Pluri Inc.

An investment in our securities involves a high degree of risk. You should consider carefully the following information about these risks, together with the other information contained in this Annual Report before making an investment decision. Our business, prospects, financial condition and results of operations may be materially and adversely affected as a result of any of the following risks. The value of our securities could decline as a result of any of these risks. You could lose all or part of your investment in our securities. Some of the statements in “Item 1A. Risk Factors” are forward-looking statements. The following risk factors are not the only risk factors facing our Company. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our business, prospects, financial condition and results of operations.

Summary of Risk Factors

Risks Related to Our Business

Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements included in this Annual Report. The financial statements have been prepared under the assumption that we will continue as a going concern and do not include any adjustments that might result if we are unable to continue as a going concern.

As indicated in the independent auditor’s report for the fiscal year ended June 30, 2026, the accompanying consolidated financial statements have been prepared assuming that we will continue as a going concern. Our recurring operating losses and negative cash flow raise substantial doubt about our ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

As of June 30, 2026, our cash balances (cash and cash equivalents, short-term bank deposits, restricted cash and restricted bank deposits) totaled to $8,851,000. According to management estimates, we only have sufficient resources to meet our operating obligations for a period of less than three months from the issuance date of the consolidated financial statements. To sustain operations beyond this period, we will require additional capital to sustain operations. There can be no assurance that such financing will be available on favorable terms, or at all.

If we are unable to secure additional capital, we may need to implement cost-containments measures, such as reducing discretionary expenditures and streamlining operations. While these actions may provide temporary relief, they could also delay key initiatives and negatively affect our business outlook.

We may need to raise additional financing to support the research, development and manufacturing of our cell-based products in the future, but we cannot be sure we will be able to obtain additional financing on terms favorable to us when needed. If we are unable to obtain additional financing to meet our needs, our operations may be adversely affected or terminated.

We will need to raise significant additional capital in the future. Although we were successful in raising capital in the past, our current financial resources are limited, and may not be sufficient to finance our operations until we become profitable, if that ever happens.

We will need to raise additional funds in order to satisfy our working capital and capital expenditure requirements. Therefore, we are dependent on our ability to sell our common shares for funds, receive grants, enter into collaborations and licensing deals or to otherwise raise capital. Any sale of our common shares in the future could result in dilution to existing shareholders and could adversely affect the market price of our common shares.

Also, we may not be able to raise additional capital in the future to support the development and commercialization of our products, which could result in in a significant decline in the value of our common shares or the loss of all or a portion of an investment in our common shares.

Our likelihood of profitability depends on our ability to license and/or develop and commercialize our products based on our technology, which is currently in the development stage. If we are unable to complete the development and commercialization of our cell-based products and CDMO services successfully, or are unable to obtain the necessary regulatory approvals, our likelihood of profitability will be limited severely.

We are engaged in the business of developing cell-based products. We have not realized a profit from our operations to date and there is little likelihood that we will realize any profits in the short or medium term. Any profitability in the future from our business will be dependent upon successful commercialization of our regenerative aesthetics, wellness and longevity activities, cell-based services and products and/or licensing of our products, which will require additional research and development.

If our cell therapy product candidates do not prove to be safe and effective in clinical trials, we will not obtain the required regulatory approvals. If we fail to obtain such approvals, we may not generate sufficient revenues to continue our business operations.

Even after granting regulatory approval, the FDA, the EMA, and regulatory agencies in other countries continue to regulate marketed products, manufacturers and manufacturing facilities, which may create additional regulatory barriers and burdens. Later discovery of previously unknown problems with a product, manufacturer or facility, may result in restrictions on the product or manufacturer, including a withdrawal of the product from the market.

We have not generated significant or consistent revenues to date, which raises doubts with respect to our ability to generate revenues in the future.

We have a limited operating history in our business of commercializing cell-based products and cell technology, and we have not generated material revenues to date. It is not clear whether we will generate material revenues or whether we will generate material revenues in the future. We cannot give assurances that we will be able to generate any significant revenues or income in the future. There is no assurance that we will ever be profitable.

Failure to reach an agreement with the EIB about the repayment of the EIB Loan could adversely affect our financial condition and liquidity.

On April 30, 2020, we and our subsidiaries, Pluri Biotech Ltd. and Pluristem GmbH, entered into the EIB Finance Agreement for a loan in the amount of up to €50 million in the aggregate, subject to certain milestones being reached, receivable in three tranches. During June 2021, we received the first and final tranche in the amount of €20 million. The amount received was due to be repaid on June 1, 2026, and bears annual interest of 4% to be paid together with the principal amount of the loan. As of June 30, 2026, the interest accrued was in the amount of approximately €4.1 million. In addition to the interest payable, the EIB is also entitled to royalty payments, pro-rated to the amount disbursed from the EIB Loan, on our consolidated revenues beginning in the fiscal year 2024 up to and including its fiscal year 2030, in an amount equal to up to 2.3% of our consolidated revenues below $350 million, 1.2% of our consolidated revenues between $350 million and $500 million and 0.2% of our consolidated revenues exceeding $500 million. As of June 30, 2026, we had an accrued royalty in the amount of $9 thousand.

We maintained discussions with the EIB with the objective of reaching a mutually agreed resolution regarding the EIB Loan. The EIB confirmed that during such discussion period, and while discussions remain ongoing, the EIB is not contemplating any enforcement action, all without prejudice to any of its rights and remedies. On August 17, 2026, we were notified by the EIB that its relevant committee had approved, subject to certain conditions, a proposed sale of the EIB Loan not involving the Company as purchaser, on terms agreed with a third-party purchaser, who may be a related party. Completion of such sale remains subject to, among other things, execution of definitive legal documentation and completion of the EIB’s review process and other conditions. If the proposed sale is completed, the Company intends to seek to reach an arrangement with the purchaser regarding the settlement of the purchased loan, which may include the conversion of all or a portion of the outstanding loan amount into equity of the Company. Any such arrangement would be subject to negotiation with the purchaser and the receipt of all required corporate and other approvals. Until the proposed sale is finalized and any subsequent arrangement with the purchaser is agreed and approved, there can be no certainty as to the outcome of the discussions, or that the EIB will continue to refrain from exercising remedies available to it under the finance agreement, or any assurance that any sale of the EIB Loan will be completed, that any settlement or conversion arrangement will be entered into or consummated, or as to the timing, structure, accounting treatment or financial statement impact of any such transaction.

If we fail to resolve, on acceptable terms, our obligations in respect with the EIB about the repayment of the EIB Loan, our financial condition and liquidity would be materially affected and could materially adversely affect our ability to continue as a going concern.

Because most of our officers and directors are located in non-U.S. jurisdictions, you may have no effective recourse against the management for misconduct and may not be able to enforce judgment and civil liabilities against our officers, directors, experts and agents.

Most of our directors and officers are nationals and/or residents of countries other than the United States, and all or a substantial portion of their assets are located outside the United States.

As a result, it may be difficult to enforce within the United States any judgments obtained against our officers or directors, including judgments predicated upon the civil liability provisions of the securities laws of the United States or any U.S. state.

While we may seek partners for licensing deals, joint ventures, partnerships, and direct sale of our products in various industries, there is no guarantee we will be successful in doing so.

To date, we have focused our efforts primarily in the regenerative medicine field, in the FoodTech field, in the CDMO field, and in regenerative aesthetics, wellness and longevity activities, but we may seek partners for licensing deals, joint ventures, partnerships, and direct sale of our products or use of our technology in various industries. Licensing deals, joint ventures and partnerships in new fields involve numerous risks, including the potential integration of our technology and products in various new ways, which may or may not be successful. Such projects may require significant funds, time and attention from management and other key personnel. In addition, as we do not have experience in areas outside of the regenerative medicine field and limited experience in the FoodTech, CDMO and regenerative aesthetics, wellness and longevity activities, we may lack the personnel to properly lead such initiatives. There can be no assurance that we will be successful in finding the relevant partners to fund and market our cell-based products.* *

Changes in U.S. trade policy and tariffs may have an adverse impact on our business.

