully develop, commercialize and manufacture product candidates based on this technology. We are currently concentrating our development efforts on the IL-17 NanoAb as a treatment for all potential indications where IL-17 plays a meaningful role, starting with psoriasis and psoriatic arthritis.
We are currently concentrating our development efforts on the IL-17 NanoAb as a treatment for all potential indications where IL-17 plays a meaningful role, starting with psoriasis and psoriatic arthritis. The processes and requirements imposed by the U.S.
Efforts to ensure that our current and future business arrangements with third parties, and our business generally, continue to comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with any such laws and regulations.
It is possible that governmental authorities may conclude that our business practices do not comply with such laws and regulations.
Accordingly, the results from preclinical studies and clinical trials for current and future product candidates may not be predictive of the results we may obtain in later stage trials. 13 Our clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials.
Our clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials.

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Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeIn the event we or our affiliates have not filed an IND application for PC111 to the FDA, or any similar dossier application in a country other than the U.S., by December 31, 2028, the option agreement grants each seller the right to repurchase the shares of Pincell it sold to us for the lower of (i) the fair market value of Pincell and (ii) the sum funded by us or our affiliates into Pincell.
Biggest changeUnder the terms of the option agreement, if we or our affiliates do not file an Investigational New Drug (IND) application for PC111 with the FDA, or a comparable regulatory submission in another jurisdiction, by December 31, 2028, each seller will have the right to repurchase the shares it sold at the lower of (i) fair market value and (ii) the aggregate amount funded by us or our affiliates into Pincell (subject to a minimum equal to the nominal value of the shares).
For example, the ACA: ● increased the minimum level of Medicaid rebates payable by manufacturers of brand name drugs from 15.1% to 23.1% of the AMP; 67 ● required collection of rebates for drugs paid by Medicaid managed care organizations; ● expanded beneficiary eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income at or below 138% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability; ● extended manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; ● expanded the types of entities eligible for the 340B Drug Pricing Program; ● established a new methodology by which rebates owed by manufacturers under MDRP are calculated for drugs that are inhaled, infused, instilled, implanted or injected; ● required manufacturers to participate in a coverage gap discount program, under which they must agree to offer 70 percent point-of-sale discounts off negotiated prices of applicable branded drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; ● imposed a non-deductible annual fee on pharmaceutical manufacturers or importers who sell “branded prescription drugs” and biologic agents apportioned among these entities according to their market share in certain federal government programs; ● established the Center for Medicare and Medicaid Innovation within CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending; ● created the Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; ● required reporting of certain financial arrangements between manufacturers of drugs, biologics, devices, and medical supplies and physicians and teaching hospitals under the federal Physician Payments Sunshine Act; and ● required annual reporting of certain information regarding drug samples that manufacturers and distributors provide to licensed practitioners.
For example, the ACA: ● increased the minimum level of Medicaid rebates payable by manufacturers of brand name drugs from 15.1% to 23.1% of the AMP; 56 ● required collection of rebates for drugs paid by Medicaid managed care organizations; ● expanded beneficiary eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income at or below 138% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability; ● extended manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; ● expanded the types of entities eligible for the 340B Drug Pricing Program; ● established a new methodology by which rebates owed by manufacturers under MDRP are calculated for drugs that are inhaled, infused, instilled, implanted or injected; ● required manufacturers to participate in a coverage gap discount program, under which they must agree to offer 70 percent point-of-sale discounts off negotiated prices of applicable branded drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; ● imposed a non-deductible annual fee on pharmaceutical manufacturers or importers who sell “branded prescription drugs” and biologic agents apportioned among these entities according to their market share in certain federal government programs; ● established the Center for Medicare and Medicaid Innovation within CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending; ● created the Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; ● required reporting of certain financial arrangements between manufacturers of drugs, biologics, devices, and medical supplies and physicians and teaching hospitals under the federal Physician Payments Sunshine Act; and ● required annual reporting of certain information regarding drug samples that manufacturers and distributors provide to licensed practitioners.
The FCA also permits a private individual acting as a “whistleblower” to bring qui tam actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery or settlement. 65 ● The federal civil monetary penalties laws, which prohibit, among other activities (1) arranging for or contracting with an individual or entity that is excluded from participation in federal healthcare programs to provide items or services reimbursable by a federal healthcare program, (2) failing to report and return a known overpayment, or (3) offering or transferring any remuneration to a Medicare or Medicaid beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of items or services reimbursable by Medicare or Medicaid, unless an exception applies. ● The federal criminal statutes enacted under HIPAA which impose criminal liability for knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program; knowingly and willfully embezzling or stealing from a healthcare benefit program; willfully preventing, obstructing, misleading, or delaying a criminal investigation of a healthcare offense; and knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false statements in connection with the delivery of or payment for healthcare benefits, items, or services.
The FCA also permits a private individual acting as a “whistleblower” to bring qui tam actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery or settlement. 54 ● The federal civil monetary penalties laws, which prohibit, among other activities (1) arranging for or contracting with an individual or entity that is excluded from participation in federal healthcare programs to provide items or services reimbursable by a federal healthcare program, (2) failing to report and return a known overpayment, or (3) offering or transferring any remuneration to a Medicare or Medicaid beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of items or services reimbursable by Medicare or Medicaid, unless an exception applies. ● The federal criminal statutes enacted under HIPAA which impose criminal liability for knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program; knowingly and willfully embezzling or stealing from a healthcare benefit program; willfully preventing, obstructing, misleading, or delaying a criminal investigation of a healthcare offense; and knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false statements in connection with the delivery of or payment for healthcare benefits, items, or services.
The process required by the FDA before a new drug product may be marketed in the United States generally involves the following: completion of extensive preclinical laboratory tests and preclinical animal studies, all performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations; submission to the FDA of an IND application, which must allow become effective before human clinical trials may begin and must be updated annually; performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the product candidate for each proposed indication; and submission to the FDA of a “new drug application (“NDA”) for a drug, and Biologic License Application (BLA) for biological product, after completion of all pivotal clinical trials. 58 An IND application, while technically a request for a federal approval to transport or distribute a drug across state lines, is, in effect, a request for authorization from the FDA to administer an investigational drug product to humans.
The process required by the FDA before a new drug product may be marketed in the United States generally involves the following: completion of extensive preclinical laboratory tests and preclinical animal studies, all performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations; submission to the FDA of an IND application, which must allow become effective before human clinical trials may begin and must be updated annually; performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the product candidate for each proposed indication; and submission to the FDA of a “new drug application (“NDA”) for a drug, and Biologic License Application (BLA) for biological product, after completion of all pivotal clinical trials. 47 An IND application, while technically a request for a federal approval to transport or distribute a drug across state lines, is, in effect, a request for authorization from the FDA to administer an investigational drug product to humans.
Other potential consequences include, among other things: ● restrictions on the marketing or manufacturing of the product, including total or partial suspension of production, complete withdrawal of the product from the market or product recalls; ● fines, warning letters or holds on post-licensure clinical trials; ● refusal of the FDA to license pending BLAs or supplements, or suspension or revocation of product licensure; ● product seizure or detention, or refusal to permit the import or export of products; ● consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs; ● mandated modification of promotional materials and labeling and the issuance of corrective information; ● the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other safety information about the product; or ● injunctions or the imposition of civil or criminal penalties. 64 The FDA closely regulates marketing, labeling, advertising and promotion of products that are placed on the market.
Other potential consequences include, among other things: ● restrictions on the marketing or manufacturing of the product, including total or partial suspension of production, complete withdrawal of the product from the market or product recalls; ● fines, warning letters or holds on post-licensure clinical trials; ● refusal of the FDA to license pending BLAs or supplements, or suspension or revocation of product licensure; ● product seizure or detention, or refusal to permit the import or export of products; ● consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs; ● mandated modification of promotional materials and labeling and the issuance of corrective information; ● the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other safety information about the product; or ● injunctions or the imposition of civil or criminal penalties. 53 The FDA closely regulates marketing, labeling, advertising and promotion of products that are placed on the market.
Once granted, product licenses may be withdrawn if compliance with regulatory standards is not maintained or problems are identified following initial marketing. 62 If the FDA approves a product, it may limit the approved indications for use for the product; require that contraindications, warnings or precautions be included in the product labeling; require that postmarketing studies, including Phase 4 clinical trials, be conducted to further assess the drug’s safety after licensure; require testing and surveillance programs to monitor the product after commercialization; or impose other conditions, including distribution restrictions or other risk management mechanisms, including REMS, which can materially affect the potential market and profitability of the product.
Once granted, product licenses may be withdrawn if compliance with regulatory standards is not maintained or problems are identified following initial marketing. 51 If the FDA approves a product, it may limit the approved indications for use for the product; require that contraindications, warnings or precautions be included in the product labeling; require that postmarketing studies, including Phase 4 clinical trials, be conducted to further assess the drug’s safety after licensure; require testing and surveillance programs to monitor the product after commercialization; or impose other conditions, including distribution restrictions or other risk management mechanisms, including REMS, which can materially affect the potential market and profitability of the product.
Any such developments could have a material adverse effect on our business. 69 Israel Before an entity or person can conduct clinical testing on humans in Israel, such entity or person must receive special authorization from the ethics committee (also known as a “Helsinki Committee”) and general manager of the institution in which such entity or person intends to conduct its study, as required under the Guidelines for Clinical Trials in Human Subjects implemented pursuant to the Israeli Public Health Regulations (Clinical Trials in Human Subjects), as amended from time to time, and other applicable legislation.
Any such developments could have a material adverse effect on our business. 58 Israel Before an entity or person can conduct clinical testing on humans in Israel, such entity or person must receive special authorization from the ethics committee (also known as a “Helsinki Committee”) and general manager of the institution in which such entity or person intends to conduct its study, as required under the Guidelines for Clinical Trials in Human Subjects implemented pursuant to the Israeli Public Health Regulations (Clinical Trials in Human Subjects), as amended from time to time, and other applicable legislation.
FDA may revoke the Fast Track designation if it believes that the designation is no longer supported by data emerging in the clinical trial process. 60 Under the Breakthrough Therapy program, products intended to treat a serious or life-threatening disease or condition may be eligible for Breakthrough Therapy designation, which includes eligibility for the benefits of the Fast Track program, when preliminary clinical evidence demonstrates that such product may have substantial improvement on one or more clinically significant endpoints over existing therapies.
FDA may revoke the Fast Track designation if it believes that the designation is no longer supported by data emerging in the clinical trial process. 49 Under the Breakthrough Therapy program, products intended to treat a serious or life-threatening disease or condition may be eligible for Breakthrough Therapy designation, which includes eligibility for the benefits of the Fast Track program, when preliminary clinical evidence demonstrates that such product may have substantial improvement on one or more clinically significant endpoints over existing therapies.
Israeli Innovation Authority Since 2006, we have received approximately $6 million in grants to the Israeli Innovation Authority (IIA), formerly known as the Office of the Chief Scientist. The grants were for research and development of M-001.
Israeli Innovation Authority Since 2006, we have received approximately $6.2 million in grants to the Israeli Innovation Authority (IIA), formerly known as the Office of the Chief Scientist. The grants were for research and development of M-001.
There also are continuing annual user fee requirements for any marketed products and the establishments at which such products are manufactured, as well as new application fees for supplemental applications with clinical data. 63 Often times, even after a biological product has been licensed by the FDA for sale, the FDA may require that certain post-licensure requirements be satisfied, including the conduct of additional clinical studies.
There also are continuing annual user fee requirements for any marketed products and the establishments at which such products are manufactured, as well as new application fees for supplemental applications with clinical data. 52 Often times, even after a biological product has been licensed by the FDA for sale, the FDA may require that certain post-licensure requirements be satisfied, including the conduct of additional clinical studies.
This is not a patent term extension, but it effectively extends the regulatory period during which the FDA cannot approve another application. 61 FDA Review of BLAs After completion of the required clinical testing, a BLA is prepared and submitted to the FDA. FDA approval of the BLA is required before marketing of the product may begin in the U.S.
This is not a patent term extension, but it effectively extends the regulatory period during which the FDA cannot approve another application. 50 FDA Review of BLAs After completion of the required clinical testing, a BLA is prepared and submitted to the FDA. FDA approval of the BLA is required before marketing of the product may begin in the U.S.
Such post-market testing may include Phase 4 clinical trials and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization. 59 After regulatory approval of a drug product is obtained, the drug producer is required to comply with a number of post-approval regulations.
Such post-market testing may include Phase 4 clinical trials and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization. 48 After regulatory approval of a drug product is obtained, the drug producer is required to comply with a number of post-approval regulations.
In addition, we face competition from large, fully integrated pharmaceutical companies that are already commercially selling products for the treatment of therapeutic indications that we aim to address. In the case of PC111, the current first-line treatment for P emphigus, is systemic corticosteroids, and the current second-line treatment is Rituximab, sold under the brand name Rituxan ® .
In addition, we face competition from large, fully integrated pharmaceutical companies that are already commercially selling products for the treatment of therapeutic indications that we aim to address. In the case of PC111, the current first-line treatment for Pemphigus, is systemic corticosteroids, and the current second-line treatment is Rituximab, sold under the brand name Rituxan ® .
For reports submitted to CMS on or after January 1, 2022, such obligations will include the reporting of payments and other transfers of value provided in the previous year to certain other healthcare professionals, including physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, anesthesiologist assistants and certified nurse midwives. ● The FDCA and PHSA, which regulate licensure of biological products and prohibit the misbranding and adulteration of biological products. ● Analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply with respect to healthcare items or services reimbursed by non-governmental third party-payors and may be broader than their federal equivalents; state and foreign laws requiring pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and/or the relevant compliance guidance promulgated by the federal government or otherwise restricting payments that may be made to healthcare providers; state laws and regulations requiring drug manufacturer disclosures to state agencies and/or commercial purchasers with respect to certain price increases; state and foreign laws requiring drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers and restricting marketing practices or requiring disclosure of marketing expenditures and pricing information; and state and local laws that requiring registration of pharmaceutical sales representatives. 66 We are also subject to the Foreign Corrupt Practices Act, or FCPA, which prohibits improper payments or offers of payments to foreign governments and their officials for the purpose of obtaining or retaining business.
For reports submitted to CMS on or after January 1, 2022, such obligations will include the reporting of payments and other transfers of value provided in the previous year to certain other healthcare professionals, including physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, anesthesiologist assistants and certified nurse midwives. ● Analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply with respect to healthcare items or services reimbursed by non-governmental third party-payors and may be broader than their federal equivalents; state and foreign laws requiring pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and/or the relevant compliance guidance promulgated by the federal government or otherwise restricting payments that may be made to healthcare providers; state laws and regulations requiring drug manufacturer disclosures to state agencies and/or commercial purchasers with respect to certain price increases; state and foreign laws requiring drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers and restricting marketing practices or requiring disclosure of marketing expenditures and pricing information; and state and local laws that requiring registration of pharmaceutical sales representatives. 55 We are also subject to the Foreign Corrupt Practices Act, or FCPA, which prohibits improper payments or offers of payments to foreign governments and their officials for the purpose of obtaining or retaining business.
Our agent for service of process in the United States is Puglisi & Associates, whose address is 850 Library Avenue, Suite 204, Newark, Delaware, and whose telephone number is (302) 738-6680. Our capital expenditures for twelve months ended December 31, 2024 and December 31, 2023 amounted to approximately $12 and $637 thousand, respectively.
Our agent for service of process in the United States is Puglisi & Associates, whose address is 850 Library Avenue, Suite 204, Newark, Delaware, and whose telephone number is (302) 738-6680. Our capital expenditures for twelve months ended December 31, 2025 and December 31, 2024 amounted to approximately $24 and $12 thousand, respectively.
On March 24, 2025, we acquired a Polish company, Scinai Immunotherapeutics Spółka z ograniczoną odpowiedzialnością, as to serve as our wholly-owned subsidiary in Poland and as an applicant for potential grants under programs established by the Polish government. 71 D.
On March 24, 2025, we acquired a Polish company, Scinai Immunotherapeutics Spółka z ograniczoną odpowiedzialnością, as to serve as our wholly-owned subsidiary in Poland and as an applicant for potential grants under programs established by the Polish government. On February 16, 2026, we acquired Scinai Biopharma, our wholly-owned subsidiary incorporated in Israel.
Abe) in an established SJS/TEN model (induced by patients' PBMCs plus acetaminophen) PC111 group had a significantly (p Competition Generally, our competitors include large, fully integrated pharmaceutical companies as well as companies and academic research institutes in various developmental stages attempting to develop (i) products for the prevention and treatment of disease targets that are the subject of our broader agreement with MPG and UMG, such as psoriasis, atopic dermatitis, asthma and AMD and (ii) the indications targeted by PC111.
Competition Generally, our competitors include large, fully integrated pharmaceutical companies as well as companies and academic research institutes in various developmental stages attempting to develop (i) products for the prevention and treatment of disease targets that are the subject of our broader agreement with MPG and UMG, such as psoriasis, atopic dermatitis, asthma and AMD and (ii) the indications targeted by PC111.
Europe and Other Territories Before obtaining the regulatory approval for a product (FDA or other), we must obtain approval to commence clinical trials. For example, in the European Union, the Clinical Trials Regulation (EU No 536/2014), which became fully applicable on January 31, 2022, harmonizes the processes for assessment and supervision of clinical trials throughout the EU.
Europe and Other Territories Before obtaining regulatory approval for a product, we must obtain authorization to conduct clinical trials. In the European Union, clinical trials are governed by the Clinical Trials Regulation (EU No. 536/2014), which became fully applicable on January 31, 2022.
As part of the abovementioned turnaround, on December 22, 2021, the Company signed a definitive exclusive, worldwide, License Agreement (“LA”) with the Max Planck Society (“MPG”), the parent organization of the Max Planck Institute for Multidisciplinary Sciences (“MPI”), and the University Medical Center Göttingen (“UMG”), both in Gottingen, Germany, for the development and commercialization of innovative NanoAbs for the treatment of COVID-19.
As part of the turnaround, on December 22, 2021, we entered into a definitive exclusive, worldwide license agreement with the Max Planck Society (“MPG”), the parent organization of the Max Planck Institute for Multidisciplinary Sciences (“MPI”), and the University Medical Center Göttingen (“UMG”), for the development and commercialization of NanoAb-based therapeutics targeting COVID-19.
We have the right to license nanobodies against certain other molecular targets on the same terms described above. Environmental Matters We are subject to various environmental, health and safety laws and regulations, including those governing the use, management and disposal of hazardous, and biological materials and wastes and the cleanup of contaminated sites.
Environmental Matters We are subject to various environmental, health and safety laws and regulations, including those governing the use, management and disposal of hazardous and biological materials and wastes and the cleanup of contaminated sites.
In addition, the management team of Pincell will join Scinai’s wholly owned, newly created subsidiary in Poland and Pincell’s founder, Prof. Carlo Pincelli, will join Scinai’s Scientific Advisory Board.
In addition, Pincell’s management team is expected to join a wholly owned subsidiary of the Company in Poland, and Pincell’s founder, Prof. Carlo Pincelli, is expected to join the Company’s Scientific Advisory Board.
The WFI system is controlled and monitored continuously. 57 Research and other Grants Finance Contract with European Investment Bank and Restructuring We borrowed 24 million Euro under a Finance Contract with the EIB, to finance a portion of the cost of developing our previous leading drug candidate M-001and building our GMP biologics manufacturing facility.
Both sites are supported by quality systems, controlled storage areas and infrastructure designed to meet applicable regulatory requirements. 46 Research and other Grants Finance Contract with European Investment Bank and Restructuring We borrowed 24 million Euro under a Finance Contract with the EIB, to finance a portion of the cost of developing our previous leading drug candidate M-001and building our GMP biologics manufacturing facility.
Pursuant to the terms of the license agreement, unless earlier terminated in accordance with the provisions thereof, the license agreement will expire on a product-by-product and country-by-country basis upon the later of (i) the expiration or abandonment of the patent rights that relate to such product in such country and (ii) ten years from the date of first commercial sale of such product in such country.
Under the terms of the agreement, the license continues on a product-by-product and country-by-country basis until the later of (i) the expiration or abandonment of the relevant patent rights in such country and (ii) ten years from the date of first commercial sale of such product in such country.
This regulation allows for a single submission via the Clinical Trials Information System (CTIS) for approval to run a clinical trial in multiple EU countries, streamlining the process. The CTA must be approved by both the national health authority and the independent ethics committee prior to the commencement of a clinical trial in the member state.
This regulation harmonizes the assessment and supervision of clinical trials across EU member states and allows for a single submission through the Clinical Trials Information System (CTIS) for trials conducted in multiple countries. Clinical trial applications must be approved by both the relevant national competent authority and an independent ethics committee prior to initiation.
Fixed Assets Our fixed assets are comprised of factory leasehold improvements, laboratory equipment, furniture, software and improvements in the leased property. The accumulated depreciation as stated in our financial reports is deducted from the fixed assets value.
For the year ended December 31, 2025, cash outflow for our office and laboratory leases amounted to $0.09 million. Our fixed assets are comprised of factory leasehold improvements, laboratory equipment, furniture and software. The accumulated depreciation as stated in our financial reports is deducted from the fixed assets value.
Intellectual Property We license the core intellectual property for our NanoAbs program from MPG under an exclusive license agreement, pursuant to which we received an exclusive worldwide license for the development and commercialization of NanoAbs based on certain patents and intellectual property owned by MPG and related thereto.
NanoAbs Platform We license the core intellectual property for our NanoAbs program from the Max Planck Society (MPG) under an exclusive license agreement. This agreement provides us with an exclusive, worldwide license to develop and commercialize NanoAbs based on certain patents and related intellectual property owned by MPG.
On March 23, 2022, we signed a five-year Research Collaboration Agreement (“RCA”; collectively, with the LA and aRCA, the “MPG/UMG Agreements”) with MPG and UMG covering the discovery, selection and characterization of NanoAbs for up to nine molecular targets that have the potential to be further developed into drug candidates for the treatment of disease indications such as plaque psoriasis, psoriatic arthritis, asthma and wet macular degeneration.
On March 23, 2022, we entered into a five-year Research Collaboration Agreement (the “RCA”) with MPG and UMG, covering the discovery, selection and characterization of NanoAbs directed against up to nine molecular targets across multiple indications, including plaque psoriasis, psoriatic arthritis, asthma and wet macular degeneration.
If such share sale and transfer is exercised, Pincell’s current shareholders will be eligible for development milestone payments, pass through payments from sublicenses with a staggered percentage based on the stage of development at the time of the sublicense, and royalties out of future net sales of PC111 in the low single digits.
If the option is exercised and the acquisition is completed, Pincell’s shareholders will be eligible for development milestone payments, sublicense-related payments based on the stage of development at the time of such sublicense, and royalties on future net sales of PC111 in the low single-digit range.
SCINAI has no affiliation with and is not endorsed by Sanofi. We have also established our CDMO business unit to take advantage of our laboratory and manufacturing capacity at our cGMP facility in Jerusalem.
“Nanobody” is a registered trademark of ABLYNX N.V., a wholly owned subsidiary of Sanofi. We have no affiliation with, and are not endorsed by, Sanofi. In parallel, we established our CDMO business unit to leverage our laboratory and manufacturing capabilities at our cGMP facility in Jerusalem.
As mentioned above, on June 5, 2023, we signed an exclusive worldwide license agreement to develop and commercialize VHH antibodies (NanoAbs) targeting Interleukin-17 (IL-17) as treatments for all potential indications, starting with psoriasis and psoriatic arthritis.
On June 5, 2023, as part of this collaboration, we entered into an exclusive worldwide license agreement to develop and commercialize NanoAbs targeting Interleukin-17 (IL-17) across multiple potential indications, initially focusing on psoriasis and psoriatic arthritis.
We have manufactured the COVID-19 and IL-17 NanoAbs for our preclinical in vivo studies in our facility, and although we currently anticipate using our facility for future manufacturing of product candidates, we may also rely on a third party CMO for commercial manufacturing. 56 Properties Office Leasing Agreement We lease approximately 1,850 square meters (20,000 square feet) in the Jerusalem BioPark, located in the Ein Kerem Hadassah campus, next to Hadassah University Hospital and Hebrew University’s Medical School.
We have manufactured the COVID-19 and IL-17 NanoAbs for our preclinical in vivo studies in our facility, and although we currently anticipate using our facility for future manufacturing of product candidates, we may also rely on a third party CMO for commercial manufacturing.
Our fixed assets are comprised of factory leasehold improvements, laboratory equipment, furniture and software. The accumulated depreciation as stated in our financial reports is deducted from the fixed assets value. Our fixed assets, less deduction for the accumulated depreciation, were $9.2 million as of December 31, 2024 and $10.8 million as of December 31, 2023.
The accumulated depreciation as stated in our financial statements is deducted from the gross value of fixed assets. Our fixed assets, net of accumulated depreciation, were $7.8 million as of December 31, 2025 and $9.2 million as of December 31, 2024.
We recently filed new patents for a novel NanoAb targeting IL-13 and, as per the RCA, we have an exclusive option to execute an exclusive license for this drug candidate for a worldwide development and commercialization rights at pre-agreed financial terms.
In addition, we have filed new patent applications for a NanoAb targeting IL-13 and, under the RCA, we hold an exclusive option to enter into a worldwide license agreement for its development and commercialization under pre-agreed financial terms.
Such requirements include either the award of a grant to our wholly owned Polish subsidiary under the European Funds for a Modern Economy (FENG) program in Poland referred to below or our securing $3 million.
These conditions include receipt of Golden Power regulatory clearance by the Italian government and the fulfillment of specified funding requirements, consisting of either obtaining a grant award under the European Funds for a Modern Economy (FENG) program for our wholly owned Polish subsidiary or securing $3 million to fund the development of PC111.
We perform our CDMO services at our approximately 1,850 square meters (20,000 square feet) facility which we lease in the Jerusalem BioPark, located in the Ein Kerem Hadassah campus, next to Hadassah University Hospital and the Hebrew University’s Medical School.
We lease approximately 1,850 square meters (approximately 20,000 square feet) in the Jerusalem BioPark, located on the Ein Kerem Hadassah campus, adjacent to Hadassah University Hospital and the Hebrew University Medical School. The lease expires on December 31, 2032. The Jerusalem facility is focused on biologics development and clinical-stage manufacturing and includes laboratories, offices, and cGMP manufacturing suites.
Utilizing advanced laboratories and a cGMP pilot plant designed to meet EMA and FDA regulatory standards, we provide upstream and downstream process development, process optimization and scale-up, cGMP manufacturing, fill & finish operations, analytical method development, and GMP quality control, all supported by a robust quality management system. 52 Our manufacturing facility features modular, single-use infrastructure, enhancing flexibility, reducing changeover time, and lowering costs associated with cleaning and QC testing.
Our capabilities include upstream and downstream process development, process optimization and scale-up, cGMP manufacturing, fill and finish operations, analytical method development and GMP quality control, all supported by a comprehensive quality management system. Our manufacturing infrastructure incorporates modular, single-use technologies that provide operational flexibility, reduce changeover time and associated costs, and support efficient clinical manufacturing.
On March 27, 2025, we announced that we had entered into a binding option agreement for the acquisition of the Italian biotech company Pincell srl, the owner of PC111, a monoclonal antibody in development for treating Pemphigus, Steven Johnson’s Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
Furthermore, we expect to apply for funding under the European Funds for a Modern Economy (FENG) program to support the development of a multi-specific antibody targeting TH2-related diseases, including asthma, atopic dermatitis and COPD. 39 PC111 On March 27, 2025, we announced that we had entered into a binding option agreement for the acquisition of the Italian biotech company Pincell S.r.l., the owner of PC111, a fully human monoclonal antibody in development for the treatment of pemphigus, Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
After receiving the phase 3 trial results in Q4 2020, indicating that M-001 did not meet its clinical endpoints, we performed a turnaround process that included raising fresh capital, hiring new talent (including a new CEO), signing a research collaboration agreement with and in-licensing new intellectual property from world leading academic research institutes.
Following the Phase 3 results in the fourth quarter of 2020, which did not meet the primary clinical endpoints, the Company implemented a strategic turnaround. This process included raising additional capital, strengthening management (including the appointment of a new CEO), entering into a research collaboration agreement, and in-licensing new intellectual property from leading academic institutions.
Property, Plants and Equipment Our principal executive offices and main laboratory are located at Jerusalem BioPark, 2nd floor, Hadassah Ein Kerem Campus, Jerusalem, Israel, next to Hadassah University Hospitals and Hebrew University’s Medical School. For the year ended December 31, 2024, cash outflow for our office and laboratory leases amounted to $0.4 million.
Scinai Biopharma operates a cGMP manufacturing site, providing early chemistry development and small-scale manufacturing of active pharmaceutical ingredients (APIs) for biopharmaceutical customers’ clinical programs. 60 D. Property, Plants and Equipment Our principal executive offices and main laboratory are located at Jerusalem BioPark, 2nd floor, Hadassah Ein Kerem Campus, Jerusalem, Israel, next to Hadassah University Hospitals and Hebrew University’s Medical School.
Our fixed assets, less deduction for the accumulated depreciation, were $9.2 million for the year ended December 31, 2024 and $10.8 million for the year ended December 31, 2023. Our Main Laboratory Our facility in Jerusalem consists of laboratories, manufacturing suites, and offices.
Our fixed assets, less deduction for the accumulated depreciation, were $7.8 million as of December 31, 2025 and $9.2 million as of December 31, 2024. For a description of our current laboratory see Item 4B. “Business Overview – Properties”.
Pemphigus is a rare autoimmune blistering disease of the skin and mucous membranes with the incidence of new cases ranging between 0.5 and 3.0 new cases per year per 100,000 people and prevalence of between 15 to 30 per 100,000 people at any point in time.
Pemphigus is a chronic autoimmune blistering disease with an incidence of approximately 0.5 to 3.0 cases per 100,000 people annually and a prevalence of 15 to 30 per 100,000 people. The disease often requires long-term immunosuppressive treatment, has a substantial impact on quality of life and may be life-threatening without treatment.
Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis are rare but severe mucocutaneous reactions and are both part of the same disease spectrum, which is a serious reaction to medications. SJS has an incidence rate of between one and six cases per million people annually, and TEN has an incidence rate of 0.4 to 1.2 cases per million people annually.
SJS and TEN are severe mucocutaneous reactions, typically triggered by medications, with an incidence of approximately one to six cases per million people annually for SJS and 0.4 to 1.2 cases per million for TEN. These conditions are characterized by widespread epidermal cell death and skin detachment.
Pursuant to the terms of the option agreement, we have the right to exercise, at our sole discretion (pending our satisfaction of closing requirements and approval of the Golden Power regulatory clearance by the Italian government), a full sale and transfer of Pincell’s shares by the end of 2025.
PC111 targets soluble Fas ligand (FasL) and is designed to inhibit apoptosis of keratinocytes, a pathway implicated in severe skin blistering disorders. Pursuant to the terms of the option agreement, we have the right to exercise, at our sole discretion, a full transfer of Pincell’s shares, subject to the satisfaction of certain closing conditions.
Since then, we are in the process of developing a pipeline of diversified and commercially viable products built around innovative nanosized antibodies (NanoAb). NanoAbs are nanosized antibody fragments derived from camelid animals and are also known as VHH-antibodies or Nanobodies. “Nanobody” is a trademark registered by ABLYNX N.V., a wholly owned subsidiary of Sanofi.
Since then, we have been developing a pipeline of diversified product candidates based on nanosized antibody fragments (NanoAbs), as well as, more recently, additional molecules that we may acquire, such as the antibody PC111. NanoAbs are nanosized antibody fragments derived from camelid animals, also referred to as VHH antibodies or Nanobodies.