Our business involves the importation of certain raw materials, components, and finished goods essential for our cell expansion platform and related applications. Changes in U.S. trade policy, including the imposition of new tariffs or modifications to existing trade agreements, could affect our supply chain, increase costs, and impact our financial performance. For the year ended June 30, 2026, we estimate that the impact of tariffs currently imposed on our imports was not material. However, we are unable to estimate the impacts of any future tariffs that may be enacted. While we actively monitor trade developments and assess potential impacts, the evolving nature of trade policies makes it challenging to predict the full extent of these effects. We may not be able to mitigate all adverse consequences, which could include increased production costs, delays in product development, or reduced margins.

Risks Related to Development, Clinical Studies, and Regulatory Approval of Our Product Candidates

If we are not able to conduct our clinical trials properly and on schedule, marketing approval by FDA, EMA, MOH and other regulatory authorities may be delayed or denied.

The completion of our future clinical trials may be delayed or terminated for many reasons, such as:

If we are unable to conduct clinical trials properly and on schedule, marketing approval may be delayed or denied by the FDA, EMA, MOH and other regulatory authorities.

The results of our clinical trials may not support our product candidates’ claims or any additional claims we may seek for our product candidates, and our clinical trials may result in the discovery of adverse side effects.

Even if any clinical trial that we need to undertake is completed as planned, or if interim results from existing clinical trials are released, we cannot be certain that such results will support our product candidates claims or any new indications that we may seek for our products or that the FDA or foreign authorities will agree with our conclusions regarding the results of those trials. The clinical trial process may fail to demonstrate that our products or a product candidate is safe and effective for the proposed indicated use, which could cause us to stop seeking additional clearances or approvals for our product candidates. Any delay or termination of our clinical trials will delay the filing of our regulatory submissions and, ultimately, our ability to commercialize a product candidate. It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of the product candidate’s profile.

Favorable results from compassionate use treatment or initial interim results from a clinical trial do not ensure that later clinical trials will be successful and success in early-stage clinical trials does not ensure success in later-stage clinical trials.

PLX cells have been administered as part of compassionate use treatments, which permit the administration of the PLX cells outside of clinical trials. No assurance can be given that any positive results are attributable to the PLX cells, or that administration of PLX cells to other patients will have positive results. Compassionate use is a term that is used to refer to the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options. Regulators often allow compassionate use on a case-by-case basis for an individual patient or for defined groups of patients with similar treatment needs.

Success in early clinical trials does not ensure that later clinical trials will be successful, and initial results from a clinical trial do not necessarily predict final results. While results from treating patients through compassionate use have in certain cases been successful, we cannot be assured that further trials will ultimately be successful. Results of further clinical trials may be disappointing.

Even if early-stage clinical trials are successful, we may need to conduct additional clinical trials for product candidates with patients receiving the drug for longer periods before we are able to seek approvals to market and sell these product candidates from the FDA and regulatory authorities outside the United States. Even if we are able to obtain approval for our product candidates through an accelerated approval review program, we may still be required to conduct clinical trials after such an approval. If we are not successful in commercializing any of our lead product candidates, or are significantly delayed in doing so, our business will be materially harmed.

Our product development programs are based on novel technologies and are inherently risky.

We are subject to the risks of failure inherent in the development of products based on new technologies. The novel nature of our therapeutics creates significant challenges in regard to product development and optimization, manufacturing, government regulation, third party reimbursement and market acceptance. For example, the FDA, the EMA and other countries’ regulatory authorities have relatively limited experience with cell therapies. Very few cell therapy products have been approved by regulatory authorities to date for commercial sale, and the pathway to regulatory approval for our cell therapy product candidates may accordingly be more complex and lengthier. As a result, the development and commercialization pathway for our therapies may be subject to increased uncertainty, as compared to the pathway for new conventional drugs.

Our cell therapy drug candidates represent new classes of therapy that the marketplace may not understand or accept.

Even if we successfully develop and obtain regulatory approval for our cell therapy candidates, the market may not understand or accept them. We are developing cell therapy product candidates that represent novel treatments and will compete with a number of more conventional products and therapies manufactured and marketed by others, including major pharmaceutical companies. The degree of market acceptance of any of our developed and potential products will depend on a number of factors, including:

If the health care community does not accept our potential products for any of the foregoing reasons, or for any other reason, it could affect our sales, having a material adverse effect on our business, financial condition, and results of operations.

Interim, “top-line,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or as additional analyses are conducted, and as the data are subject to audit and verification procedures, which could result in material changes in the final data.

From time to time, we may publish interim, “top-line,” or preliminary data from our clinical studies. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary or “top-line” data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Material adverse changes between preliminary, “top-line,” or interim data and final data could significantly harm our business prospects.

Risks Related to Our Longevity, Wellness and Aesthetics Business

Our longevity, wellness and aesthetics products may not achieve market acceptance, and we have limited operating and commercialization history in this business. Regulatory uncertainty and the potential for differing product classifications could subject these products to additional requirements and adversely affect our ability to commercialize them.

Our longevity, wellness and aesthetics products are at an early stage of either development or commercialization, and we have limited operating and commercialization history in this business. Market acceptance by consumers, clinics, medical spas, distributors, strategic partners and other channels is uncertain and will depend on, among other things, successful development, validation, scale-up, manufacturing, quality control, shelf life, stability, formulation, packaging, supply chain management and third-party distribution. Regulation of these products in the United States, United Kingdom, European Union, Israel and other markets is evolving and uncertain, and products may be classified or reclassified as cosmetics, wellness products, consumer health products, medical devices, drugs, biologics, tissue- or cell-based products or other regulated products depending on their intended use, ingredients, claims, labeling, distribution channels and professional use.

The FDA, Federal Trade Commission (the “FTC”) and comparable international authorities oversee cosmetic labeling, advertising and claims, which must be truthful and not misleading, and products marketed as affecting the structure or function of the body or treating or preventing disease may be regulated as drugs or otherwise subject to additional requirements. Use of cell-derived ingredients, conditioned media, exosomes or other biologically derived materials could increase regulatory, safety, claims-substantiation, adverse-event, post-market monitoring, recall, import/export and enforcement risks. Regulators, customers or partners may disagree with our product characterization or claims, which could result in delays, increased costs, enforcement actions, product restrictions, recalls, reputational harm, inability to commercialize products or an adverse effect on our business, results of operations and prospects. Any failure to comply with applicable requirements could result in delays, restrictions, recalls, enforcement actions, an inability to commercialize, reputational harm or an adverse impact on our business.

Risks Related to Our Cultivated FoodTech Business

Ever After Foods has a limited operating history in the field of cultivated meat and is seeking to expand its capabilities to additional cultivated protein and seafood applications, including through the recently announced Fishway Acquisition. To-date, Ever After Foods and its prospects are, and are expected to continue being, dependent on its ability to meet a number of challenges.

Ever After Foods’ business prospects are difficult to predict due to its lack of operational history in the new and emerging food tech field, and its success will be dependent on its ability to meet a number of challenges. Because it has a limited operating history in the field of cultivated meat and it is in the early stages of development, Ever After Foods may not be able to evaluate its future prospects accurately. Ever After Foods’ prospects will be primarily dependent on its ability to successfully develop industrial scale cultivated meat and related cultivated protein or seafood applications, technologies and processes, and market these to its potential customers. If Ever After Foods is not able to successfully meet these challenges, its prospects, business, financial condition, and results of operations could be adversely impacted. In addition, Ever After Food may not successfully integrate or implement the newly acquired Fishway assets, know-how, scientific capabilities, aquatic cell biology, animal-component-free media development, team and European presence, and the expected benefits may not be realized, may take longer or cost more than expected, or may disrupt our existing efforts

In addition, Ever After Foods will be subject to changing laws, rules and regulations in the United States, Israel, Asia Pacific, the European Union and other jurisdictions relating to the food tech industry. Such laws and regulations may negatively impact Ever After Foods’ ability to expand its business and pursue business opportunities. Ever After Foods may also incur significant expenses to comply with the laws, regulations and other obligations that will apply to it.

Ever After Foods is primarily focused on utilizing its technology for the development of cultivated meat, and it has limited data on the performance of our and its technologies in the field of cultivated meat to date.