Pincell has carried out a large number of in-vitro, ex-vivo and in-vivo experiments using PC111 without steroids in validated models of pemphigus, to prove that soluble FasL is a critical target in this disease.
Pincell has developed a proprietary humanized FasL mouse model and has conducted in vitro, ex vivo and in vivo studies supporting the role of soluble FasL as a therapeutic target. In preclinical models of pemphigus, PC111 has been shown to inhibit blister formation without the use of steroids.
Under current law enacted as part of the ACA, drug manufacturers’ MDRP rebate liability is capped at 100% of AMP for a covered outpatient drug. 68 The cost of prescription drugs has been the subject of considerable policy discussion and debate in the U.S.
In the future, there may be additional challenges and/or amendments to the ACA. 57 The cost of prescription drugs has been the subject of considerable policy discussion and debate in the U.S.
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These expenditures were primarily for factory leasehold improvements, computers and laboratory equipment. B.
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These expenditures were primarily for factory leasehold improvements, computers and laboratory equipment. B. Business Overview We are a biopharmaceutical company with two complementary business units: (i) Scinai R&D, focused on the development of innovative therapeutics in inflammation and immunology, and (ii) our contract development and manufacturing organization (CDMO) business, which operates through our subsidiary, Scinai Biopharma Services Ltd.
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Business Overview We are a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products beginning with an innovative, de-risked, pipeline of nanosized VHH antibodies (NanoAbs) targeting diseases with large unmet medical needs, and the other a boutique CDMO providing services to help biotech companies efficiently bring their products to by leveraging Scinai’s drug development and GMP and non-GMP manufacturing capabilities for pre-clinical and clinical studies.
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Our R&D activities are centered around two pillars: ● PC111 Program – In 2025, we entered into an option agreement, as amended on September 11, 2025 and February 28, 2026, to acquire Pincell S.r.l., an Italian biotechnology company and the owner of PC111, a fully human monoclonal antibody targeting pathways involved in keratinocyte cell death and inflammation, with potential applications in severe dermatological conditions. ● NanoAbs Platform – We are developing a pipeline of novel therapeutics based on NanoAbs (VHH antibody fragments), which possess unique physicochemical properties and are suitable for advanced mono- and multi-specific antibody formats.
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We have also recently signed an option agreement to acquire the Italian biotech company, Pincell srl, the owner of PC111, a fully human, monoclonal antibody that blocks its activation of apoptosis of skin cells (keratinocytes). 46 Development of I&I biological therapeutic products NanoAbs Since inception, we have executed eight clinical trials including a seven country, 12,400 participant phase 3 trial of our prior lead drug candidate, a universal influenza vaccine candidate (“M-001”) and have built a GMP biologics manufacturing facility for biopharmaceutical products.
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Our NanoAbs activities are conducted in collaboration with the Max Planck Society (“MPG”), including the Max Planck Institute for Multidisciplinary Sciences (“MPI-MS”), and the University Medical Center Göttingen (“UMG”) in Germany. We continue to evaluate and in-license or acquire additional therapeutic assets aligned with our focus areas.
Removed
The agreement provides for an upfront payment, development and sales milestones and royalties based on sales and sharing of sublicense revenues. In addition, the Company signed an accompanying Research Collaboration Agreement (“aRCA”) with MPG and UMG in support of the abovementioned development of a COVID-19 NanoAb by MPI and UMG.
Added
In addition, we are currently evaluating the development strategy for our IL-17 program in light of scientific, technical and market considerations, including the evolving competitive landscape for IL-17-targeting therapies. As part of this process, we are assessing alternative approaches and prioritization of our R&D programs.
Removed
The aRCA provided for monthly payments to MPG and UMG and had a term until the earlier of two years or the date the Company enters into first in-human clinical trials with the COVID-19 NanoAb. Consequently with our decision to put the COVID19 Nanoab for partnering, we have agreed with MPG/UMG to stop the aRCA.
Added
Our CDMO business provides integrated development and manufacturing services to small and emerging biotech companies, supporting clients from early-stage development through clinical-stage production.
Removed
These are all large and growing markets with underserved medical needs. In each case, the molecular target has been validated as an appropriate target for therapeutic intervention through inhibition by an antibody, thereby significantly reducing the discovery work that typically entails many years of research, high cost and high risk of failure.
Added
Following our acquisition of Recipharm Israel Ltd. on February 17, 2026 (subsequently renamed Scinai Biopharma Services Ltd.), we are in the process of consolidating our CDMO activities under this subsidiary, including the planned transfer of certain CDMO-related assets, operations and employees pursuant to Section 104 of the Israeli Income Tax Ordinance, subject to applicable approvals and implementation.
Removed
We believe that we can leverage our NanoAbs’ unique and strong binding affinity, stability at high temperatures, and potential for more effective and convenient routes of administration towards competitive commercial viability.
Added
Under our license agreements with MPG and UMG, certain development milestones apply, including the submission of an Investigational New Drug (IND) application within specified timelines. We have requested extensions to the applicable IND submission deadlines in order to support modifications to our development strategy. There can be no assurance that such extensions will be granted or on what terms.
Removed
We believe that since these are clinical validated targets, we can develop NanoAb treatments with reduced risk and cost and accelerate the time from NanoAb selection to initiation of clinical development. Each NanoAb candidate is therefore positioned as a “biobetter” piggybacking on prior discoveries of others to mitigate risk but with significant potential advantages over existing therapeutics.
Added
In addition, we are currently evaluating the development strategy for our IL-17 program in light of scientific, technical and market considerations, including the evolving competitive landscape for IL-17-targeting therapies.
Removed
In addition, while each NanoAb constitutes a novel molecule for which we file patent applications thereby creating a proprietary position, all of the developed NanoAbs when viewed together constitute a pipeline that is built around the same drug discovery, development and manufacturing platform allowing us to reduce risks and save costs.
Added
As part of this process, we are assessing alternative approaches and prioritization of our R&D programs. 38 Development of I&I biological therapeutic products NanoAbs Since inception, we have conducted eight clinical trials, including a Phase 3 trial of our former lead product candidate, M-001, a universal influenza vaccine, which enrolled approximately 12,400 participants across seven countries.
Removed
We have the exclusive option for an exclusive, pre-negotiated worldwide license agreement for the development and commercialization of each of the NanoAbs covered by the RCA with MPG and UMG.
Added
The agreement included upfront payments, development and commercial milestones, and royalties. In addition, we entered into a related research collaboration agreement to support development activities conducted by MPI and UMG. This collaboration included monthly payments and was intended to continue until the earlier of two years or the initiation of first-in-human clinical trials.
Removed
On June 5, 2023, we announced that as part of our ongoing broad-based collaboration with the Max Planck Society and the University Medical Center Gottingen (UMG), we signed an exclusive worldwide license agreement to develop and commercialize VHH antibodies (NanoAbs) targeting Interleukin-17 (IL-17) as treatments for all potential indications, starting with psoriasis and psoriatic arthritis. 47 In June 2023, we disclosed that we were ceasing active development of our COVID-19 program due to ongoing generation of variants of the coronavirus, difficulty in identifying a broad spectrum NanoAb and a significant reduction in both market interest in a COVID-19 therapeutic and funding.
Added
Following our decision to pursue partnering opportunities for the COVID-19 program, we agreed with MPG and UMG to terminate this research collaboration.
Removed
As a result, we would expect any continued development to be based on finding a strategic partnership for our COVID-19 self-administered inhaled NanoAb therapeutic/prophylactic which demonstrated highly promising in vivo results in animals and that we will focus on developing the anti-IL-17 NanoAb.
Added
These targets are clinically validated for antibody-based intervention, which we believe reduces discovery risk and may shorten development timelines. We believe that NanoAbs offer advantages such as strong binding affinity, thermal stability, and potential flexibility in routes of administration.
Removed
On June 4, 2024, the Company met for a scientific advisory meeting with the Paul Erlich Institute (the PEI) of Germany, the scientific advice of which is considered acceptable guidance for IMPD filing with the European Medicines Agency (EMA) and is also considered the European comparable to a pre-IND meeting with the FDA in the U.S.
Added
Each NanoAb candidate is intended to represent a novel molecule, supported by patent filings, while collectively forming a pipeline based on a shared discovery, development and manufacturing platform. Under the RCA, we hold an exclusive option to enter into pre-negotiated worldwide license agreements for the development and commercialization of each NanoAb candidate.
Removed
Consequently, on July 23, 2024, the Company announced the receipt of positive regulatory feedback from the PEI for its drug development program towards Phase 1/2a clinical trial of its anti-IL-17A/F nanoAb (SCN-1) in Plaque Psoriasis.
Added
In June 2023, we also announced the cessation of active development of our COVID-19 NanoAb program, due to evolving viral variants, challenges in achieving broad-spectrum activity, and reduced market and funding interest. Any further development of this program would be subject to securing a strategic partner.
Removed
The Phase 1/2a study is expected to include approximately 24 plaque psoriasis patients and is expected to commence in the second half of 2026 with readout in 2027.
Added
We are currently advancing our IL-17 NanoAb program with two product profiles in development, subject to ongoing evaluation of development strategy and positioning within the competitive landscape for IL-17-targeting therapies. The first is an intradermal IL-17A/F NanoAb designed for localized treatment of mild-to-moderate psoriasis, targeting patients with limited but clinically meaningful disease.
Removed
On July 15, 2024, we announced a successful in-vivo preclinical study results of our innovative anti IL-17A/F VHH antibody fragment (NanoAb) as a local, first of its kind, intralesional biological treatment for the large and underserved population of patients suffering from mild to moderate plaque psoriasis.
Added
This approach is intended to enable localized delivery with minimal systemic exposure and is supported by translational data. The second program is a bispecific IL-17A/F NanoAb combined with an additional target (VHH-Fc format), designed as a long-acting systemic therapy for moderate-to-severe inflammatory and immunology indications, including psoriasis, psoriatic arthritis, hidradenitis suppurativa (HS) and other related conditions.
Removed
The study aimed to demonstrate that local, intralesional treatment with Scinai’s NanoAb, which targets the two isoforms of the cytokine IL-17 (A and F) implicated in plaque psoriasis, has at least a non-inferior anti-inflammatory effect on the psoriatic lesions compared to corticosteroids and systemic biologics.
Added
This approach is intended to leverage a multi-specific antibody design to enhance biological activity and extend half-life.

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Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

48 edited+26 added−24 removed42 unchanged
Biggest changeMarketing, General and Administrative Expenses Our marketing, general and administrative expenses consist primarily of salaries and expenses related to employee benefits, including share-based compensation, for our general and administrative employees, which includes employees in executive and operational roles, including finance and human resources, as well as consulting, legal and professional services related to our general and administrative operations.
Biggest changeThis group which includes employees in executive, operational, finance, and human resources roles. In addition, these expenses include consulting, legal, and other professional services related to general and administrative operations, business development, as well as costs associated with conferences and investor relations activities.
Each unit consisted of one ADS and two warrants, each to purchase one ADS, and each pre-funded unit consisted of one pre-funded warrant to purchase one ADS and two warrants each to purchase one ADS.
Each unit consisted of one ADS and two warrants, , and each pre-funded unit consisted of one pre-funded warrant to purchase one ADS and two warrants.
Because of the risk factors set forth above in “Risk Factors”, we are not able to estimate with any certainty when we would recognize any net cash inflows from our projects. Developing bio-pharmaceutical products, conducting clinical trials, obtaining commercial manufacturing capabilities and commercializing products is expensive and we will need to raise substantial additional funds to achieve our strategic objectives.
Because of the risk factors set forth above in “Risk Factors”, we are not able to estimate with any certainty when we will recognize any net cash inflows from our projects. Developing bio-pharmaceutical products, conducting clinical trials, obtaining commercial manufacturing capabilities and commercializing products is expensive and we will need to raise substantial additional funds to achieve our strategic objectives.
Our future capital requirements will depend on many factors, including: ● the progress and costs of our clinical trials and other research and development activities; 74 ● the scope, prioritization and number of our clinical trials and other research and development programs; ● the amount of revenues and contributions we receive under future licensing, collaboration, development and commercialization arrangements with respect to our Company product candidates; ● the costs of the development and expansion of our operational infrastructure; ● the costs and timing of obtaining regulatory approvals for our Company product candidates; ● the ability of us, or our collaborators, to achieve development milestones, marketing approvals and other events or developments under our potential future licensing agreements; ● the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights; ● the costs and timing of building and securing manufacturing arrangements for clinical or commercial production; ● the costs of contracting with third parties to provide sales and marketing capabilities for us or establishing such capabilities ourselves; ● the costs of acquiring or undertaking development and commercialization efforts for any Company product candidate or platforms; ● the magnitude of our general and administrative expenses; and ● any cost that we may incur under future in- and out-licensing arrangements relating to one or more of our Company product candidates.
Our future capital requirements will depend on many factors, including: ● the progress and costs of our clinical trials and other research and development activities; 63 ● the scope, prioritization and number of our clinical trials and other research and development programs; ● the amount of revenues and contributions we receive under future licensing, collaboration, development and commercialization arrangements with respect to our Company product candidates; ● the costs of the development and expansion of our operational infrastructure; ● the costs and timing of obtaining regulatory approvals for our Company product candidates; ● the ability of us, or our collaborators, to achieve development milestones, marketing approvals and other events or developments under our potential future licensing agreements; ● the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights; ● the costs and timing of building and securing manufacturing arrangements for clinical or commercial production; ● the costs of contracting with third parties to provide sales and marketing capabilities for us or establishing such capabilities ourselves; ● the costs of acquiring or undertaking development and commercialization efforts for any Company product candidate or platforms; ● the magnitude of our general and administrative expenses; and ● any cost that we may incur under future in- and out-licensing arrangements relating to one or more of our Company product candidates.
SCINAI has no affiliation with and is not endorsed by Sanofi. 72 As part of the abovementioned turnaround, on December 22, 2021, the Company signed a definitive exclusive, worldwide, License Agreement (“LA”) with the Max Planck Society (“MPG”), the parent organization of the Max Planck Institute for Multidisciplinary Sciences (“MPI”), and the University Medical Center Göttingen (“UMG”), both in Gottingen, Germany, for the development and commercialization of innovative NanoAbs for the treatment of COVID-19.
SCINAI has no affiliation with and is not endorsed by Sanofi. 61 As part of the abovementioned turnaround, on December 22, 2021, the Company signed a definitive exclusive, worldwide, License Agreement (“LA”) with the Max Planck Society (“MPG”), the parent organization of the Max Planck Institute for Multidisciplinary Sciences (“MPI”), and the University Medical Center Göttingen (“UMG”), both in Gottingen, Germany, for the development and commercialization of innovative NanoAbs for the treatment of COVID-19.
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value (note 4) The carrying amounts of cash and cash equivalents, restricted cash, trade receivables, prepaid expenses and other receivables, trade payables and other current payables approximate their fair value due to the short-term maturity of such instruments. 80
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value (note 4) The carrying amounts of cash and cash equivalents, restricted cash, trade receivables, prepaid expenses and other receivables, trade payables and other current payables approximate their fair value due to the short-term maturity of such instruments. 69
The financial statements for the year ended December 31, 2024, do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from uncertainty related to the Company’s ability to continue as a going concern.
The financial statements for the year ended December 31, 2025, do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from uncertainty related to the Company’s ability to continue as a going concern.
Research and development grants received from the European Union and from the IIA are recorded against a corresponding reduction in research and development expenses. Taxes on Income Israeli resident companies, such as the Company, are generally subject to corporate tax at the rate of 23% as of 2024.
Research and development grants received from the European Union and from the IIA are recorded against a corresponding reduction in research and development expenses. Taxes on Income Israeli resident companies, such as the Company, are generally subject to corporate tax at the rate of 23% as of 2025.
Item 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS A. Operating Results The information contained in this section should be read in conjunction with our consolidated financial statements for the year ended December 31, 2024 and related notes and the information contained elsewhere in this annual report.
Item 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS A. Operating Results The information contained in this section should be read in conjunction with our consolidated financial statements for the year ended December 31, 2025 and related notes and the information contained elsewhere in this annual report.
Our ability to generate positive cashflows from such facility may impact the recoverability of such assets and may trigger future impairment to such facility. During the years ended December 31, 2024 and 2023, no impairment indicators were recognized.
Our ability to generate positive cashflows from such facility may impact the recoverability of such assets and may trigger future impairment to such facility. During the years ended December 31, 2025 and 2024, no impairment indicators were recognized.
Information regarding the outstanding loan from the EIB is set forth above in “ Research and other Grants: Finance Contract - European Investment Bank.” As of December 31, 2024, we had cash and cash equivalents and short-term deposits of $1.9 million as compared to $4.9 million as of December 31, 2023.
Information regarding the outstanding loan from the EIB is set forth above in “ Research and other Grants: Finance Contract - European Investment Bank.” As of December 31, 2025, we had cash and cash equivalents and short-term deposits of $1.6 million as compared to $1.9 million as of December 31, 2024.
Liquidity and Capital Resources Since our inception, we have funded our operations primarily through public and private offerings of our equity securities in Israel and the U.S., grants from the OCS (today known as the IIA), grants received by the Israeli Ministry of Economy and European grants under the UNISEC consortium and the loan from the EIB.
Liquidity and Capital Resources Since our inception, we have funded our operations primarily through public and private offerings of our equity securities in Israel and the U.S., grants from the IIA, grants received by the Israeli Ministry of Economy and European grants under the UNISEC consortium and the loan from the EIB.
Research and development grants received from the OCS, today known as the IIA, are recognized upon receipt as a liability if future economic benefits are expected from the project that will result in royalty-bearing sales.
Research and development grants received from the IIA are recognized upon receipt as a liability if future economic benefits are expected from the project that will result in royalty-bearing sales.
The purchase price of the ADSs that we may direct YA to purchase from time to time under the Purchase Agreement will be equal to 97% of the lowest daily volume weighted average price (VWAP) during the three consecutive trading day period commencing on the date that we deliver any Advance Notice to YA.
The purchase price of the ADSs that we may direct YA to purchase from time to time under the March 2025 SEPA will be equal to 97% of the lowest daily volume weighted average price (VWAP) during the three consecutive trading day period commencing on the date that we deliver any Advance Notice to YA.
(“YA”), pursuant to which YA has committed to purchase up to $10.0 million of ADSs, or the Commitment Amount, at our direction from time to time, subject to the restrictions and satisfaction of the conditions in the Purchase Agreement, during the period commencing on the date of execution of the Purchase Agreement until the earlier of (i) the 36-month anniversary of the date of execution of the Purchase Agreement, and (ii) YA’s purchase of the total Commitment Amount under the Purchase Agreement, such period the Commitment Period.
(“YA”), pursuant to which YA has committed to purchase up to $10.0 million of ADSs, or the First Commitment Amount, at our direction from time to time, subject to the restrictions and satisfaction of the conditions in the March 2025 SEPA, during the period commencing on the date of execution of the March 2025 SEPA until the earlier of (i) the 36-month anniversary of the date of execution of the March 2025 SEPA, and (ii) YA’s purchase of the total First Commitment Amount under the March 2025 SEPA, such period the First Commitment Period.
YA has no right to require us to sell any ADSs to YA, but YA is obligated to make purchases of the ADSs as directed by us, subject to the restrictions and satisfaction of conditions set forth in the Purchase Agreement upon receipt of a notice sent by us to YA setting forth the number of ADSs that we desire to issue and sell to YA, or an Advance Notice.
YA has no right to require us to sell any ADSs to YA, but YA is obligated to make purchases of the ADSs as directed by us, subject to the restrictions and satisfaction of conditions set forth in the March 2025 SEPA upon receipt of a notice sent by us to YA setting forth the number of ADSs that we desire to issue and sell to YA, or an Advance Notice.
Our research and development expenses consist primarily of salaries and related personnel expenses, fees paid to consultants, patent-related legal fees, costs of preclinical studies and clinical studies, drug and laboratory supplies, and costs for facilities and equipment. We charge all research and development expenses to operations as they are incurred.
Our research and development expenses consist primarily of expenses related to our Research Collaboration Agreement, fees paid to consultants, patent-related legal fees, costs of preclinical studies and clinical studies, drug and laboratory supplies, and costs for facilities and equipment. We charge all research and development expenses to operations as they are incurred.
Each ADS (or pre-funded warrant) was sold together with two warrants at a combined purchase price of $50.00 per unit (or $49.99 per pre-funded unit after reducing $0.001 attributable to the exercise price of the pre-funded warrants).
Each ADS (or pre-funded warrant) was sold together with two warrants at a combined purchase price of $50.00 per unit (or $49.99 per pre-funded unit after reducing $0.001 attributable to the exercise price of the pre-funded warrant). All the warrants have since expired.
We filed a registration statement on Form F-1 to register the resale of up to 3,022,796 ADSs issuable to YA under the Purchase Agreement from time to time during the Commitment Period (including the Commitment Shares), subject to the restrictions and satisfaction of the conditions in the Purchase Agreement, if and when we determine to sell additional ADSs to YA under the Purchase Agreement.
We filed a registration statement on Form F-1 to register the resale of up to 3,022,796 ADSs issuable to YA under the March 2025 SEPA from time to time during the First Commitment Period (including the Commitment Shares), subject to the restrictions and satisfaction of the conditions in the March 2025 SEPA, if and when we determine to sell additional ADSs to YA under the March 2025 SEPA.
As a result of the failure of the Phase 3 clinical trial, the Company’s management estimates that there will be no future revenues from M-001. Therefore, most likely, there will be no future royalty payments to the Israel Innovation Authority (“IIA”).
As a result of the failure of the Phase 3 clinical trial, the Company’s management estimates that there will be no future revenues from M-001. Therefore, most likely, there will be no future royalty payments to the IIA.
Pursuant to the terms of the Purchase Agreement, we issued 28,784 ADSs (the “Commitment Shares”) to YA as consideration for its irrevocable commitment to purchase the Advance Shares under the Purchase Agreement.
Pursuant to the terms of the March 2025 SEPA, we issued 28,784 ADSs (the “Commitment Shares”) to YA as consideration for its irrevocable commitment to purchase the Advance Shares under the March 2025 SEPA.
Under Israeli tax legislation, a corporation will be considered as an “Israeli Resident” if it meets one of the following: (a) it was incorporated in Israel; or (b) the control and management of its business are exercised in Israel. Year Ended December 31, 2024 Compared to Year Ended December 31, 2023 Research and Development Expenses, net Research and development expenses.
Under Israeli tax legislation, a corporation will be considered as an “Israeli Resident” if it meets one of the following: (a) it was incorporated in Israel; or (b) the control and management of its business are exercised in Israel. Year Ended December 31, 2025 Compared to Year Ended December 31, 2024 Revenues Revenues.
See Item 5 of the Company’s Annual Report on Form 20-F for the year ended December 31, 2023.
Year Ended December 31, 2025 Compared to Year Ended December 31, 2024. See Item 5 of the Company’s Annual Report on Form 20-F for the year ended December 31, 2024.
On March 3, 2025, we entered into the Standby Equity Purchase Agreement (“Purchase Agreement”) with YA II PN, Ltd.
March 2025 Standby Equity Purchase Agreement On March 3, 2025, we entered into a Standby Equity Purchase Agreement (the “March 2025 SEPA”) with YA II PN, Ltd.
Our cash and cash equivalents are denominated in US dollars. Net cash used in operating activities was $6.3 million for the year ended December 31, 2024, compared with net cash used in operating activities of $9.4 million for the year ended December 31, 2023.
Our cash and cash equivalents are denominated in U.S. dollars. Net cash used in operating activities was $6.0 million for the year ended December 31, 2025, compared with net cash used in operating activities of $6.3 million for the year ended December 31, 2024.
Net cash used by investing activities for the year ended December 31, 2024 was $0.01 million compared with net cash used by investing activities of $0.64 million for the year ended December 31, 2023, and primarily reflects purchase of property, plant and equipment.
Net cash used by investing activities for the year ended December 31, 2025 was $0.024 million, consisting primarily of purchase of property, plant and equipment compared with net cash used by investing activities of $0.012 million for the year ended December 31, 2024.
These expenses represent the allocation of the cost of our manufacturing facilities, which are utilized to generate our CDMO revenues, over their estimated useful lives, and constitute a significant portion of our operational costs Operating Expenses our Operating expenses consist primarily of Deprciation,.
These expenses represent the allocation of the cost of our manufacturing facilities, which are utilized to generate our CDMO revenues, over their estimated useful lives, and constitute a significant portion of our operational costs. Operating Expenses Our operating expenses consist primarily of salary and related personnel expenses, Research Collaboration Agreement costs, depreciation and professional services. Research and development expenses.
Financial expenses consist primarily of expenses related to bank charges foreign currency exchange expense and expenses in respect of EIB. 75 Participation by Third Parties Our research and development expenses are net of certain participations by third parties.
Financial expenses consist primarily of expenses related to bank charges, foreign currency exchange, SEPA expenses and issuance costs. 64 Participation by Third Parties Our research and development expenses are net of certain participations by third parties.
The Company received gross proceeds of $9.020 million and a net sum of $8.817 million after deduction of issuance expenses. On December 20, 2022, we closed an underwritten offering in which we sold 160,000 units and pre-funded units.
On December 20, 2022, we closed an underwritten offering in which we sold 160,000 units and pre-funded units resulting in gross proceeds of $7.3 million and a net sum of $7.2 million after deduction of issuance expenses.
We received gross proceeds of approximately $1.33 million and a net sum of approximately $1.0 million after deduction of placement agent fees and issuance expenses. 78 On January 4, 2024, we closed an offering in which we issued new unregistered warrants to purchase up to 521,310 ADSs in consideration for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 260,655 ADSs, issued by us in September 2023 and December 2022, at a reduced exercise price of $6.50 per ADS.
On January 4, 2024, we closed an offering in which we issued new unregistered warrants to purchase up to 521,310 ADSs in consideration for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 260,655 ADSs, issued by us in September 2023 and December 2022, at a reduced exercise price of $6.50 per ADS.
On March 23, 2022, we signed a five-year Research Collaboration Agreement (“RCA”; collectively, with the LA and aRCA, the “MPG/UMG Agreements”) with MPG and UMG covering the discovery, selection and characterization of NanoAbs for up to nine molecular targets that have the potential to be further developed into drug candidates for the treatment of disease indications such as psoriasis, psoriatic arthritis, asthma and wet macular degeneration.
On March 23, 2022, we signed a five-year Research Collaboration Agreement (“RCA”; collectively, with the LA and aRCA, the “MPG/UMG Agreements”) with MPG and UMG covering the discovery, selection and characterization of NanoAbs for up to nine molecular targets across multiple indications, including plaque psoriasis, psoriatic arthritis, asthma and wet macular degeneration.
The decrease of $1.9 million was primarily due to a decrease in wages, share based compensation and professional services. 76 Financial Income, Net Our financial income, net for the year ended December 31, 2024 amounted to $13.5 million primarily from financial income from loan conversion of $14.8 million offset principally by exchange rate differences of approximately $1.5 million.
Our financial income, net for the year ended December 31, 2024 amounted to $13.5 million primarily from financial income from loan conversion of $14.8 million offset principally by exchange rate differences of approximately $1.5 million.
On February 2, 2021, we closed an underwritten offering in which we sold 24,347 ADSs at a public offering price of $495 per ADS.
In February 2021, we closed an underwritten offering in which we sold 24,712 ADSs at a public offering price of $495 per ADS resulting in gross proceeds of approximately $13.8 million.
The company financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and liabilities and commitments in the normal course of business.
Our financial statements do not include any adjustments that might result from the outcome of this uncertainty 66 The Company’s financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and liabilities and commitments in the normal course of business.
Key Components of Statements of Operations Revenues Sources of revenues. Since our inception, we have generated significant losses in connection with our research and development, clinical trials and general administrative expenses in support of our operations.
This expanded platform is intended to support a wider range of customer needs and increase our ability to attract and retain clients. Key Components of Statements of Operations Revenues Sources of revenues. Since our inception, we have generated significant losses in connection with our research and development, clinical trials and general administrative expenses in support of our operations.
The warrants have an exercise price of $11.6 per ADS and are exercisable for a period of five and one-half years from issuance.
The warrants have an exercise price of $11.6 per ADS and are exercisable for a period of five and one-half years from issuance. We received gross proceeds of approximately $1.33 million and a net sum of approximately $1.0 million after deduction of placement agent fees and issuance expenses.
Pursuant to the agreement, we issued 28,698 ADSs to RK Stone as a commitment fee. In addition, we issued pre-funded warrants to RK Stone to acquire an aggregate of 602,826 ADSs for an aggregate purchase price of $2.0 million, which was the entire amount we were able to raise under the agreement.
In addition, we issued pre-funded warrants to RK Stone to acquire an aggregate of 602,826 ADSs for an aggregate purchase price of $2.0 million, which was the entire amount we were able to raise under the agreement. 67 In June 2025, we raised $1.5 million in gross proceeds through drawdowns under the Standby Equity Purchase Agreement, dated as of March 3, 2025, with YA II PN, Ltd. and issued 511,690 ADSs.
On December 29, 2021, we closed an underwritten offering in which it sold 41,440 ADSs at a public offering price of $236 per ADS for total proceeds of approximately $9.780 million, including ADSs acquired upon the full exercise by Aegis Capital Corp., the sole bookrunning manager for the underwritten offering, of its over-allotment option to purchase additional ADSs.
In December 29, 2021, we closed an underwritten offering in which we sold 41,440 ADSs at a public offering price of $236 per ADS resulting in total proceeds of approximately $9.780 million.
Net cash provided by financing activities for the year ended December 31, 2024 was $3.4 million, primarily from proceeds from issuance of shares and warrants compared to $1.1 million as of December 31, 2023, mostly from proceeds from issuance of warrants. As of December 31, 2024, the Company’s cash and cash equivalents totaled $1.9 million.
Net cash provided by financing activities for the year ended December 31, 2025 was $5.7 million, primarily from proceeds from issuance of ADSs under the Standby Equity Purchase Agreement with Yorkville Advisors compared to $3.4 million as of December 31, 2024.
Our research and development expenses for the year ended December 31, 2024 amounted to $5.6 million, compared to $5.2 million for the year ended December 31, 2023. Marketing, General and Administrative Expenses Our marketing, general and administrative expenses for the year ended December 31, 2024 amounted to $2.6 million, compared to $4.5 million for the year ended December 31, 2023.
Our research and development expenses for the year ended December 31, 2025 amounted to $2.4 million, compared to $5.6 million for the year ended December 31, 2024. The decrease was primarily due to a decrease in the allocation of employees and facilities to the R&D business unit.
O n March 24, 2025, we delivered an Advance Notice for 31,746 ADSs and thereafter delivered the ADSs, and on March 27, 2025, the Company received gross proceeds of approximately $104,000. We expect that we will incur additional losses soon as a result of our research and development activities.
On March 24, 2025, we delivered an Advance Notice for 31,746 ADSs and thereafter delivered the ADSs, and on March 27, 2025, the Company received gross proceeds of approximately $104,000. September 2025 Standby Equity Purchase Agreement On September 10, 2025, we entered into a Standby Equity Purchase Agreement (the “September 2025 SEPA”) with YA.
As a result, we expect to continue to incur operating losses, and we may be required to obtain additional funds to further develop our research and development programs. 79 Trend Information We are a development stage company with no significant revenues to date.
As a result, we expect to continue to incur operating losses, and we may be required to obtain additional funds to additional funding to support CDMO scale-up to breakeven and to continue our research and development activities.
Net Income (Loss) Our net income for the year ended December 31, 2024 was $4.8 million, compared to our net loss for the year ended December 31, 2023 of $6.5 million.
Net Income (Loss) Our net loss for the year ended December 31, 2025 was $8.3 million, compared to our net income for the year ended December 31, 2024 of $4.8 million. The decrease was primarily due to financial income from loan conversion of $14.8 million recognized in 2024, which did not recur in 2025.