Ever After Foods does not currently have any products or technologies approved for sale and it is still in the early stages of development. To date, Ever After Foods has limited data on the ability of our and its technologies to successfully manufacture cultivated meat, towards which they have devoted substantial resources to date. Ever After Foods’ current technologies are, in large part, based on our technologies and IP. It may not be successful in developing its technologies in a manner sufficient to support its expected scale-ups and future growth, or at all. Ever After Foods expects that a substantial portion of its efforts and expenditures over the next few years will be devoted to the development of technologies designed to enable Ever After Foods to market industrial scale cultivated meat manufacturing processes. Ever After Foods cannot guarantee that it will be successful in developing these technologies, based on its current roadmap, or at all. If Ever After Foods is able to successfully develop its cultivated meat and related cultivated protein or seafood technologies, it cannot ensure that it will obtain regulatory approval or that, following approval, upon commercialization its technologies will achieve market acceptance. Any such delay or failure could materially and adversely affect Ever After Foods’ financial condition, results of operations and prospects.

Consumer preferences for alternative proteins in general, and more specifically cultivated meats, are difficult to predict and may change, and, if we are unable to respond quickly to new trends, Ever After Foods’ business may be adversely affected.

Ever After Foods’ business is focused on the development of cultivated meat manufacturing technologies. Consumer demand for the cultivated meats manufactured using these technologies could change based on a number of possible factors, including dietary habits and nutritional values, concerns regarding the health effects of ingredients and shifts in preference for various product attributes. If consumer demand for such products decreases, Ever After Foods’ business and financial condition would suffer. Consumer trends that we believe favor sales of products manufactured using our licensed technologies could change based on a number of possible factors, including a shift in preference from animal-based protein products, economic factors and social trends. A significant shift in consumer demand away from products manufactured using our technologies could reduce our sales or our market share and the prestige of our brand, which would harm our business and financial condition.

We expect that products utilizing Ever After Foods’ technologies will be subject to regulations that could adversely affect Ever After Foods’ business and operations.

The manufacture, distribution and marketing of food products is highly regulated. Ever After Foods and its suppliers and licensees, may be subject to a variety of laws and regulations. These laws and regulations apply to many aspects of Ever After Foods’ business, including the manufacture, composition and ingredients, packaging, labeling, distribution, advertising, sale, quality and safety of food products and food contact substances (including some manufacturing equipment), as well as the health and safety of our employees and the protection of the environment.

As applicable, the manufacturing equipment that will be manufactured by Ever After Foods will comply with the FDA’s regulatory requirements for food contact substances and analogous foreign regulations. Ever After Foods will also ensure that the edible scaffolds and any other production materials it sells to its customers comply with applicable FDA standards. From a regulatory perspective, in the United States, we expect companies manufacturing finished cultivated meat and related cultivated protein or seafood products ( i.e., the companies that will license Ever After Foods’ manufacturing technologies) to be subject to regulation by various government agencies, including the FDA, the USDA, the FTC, the Occupational Safety and Health Administration and the Environmental Protection Agency, as well as the requirements of various state and local agencies and laws, such as the California Safe Drinking Water and Toxic Enforcement Act of 1986. We likewise expect these products to be regulated by equivalent agencies outside the United States by various international regulatory bodies.

While, as noted above, Ever After Foods will ensure that the products it sells to its customers (including manufacturing equipment and scaffolds) comply with applicable FDA and USDA standards, we believe that our customers, as entities engaged in the manufacture, distribution, and sale of cultivated meat products, will bear primary legal responsibility for ensuring that all finished foods produced using our technology is wholesome and not adulterated and otherwise in compliance with applicable laws and regulations. Consistent with food industry norms, we expect that our customers will therefore request assurances from us that our products are suitable for their intended use under applicable U.S. legal requirements.

The manufacturing of cultivated meat is expected to be subject to extensive regulations internationally, with products subject to numerous food safety and other laws and regulations relating to the sourcing, manufacturing, composition and ingredients, storing, labeling, marketing, advertising and distribution of these products. In addition, enforcement of existing laws and regulations, changes in legal requirements and/or evolving interpretations of existing regulatory requirements may result in increased compliance costs and create other obligations, financial or otherwise, that could adversely affect our business, financial condition or operating results. In addition, we could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act (“FCPA”), and similar worldwide anti-bribery laws, which generally prohibit companies and their intermediaries from making payments to foreign government officials for the purpose of obtaining or retaining business, and require companies both to keep accurate books and records and to devise and maintain an adequate system of internal accounting controls. While our policies mandate compliance with anti-bribery laws, including the FCPA, our internal control policies and procedures may not protect us from reckless or criminal acts committed by our employees, contractors or agents. Violations of these laws, or allegations of such violations, could result in government investigations, the assessment of fines and penalties, reputational damage, disruption to our business, and adverse impacts on our results of operations, cash flows and financial condition.

Any changes in, or changes in the interpretation of, applicable laws, regulations or policies of the USDA, state regulators or similar foreign regulatory authorities that relate to the use of the terms “meat” or “poultry” or other similar terms in connection with cultivated meat products could adversely affect our business, prospects, results of operations or financial condition.

The USDA, state regulators or similar foreign regulatory authorities, such as Health Canada or the Canadian Food Inspection Agency (“CFIA”), or authorities of the EU or the EU member states (e.g., European Food Safety Authority, or EFSA), could take action that impacts our customers’ ability to use the term “meat” or “poultry” or similar words, such as “beef” or “chicken”, to describe their finished products. In addition, a food may be deemed misbranded if its labeling is false or misleading in any particular way, and the USDA, CFIA, EFSA or other regulators could interpret the use of the terms “meat” or “poultry” or any similar phrase(s) to describe our customers’ cultivated meat and related cultivated protein or seafood products as false or misleading or likely to create an erroneous impression regarding their composition. In the U.S., the USDA intends to issue new labeling requirements for foods under its jurisdiction produced through cell culture technology as noted in an ANPR published in September 2021.

Our various new lines of business, including our plant-based vertical (e.g. Coffeesai and Kokomodo), and Ever After Foods, are new businesses with limited operating activity to date, and their success is dependent on the ability to deliver a high-quality product while overcoming multiple challenges.

The success of our various new lines of business is difficult to predict due to our lack of operational history in these industries, and we will be dependent on our ability to meet a number of challenges. Since our new lines of business have a limited operating history, these lines of business may not be able to deliver a successful high-quality product at the scale of production they aim to deliver. The success of these lines of business will be primarily, but not only, dependent on their ability to develop manufacturing solutions, and leveraging Pluri’s 3D cell expansion technology to create compelling products. If our businesses will not be able to successfully meet these challenges, and our prospects, business, financial condition and results of operations could be adversely impacted.

In addition, certain of our lines of business, such as our biopharming and FoodTech lines (which include Coffeesai, Kokomodo and Ever After Foods), will be subject to changing laws, rules and regulations in the United States, Israel, Asia Pacific, the European Union and other jurisdictions. Such laws and regulations may negatively impact their ability to expand their businesses and pursue business opportunities. Our subsidiaries may also incur significant expenses to comply with the laws, regulations and other obligations that will apply to them.

Additionally, Kokomodo faces several key risks in connection with the development and potential commercialization of its cell-based cacao products. First, the regulatory landscape for cell-based cacao remains uncertain, as no regulatory agency has approved such products for commercial sale to date. Any delay or failure to obtain the necessary regulatory approvals could materially impact on the timing and feasibility of market entry. Second, the bioprocessing technology underlying Kokomodo’s platform is subject to significant technical challenges, including the need to optimize culture media composition, fermentation conditions, and quality control systems to ensure consistency and scalability. Finally, Kokomodo must successfully scale its technology beyond the POC stage to reach industrial-scale production. The transition from laboratory to commercial manufacturing involves substantial operational, financial, and technical risks, and any failure to do so may adversely affect our ability to achieve our commercial objectives.

We may need to raise additional financing to support our biopharming and plant-based business vertical and the research, development and manufacturing of their respective products. If we are unable to obtain additional financing to meet their needs, their operations may be adversely affected or terminated.