During 2023 we did not generate revenues from sales of services or products and started to generate revenues only from 2024. 73 Cost of Revenues Our Cost of Revenues consist primarily of Depreciation expenses.
We started to generate revenues only from 2024 from our CDMO business unit. 62 Cost of Revenues Our Cost of Revenues consist primarily of salaries and related personnel expenses.
CDMO services On September 6, 2023, we announced the launch of a new business unit named Scinai Bioservices to serve as a CDMO offering a multitude of services to support biotech companies through process development, as well as pilot and clinical GMP manufacturing.
CDMO services On September 6, 2023, we announced the launch of a new business unit named Scinai Bioservices now renamed Scinai Biopharma Services), focused on providing contract development and manufacturing services for early-stage biopharmaceutical programs.
The aRCA provided for monthly payments to MPG and UMG and had a term until the earlier of two years or the date the Company enters into first in-human clinical trials with the COVID-19 NanoAb.
This collaboration included monthly payments and was intended to continue until the earlier of two years or the initiation of first-in-human clinical trials. Following our decision to pursue partnering opportunities for the COVID-19 program, we agreed with MPG and UMG to terminate this research collaboration.
Since 2006, we received $6.4 million in IIA grants and Euro 24 million ($25.6 million) in EIB loans.
Since 2006, we received $6.2 million in IIA grants and Euro 24 million ($25.6 million) in EIB loans. Marketing, General and Administrative Expenses Our marketing, general and administrative expenses consist primarily of salaries and expenses related to employee benefits, including share-based compensation, for our general and administrative staff.
Our financial income, net for the year ended December 31, 2023 amounted to $3.2 million, primarily from remeasurement of warrants liabilities of $4.0 million and finance income in respect of loans from others of $0.05 million, offset by exchange rate differences of $0.85 million.
Marketing, General and Administrative Expenses Our marketing, general and administrative expenses for the year ended December 31, 2025 amounted to $2.6 million, compared to $2.6 million for the year ended December 31, 2024. 65 Financial Income, Net Our financial income, net for the year ended December 31, 2025 amounted to $ 1million, primarily from exchange rate differences, SEPA commitment fees.
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Company Overview We are a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products beginning with an innovative, de-risked, pipeline of nanosized VHH antibodies (NanoAbs) targeting diseases with large unmet medical needs, and the other a boutique CDMO providing services to help biotech companies efficiently bring their products to market by leveraging Scinai’s drug development and GMP and non-GMP manufacturing capabilities for pre-clinical and clinical studies.
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Company Overview We are a biopharmaceutical company with two complementary business units: (i) Scinai R&D, focused on the development of innovative therapeutics in inflammation and immunology, and (ii) our contract development and manufacturing organization (CDMO) business, which operates through our subsidiary, Scinai Biopharma Services Ltd.
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For financial reporting purposes, we treat our R&D business unit and our CDMO business unit as one reporting segment.
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Our R&D activities are centered around two pillars: ● PC111 Program – In 2025, we entered into an option agreement, as amended on September 11, 2025 and February 28, 2026, to acquire Pincell S.r.l., an Italian biotechnology company and the owner of PC111, a fully human monoclonal antibody targeting pathways involved in keratinocyte cell death and inflammation, with potential applications in severe dermatological conditions. ● NanoAbs Platform – We are developing a pipeline of novel therapeutics based on NanoAbs (VHH antibody fragments), which possess unique physicochemical properties and are suitable for advanced mono- and multi-specific antibody formats.
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These are all large and growing markets with underserved medical needs. In each case, the molecular target has been validated as an appropriate target for therapeutic intervention through inhibition by an antibody, thereby significantly reducing the discovery work that typically entails many years of research, high cost and high risk of failure.
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Our NanoAbs activities are conducted in collaboration with the Max Planck Society (MPG), including the Max Planck Institute for Multidisciplinary Sciences (MPI-MS), and the University Medical Center Göttingen (UMG) in Germany. We continue to evaluate and in-license or acquire additional therapeutic assets aligned with our focus areas.
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We believe that we can leverage our NanoAbs’ unique and strong binding affinity, stability at high temperatures, and potential for more effective and convenient routes of administration towards competitive commercial viability.
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In addition, we are currently evaluating the development strategy for our IL-17 program in light of scientific, technical and market considerations, including the evolving competitive landscape for IL-17-targeting therapies. As part of this process, we are assessing alternative approaches and prioritization of our R&D programs.
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We believe that since these are clinical validated targets, we can develop NanoAb treatments with reduced risk and cost and accelerate the time from NanoAb selection to initiation of clinical development. Each NanoAb candidate is therefore positioned as a “biobetter” piggybacking on prior discoveries of others to mitigate risk but with significant potential advantages over existing therapeutics.
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Our CDMO business provides integrated development and manufacturing services to small and emerging biotech companies, supporting clients from early-stage development through clinical-stage production. Following our acquisition of Recipharm Israel Ltd. on February 17, 2026 (subsequently renamed Scinai Biopharma Services Ltd.), we are in the process of consolidating our CDMO activities under this subsidiary.
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In addition, while each NanoAb constitutes a novel molecule for which we file patent applications thereby creating a proprietary position, all of the developed NanoAbs when viewed together constitute a pipeline that is built around the same drug discovery, development and manufacturing platform allowing us to reduce risks and save costs.
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This includes the planned transfer of certain CDMO-related assets, operations and employees to Scinai Biopharma Services Ltd. pursuant to Section 104 of the Israeli Income Tax Ordinance, subject to applicable approvals and implementation.
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SCINAI has the exclusive option for an exclusive, pre-negotiated worldwide license agreement for the development and commercialization of each of the NanoAbs covered by the RCA with MPG and UMG.
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These targets are clinically validated for antibody-based intervention, which we believe reduces discovery risk and may shorten development timelines. We believe that NanoAbs offer advantages such as strong binding affinity, thermal stability, and potential flexibility in routes of administration.
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We seek to provide high quality, yet affordable CDMO services to accelerate the drug development processes of small biotech companies, including cGMP aseptic processing required for manufacturing of clinical batches. We lease approximately 1,850 square meters (20,000 square feet) in the Jerusalem BioPark, located in the Ein Kerem Hadassah campus, next to Hadassah University Hospital and Hebrew University’s Medical School.
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Each NanoAb candidate is intended to represent a novel molecule, supported by patent filings, while collectively forming a pipeline based on a shared discovery, development and manufacturing platform. Under the RCA, we hold an exclusive option to enter into pre-negotiated worldwide license agreements for the development and commercialization of each NanoAb candidate.
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The facility includes laboratories, offices, and upstream and downstream manufacturing suites for bulk production and limited capacity for single-dose syringe filling. We also have infrastructure to support future product manufacturing processes and equipment. The manufacturing facility features modular, single-use infrastructure, which enables us to adapt the facility to various manufacturing platforms (such as, for example, fermenters or bioreactors).
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Our CDMO activities are primarily focused on analytical method development, process development, and cGMP manufacturing of clinical-stage materials, including aseptic processing and biologic drug substance development, with an emphasis on supporting early-stage biotechnology companies. Our CDMO services are supported by advanced laboratory infrastructure and a cGMP pilot manufacturing facility in Jerusalem, designed to meet EMA and FDA regulatory requirements.
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This expense reflects the allocation of the cost of our manufacturing facilities over their useful lives and is a substantial part of our operational costs. Research and development expenses.
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Our capabilities include upstream and downstream process development, process optimization and scale-up, cGMP manufacturing, fill and finish operations, analytical method development and GMP quality control, all supported by a comprehensive quality management system. Our manufacturing infrastructure incorporates modular, single-use technologies that provide operational flexibility, reduce changeover time and associated costs, and support efficient clinical manufacturing.
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The increase from net loss to income was primarily due to financial income from loan conversion of $14.8 million. offset by the gross loss of $0.5 million from the CDMO operation and $8.0 million operating expenses during the year ended December 31, 2024. Year Ended December 31, 2023 Compared to Year Ended December 31, 2022.
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On February 17, 2026, we acquired 100% of the shares of Recipharm Israel Ltd. (subsequently renamed Scinai Biopharma Services Ltd.), which operates a cGMP manufacturing site in Yavne, Israel, and entered into a long-term strategic commercial collaboration with Recipharm.
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In the year ended December 31, 2024, the Company had an operating loss of $8.6 million and negative cash flows from operating activities of $6.3 million. The Company’s current cash and cash equivalents position is not sufficient to fund the Company’s planned operations for at least a year beyond the date of the filing date of the financial statements.
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The Yavne site provides early chemistry development and small-scale manufacturing of active pharmaceutical ingredients (APIs), expanding our capabilities beyond biologics to include small-molecule development. The acquisition of the Yavne site and the collaboration with Recipharm expand our manufacturing footprint, enhance our technical capabilities, and broaden our service offering to include both biologics and small-molecule programs.
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Those factors raise substantial doubt about the Company’s ability to continue as a going concern. The ability to continue as a going concern is dependent upon the Company obtaining the necessary financing to meet its obligations and repay its liabilities arising from normal business operations when they become due.
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Our revenues for the year ended December 31, 2025 were $1.3 million, compared to $0.7 million for the year ended December 31, 2024. The increase reflects continued expansion of our CDMO activities and growing customer engagement. Research and Development Expenses, net Research and development expenses.
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While the Company has successfully raised funds in the past, there is no guarantee that it will be able to do so in the future.
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Our current cash position is not sufficient to fund our planned operations for at least one year from the date of the issuance of our financial statements. Accordingly, there is substantial doubt about our ability to continue as a going concern. While we generate revenues from our CDMO activities, these revenues are not currently sufficient to fund our operations.
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The inability to borrow or raise sufficient funds on commercially reasonable terms, would have serious consequences on our financial condition and results of operations. 77 The Company’s current operating budget includes various assumptions concerning the level and timing of cash receipts and cash outlays for operating expenses and capital expenditures, including a cost-saving plan.
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Our ability to continue as a going concern is dependent on our ability to obtain additional financing, reduce costs and manage our liabilities as they become due. There can be no assurance that we will be able to obtain such financing on acceptable terms, or at all, particularly in light of current market conditions and our market capitalization.
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The Company is planning to finance its operations from its existing working capital resources and additional sources of capital and financing.
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We will require substantial additional financing not only to continue our operations but also to support the growth of our CDMO business and advance our therapeutic development programs. We expect to continue to incur significant operating and capital expenditures, including costs related to expanding our CDMO capabilities, research and development activities, manufacturing and regulatory compliance.

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Item 6. [Reserved]

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

62 edited+14 added−33 removed143 unchanged
Biggest change(2) Member of the Compensation Committee. Executive Officers Mr. Amir Reichman became full-time CEO of the Company on March 2, 2021, after sharing CEO duties during a transition period beginning on January 21, 2021. Mr. Reichman served as Head of Global Vaccines Engineering Core Technologies and Asset Management at GSK Vaccines (“GSK”) in Belgium from December 2017 until March 2021.
Biggest changeReichman served as Head of Global Vaccines Engineering Core Technologies and Asset Management at GSK Vaccines (“GSK”) in Belgium from December 2017 to March 2021. Before that, he served as Senior Director of Vaccines Supply Chain at GSK from September 2015 to November 2017. Prior to GSK, Mr.
Pursuant to their respective appointment letters, our advisory board members are entitled to receive the following compensation: As approved by the board of directors of the Company, each SAB member receives in consideration for his/her Advisory Board membership and for provision of the Services as detailed in the standard SAB agreement approved by the board of directors, an award of RSUs for 5,000 (five thousand) ADSs, each representing 4,000 Ordinary Shares of the Company, as of the effective date of each SAB member agreement, pursuant to the 2018 Israeli Share Option Plan, to vest in three equal tranches each consisting of 1,667 RSUs starting on the first anniversary of each SAB agreement subject to the continued provision of services on each vesting date.
Pursuant to their respective appointment letters, our advisory board members are entitled to receive the following compensation: As approved by the board of directors of the Company, each SAB member receives in consideration for his/her Advisory Board membership and for provision of the Services as detailed in the standard SAB agreement approved by the board of directors, an award of RSUs for 5,000 (five thousand) ADSs, each representing 4,000 Ordinary Shares of the Company, as of the effective date of each SAB member agreement, pursuant to the 2018 Israeli Share Option Plan (the “Plan”), to vest in three equal tranches each consisting of 1,667 RSUs starting on the first anniversary of each SAB agreement subject to the continued provision of services on each vesting date.
We granted to each such director (other than our chairman) options to purchase 2,,00 ADSs of the Company, and to our chairman options to purchase 4,000 ADSs, all at an exercise price of $18.10, which was the higher of (i) 130% of the closing price of the Company’s ADSs on June 15, 2023 (the date the Board approved this proposal) or (ii) 100% of the closing price of the Company’s ADS on August 24, 2023 (the date of shareholder approval).
We granted to each such director (other than our chairman) options to purchase 2,000 ADSs of the Company, and to our chairman options to purchase 4,000 ADSs, all at an exercise price of $18.10, which was the higher of (i) 130% of the closing price of the Company’s ADSs on June 15, 2023 (the date the Board approved this proposal) or (ii) 100% of the closing price of the Company’s ADS on August 24, 2023 (the date of shareholder approval).
The Compensation Policy must furthermore consider the following additional factors: ● the knowledge, skills, expertise and accomplishments of the relevant office holder; ● the office holder’s roles and responsibilities and prior compensation agreements with him or her; ● the ratio between the cost of the terms of employment of an office holder and the cost of the compensation of the other employees of the company, including those employed through manpower companies, in particular the ratio between such cost and the average and median compensation of the other employees of the company, as well as the impact such disparities may have on the work relationships in the company; 94 ● the possibility of reducing variable compensation, if any, at the discretion of the board of directors; and the possibility of setting a limit on the exercise value of non-cash variable equity-based compensation; and ● as to severance compensation, if any, the period of service of the office holder, the terms of his or her compensation during such service period, the company’s performance during that period of service, the person’s contribution towards the company’s achievement of its goals and the maximization of its profits, and the circumstances under which the person is leaving the company.
The Compensation Policy must furthermore consider the following additional factors: ● the knowledge, skills, expertise and accomplishments of the relevant office holder; ● the office holder’s roles and responsibilities and prior compensation agreements with him or her; ● the ratio between the cost of the terms of employment of an office holder and the cost of the compensation of the other employees of the company, including those employed through manpower companies, in particular the ratio between such cost and the average and median compensation of the other employees of the company, as well as the impact such disparities may have on the work relationships in the company; 82 ● the possibility of reducing variable compensation, if any, at the discretion of the board of directors; and the possibility of setting a limit on the exercise value of non-cash variable equity-based compensation; and ● as to severance compensation, if any, the period of service of the office holder, the terms of his or her compensation during such service period, the company’s performance during that period of service, the person’s contribution towards the company’s achievement of its goals and the maximization of its profits, and the circumstances under which the person is leaving the company.
Reichman and the Company may terminate Mr. Reichman’s employment by prior written notice of 60 days. In the event of termination by the Company without cause, the Company will pay Mr. Reichman nine monthly salaries, which includes amounts accrued in a pension insurance policy and amounts required by Israeli law. In May 2022, we granted Mr.
Each of Mr. Reichman and the Company may terminate Mr. Reichman’s employment by prior written notice of 60 days. In the event of termination by the Company without cause, the Company will pay Mr. Reichman nine monthly salaries, which includes amounts accrued in a pension insurance policy and amounts required by Israeli law. In May 2022, we granted Mr.
We may terminate our service agreement with CFO Direct at any time and effective immediately, without need for prior written notice, and without derogating from any other remedy to which we may be entitled, for cause (i.e., termination due to the conviction of CFO Direct and/or Uri Ben-Or of any felony, the liability of CFO Direct by a court of competent jurisdiction for fraud against us, any conduct that has a material adverse effect or is materially detrimental to us, including but not limited to, a breach of contract or any claim by CFO direct or any one connect thereto that CFO Direct is our employee). 89 In addition, pursuant to a separate employment agreement entered into between us and Mr.