We will need to raise significant additional capital from investors in the future to finance our biopharming and plant-based business vertical operations. Our current capital may not be sufficient to finance our biopharming and plant-based operations until we are able to complete the development of a high-quality coffee and cacao, and other biopharming initiatives. If we are not able to attract investors and obtain additional financing, the biopharming and plant-based operations may be adversely affected or terminated.

Cultivated plant-based products utilizing our 3D cell expansion technology may be subject to regulations that could adversely affect its business and results of operations.

In connection with our cultivated plant-based initiative, we are working with external regulatory consultants to assess the technical and scientific requirements for determining whether the plant-based cultivated coffee products (including all components) may be considered “Generally Recognized as Safe” (“GRAS”) under Section 201(s) of the Federal Food, Drug, and Cosmetic Act (“FDCA”) and FDA’s implementing regulations (21 C.F.R. § 170.30). If determined to be GRAS in accordance with FDA requirements, the products would be excluded from the definition of a “food additive” under the FDCA and may be lawfully marketed in the United States without prior FDA authorization.

If the products (or any of their components) are not determined to be GRAS, they would be classified as food additives under Section 201(s) of the FDCA. In that case, the products or ingredients could only be marketed in the U.S. if authorized for its intended use under an applicable food additive regulation and in compliance with all other relevant FDA requirements. If no such regulation exists, the respective plant-based initiative may need to submit a food additive petition to request that FDA issue a new regulation authorizing the product’s intended use.

Additionally, before marketing the plant-based products in the United States, the respective plant-based initiative must also ensure compliance with applicable FDA food labeling requirements under section 403 of the FDCA and FDA’s implementing regulations (21 C.F.R. Part 101), manufactured at an FDA-registered food facility pursuant to section 415 of the FDCA and FDA’s implementing regulations (21 C.F.R. Part 1, Subpart H), and manufactured in accordance with all applicable FDA food safety requirements including, but not limited to, FDA’s Hazard Analysis and Preventive Controls and Current Good Manufacturing Practice requirements (21 C.F.R. Part 117). If the cultivated plant products are imported into the United States, additional regulatory requirements may apply, including submission of prior notice to FDA (21 C.F.R. Part 1, Subpart I) and compliance with Foreign Supplier Verification Program requirements (21 C.F.R. Part 1, Subpart L), as applicable.

We may not successfully establish new collaborations, joint ventures or licensing arrangements, which could adversely affect our ability to develop and commercialize our product candidates.

One of the elements of our business strategy is to collaborate with partners and to license our technology to other companies. Our business strategy includes development and in-house manufacturing of innovative new cell- based products and solutions powered by our 3D cell expansion technology platforms and establishing joint ventures and partnerships that leverage our cell expansion technology and cell-based product portfolio to expand product pipelines and meet cell-based manufacturing needs for a variety of industries. To date, we have established Ever After Foods, a strategic partnership with Tnuva, with ICL Group (through its Open Innovation program) for advanced bioactive carriers and bio stimulants, and with an international agriculture corporation to enhance the global sustainable vegetable supply.

Notwithstanding, we may not be able to further establish or maintain such licensing and collaboration arrangements necessary to develop and commercialize our product candidates.

Even if we are able to maintain or establish licensing or collaboration arrangements, these arrangements may not be on favorable terms and may contain provisions that will restrict our ability to develop, test and market our product candidates. Any failure to maintain or establish licensing or collaboration arrangements on favorable terms could adversely affect our business prospects, financial condition, or ability to develop and commercialize our product candidates.

Our agreements with our collaborators and licensees may have provisions that give rise to disputes regarding the rights and obligations of the parties. These and other possible disagreements could lead to termination of the agreement or delays in collaborative research, development, supply, or commercialization of certain product candidates, or could require or result in litigation or arbitration. Moreover, disagreements could arise with our collaborators over rights to IP or our rights to share in any of the future revenues of products developed by our collaborators. These kinds of disagreements could result in costly and time-consuming litigation. Any such conflicts with our collaborators could reduce our ability to obtain future collaboration agreements and could have a negative impact on our relationship with existing collaborators.

The market for our cell therapy products will be heavily dependent on third party reimbursement policies.

Our ability to successfully commercialize our cell therapy product candidates will depend on the extent to which government healthcare programs, as well as private health insurers, health maintenance organizations and other third-party payers will pay for our products and related treatments.

Reimbursement by third party payers depends on a number of factors, including the payer’s determination that use of the product is safe and effective, not experimental, or investigational, medically necessary, appropriate for the specific patient and cost-effective. Reimbursement in the United States or foreign countries may not be available or maintained for any of our product candidates. If we do not obtain approvals for adequate third-party reimbursements, we may not be able to establish or maintain price levels sufficient to realize an appropriate return on our investment in product development. Any limits on reimbursement from third party payers may reduce the demand for, or negatively affect the price of, our products. The lack of reimbursement for these procedures by insurance payers has negatively affected the market for our products in this indication in the past.

Managing and reducing health care costs has been a general concern of federal and state governments in the United States and of foreign governments. In addition, third party payers are increasingly challenging the price and cost-effectiveness of medical products and services, and many limit reimbursement for newly approved health care products. Third-party payers may limit the indications for which they will reimburse patients who use any products that we may develop. Cost control initiatives could decrease the price for products that we may develop, which would result in lower product revenues for us.

Risks Related to Intellectual Property

Our success depends in large part on our ability to develop and protect our technology and our cell therapy products. If our patents and proprietary rights agreements do not provide sufficient protection for our technology and our cell therapy products, our business and competitive position will suffer.

Our success will also depend in part on our ability to develop our technology and commercialize our products without infringing the proprietary rights of others. We have not conducted full freedom of use patent searches, and no assurance can be given that patents do not exist or could not be filed which would have an adverse effect on our ability to develop our technology or maintain our competitive position with respect to our potential cell therapy products. If our technology components, devices, designs, products, processes or other subject matter are claimed under other existing United States or foreign patents or are otherwise protected by third party proprietary rights, we may be subject to infringement actions. In such event, we may challenge the validity of such patents or other proprietary rights, or we may be required to obtain licenses from such companies in order to develop, manufacture or market our technology or products. There can be no assurances that we would be able to obtain such licenses or that such licenses, if available, could be obtained on commercially reasonable terms. Furthermore, the failure to either develop a commercially viable alternative or obtain such licenses could result in delays in marketing our proposed products or the inability to proceed with the development, manufacture or sale of products requiring such licenses, which could have a material adverse effect on our business, financial condition and results of operations. If we are required to defend ourselves against charges of patent infringement or to protect our proprietary rights against third parties, substantial costs will be incurred regardless of whether we are successful. Such proceedings are typically protracted with no certainty of success. An adverse outcome could subject us to significant liabilities to third parties and force us to curtail or cease our development of our technology and the commercialization of our potential cell therapy products.

We have built the ability to manufacture clinical grade adherent stromal cells in-house. Through our experience with adherent stromal cell-based product development, we have developed expertise and know-how in this field. We also have built the ability to grow on a large scale various immune cells including engineered placental MAIT cells for use in cell therapy. Additionally, we have built the ability to grow on a large-scale plant cells for various biofarming uses. To protect this expertise and know-how, our policies require confidentiality agreements with our employees, consultants, contractors, manufacturers and advisors. These agreements generally provide for protection of confidential information, restrictions on the use of materials and assignment of inventions conceived during the course of performance for us. These agreements might not effectively prevent disclosure of our confidential information.

Third parties may initiate legal proceedings alleging that we are infringing their IP rights, the outcome of which would be uncertain and could have a material adverse effect on our business.

Our commercial success depends upon our ability and the ability of our collaborators to develop, manufacture, market and sell our product candidates and use our proprietary technologies without infringing the proprietary rights of third parties. We have yet to conduct comprehensive freedom-to-operate searches to determine whether our proposed business activities or use of certain of the patent rights owned by us would infringe patents issued to third parties. We may become party to, or threatened with, future adversarial proceedings or litigation regarding IP rights with respect to our products and technology, including interference proceedings before the U.S. Patent and Trademark Office. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future. If we are found to infringe a third party’s IP rights, we could be required to obtain a license from such third party to continue developing and marketing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all.

Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing technology or product. In addition, we could be found liable for monetary damages. A finding of infringement could prevent us from commercializing our product candidates or force us to cease some of our business operations, which could materially harm our business. For example, we are aware of issued third party patents directed to placental stem cells and their use for therapy and in treating various diseases. We may need to seek a license for one or more of these patents. No assurances can be given that such a license will be available on commercially reasonable terms, if at all. Claims that we have misappropriated confidential information or trade secrets of third parties could have a similar negative impact on our business.

Even if resolved in our favor, litigation or other legal proceedings relating to IP claims may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements about the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common shares. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors are able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.

The patent approval process is complex, and we cannot be sure that our pending patent applications or future patent applications will be approved.

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of our and any future licensors’ patent rights are highly uncertain. Our pending and future patent applications may not result in patents being issued which protect our technology or products or which effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection. The laws of foreign countries may not protect our rights to the same extent as the laws of the United States, and we may not be able to obtain meaningful patent protection for any of our commercial products either in or outside the United States.

No assurance can be given that the scope of any patent protection granted will exclude competitors or provide us with competitive advantages, that any of the patents that have been or may be issued to us will be held valid if subsequently challenged, or that other parties will not claim rights to or ownership of our patents or other proprietary rights that we hold. Furthermore, there can be no assurance that others have not developed or will not develop similar products, duplicate any of our technology or products or design around any patents that have been or may be issued to us or any future licensors. Since patent applications in the United States and in Europe are not publicly disclosed until patents are issued, there can be no assurance that others did not first file applications for products covered by our pending patent applications, nor can we be certain that we will not infringe any patents that may be issued to others.

Risks Related to Our Common Shares

The price of our common shares may fluctuate significantly.

The market price of our common shares may fluctuate significantly. A number of events and factors may have an adverse impact on the market price of our common shares, such as:

In addition, global or regional economic, political, public-health, military or security events, including regional security instability, and market downturns generally or in the biopharmaceutical sector in particular, may adversely affect the market price of our securities, which may not necessarily reflect the actual or perceived value of our Company.

We could fail to regain compliance with Nasdaq Listing Rules and to maintain the listing of our common shares on Nasdaq, which could seriously harm the liquidity of our shares and our ability to raise capital or complete a strategic transaction.

On July 7, 2026, we received a deficiency letter (the “Nasdaq Letter”) from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”), notifying us that we are not in compliance with the MVLS Requirement under Nasdaq Listing Rule 5550(b)(2), and are not in compliance with either of the alternative listing standards, including having stockholders’ equity of at least $2.5 million or net income of $500,000 from continuing operations in the most recently completed fiscal year, or in two of the three most recently completed fiscal years.

The Nasdaq Letter has no immediate effect on the listing or trading of our common shares, which continue to trade on The Nasdaq Capital Market under the symbol “PLUR”.

Pursuant to the Nasdaq Letter, and in accordance with Nasdaq Listing Rule 5810(c)(3)(C), we have been provided with an initial period of 180 calendar days, until January 4, 2027, to regain compliance with the MVLS Requirement (the “Compliance Period”). Nasdaq indicated that if, at any time during the Compliance Period, our MVLS closes at $35 million or more for a minimum of 10 consecutive business days (unless Nasdaq, in its discretion, requires a longer period, but generally no more than 20 consecutive business days), Nasdaq will provide a written confirmation that we have regained compliance and the matter will be closed. In the event we do not regain compliance within the Compliance Period, we expect that Nasdaq will provide written notification that our securities are subject to delisting. At that time, we may be eligible to appeal any delisting determination to a Nasdaq Hearings Panel. The hearing request would stay any suspension or delisting action pending the conclusion of the hearing process and the expiration of any additional extension period granted by the panel following the hearing.

We are evaluating options to regain compliance with the MVLS Requirement and intend to take appropriate actions to regain compliance; however, there can be no assurance that we will be able to regain compliance with all applicable requirements or maintain compliance thereafter.

If we do not maintain compliance with Nasdaq’s listing requirements, our common shares will be subject to delisting. A delisting from Nasdaq would likely result in a reduction in some or all of the following, each of which could have a material adverse effect on shareholders:

We intend to take all reasonable measures available to maintain compliance with Nasdaq’s listing requirements, including the MVLS Requirement and remain listed on Nasdaq. However, there can be no assurance that we will ultimately continue to maintain compliance with all applicable requirements for continued listing.

Future sales of our common shares may cause dilution.

Future sales of our common shares, or the perception that such sales may occur, could cause immediate dilution and adversely affect the market price of our common shares. If we raise additional capital by issuing equity securities, the percentage ownership of our existing shareholders may be reduced, and accordingly these shareholders may experience substantial dilution. We may also issue equity securities that provide for rights, preferences and privileges senior to those of our common shares. Given our need for cash and that equity raising is the most common type of fundraising for companies like ours, the risk of dilution is particularly significant for shareholders of our common shares.

Shareholder activism, proxy contests, shareholder proposals and other efforts by shareholders to influence our business, strategy, governance or Board composition could disrupt our business and adversely affect our results of operations and the market price of our common shares

Shareholders may seek to influence our business, strategy, capital allocation, governance practices or Board composition through private or public engagement, the accumulation of our common shares, shareholder proposals, director nominations, proxy contests, litigation, requests to inspect corporate books and records or other actions. These activities may relate to economic, strategic, environmental, social, governance or other matters, and may be undertaken by investors with differing or conflicting objectives, including objectives that may not align with the interests of our other shareholders or our long-term strategy.

Responding to actual or threatened shareholder activism or other efforts to influence the Company could require significant time and attention from our Board, management and employees, divert resources from our business and strategic initiatives, require us to incur substantial legal, advisory, proxy solicitation, public relations and other costs, and create uncertainty or adversely affect relationships with investors, employees, collaborators, customers and other business partners. Such activities could also result in changes to our strategy or operations, proxy contests or litigation and may adversely affect the market price or trading volatility of our common shares.

Beneficial ownership information may be incomplete, delayed or inaccurate because it depends on information reported by our shareholders and in SEC filings.

Beneficial ownership information included in our periodic reports is based on information furnished by the applicable beneficial owners or contained in filings made with the SEC. Under Sections 13(d) and 13(g) of the Exchange Act, and the rules thereunder, persons who beneficially own more than 5% of our outstanding common shares may be required to report their beneficial ownership and certain changes in ownership to the SEC on Schedule 13D or Schedule 13G, as applicable. We report beneficial ownership information based on the information made available to us by applicable beneficial owners or through publicly available SEC filings, as and when received or filed, and cannot independently verify the completeness or accuracy of that information.

A person or group that acquires beneficial ownership of more than 5% of our outstanding common shares and does not qualify to report on Schedule 13G generally must file a Schedule 13D within five business days after the acquisition. Schedule 13D requires disclosure regarding, among other matters, the reporting person’s purpose in acquiring or holding our common shares and any plans or proposals relating to a potential change in or influence over control of the Company or certain other significant corporate transactions. Certain investors that satisfy applicable eligibility requirements, including passive investors that certify that their acquisition and holding of our common shares is not for the purpose of or with the effect of changing or influencing control of the Company, may report their ownership on Schedule 13G instead.

The SEC has amended its beneficial-ownership reporting rules and issued interpretive guidance regarding the circumstances in which an investor may remain eligible to report on Schedule 13G rather than Schedule 13D. These requirements and related interpretations may affect the timing, content and availability of beneficial-ownership information publicly reported by significant shareholders. Accordingly, beneficial-ownership information reported in our periodic reports may not reflect changes in ownership or reporting status that occur after the date of the applicable information or filing, and investors may make investment or voting decisions based on information that is incomplete, delayed or inaccurate.