We may terminate our service agreement with CFO Direct at any time and effective immediately, without need for prior written notice, and without derogating from any other remedy to which we may be entitled, for cause (i.e., termination due to the conviction of CFO Direct and/or Uri Ben-Or of any felony, the liability of CFO Direct by a court of competent jurisdiction for fraud against us, any conduct that has a material adverse effect or is materially detrimental to us, including but not limited to, a breach of contract or any claim by CFO direct or any one connect thereto that CFO Direct is our employee). 77 In addition, pursuant to a separate employment agreement entered into between us and Mr.
Yael Margolin has more than 35 years of experience as senior manager, CEO and board member in venture capital and in the pharmaceutical and biotech industries, leading strategic and business planning, financing, team building, product development and corporate partnerships. From 2005 to 2019, Dr.
Margolin has more than 35 years of experience as senior manager, CEO and board member in venture capital and in the pharmaceutical and biotech industries, leading strategic and business planning, financing, team building, product development and corporate partnerships. From 2005 to 2019, Dr.
Under the Companies Law and the Israeli Securities Law 5728-1968 (the “Israeli Securities Law”), a company may insure an office holder against the following liabilities incurred for acts performed by him or her as an office holder if and to the extent provided in the company’s articles of association: ● a breach of the duty of loyalty to the company, provided that the office holder acted in good faith and had a reasonable basis to believe that the act would not harm the company; 99 ● a breach of duty of care to the company or to a third party, to the extent such a breach arises out of the negligent conduct of the office holder; and ● a financial liability imposed on the office holder in favor of a third party.
Under the Companies Law and the Israeli Securities Law 5728-1968 (the “Israeli Securities Law”), a company may insure an office holder against the following liabilities incurred for acts performed by him or her as an office holder if and to the extent provided in the company’s articles of association: ● a breach of the duty of loyalty to the company, provided that the office holder acted in good faith and had a reasonable basis to believe that the act would not harm the company; 87 ● a breach of duty of care to the company or to a third party, to the extent such a breach arises out of the negligent conduct of the office holder; and ● a financial liability imposed on the office holder in favor of a third party.
Shareholder Duties Pursuant to the Companies Law, a shareholder has a duty to act in good faith and in a customary manner toward the company and other shareholders and to refrain from abusing his or her power in the company, including, among other things, in voting at a general meeting and at shareholder class meetings with respect to the following matters: ● an amendment to the company’s articles of association; ● an increase of the company’s authorized share capital; ● a merger; or ● the approval of related party transactions and acts of office holders that require shareholder approval. 98 In addition, a shareholder also has a general duty to refrain from discriminating against other shareholders.
Shareholder Duties Pursuant to the Companies Law, a shareholder has a duty to act in good faith and in a customary manner toward the company and other shareholders and to refrain from abusing his or her power in the company, including, among other things, in voting at a general meeting and at shareholder class meetings with respect to the following matters: ● an amendment to the company’s articles of association; ● an increase of the company’s authorized share capital; ● a merger; or ● the approval of related party transactions and acts of office holders that require shareholder approval. 86 In addition, a shareholder also has a general duty to refrain from discriminating against other shareholders.
Jay Green CPA, CA, MAcc, joined the board in 2022. He is currently the Chief Financial Officer of a privately held, Canadian-based healthcare services company, a role that he has held since January 2022.
Jay Green CPA, CA, MAcc, joined the board of directors in 2022. He is currently the Chief Financial Officer of a privately held, Canadian-based healthcare services company, a role that he has held since January 2022.
Our compensation committee’s responsibilities include: ● reviewing and recommending overall compensation policies with respect to our Chief Executive Officers and other executive officers; ● reviewing and approving corporate goals and objectives relevant to the compensation of our Chief Executive Officers and other executive officers including evaluating their performance in light of such goals and objectives; ● reviewing and approving the granting of options and other incentive awards; and ● reviewing, evaluating and making recommendations regarding the compensation and benefits for our non-employee directors. 95 Internal Auditor Under the Companies Law, the board of directors of an Israeli public company must appoint an internal auditor in accordance with the recommendation of the audit committee.
Our compensation committee’s responsibilities include: ● reviewing and recommending overall compensation policies with respect to our Chief Executive Officers and other executive officers; ● reviewing and approving corporate goals and objectives relevant to the compensation of our Chief Executive Officers and other executive officers including evaluating their performance in light of such goals and objectives; ● reviewing and approving the granting of options and other incentive awards; and ● reviewing, evaluating and making recommendations regarding the compensation and benefits for our non-employee directors. 83 Internal Auditor Under the Companies Law, the board of directors of an Israeli public company must appoint an internal auditor in accordance with the recommendation of the audit committee.
In the event that options allocated under the 2018 Plan expire or otherwise terminate in accordance with the provisions of the 2018 Plan, such expired or terminated options will become available for future grant awards and allocations under the 2018 Plan. 90 Restricted share units granted under the 2018 Plan are subject to applicable vesting schedules, and the Board may condition the grant or vesting of restricted share units upon the attainment of specified performance targets or such other factors as the Board may determine, in its sole discretion.
In the event that options allocated under the 2018 Plan expire or otherwise terminate in accordance with the provisions of the 2018 Plan, such expired or terminated options will become available for future grant awards and allocations under the 2018 Plan. 78 Restricted share units granted under the 2018 Plan are subject to applicable vesting schedules, and the Board may condition the grant or vesting of restricted share units upon the attainment of specified performance targets or such other factors as the Board may determine, in its sole discretion.
Reichman voluntarily agreed to a 25% reduction in his monthly salary from mid-October 2024 until February 1, 2025. 87 The agreement also provides that Mr.
Reichman voluntarily agreed to a 25% reduction in his monthly salary from mid-October 2024 until February 1, 2025. The agreement also provides that Mr.
The duty of loyalty includes a duty to: ● refrain from any conflict of interest between the performance of his or her duties to the company and his or her other duties or personal affairs; 96 ● refrain from any activity that is competitive with the company; ● refrain from exploiting any business opportunity of the company to receive a personal gain for himself or herself or others; and ● disclose to the company any information or documents relating to the company’s affairs which the office holder received as a result of his or her position as an office holder.
The duty of loyalty includes a duty to: ● refrain from any conflict of interest between the performance of his or her duties to the company and his or her other duties or personal affairs; 84 ● refrain from any activity that is competitive with the company; ● refrain from exploiting any business opportunity of the company to receive a personal gain for himself or herself or others; and ● disclose to the company any information or documents relating to the company’s affairs which the office holder received as a result of his or her position as an office holder.
Services and Employment Agreement with Our Chief Financial Officer Pursuant to the service agreement entered into on June 20, 2007, between us, Mr. Ben-Or and CFO Direct, an Israeli company solely owned by him through which he provides his services to us, as amended to date. CFO Direct is entitled to a monthly fee of NIS 30,000.
Services and Employment Agreement with Our Chief Financial Officer Pursuant to the service agreement entered into on June 20, 2007, between us, Mr. Ben-Or and CFO Direct, an Israeli company solely owned by him through which he provides his services to us, as amended to date. CFO Direct is entitled to a monthly fee of NIS 40,000.
That policy must be adopted by the company’s board of directors, after considering the recommendations of the compensation committee, and will need to be brought for approval by the company’s shareholders, which approval requires a special approval for Compensation as described below under “Approval of Related Party Transactions Under Israeli Law — Fiduciary Duties of Directors and Executive Officers”. 93 Under the Companies Law, the board of directors of a public company must appoint a compensation committee and adopt a compensation policy.
That policy must be adopted by the company’s board of directors, after considering the recommendations of the compensation committee, and will need to be brought for approval by the company’s shareholders, which approval requires a special approval for Compensation as described below under “Approval of Related Party Transactions Under Israeli Law — Fiduciary Duties of Directors and Executive Officers”. 81 Under the Companies Law, the board of directors of a public company must appoint a compensation committee and adopt a compensation policy.
In addition, our shareholders may appoint an additional director/s to the Company, whether for the purpose of filling a position that was vacated or as an additional director/s. 91 Under the Companies Law, our board of directors must determine the minimum number of directors who are required to have accounting and financial expertise.
In addition, our shareholders may appoint an additional director/s to the Company, whether for the purpose of filling a position that was vacated or as an additional director/s. 79 Under the Companies Law, our board of directors must determine the minimum number of directors who are required to have accounting and financial expertise.
For the purpose of approving transactions with controlling shareholders, the term “controlling shareholder” also includes any shareholder that holds 25% or more of the voting rights of the company if no other shareholder holds more than 50% of the voting rights in the company. 92 Audit Committee Our audit committee consists of Mr. Adi Raviv, Dr. Yael Margolin and Dr.
For the purpose of approving transactions with controlling shareholders, the term “controlling shareholder” also includes any shareholder that holds 25% or more of the voting rights of the company if no other shareholder holds more than 50% of the voting rights in the company. 80 Audit Committee Our audit committee consists of Mr. Adi Raviv, Dr. Yael Margolin and Mr.
In addition, Professor Dobbelstein, together with Professor Görlich, is collaborating with Scinai under a five-year strategic research agreement for the discovery, characterization and cloning of additional NanoAbs for the treatment of autoimmune diseases such as psoriasis, psoriatic arthritis, asthma and macular degeneration. Prof. George H.
In addition, Professor Dobbelstein, together with Professor Görlich, is collaborating with Scinai under a five-year strategic research agreement for the discovery, characterization and cloning of additional NanoAbs for the treatment of autoimmune diseases such as psoriasis, psoriatic arthritis, asthma and macular degeneration. Prof.
In the event a majority of the members of the board of directors have a personal interest in the approval of a transaction, then the approval thereof shall also require the approval of the shareholders. 97 Disclosure of Personal Interests of Controlling Shareholders and Approval of Certain Transactions Pursuant to Israeli law, the disclosure requirements regarding personal interests that apply to directors and executive officers also apply to a controlling shareholder of a public company.
In the event a majority of the members of the board of directors have a personal interest in the approval of a transaction, then the approval thereof shall also require the approval of the shareholders. 85 Disclosure of Personal Interests of Controlling Shareholders and Approval of Certain Transactions Pursuant to Israeli law, the disclosure requirements regarding personal interests that apply to directors and executive officers also apply to a controlling shareholder of a public company.
Reichman other benefits, such as a company car, vacation, sick days, contribution towards work disability insurance, monthly contributions equal to 7.5% of monthly salary to an Education Fund (“Keren Hishtalmut”, a short-term savings plan available in Israel which is tax free to the employee up to a cap determined by law) and a manager’s insurance policy or a pension fund and other benefits and perquisites similar to those of other officers of the Company. 88 Each of Mr.
Reichman other benefits, such as a company car, vacation, sick days, contribution towards work disability insurance, monthly contributions equal to 7.5% of monthly salary to an Education Fund (“Keren Hishtalmut”, a short-term savings plan available in Israel which is tax free to the employee up to a cap determined by law) and a manager’s insurance policy or a pension fund and other benefits and perquisites similar to those of other officers of the Company.
The options are subject to accelerated vesting and will become immediately exercisable in the event of a change of control. 85 Following shareholder approval, we also cancelled options previously granted to our non-management directors and granted replacement options to these directors.
The options are subject to accelerated vesting and will become immediately exercisable in the event of a change of control. 74 Following shareholder approval, we also cancelled options previously granted to our non-management directors and granted replacement options to these directors.
(“Angels”) of more than 50% of the voting power of the Company, in a single or series of related transactions; and (iv) when a person, entity or group not directly or indirectly affiliated with Angels becomes a shareholder that has “control,” as defined in the Israeli Companies Law, 1999. The Company will provide Mr.
(“Angels”) of more than 50% of the voting power of the Company, in a single or series of related transactions; and (iv) when a person, entity or group not directly or indirectly affiliated with Angels becomes a shareholder that has “control,” as defined in the Israeli Companies Law, 1999. The Company provides Mr.
Morris Laster. Mr. Adi Raviv serves as the chairman of the audit committee. Under the NASDAQ Capital Market corporate governance rules, we are required to maintain an audit committee consisting of at least three independent directors, each of whom is financially literate and one of whom has accounting or related financial management expertise.
Jay Green. Mr. Adi Raviv serves as the chairman of the audit committee. Under the NASDAQ Capital Market corporate governance rules, we are required to maintain an audit committee consisting of at least three independent directors, each of whom is financially literate and one of whom has accounting or related financial management expertise.
Germain a cash bonus of $37,500. Mr. Germain voluntarily agreed to a 20% reduction in his monthly payment commencing mid-October 2024 until February 2025. Services and Employment Agreements with Our Chief Executive Officer Pursuant to his employment agreement entered into with us on January 20, 2021, Mr. Reichman is entitled to an annual gross salary of $350,000. Mr.
Germain voluntarily agreed to a 20% reduction in his monthly payment commencing mid-October 2024 until February 2025. 76 Services and Employment Agreements with Our Chief Executive Officer Pursuant to his employment agreement entered into with us on January 20, 2021, Mr. Reichman is entitled to an annual gross salary of $350,000. Mr.
Our audit committee also oversees the audit efforts of our independent accountants and takes those actions that it deems necessary to satisfy itself that the accountants are independent of management. Compensation Committee and Compensation Policy Compensation Committee Our compensation committee currently consists of Mr. Adi Raviv, Dr. Yael Margolin and Dr. Morris Laster. Dr.
Our audit committee also oversees the audit efforts of our independent accountants and takes those actions that it deems necessary to satisfy itself that the accountants are independent of management. Compensation Committee and Compensation Policy Compensation Committee Our compensation committee currently consists of Mr. Adi Raviv, Dr. Yael Margolin and Mr. Sam Moed. Dr.
Samuel Moed is a healthcare executive with over 35 years of experience. Mr. Moed was for seven years Head of Corporate Strategy at Bristol Myers Squibb (“BMS”), a global biopharma company, until his retirement in 2020. Prior to that role, Mr.
Samuel Moed joined the board of directors in 2020. Mr. Moed is a healthcare executive with over 35 years of experience. He was for seven years Head of Corporate Strategy at Bristol Myers Squibb (“BMS”), a global biopharma company, until his retirement in 2020. Prior to that role, Mr.
We have set aside or accrued a total amount of $515 thousands during 2024 to provide pension, retirement or similar benefits. Services Agreement with Our Chairman of the Board We are party to a services agreement with Mr. Germain, pursuant to which he receives a monthly payment of $12,500. Pursuant to this agreement, in May 2019 and May 2021 Mr.
We have set aside or accrued a total amount of $400 thousand during 2025 to provide pension, retirement or similar benefits. Services Agreement with Our Chairman of the Board We are party to a services agreement with Mr. Germain, pursuant to which he receives a monthly payment of $12,500. Pursuant to this agreement, in May 2019 and May 2021 Mr.
Israeli labor laws principally govern the length of the workday, minimum wages for employees, procedures for hiring and dismissing employees, determination of severance pay, annual leave, sick days, advance notice of termination of employment, equal opportunity and anti-discrimination laws and other conditions of employment.
All Company employees are in Israel. Israeli labor laws principally govern the length of the workday, minimum wages for employees, procedures for hiring and dismissing employees, determination of severance pay, annual leave, sick days, advance notice of termination of employment, equal opportunity and anti-discrimination laws and other conditions of employment.
Elad Mark on September 5, 2018, he is entitled to a monthly salary of NIS 46,000 (approximately $13,000), which also includes monthly contributions equal to 7.5% of his monthly salary to an Education Fund and a manager’s insurance policy and other benefits and perquisites similar to those of other officers of the Company. In addition, we provide Mr.
Elad Mark on September 5, 2018, as amended, he is entitled to a monthly salary of NIS 55,000 (approximately $15,540), which also includes monthly contributions equal to 7.5% of his monthly salary to an Education Fund and a manager’s insurance policy and other benefits and perquisites similar to those of other officers of the Company. In addition, we provide Mr.
Moed received his BA in history from Columbia University in New York City in 1985. Mr. Adi Raviv is a senior financial executive with a career spanning over 35 years. Mr. Raviv founded HTI Associates LLC in 1996 and since then has served as its managing member.