Risks Related to Foreign Exchange Rates

A significant portion of our business is conducted outside the United States. Therefore, we are exposed to currency exchange fluctuations in other currencies such as the NIS and Euro. A significant portion of our expenses in Israel are paid in NIS, and we have also received €20 million pursuant to the EIB Finance Agreement, that bears 4% annual interest. All of these factors subject us to the risks of foreign currency fluctuations. Our primary expenses paid in NIS are employee salaries and lease payments on our facilities. From time to time, we may apply a hedging strategy by using options and forward contracts to protect ourselves against some of the risks of currency exchange fluctuations and we are actively monitoring the exchange rate differences of the NIS, Euro and U.S. Dollar; however, we are still exposed to potential losses from currency exchange fluctuation.

Our cash may be subject to a risk of loss.

Our assets include a significant component of cash and cash equivalents and bank deposits. Our investment committee sets investment guidelines, when applicable, which aims to preserve our financial assets, maintain adequate liquidity and maximize returns. We believe that our cash is held in institutions whose credit risk is minimal and that the value and liquidity of our deposits are accurately reflected in our consolidated financial statements as of June 30, 2026. Currently, we hold most of our cash assets in bank deposits in Israel. However, nearly all of our cash and bank deposits are not insured by the Federal Deposit Insurance Corporation (the “FDIC”), or similar governmental deposit insurance outside the United States. Therefore, our cash and any bank deposits that we now hold or may acquire in the future may be subject to risks, including the risk of loss or of reduced value or liquidity, particularly in light of the increased volatility and worldwide pressures in the financial and banking sectors.

Risks Related to Our Industries

Consolidationand other strategic transactionsin the pharmaceutical and biotechnology industries may adversely affect us.

Companies in the pharmaceutical and biotechnology industries may consummate mergers, acquisitions, business combinations, divestitures, restructurings and other strategic transactions from time to time. These developments may result in larger companies with greater financial resources, broader product portfolios, enhanced development, manufacturing, regulatory or commercialization capabilities, and increased bargaining power, which could intensify competition. Such transactions may also reduce the number of potential collaborators, licensees, suppliers, contract manufacturers, contract research organizations or acquirers for our product candidates or technologies. In addition, following a transaction, a potential or existing collaborator may reprioritize its pipeline or strategic objectives, reduce or discontinue investment in a program relevant to us, seek to renegotiate commercial terms, or elect to focus on products or technologies that compete with ours. As a result, we may be unable to enter into, maintain or obtain favorable terms under collaboration, license, development, manufacturing or commercialization arrangements, which could materially adversely affect our business, financial condition, results of operations and prospects.

If we do not keep pace with our competitors and with technological and market changes, our technology and products may become obsolete, and our business may suffer.

The cellular therapeutics industry, of which we are a part, is very competitive and is subject to technological changes that can be rapid and intense. We have faced, and will continue to face, intense competition from biotechnology, pharmaceutical and biopharmaceutical companies, academic and research institutions and governmental agencies engaged in cellular therapeutic and drug discovery activities or funding, both in the United States and internationally. Some of these competitors are pursuing the development of cellular therapeutics, drugs and other therapies that target the same diseases and conditions that we target in our clinical and pre-clinical programs.

Some of our competitors have greater resources, more product candidates and have developed product candidates and processes that directly compete with our products. Our competitors may have developed, or could develop in the future, new products that compete with our products or even render our products obsolete.

Moreover, the alternative protein market is highly competitive, with numerous brands vying for limited space in retail, foodservice, and consumer preference. To succeed, Ever After Foods’ cultured meat products must excel in costs, taste, ingredients, marketing and branding. Generally, the food industry is dominated by multinational corporations with substantially greater resources and operations than Ever After Foods. We cannot be certain that Ever After Foods will successfully compete with larger competitors that have greater financial, marketing, sales, manufacturing, distributing and technical resources. Conventional food companies may acquire Ever After Foods’ competitors or launch their own competing products, and they may be able to use their resources and scale to respond to competitive pressures and changes in consumer preferences by introducing new products, reducing prices or increasing promotional activities, among other things. Competitive pressures or other factors could prevent Ever After Foods from acquiring market share or cause us to lose market share, which may require Ever After Foods to lower prices, or increase marketing and advertising expenditures, either of which would adversely affect its margins and could result in a decrease in its operating results and profitability. We cannot assure that we will be able to maintain a competitive position or compete successfully against such sources of competition.

Potential product liability claims could adversely affect our future earnings and financial condition.

We face an inherent business risk of exposure to product liability and CDMO service claims in the event that the use of our products or CDMO services results in adverse effects. We may not be able to maintain adequate levels of insurance for these liabilities at reasonable cost and/or reasonable terms. Excessive insurance costs or uninsured claims would add to our future operating expenses and adversely affect our financial condition.

We are dependent upon third party suppliers and service providers for raw materials, components, consumables, cleaning and sanitation materials, equipment, utilities and complementary services needed to manufacture PLX, provide CDMO services and support our longevity, wellness and aesthetics business; if any of these third parties fails or is unable to perform in a timely manner, our ability to manufacture products, provide services and satisfy our obligations to customers may be compromised.

In addition to the placenta used in the clinical manufacturing process of PLX, we require certain raw materials, components, consumables, process aids, reagents, packaging materials, cleaning and sanitation materials, equipment and other supplies and services. These items and services must be available to us in sufficient quantities, at acceptable quality levels and, where applicable, in compliance with current GMP requirements. To meet these requirements, we have entered into supply agreements with third parties that manufacture, supply or provide certain of these materials, components and services in accordance with applicable standards. Our requirements for these items and services are expected to increase if and when we transition to the manufacture of commercial quantities of our cell-based drug candidates or expand our CDMO activities or longevity, wellness and aesthetics business. In addition, the development and manufacture of potential CAR/TCR-MAIT products may require us to obtain from third parties proprietary CAR or TCR constructs and associated intellectual-property rights, in sufficient quantities and, where applicable, in compliance with current GMP requirements.

Certain materials, components, supplies and services used in our operations may be made available to us from a limited number of qualified suppliers or service providers. Although we seek to qualify alternative sources where practicable and maintain business-continuity measures designed to mitigate supply-chain and service interruptions, we may be unable to do so in a timely manner, on commercially reasonable terms or at all. For potential CAR/TCR-MAIT products, suitable construct suppliers or licensors may be limited, and we may be unable to obtain the required constructs or associated rights on acceptable terms, or at all.

In addition, if we proceed with clinical-development activities, we must be able to continuously demonstrate to the FDA, EMA and other regulatory authorities that we can manufacture our cell therapy product candidates with consistent characteristics. Accordingly, we are materially dependent on these suppliers for supply of current GMP-grade materials and other inputs and services of consistent quality. Our ability to complete ongoing clinical trials may be negatively affected in the event that we are forced to seek and validate a replacement source for any of these critical materials, components, supplies or services. Similarly, if we advance potential CAR/TCR-MAIT products into clinical development, we would need to establish and validate manufacturing processes for incorporating the applicable CAR or TCR constructs into MAIT cells and demonstrate the required quality, consistency, safety and other characteristics of the resulting product candidates.

Our CDMO activities and our longevity, wellness and aesthetics business may similarly depend on the timely availability of qualified suppliers and service providers for materials, components, consumables, equipment maintenance and calibration, testing, logistics, cleaning and sanitation, waste disposal, utilities and other complementary services. Certain materials or services may be available from a limited number of qualified sources, may require qualification, validation or regulatory approval before use, or may be subject to supply-chain disruptions, shortages, quality failures, price increases, import or export restrictions, labor disruptions or other delays. Any failure, delay or inability of any supplier or service provider to perform as required could delay or interrupt our operations or the delivery of products or services, increase our costs, impair product quality, result in regulatory or contractual claims, or harm our reputation and customer relationships.

We seek to qualify alternative suppliers and service providers where practicable and to maintain business-continuity measures designed to mitigate supply-chain and service interruptions. However, we may not be able to do so in a timely manner, on commercially reasonable terms or at all. The qualification, validation or replacement of a supplier or service provider may require substantial time, expense, technical resources, customer approval or regulatory review, particularly where the relevant material, component, process or service is critical to a regulated manufacturing process. Accordingly, disruptions affecting our suppliers or service providers may materially adversely affect our ability to conduct our operations, manufacture and deliver products, provide CDMO services, serve our longevity, wellness and aesthetics customers, advance our potential CAR/TCR-MAIT products and achieve our business objectives.