Moed received his BA in history from Columbia University in New York City in 1985. Mr. Adi Raviv joined the board of directors in 2020. Mr. Raviv is a senior financial executive with a career spanning over 35 years. He founded HTI Associates LLC in 1996 and since then has served as its managing member.
Germain is a Managing Director at The Aentib Group, a boutique merchant bank, and served as a director on the board of Pluristem Therapeutics from 2007 through June 2022, including time as Co-Chairman and lead independent director. He is also a co-founder and director of a number of private companies in and outside the biotech field. Mr.
Germain is a Managing Director at The Aentib Group, a boutique merchant bank, and previously served on the board of Pluristem Therapeutics from 2007 through June 2022, including as Co-Chairman and lead independent director. He is also a co-founder and director of a number of private companies in and outside the biotechnology sector. 71 Mr.
For the year ended December 31, 2024, we paid an aggregate of approximately $413 thousand to our directors. 86 Executive Officers The following table presents information regarding compensation actually received by our executive officers during the year ended December 31, 2024.
For the year ended December 31, 2025, we paid an aggregate of approximately $430 thousand to our directors. 75 Executive Officers The following table presents information regarding compensation received by our executive officers during the year ended December 31, 2025.
Mark was granted 5,089 RSUs which vest over three years Equity Compensation Plans 2018 Israeli Share Option Plan The 2018 Israeli Share Option Plan (the “2018 Plan”) permits the granting of options, restricted share units or allotment of shares or other equity-based awards to employees, directors, consultants, service providers and other entities which the board shall decide their services are considered valuable to the Company, under similar terms and conditions to the 2005 Plan.
Equity Compensation Plans 2018 Israeli Share Option Plan The 2018 Plan permits the granting of options, restricted share units or allotment of shares or other equity-based awards to employees, directors, consultants, service providers and other entities which the board shall decide their services are considered valuable to the Company, under similar terms and conditions to the 2005 Plan.
Ben-Or a pension insurance to Mr. Ben-Or, in a Managers Insurance and/or a pension fund, according to Mr. Ben-Or’s discretion. Mr. Ben-Or’s employment agreement may be terminated by either us or Mr. Ben-Or with 60 days prior written notice, or by us immediately for cause.
Ben-Or a pension insurance to Mr. Ben-Or, in a Managers Insurance and/or a pension fund, according to Mr. Ben-Or’s discretion. Mr. Ben-Or’s employment agreement may be terminated by either us or Mr. Ben-Or with 60 days prior written notice, or by us immediately for cause. In October 2025, the Board approved a cash bonus of $30,000 to Mr. Ben-Or.
Ben-Or holds a B.A degree in Business from the College of Administration, and a M.B.A degree from the Bar Ilan University and is a certified public accountant in Israel. 81 Mr. Elad Mark joined the company in 2018 as Site Head and has been serving as Chief Operating Officer since September 2019.
Ben-Or holds a B.A. in Business from the College of Administration, an M.B.A. from Bar-Ilan University and is a certified public accountant in Israel. 70 Mr. Elad Mark joined the Company in 2018 as Site Head and served as Chief Operating Officer from September 2019. As of March 31, 2026, Mr.
As of March 31, 2025, the Company had awarded grants under the Option Plan to acquire 494,440,729 ordinary shares represented by 123,610 ADSs. C. Board Practices Board of Directors Under the Companies Law and our articles of association, our board of directors shall direct the Company’s policy and shall supervise the performance of the Company’s Chief Executive Officer.
As of March 31, 2026, the Company had awarded grants under the Option Plan to acquire 1,778,588,298 ordinary shares represented by 444,647 ADSs. C. Board Practices Board of Directors Under the Companies Law and our articles of association, our board of directors shall direct the Company’s policy and shall supervise the performance of the Company’s Chief Executive Officer.
He graduated from New York University School of Law in 1975, Order of the Coif, and was a partner in a New York law firm practicing corporate and securities law before leaving in 1986.
Germain graduated from New York University School of Law in 1975, where he was a member of the Order of the Coif, and was a partner at a New York law firm specializing in corporate and securities law until 1986.
Mark served for more than three years at Novartis as TPM (Technical Process Manager) and Area Lead Process for a large-scale biological facility establishment in Singapore, a $800 million investment in a biologics facility focused on drug substance manufacturing based on cell culture technology, which was designed to support both clinical and commercial production of potential new products that include monoclonal antibodies for use in helping patients with autoimmune, respiratory and oncology disorders.
Mark served for more than three years at Novartis as Technical Process Manager and Area Lead Process for the establishment of a large-scale biologics manufacturing facility in Singapore, a $800 million investment focused on drug substance manufacturing based on cell culture technology, supporting both clinical and commercial production of monoclonal antibodies for autoimmune, respiratory and oncology indications. Before that, Mr.
Such maximum amount is in addition to any amount paid (if paid) under insurance and/or by a third-party pursuant to an indemnification arrangement. 100 D. Employees As of March 31, 2025, we had 31 employees, four of whom were employed in finance and administration and 27 of whom were employed in research and development. All Company employees are in Israel.
Such maximum amount is in addition to any amount paid (if paid) under insurance and/or by a third-party pursuant to an indemnification arrangement. 88 D. Employees As of March 31, 2026, we had 45 employees, 41 of whom were employed in the CDMO subsidiary company and 4 of whom were employed in research and development.
Base Salary or Other Payment Value of Social Benefits (1) Value of Equity Based Compensation Granted (2) All Other Compensation (3) Total Name USD Thousands USD Thousands USD Thousands USD Thousands USD Thousands Mr. Amir Reichman Chief Executive Officer 338 34 272 15 659 Dr. Tamar Ben-Yedidia Chief Scientific Officer 146 44 50 11 250 Mr.
Base Salary or Other Payment Value of Social Benefits (1) Value of Equity Based Compensation Granted (2) All Other Compensation (3) Total Name USD Thousands USD Thousands USD Thousands USD Thousands USD Thousands Mr. Amir Reichman Chief Executive Officer 342 38 135 11 526 Dr. Tamar Ben-Yedidia(4) Former Chief Scientific Officer 98 28 (28 ) 11 109 Mr.
Germain was grantedoptions to purchase ADSs which were replaced by the Replacement Options described above. The agreement, as amended to date, expires in May 2025 and provides that either party may terminate the agreement upon 90 days’ written notice. In addition, in May 2022 we granted Mr. Germain a cash bonus of $90,000, and in August 2023, we granted Mr.
Germain was granted options to purchase ADSs which were replaced by the Replacement Options described above. The agreement was amended in May 2022 to provide for a term of three years rather than continuing on a monthly basis and provides that either party may terminate the agreement upon 90 days’ written notice. In addition, in May 2022 we granted Mr.
He also serves as Vice Dean and Deputy Director for Research and Teaching and is the former director of the Lower Saxony Institute of Occupational Dermatology. Prof. Schön has been recognized with numerous awards for his groundbreaking research on immune reactions in inflammation. From 2011 to 2024, he was the Editor-in-Chief of the Journal of the German Dermatological Society.
Schön has been recognized with numerous awards for his groundbreaking research on immune reactions in inflammation. From 2011 to 2024, he was the Editor-in-Chief of the Journal of the German Dermatological Society. Currently, he holds the position of Secretary General and Vice President of the European Dermatology Forum (EDF). Prof.
Germain has been involved as a founder, director, chairman of the board of, and/or investor in, over twenty companies in the biotech field and assisted many of them in arranging corporate partnerships, acquiring technology, entering into mergers and acquisitions, and executing financings and going public transactions.
Germain also serves as Chairman of the Board of the Company’s subsidiary, Scinai Biopharma Services Ltd. Mr. Germain has been involved as a founder, director, chairman and investor in over twenty biotechnology companies and has assisted many of them in arranging corporate partnerships, acquiring technology, executing mergers and acquisitions, and completing financing and public offering transactions. Mr.
(“NeuroDerm”), an Israeli company that developed a drug device combination product aimed at transdermal drug delivery for the treatment of Parkinson’s NeuroDerm was acquired by Mitsubishi Tanabe Pharma Corporation in 2017 for $1.1 billion. Mr. Reichman served as NeuroDerm’s first employee and Senior Scientist until his departure for an MBA at the Wharton school in 2009. Mr.
(“NeuroDerm”), an Israeli company focused on drug-device combination products for the treatment of Parkinson’s disease, which was acquired by Mitsubishi Tanabe Pharma Corporation in 2017. He served as NeuroDerm’s first employee and as a Senior Scientist until 2009. Mr.
Name Age Position Amir Reichman 49 Chief Executive Officer and Director Tamar Ben-Yedidia 61 Chief Scientist Uri Ben-Or 54 Chief Financial Officer Elad Mark 43 Chief Operating Officer Dalit Weinstein Fischer 54 Chief Technology Officer Mark Germain 74 Chairman of the Board of Directors Jay Green 53 Director Morris Laster (1) (2) 60 Director Yael Margolin (1) (2) 72 Director Samuel Moed 62 Director Adi Raviv (1) (2) 69 Director Avner Rotman 81 Director (1) Member of the Audit Committee.
Name Age Position Amir Reichman 50 Chief Executive Officer and Director Uri Ben-Or 55 Chief Financial Officer Elad Mark 44 Chief Operating Officer Mark Germain 75 Chairman of the Board of Directors Jay Green (1) 54 Director Yael Margolin (1) (2) 72 Director Samuel Moed (2) 63 Director Adi Raviv (1) (2) 70 Director (1) Member of the Audit Committee.
Before his appointment at the University Medical Center Göttingen, he held a professorship in Experimental Biomedicine at the University of Würzburg. Michael has further qualifications in dermatopathology, allergology, immunology and health economics. 84 Dr. Jonathan Sadeh is an accomplished physician-scientist with over 20 years of experience in drug development and clinical research.
Michael has further qualifications in dermatopathology, allergology, immunology and health economics. 73 Dr. Jonathan Sadeh is an accomplished physician-scientist with over 20 years of experience in drug development and clinical research.
Since then, and until he entered the biotech field in 1991, he served in senior executive capacities, including as president of a public company that was sold in 1991. In addition to being a director of Scinai, Mr.
From 1986 to 1991, he served in senior executive roles, including as president of a public company that was subsequently sold. In addition to serving as Chairman of the Company, Mr.
Currently, he holds the position of Secretary General and Vice President of the European Dermatology Forum (EDF). Prof. Schön earned his MD in Medicine from the University of Ulm, Germany. He has worked at the Free University of Berlin, Harvard Medical School and the universities of Düsseldorf and Magdeburg.
Schön earned his MD in Medicine from the University of Ulm, Germany. He has worked at the Free University of Berlin, Harvard Medical School and the universities of Düsseldorf and Magdeburg. Before his appointment at the University Medical Center Göttingen, he held a professorship in Experimental Biomedicine at the University of Würzburg.
Prior to this, Mr. Reichman served as Senior Director of Vaccines Supply Chain for GSK from September 2015 to November 2017. Prior to GSK, Mr. Reichman held various leadership roles of increasing responsibility in the Global Vaccines Value Chain Management organization of Novartis Vaccines and Diagnostics Ltd.
Reichman held various leadership roles of increasing responsibility within the Global Vaccines Value Chain Management organization of Novartis Vaccines and Diagnostics Ltd. (“Novartis”) in Holly Springs, North Carolina from 2011 to 2015, prior to the acquisition of Novartis Vaccines by GSK. Mr. Reichman was also among the founding team of NeuroDerm Ltd.
Ben-Or founded CFO Direct, in which he has served as the chief executive officer and through which he provides his services to our company. Mr.
Ben-Or also serves as Chief Financial Officer of the Company’s subsidiary, Scinai Biopharma Services Ltd. In January 2007, Mr. Ben-Or founded CFO Direct, through which he provides financial management services to the Company. Mr.
Reichman earned an M.Sc. in Biotechnology Engineering from the Ben-Gurion University of the Negev in Be’er Sheva, Israel and an MBA in Finance and Health Care Management from the Wharton School of the University of Pennsylvania in Philadelphia, PA. Dr.
Reichman holds an M.Sc. in Biotechnology Engineering from Ben-Gurion University of the Negev and an MBA in Finance and Health Care Management from the Wharton School of the University of Pennsylvania. Mr. Uri Ben-Or, CPA, MBA, has served as Chief Financial Officer of the Company since 2007. As of March 31, 2026, Mr.
Raviv served on the boards of directors of many private and several public companies, as well as various non-profit entities. He received a bachelor’s degree in International Relations with honors from the Hebrew University of Jerusalem and an MBA, with honors, from Columbia University in New York City.
Raviv served on the boards of directors of many private and several public companies, as well as various non-profit entities.
(2) Includes RSU’s and options. (3) Includes payments for car allowance and bonus payment. Employment and Services Agreements Our employees are employed under the terms prescribed in their respective personal contracts, in accordance with the decisions of our management.
Ben-Yedidia resigned from the Company, effective September 8, 2025. (5) Ms. Weinstein Fischer resigned from the Company, effective July 8, 2025. Employment and Services Agreements Our employees are employed under the terms prescribed in their respective personal contracts, in accordance with the decisions of our management.
He is a Chartered Professional Accountant who holds a Master of Accounting from the University of Waterloo, Ontario, Canada. Dr. Morris Laster has served as a member of our board of directors since November 2017. Dr. Laster is a healthcare executive and entrepreneur with 30 years of experience in the biopharmaceutical industry.
He is a Chartered Professional Accountant who holds a Master of Accounting from the University of Waterloo, Ontario, Canada. Dr. Yael Margolin joined the board of directors in 2020. Dr.
Ben-Or has over 20 years of experience and significant expertise in corporate finance, accounting, M&A transactions and IPOs, and has served as CFO with life science companies traded on the TASE, on Nasdaq and over the counter. Mr.
Ben-Or has over 20 years of experience in corporate finance, accounting, mergers and acquisitions and public offerings, and has served as chief financial officer of multiple life sciences companies listed on the Tel Aviv Stock Exchange, Nasdaq and over-the-counter markets. Mr.
Reichman is entitled to receive 6,000 restricted share units (the “RSUs”) under the Company’s 2018 Israeli Share Option Plan, which will vest over a period of five years, 20% to vest each year starting on January 20, 2021 (the “Commencement Date”), and would become fully vested, in accordance with the terms of the grant, on January 20,2026.
Furthermore, under the agreement Mr. Reichman received 6,000 RSUs under the Company’s 2018 Israeli Share Option Plan, which vested over a period of five years and became fully vested on January 20, 2026. The ADSs underlying the RSUs may not be sold by Mr.
Weinstein Fischer holds a Ph.D. from the Hadassah Medical School, Molecular Genetics and Microbiology Department, Hebrew University of Jerusalem. Directors Mr. Mark Germain joined the board in 2018 and has served as the Chairman of our board of directors since 2019. Mr.
Mark holds a B.Sc. in Engineering from Afeka Academic College of Engineering in Tel Aviv and an MBA from the Open University of Israel. Directors Mr. Mark Germain joined the Board of Directors of the Company in 2018 and has served as Chairman of the Board since 2019. As of March 31, 2026, Mr.
Uri Ben-Or Chief Financial Officer 127 9 7 - 142 Mr. Elad Mark Chief Operating Officer 151 33 46 12 242 Dr. Dalit Weinstein Fischer Chief Technology Officer 121 37 31 15 203 (1) Includes payments to the National Insurance Institute, advanced education funds, managers’ insurance and pension funds; vacation pay; and recuperations pay as mandated by Israeli law.
Dalit Weinstein Fischer(5) Former Chief Technology Officer 73 21 (38 ) 6 62 (1) Includes payments to the National Insurance Institute, advanced education funds, managers’ insurance and pension funds; vacation pay; and recuperations pay as mandated by Israeli law. (2) Includes RSU’s and options. (3) Includes payments for car allowance and bonus payment. (4) Ms.
Before that Mr. Mark served as the Head of the Engineering Department in Biopharmax Group, a company which focuses on EPCM (Engineering, Procurement, Construction and Management) in the pharmaceutical field. Mr.