A cybersecurity incident, other technology disruptions, risks associated with artificial intelligence (“AI”), or failure to comply with laws and regulations relating to privacy and the protection of data relating to individuals, could negatively impact our business and our reputation.

We have relied on and utilized services provided by third parties in connection with our clinical trials, as well as other third-party service providers that may be involved in the collection, use, storage, transmission and analysis of personal health information and other sensitive, confidential or proprietary information. While we seek contractual assurances and apply a risk-based approach to assessing and overseeing cybersecurity and data-protection risks associated with third-party vendors and service providers, we do not control their information-security or privacy practices and cannot ensure that they will comply with applicable legal, regulatory, contractual or other obligations. Non-compliance, cybersecurity incidents or any other failure by such third parties could result in liability, regulatory inquiries, litigation, contractual claims, remediation costs, business disruption or reputational harm to us, any of which could have a material adverse effect on our business, financial condition and results of operations.

Future security breaches technology disruptions, system failures, unauthorized access, ransomware or other malicious activity could result in a material disruption to our development programs and our business operations. For example, the loss of clinical trial data from completed or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the lost data. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development and commercialization of our product candidates could be delayed. Although we maintain information-security measures, incident-response and recovery plans, employee training, and third-party oversight designed to prevent, detect, contain and remediate cybersecurity incidents, these measures may not be sufficient to prevent, detect, contain or remediate all incidents. See Item 1C, “Cybersecurity,” for additional information regarding our cybersecurity risk management and governance.

We use AI tools in certain administrative functions and are evaluating the suitability of these technologies for broader administrative and data-processing applications. Although AI tools are not currently embedded in our core operations or product-development systems, our use of AI, or our reliance on third-party providers that use AI, may create additional risks relating to inaccurate, incomplete, biased or misleading outputs; unauthorized access to, disclosure of or misuse of data; confidentiality, privacy and intellectual-property concerns; cybersecurity vulnerabilities; regulatory compliance; and third-party claims. The increasing availability and sophistication of AI technologies may also increase the frequency, scale and effectiveness of cyberattacks, including phishing, social-engineering, impersonation, malware and other attacks.

In addition, we are subject to laws, rules and regulations in Israel, the United States, the European Union and other jurisdictions relating to the collection, use and security of personal information and data. Such data privacy laws, regulations and other obligations may require us to change our business practices and may negatively impact our ability to expand our business and pursue business opportunities. We may incur significant expenses to comply with the laws, regulations and other obligations that apply to us. Additionally, the privacy- and data protection-related laws, rules and regulations applicable to us are subject to significant change. Several jurisdictions have passed new laws and regulations in this area, and other jurisdictions are considering imposing additional restrictions. Privacy- and data protection-related laws and regulations also may be interpreted and enforced inconsistently over time and from jurisdiction to jurisdiction. Any actual or perceived inability to comply with applicable privacy or data protection laws, regulations, or other obligations could result in significant cost and liability, litigation or governmental investigations, damage our reputation, and adversely affect our business.

Failure to comply with certain European privacy regulations could have an adverse effect on our business and reputation.

The collection and use of personal health data in the EU is governed by the provisions of the General Data Protection Regulation (“GDPR”). The GDPR imposes several requirements relating to lawful bases for processing data, including additional conditions applicable to special categories of personal data such as health data; transparency and information provided to individuals; data-subject rights; security and confidentiality; data-protection impact assessments in certain circumstances; personal-data breach notifications; governance of service providers; and restrictions on international transfers of personal data. The GDPR also extends the geographical scope of EU data protection law to non-EU entities under certain conditions, tightens existing EU data protection principles and creates new obligations for companies and new rights for individuals. Because clinical-trial activities may involve the regular processing of special categories of personal data, including health data, on a large scale, we are required to appoint a data protection officer (“DPO”). We engage with an external provider to perform DPO services; however, our use of an external DPO does not relieve us of our obligations under the GDPR. Failure to comply with the requirements of the GDPR and the related national data protection laws of the EU member States may result in fines, as well as other administrative measures, claims for damages and reputational harm. There may be circumstances under which a failure to comply with GDPR, or the exercise of individual rights under the GDPR, would limit our ability to utilize clinical trial data collected on certain subjects. The GDPR imposes significant accountability obligations and liability in relation to personal data that we process. Although we maintain compliance measures, including external DPO services, and may implement additional measures from time to time, we cannot assure that these measures will be sufficient to ensure compliance with applicable data-protection laws and regulatory guidance.

Changes to these European privacy regulations, developments in their interpretation and enforcement, and any failure to comply with them may be onerous and adversely affect our business, financial condition, prospects, results of operations and reputation.

We are subject to the Foreign Corrupt Practice Act (“FCPA”) and other laws that prohibit U.S. companies or their agents and employees from providing anything of value to a foreign official or political party for the purposes of influencing any act or decision of these individuals in their official capacity to help obtain or retain business, direct business to any person or corporate entity or obtain any unfair advantage. We have operations and agreements with third parties. Our international activities create the risk of unauthorized and illegal payments or offers of payments by our employees or consultants, even though they may not always be subject to our control. We maintain policies and procedures which are intended to promote compliance with these laws by our employees and consultants. However, our existing safeguards and any future improvements may prove to be less than effective, and our employees or consultants, may engage in conduct for which we might be held responsible. Any failure by us to adopt appropriate compliance procedures or to ensure that our employees and consultants comply with the FCPA and applicable laws and regulations in foreign jurisdictions could result in substantial penalties or restrictions on our ability to conduct business in certain foreign jurisdictions.

Violations of the FCPA may result in severe criminal or civil sanctions, and we may be subject to other liabilities, which could negatively affect our business, operating results, and financial condition. In addition, the U.S. government may seek to hold our Company liable for successor liability FCPA violations committed by companies in which we invest or that we acquire.

Other Risks

Since we received grants from the IIA, we are subject to on-going restrictions.

We have received royalty-bearing grants from the IIA, for research and development programs that meet specified criteria. The terms of the IIA’s grants limit our ability to transfer know-how developed under an approved research and development program (by way of sale and/or granting a license to use the IP), and/or the manufacturing of products developed under an approved research and development program, outside of Israel, regardless of whether the royalties are fully paid. Any non-Israeli citizen, resident or entity that, among other things, becomes a holder of 5% or more of our share capital or voting rights, is entitled to appoint one or more of our directors or our Chief Executive Officer (“CEO”), serves as a director of our Company or as our CEO, is generally required to notify the same to the IIA and to undertake to observe the law governing the grant programs of the IIA, the principal restrictions of which are the transferability limits described above. To the extent a company wishes to transfer its IIA-supported know-how outside of Israel (by way of sale and/or granting a license to use the IP) – the IIA acts under the Law for the Encouragement of research, Development and Technological Innovation in the Industry 1984 and the related IIA rules and regulations, it must be preapproved by the IIA and the company may be required to pay an additional payment to the IIA. The minimum amount of the payment is the total sum of grants received plus interest, and the maximum amount shall be no higher than six times the total sum of grants received plus interest. In the case that the IIA-supported company sells the IP but retains its research and development center in Israel for at least three consecutive years, following the year of transferring the IIA-supported know-how outside of Israel, while maintaining at least 75% of its research and development employees in Israel – the payment will be limited to three times the total sum of grants received plus interest. For more information, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources.”

Recent global inflation may adversely affect our business results.

Inflation could affect our ability to purchase materials needed to support our research, development and operational activities, which in turn could result in higher burn rate and a higher end price of our future products. As a result, we may not be able to effectively develop our cell-based product candidates or cultivated meat products. If we are not able to successfully manage inflation, our prospects, business, financial condition, and results of operations could be adversely impacted.

Non-compliance with environmental, social, and governance (“ESG”) practices could harm our reputation, or otherwise adversely impact our business, while increased attention to ESG initiatives could increase our costs.