Mark served as Head of the Engineering Department at Biopharmax Group, a company specializing in engineering, procurement, construction and management (EPCM) services for the pharmaceutical industry. Mr. Mark is a bioprocess engineer with over 15 years of experience across biotechnology engineering and manufacturing projects, including feasibility studies, conceptual and detailed design, commissioning, qualification and process validation. Mr.
Lowell is qualified to serve on our board of directors based on his extensive experience and knowledge in the field of health care and years of executive leadership in the biomedical industry. Prof. Michael Schön is a distinguished Professor and Director of the Department of Dermatology, Venereology, and Allergology at the University Medical Center Göttingen.
Michael Schön is a distinguished Professor and Director of the Department of Dermatology, Venereology, and Allergology at the University Medical Center Göttingen. He also serves as Vice Dean and Deputy Director for Research and Teaching and is the former director of the Lower Saxony Institute of Occupational Dermatology. Prof.
Rotman is qualified to serve on our board of directors based on his extensive experience and knowledge in the field of biotechnology and as an executive officer and director of multiple biotechnology companies. 83 Our Scientific Advisory Board Our Scientific Advisory Board includes specialists and experts in Israel, with experience in the fields of biochemistry, infectious diseases and medical research.
He received a bachelor’s degree in International Relations with honors from the Hebrew University of Jerusalem and an MBA, with honors, from Columbia University in New York City. 72 Our Scientific Advisory Board Our Scientific Advisory Board includes specialists and experts in Israel, with experience in the fields of biochemistry, infectious diseases and medical research.
Removed
(“Novartis”) in Holly Springs, NC from 2011 to 2015, at which time Novartis Vaccines was acquired by GSK. In 2003, Mr. Reichman’s academic research contributed to the founding of NeuroDerm Ltd.
Added
(2) Member of the Compensation Committee. Executive Officers Mr. Amir Reichman has served as Chief Executive Officer of the Company since 2021. As of March 31, 2026, Mr. Reichman also serves as Chief Executive Officer of the Company’s subsidiary, Scinai Biopharma Services Ltd. Prior to joining the Company, Mr.
Removed
Tamar Ben-Yedidia has served as our Chief Scientist since 2004 and is responsible for the pre-clinical and clinical development and trials of the Company. Dr. Ben-Yedidia began her career at Biotechnology General (Israel) Ltd., BTG (Rehovot), where she was employed as lab manager from 1991 to 1994. Dr.
Added
Mark serves as Chief Business Officer and Chief Technology Officer (CBO/CTO) of the Company’s subsidiary, Scinai Biopharma Services Ltd., where he is responsible for business development, sales and marketing, program management, and cross-site engineering and technical functions across the CDMO platform. In this role, Mr.
Removed
Ben-Yedidia joined the Department of Immunology at the Weizmann Institute of Science from 1994 - 2004. Dr. Ben-Yedidia was involved in two European Consortium projects related to the evaluation of different approaches for vaccination, and managed 7 clinical trials from Phae 1 to multinational large phase 3, with more than 12,000 participants. Dr.
Added
Mark focuses on commercial growth, client engagement and the integration of technical and operational capabilities across the subsidiary’s manufacturing sites. Prior to joining the Company, Mr.
Removed
Ben-Yedidia received her Ph.D. in immunology from the Weizmann Institute after completion of her doctoral thesis titled “A Peptide-Based Vaccine Against Influenza.” And is being invited to address conferences worldwide and to publish in peer-reviewed scientific journals. Mr. Uri Ben-Or , CPA, MBA, has served as our Chief Financial Officer since 2007. In January 2007, Mr.
Added
At our annual shareholders meeting held on December 22, 2025, our shareholders approved a grant of 60,000 restricted share units (“RSUs”) to Amir Reichman.
Removed
In his role as COO and Head of the CDMO business unit, he oversees Scinai's manufacturing facility, scale-up operations, and technology transfer activities. This includes responsibility for CDMO business development, sales, and marketing, as well as engaging with clients to ensure that processes are implemented according to their requirements. Prior to joining Scinai, Mr.
Added
The RSUs vest in three equal annual installments commencing as of the date of the meeting, are subject to accelerated vesting and immediately exercisable in the event of a change of control and were granted in accordance with the capital gains tax route of Section 102 of the Israel Income Tax Ordinance (“Section 102”) and otherwise in accordance with our 2018 Israeli Share Option Plan (the “2018 Plan”).
Removed
Mark is a principal bioprocess engineer with over 15 consecutive years of biotechnology engineering experience with diverse project stages including feasibility study, conceptual and detail design, commissioning, qualification and process validation. Mr. Mark holds a B.Sc. in Engineering from the Afeka Academic College of Engineering in Tel Aviv and an MBA from the Open University of Israel. Dr.
Added
At the meeting shareholders also approved a grant of options to purchase 25,000 ADSs to Mark Germain and options to purchase 12,500 ADSs to each of Adi Raviv, Dr. Yael Margolin, Samuel Moed and Jay Green.
Removed
Dalit Weinstein Fischer joined the Company in 2022 as VP R&D and has served as Chief Technology Officer since September 2023. From 2019 to 2022, Dr.
Added
The exercise price per ADS for the options is $1.42, and the options vest in three equal annual installments commencing as of the date of the meeting, (ii), to the extent the options are vested, they continue to be exercisable during such term unless such director is terminated for cause, (iii) are subject to accelerated vesting and immediately exercisable in the event of a change of control and (iv) have a term of ten (10) years following the date of shareholder approval, and which for Israeli grantees are granted in accordance with Section 102, with all other terms as otherwise described in the 2018 Plan.
Removed
Weinstein Fischer served as CTO of VAYU Sense AG, specializing in improving bio-based fermentation processes with an AI-based controller, and from 2016 until 2019, she served as a Director of Biological Processes at NanoSpun Technologies Ltd. From 2015 to 2016, Dr. Weinstein Fischer led the Natural Biotechnology Systems Department at Sigma Aldrich. Dr.
Added
Uri Ben-Or Chief Financial Officer 165 10 4 - 179 Mr. Elad Mark Chief Operating Officer 175 38 30 26 269 Dr.
Removed
His expertise lies in the identification, development, management and financing of advanced biomedical drugs and technologies. Dr. Laster is currently the CEO of Metabolize, Inc. and Tedence, Ltd., two innovative startups focused on metabolic health and bioelectric medicine, respectively. Dr. Laster is currently the CEO of Clil Medical Ltd., a biomedical consultancy company, a position he has held since 2010.
Added
Germain a cash bonus of $90,000, and in August 2023, we granted Mr. Germain a cash bonus of $37,500. Mr.

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Item 7. Management's Discussion & Analysis

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

14 edited+0 added−5 removed7 unchanged
Biggest change(7) Consists of 8,077 ADSs and 2,693 ADSs issuable upon settlement of vested RSUs. (8) Consists of 39 ADSs, and 1,511 ADSs issuable upon settlement of vested RSUs. (9) Consists of 276 ADSs, and 313 ADSs issuable upon settlement of vested RSUs. 102 (10) Consists of 1,355 ADSs, and 1,237 ADSs issuable upon settlement of RSUs.
Biggest change(8) Consists of 4,872 ADSs, and 1,885 ADSs issuable upon settlement of vested options and RSUs.
On March 1, 2015, our general shareholders meeting approved the grant of an indemnification and exculpation agreement under the same terms and conditions for each of our current office holders and directors. 103 Employment and Service Agreements We have or have had employment, service or related agreements with each member of our senior management. See Item 6.
On March 1, 2015, our general shareholders meeting approved the grant of an indemnification and exculpation agreement under the same terms and conditions for each of our current office holders and directors. Employment and Service Agreements We have or have had employment, service or related agreements with each member of our senior management. See Item 6.
Major Shareholders The following table sets forth certain information as of March 31, 2025 concerning the beneficial ownership of ADSs of: (i) each director and director nominee, (ii) each Named Executive Officer in the Summary Compensation Table under “Executive Compensation” above, (iii) all executive officers and directors as a group, and (iv) each person (including any “group” as that term is used in Section 13(d)(3) of the Exchange Act) known by us to be the beneficial owner of 5% or more of our ADSs.
Major Shareholders The following table sets forth certain information as of March 31, 2026 concerning the beneficial ownership of ADSs of: (i) each director and director nominee, (ii) each Named Executive Officer in the Summary Compensation Table under “Executive Compensation” above, (iii) all executive officers and directors as a group, and (iv) each person (including any “group” as that term is used in Section 13(d)(3) of the Exchange Act) known by us to be the beneficial owner of 5% or more of our ADSs.
Future issuances of ordinary shares or ADSs by us to third parties are expected to cause additional amounts of pre-funded warrants to become exercisable within the foregoing limitation, without increasing RK’s beneficial ownership percentage. The address of Daniel E Stone is 1200 Brickell Avenue, #1470 Miami, FL 33131.
Future issuances of ordinary shares or ADSs by us to third parties are expected to cause additional amounts of pre-funded warrants to become exercisable within the foregoing limitation, without increasing RK’s beneficial ownership percentage. The address of Daniel E Stone is 1200 Brickell Avenue, #1470 Miami, FL 33131. 90 B.
Family Relationships There are no family relationships between any members of our executive management and our directors. C. Interests of Experts and Counsel Not applicable.
Family Relationships There are no family relationships between any members of our executive management and our directors. C. Interests of Experts and Counsel Not applicable. 91
ADSs issuable under share options or other conversion rights that were exercisable within 60 days after March 31, 2025, are deemed outstanding for the purpose of computing the percentage ownership of the person holding the options or other conversion rights but are not deemed outstanding for the purpose of computing the percentage ownership of any other person.
ADSs issuable under share options or other conversion rights that were exercisable within 60 days after March 31, 2026, are deemed outstanding for the purpose of computing the percentage ownership of the person holding the options or other conversion rights but are not deemed outstanding for the purpose of computing the percentage ownership of any other person.
The percentage of ADSs beneficially owned is based on 999,919 ADSs outstanding as of March 31, 2025. 101 Except as indicated by the footnotes below, we believe, based on the information furnished to us, that the persons and entities named in the table below have sole voting and investment power with respect to all ADSs that they beneficially own.
The percentage of ADSs beneficially owned is based on 3,535,489 ADSs outstanding as of March 31, 2026. Except as indicated by the footnotes below, we believe, based on the information furnished to us, that the persons and entities named in the table below have sole voting and investment power with respect to all ADSs that they beneficially own.
RK holds 484,928 pre-funded warrants, which may not be exercised if such exercise would result in beneficial ownership by RK, together with its affiliates (which include the reporting person) and certain other persons, of greater than 9.99% of the ordinary shares.
(9) Includes 307,000 ADSs held directly and 283,426 ADSs issuable upon exercise of pre-funded warrants held by RK RK Stone Miami LLC (“RK”), which may not be exercised if such exercise would result in beneficial ownership by RK, together with its affiliates (which include the reporting person) and certain other persons, of greater than 9.99% of the ordinary shares.
None of our shareholders has different voting rights from other shareholders. 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.
None of our shareholders has different voting rights from other shareholders. To the best of our knowledge, we are not owned or controlled, directly or indirectly, by another corporation or by any foreign government.
Except as otherwise indicated in the footnotes to this table, we believe the persons named in this table have sole voting and investment power with respect to all the ordinary shares indicated.
We are not aware of any arrangement that may, at a subsequent date, result in a change of control of our company. 89 Except as otherwise indicated in the footnotes to this table, we believe the persons named in this table have sole voting and investment power with respect to all the ordinary shares indicated.
(3) Consists of 50 ADSs, and 1,620 ADSs issuable upon settlement of vested options and RSUs. (4) Consists of 50 ADSs, and 1,620 ADSs issuable upon settlement of vested options and RSUs. (5) (6) Consists of 50 ADSs, and 1,620 ADSs issuable upon settlement of vested options and RSUs. Consists of ADSs issuable upon exercise of options.
(4) Consists of 667 ADSs issuable upon settlement of vested options and RSUs. (5) Consists of 19,812 ADSs, and 9,014 ADSs issuable upon settlement of vested options and RSUs. (6) Consists of 50 ADSs . (7) Consists of 1,181 ADSs, and 413 ADSs issuable upon settlement of vested options and RSUs.
All investment decisions for YA are made by Mr. Mark Angelo. The business address of YA is 1012 Springfield Avenue, Mountainside, NJ 07092. B. Related Party Transactions The following is a description of some of the transactions with related parties to which we are a party to, and which were in effect within the past three fiscal years.
Related Party Transactions The following is a description of some of the transactions with related parties to which we are a party to, and which were in effect within the past three fiscal years.
Percent of ADSs Class % Directors and Executive Officers Avner Rotman (1) 1,670 * Mark Germain (2) 4,605 * Morris Laster (3) 1,670 * Adi Raviv (4) 1,670 * Yael Margolin (5) 1,670 * Sam Moed (6) 2,000 * Amir Reichman (7) 10,770 * Jay Green (8) 1,550 * Uri Ben-Or (9) 589 * Tamar Ben-Yedidia (10) 2,592 * Elad Mark (11) 2,139 * Dalit Weinstein Fischer (12) 1,464 All executive officers and directors as a group (12 people) 25,096 * 5% Shareholders Daniel E.
Percent of ADSs Class % Directors and Executive Officers Mark Germain (1) 5,180 * Adi Raviv (2) 337 * Yael Margolin (3) 337 * Sam Moed (4) 667 * Amir Reichman (5) 28,525 * Jay Green (6) 50 * Uri Ben-Or (7) 1,594 * Elad Mark (8) 6,757 * All executive officers and directors as a group (8 people) 43,746 * 5% Shareholders Daniel E.
Stone (13) 104,046 9.99 % Richard J. Kertzman (14) 102,020 9.99 % YA II PN, Ltd.(15) 93,274 9.32 % * Less than 1%. (1) (2) Consists of 50 ADSs, and 1,620 ADSs issuable upon settlement of vested options and RSUs. Consists of ADSs issuable upon exercise of options.
Stone (9) 353,195 9.99 % * Less than 1%. (1) Consists of 5,180 ADSs issuable upon settlement of vested options and RSUs. (2) Consists of 50 ADSs, and 287 ADSs issuable upon settlement of vested options and RSUs. (3) Consists of 50 ADSs, and 287 ADSs issuable upon settlement of vested options and RSUs .
Removed
(11) Consists of 1,272 ADSs, and 867 ADSs issuable upon settlement of RSUs. (12) Consists of 1,023 ADSs, and 441 ADSs issuable upon settlement of RSUs. (13) Includes 62,400 ADSs held directly and 41,646 ADSs issuable upon exercise of pre-funded warrants held by RK Stone Miami LLC (“RK”).
Removed
(14) Includes 80,736 ADSs held directly and 21,284 ADSs issuable upon exercise of pre-funded warrants held by LCK JNK1 LLC and LCK JNK LLC (together, “LCK”). LCK holds 80,757 pre-funded warrants, which may not be exercised if such exercise would result in beneficial ownership by Mr.
Removed
Kertzman, together with his affiliates (which include the reporting person) and certain other persons, of greater than 9.99% of the ordinary shares. Future issuances of ordinary shares or ADSs by us to third parties are expected to cause additional amounts of pre-funded warrants to become exercisable within the foregoing limitation, without increasing Mr. Kertzman’s person's beneficial ownership percentage.
Removed
The address of Mr. Kertzman is 3105 NW 107th Avenue, Suite 103, Doral, FL 33172. (15) Pursuant to the Standby Equity Purchase Agreement with YA, YA has committed to purchase up to $10.0 million of ADSs at our direction from time to time, subject to the restrictions and satisfaction of the conditions in the Purchase Agreement. See “Item 5.
Removed
Operating and Financial Review and Prospects – Liquidity and Capital Resources”. Under the agreement, we are prohibited from issuing and selling shares to YA II to the extent that it would cause the aggregate number of ADSs beneficially owned by YA and its affiliates to exceed 9.99% of the then outstanding ADSs.