Companies across industries are facing scrutiny from a variety of stakeholders related to their ESG and sustainability practices, disclosures, performance, goals and commitments. The nature and extent of such scrutiny continue to evolve and, in some cases, have become more fragmented and politicized, with stakeholders, jurisdictions and markets taking differing or conflicting approaches to ESG-related matters. Certain market participants, including institutional investors and capital providers, may consider ESG and sustainability factors, including through the use of third-party benchmarks, ratings and scores, in making investment, financing or voting decisions or in engaging with companies regarding their practices. At the same time, certain investors, regulators, policymakers and other stakeholders have questioned or opposed the consideration of certain ESG factors, creating additional uncertainty regarding stakeholder expectations and disclosure practices. Unfavorable ESG ratings could lead to increased negative investor sentiment towards us or our industry. If we do not comply with applicable legal or regulatory requirements, or if our practices, disclosures, goals or commitments are viewed as inadequate, misleading, insufficiently substantiated or inconsistent with stakeholder expectations or our actual performance, our business and reputation could be negatively impacted and our share price could be materially and adversely affected, as well as our access to and cost of capital.

While we may, at times, engage in voluntary initiatives (such as voluntary disclosures, certifications, or goals, among others) or commitments to improve the sustainability, environmental or social profile of our company and/or products, such initiatives or the achievement of related commitments may not have the desired effect and may be costly. They may also require significant management attention, operational changes, capital expenditures, data collection and verification processes, and engagement with suppliers, customers and other third parties.

In addition, we may commit to certain initiatives or goals but not ultimately achieve such commitments or goals due to factors that are both within or outside of our control. Moreover, actions or statements that we may take based on expectations, assumptions, or third-party information that we currently believe to be reasonable may subsequently be determined to be erroneous or be subject to misinterpretation. Our ESG- and sustainability-related disclosures, claims, targets and progress updates may be subject to heightened scrutiny by investors, customers, employees, regulators, advocacy groups and other stakeholders, including allegations that they are incomplete, inaccurate, misleading or insufficiently supported. We may also be subject to inquiries, investigations, litigation, enforcement actions or other proceedings in connection with such matters. Evolving and, in some cases, inconsistent or conflicting laws, regulations, reporting standards, customer requirements and stakeholder expectations relating to climate, emissions, environmental matters, human capital, supply chains, human rights, product sustainability and corporate governance may increase our compliance, reporting, assurance, operational and capital costs. For example, although the SEC has indicated that it does not intend to pursue or revisit its previously adopted climate-related disclosure rules (which it is now seeking to repeal), certain state laws, including California requirements concerning certain climate-related disclosures and emissions-reduction claims that may apply to companies doing business in California and meeting specified thresholds or making specified claims, may impose additional disclosure, reporting or assurance obligations.

Expectations around a company’s management of ESG matters continue to evolve rapidly, and may vary among, or conflict between, stakeholders, jurisdictions and markets. Changes in the approaches of institutional investors, proxy advisory firms, regulators and policymakers to ESG-related matters may also affect voting outcomes, shareholder engagement, access to capital and our disclosure and governance practices. To the extent ESG matters negatively impact our reputation, our ability to attract and retain employees, customers, investors, business partners and other stakeholders may decrease, which could adversely affect our operations, financial condition and results of operations.

Since we have signed the EIB Finance Agreement, we agreed to guaranty the loan as well as agreed to limitations that require us to notify the EIB, and in some cases obtain their approval, before we engage with other banks for additional sources of funding or with potential partners for certain strategic activities.

The EIB Finance Agreement contains certain limitations that we must adhere to such as the use of proceeds received from the EIB, the disposal of assets, substantive changes in the nature of our business, our potential execution of mergers and acquisitions, changes in our holding structure, distributions of future potential dividends and our engaging with other banks and financing entities for other loans.

Our principal research and development and manufacturing facilities are located in Haifa, Israel and military conditions in Israel, including the armed conflict between Israel and terrorist organizations from the Gaza Strip, Lebanon and Yemen, tensions with regional countries hostile to Israel such as Iran - may cause interruption or suspension of our business operations without warning.

Our principal R&D and manufacturing facilities are located in Haifa, Israel, thus, political, economic, and military conditions in Israel, and in particular, conflicts involving Israel and terrorist organizations such as Hamas in the Gaza Strip, Hezbollah in Lebanon, and Ansar Allah (Houthis) in Yemen, the conflict with Iran, as well as tensions with regional countries hostile to Israel, may directly affect our business.

As of September 10, 2026, there has been no material impact on our operations. According to the recent guidelines of the Israeli government, the Company’s offices in Haifa are open and functioning; however, if a war will escalate or expand, with one or more of the countries or organizations in conflict with Israel, this situation may change and the Israeli government may impose certain restrictions on movement and travel, which will affect our management and employees’ ability to effectively perform their daily tasks, and may result in disruptions and delays in some of our projects.

Any hostilities involving Israel, terrorist activities, political instability or violence in the region, or the interruption or curtailment of trade or transport between Israel and its trading partners could make it more difficult for us to raise capital, if needed in the future, and adversely affect our operations and results of operations and the market price of our common shares. In addition, to the extent the IIA no longer makes grants similar to those we have received in the past, it could adversely affect our financial results.

Furthermore, certain of our employees may be obligated to perform annual reserve duty in the Israel Defense Forces and are subject to being called up for active military duty at any time. Many Israeli citizens who have served in the army are required to perform reserve duty until they reach the age of 40 or older, depending upon the nature of their military service. Currently, none of our employees has been called for active military reserve duty.

The war’s implications, including but not only the war’s economic implications, on the Company’s business and operations and on Israel’s economy in general are difficult to predict. Such events may be intertwined with wider macroeconomic indications of a deterioration of Israel’s economic standing, for instance, a downgrade in Israel’s credit rating by rating agencies, which may have a material adverse effect on the Company and its ability to effectively conduct its operations.

In addition, Israeli-based companies and companies doing business with Israel, have been the subject of an economic boycott by members of the Arab League and certain other predominantly Muslim countries since Israel’s establishment. Although Israel has entered into various agreements with certain Arab countries and the Palestinian Authority, and various declarations have been signed in connection with efforts to resolve some of the economic and political problems in the Middle East, we cannot predict whether or in what manner these problems will be resolved. Wars and acts of terrorism have resulted in significant damage to the Israeli economy, including reducing the level of foreign and local investment.

The potential assignment of the EIB Loan to a third party and the potential conversion of such indebtedness our securities in the future, if such third party is a related party, may create conflicts of interest, or the perception of such conflicts of interest, and may result in terms that are not as favorable to us as those that could be obtained in an arm’s-length transaction.

The potential sale of the EIB Loan to a related party, or any subsequent agreement to convert the loan into our securities if such third party is a related party, may not be on the same terms as if they were negotiated on an arm’s-length basis between unrelated parties. Although our Board has formed a Special Committee of the Board, consisting of independent directors to review and approve any such related-party transaction or subsequent arrangement in connection with the EIB Loan, including the potential sale of the EIB Loan and a potential future conversion of such indebtedness into our securities, those procedures may not eliminate all actual or perceived conflicts of interest or assure that the terms of such transactions are as favorable to us as those that could be obtained with an unaffiliated lender, purchaser or investor.

If a related part purchases the EIB Loan, their interests as a creditor may differ from our interests and those of our other shareholders. Such related party may have an incentive to seek repayment, equity conversion, additional financing, collateral, fees, protections or other terms that preserve or enhance his investment, even if such terms are not optimal for us or for our other shareholders. Conversely, the Company may agree to terms that benefit such related party in his capacity as lender or investor in order to address our liquidity needs, including terms that could involve cash payments, equity or equity-linked securities, dilution, restrictive covenants, governance rights or limitations on our strategic flexibility.

In addition, the need to negotiate the potential sale of the EIB Loan and the potential future conversion of such indebtedness to our securities with a related party may increase the risk of disputes, litigation, regulatory scrutiny, adverse publicity and reputational harm. If we do not effectively manage these conflicts, or if any arrangement is not completed or is completed on unfavorable terms to us, our liquidity, financial condition, ability to raise additional capital and our ability to continue as a going concern could be materially adversely affected. There can be no assurance that the transactions described above will be completed or, if completed, as to their timing, structure or final terms.