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Pluri Inc.

For the period ended Jun 30, 2026. Filed Sep 10, 2026.

View on SEC.gov

About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2026 · Filed Sep 10, 2026

PLUR$1.18-4.5%Stored close · as of Nov 9, 2026

What changed in Risk Factors?

Read the current filing

Previous report: 10-K

Period ended 2025-06-30; filed 2025-09-17.

0001213900-25-088578

Item 1A. Risk Factors

Current report: 10-K

Period ended 2026-06-30; filed 2026-09-10.

0001213900-26-098862

Item 1A. Risk Factors

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 156 previous paragraphs and 167 current paragraphs.

92 unchanged; 45 reworded; 30 added; 19 removed; 0 previous and 0 current paragraphs rearranged.

Tables are not compared: 44 previous and 51 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (30)

Current report

Risks Related to Our Business

Current report

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.

Current report

Risks Related to Our Longevity, Wellness and Aesthetics Business

Current report

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.

Current report

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.

Current report

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.

Current report

Risks Related to Our Cultivated FoodTech Business

Current report

Risks Related to Intellectual Property

Current report

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”.

Current report

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.

Current report

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.

Current report

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

Current report

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.

Current report

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.

Current report

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

Current report

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.

Current report

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.

Current report

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.

Current report

Risks Related to Our Industries

Current report

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.

Current report

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.

Current report

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.

Current report

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.

Current report

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.

Current report

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.

Current report

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.

Current report

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.

Current report

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.

Current report

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.

Current report

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.
Removed paragraphs (19)

Previous report

Risk Related to Our Business

Previous report

We are currently in advanced discussions with the EIB regarding a potential restructuring of the terms of the EIB Loan, which are currently focused on the new terms of the EIB Loan, including an extension of the current maturity date of the EIB Loan. However, there is no certainty as to the outcome of these discussions.

Previous report

Risks Related to Our Cultivated Food Business

Previous report

Risk Related to Commercialization of Our Product Candidates

Previous report

Risk Related to Intellectual Property

Previous report

On January 6, 2025, we submitted a plan to regain compliance (the “Compliance Plan”). Based on the Compliance Plan, Nasdaq determined to grant us an extension of time to regain compliance with the Stockholders’ Equity Requirement until May 24, 2025. On May 7, 2025, we received a letter from Nasdaq, determining that the Company had regained compliance with Listing Rule 5550(b)(2), due to the fact that for the 10 consecutive business days from April 22, 2025, through May 6, 2025, the market value of the Company’s listed securities was $35 million or greater, satisfying the requirement under Rule 5550(b)(2). Accordingly, the Company has regained compliance with the Shareholders’ Equity Requirement and remains in good standing on The Nasdaq Capital Market.

Previous report

We cannot guarantee that we will continue to comply with the Nasdaq Stockholders’ Equity Requirement. If we fail to comply with the Nasdaq Stockholders’ Equity Requirement, Nasdaq could delist our common shares from trading on its exchange and if we are unable to obtain listing on another national securities exchange or take action to restore our compliance with the Nasdaq continued listing requirements, we and our shareholders could incur material adverse consequences, including a negative impact on our liquidity, our shareholders’ ability to sell shares and our ability to raise capital

Previous report

As a result of the voting outcome at our 2025 annual meeting of shareholders (the “2025 Annual Meeting”), one of our then-current directors, who was classified as an independent director, and acted as chairman of the Audit Committee and the sole member of the Investment Committee, was not re-elected to our Board, and therefore ceased to serve as a director and as a member of the respective committees on which he serves, effective June 30, 2025. On June 30, 2025, we notified Nasdaq that due to the departure of the director, we are no longer in compliance with Nasdaq Listing Rule 5605(c)(2)(A) (the “Audit Committee Requirements”), which requires the audit committee to be comprised of at least three independent directors. On July 2, 2025, we received a letter from the Listing Qualifications Department of Nasdaq, notifying us that consistent with Listing Rule 5605(c)(4), Nasdaq will provide us a cure period to regain compliance with Nasdaq Listing Rule 5605(c)(2)(A), which will expire on the earlier of (i) our next annual meeting of shareholders or June 30, 2026, or (ii) if our next annual meeting of shareholders is held before December 29, 2025, then we must evidence compliance no later than June 30, 2026. On September 10, 2025, we appointed a new independent director to our Board, who also joined our Audit Committee. Subsequently, on September 11, 2025, we received a letter from Nasdaq, confirming that the Company had regained compliance with the Audit Committee Requirement and that the matter is closed.

Previous report

Risk Related to Our Industries

Previous report

There is a trend towards consolidation in the pharmaceutical and biotechnology industries. This consolidation trend may result in the remaining companies having greater financial resources and technical discovery capabilities, thus intensifying competition in these industries. This trend may also result in fewer potential collaborators or licensees for our therapeutic product candidates. Also, if a consolidating company is already doing business with our competitors, we may lose existing licensees or collaborators as a result of such consolidation. This trend may adversely affect our ability to enter into license agreements or agreements for the development and commercialization of our product candidates, and as a result may materially harm our business.

Previous report

Risk Related to Our Dependence on Third Parties

Previous report

We intend to decrease our dependency on third party suppliers for raw materials. To that effect we have developed a serum-free formulation which is expected to support the manufacturing of cell therapy products. This serum-free formulation was developed using our deep understanding in cell therapy industrial scale production standards, and the quality methods designed to support implementation in Phase III development and marketing. Achieving this significant technological challenge is expected to provide us with large-scale, highly consistent production with operational independence from third party suppliers for standard serum, an expensive and quantity limited product. There can be no guarantee that we will successfully implement the use of our serum-free formulation to support the manufacturing of cell therapy products or any other future product candidates, if any, that we seek to produce using such formulation, or that such implementation of the serum-free formulation will decrease our dependency on third party suppliers for raw materials.

Previous report

With respect to CAR/TCR-MAIT products for immune-oncology, we are dependent upon third party suppliers for the construct of CAR or TCR, needed to manufacture the final product; if these third parties fail or are unable to perform in a timely manner, our ability to manufacture and deliver the final product will be compromised.

Previous report

In addition to the placenta used in the manufacturing process of extracting MAIT cells, the construct of CAR or TCR is needed for the manufacturing of the final product. The final product would be allogeneic placental derived MAIT cells transduced with CAR or TCR construct. The construct must be manufactured and supplied to us in sufficient quantities and in compliance with current GMP by a third party. To meet these requirements, we have started discussions with potential partners and manufacturers that obtain IP rights for these constructs, engaging in feasibility tests to ensure compliance with our MAIT cells and requirements.

Previous report

In addition to ensuring a proper partner or supplier to manufacture the construct, we must succeed in incorporating the construct into the MAIT cells to create a sufficient number of final products, i.e., CAR or TCR-MAIT products. As a first POC, the final product will be tested for efficacy and safety in pre-clinical setting and the process development will be finalized to allow pre-IND readiness and proceed to clinical development.

Previous report

If these potential partners and manufactures fail to deliver sufficient construct in a timely manner and in compliance with current GMP, our ability to incorporate the construct in the MAIT cells to create sufficient number of final products will be compromised.

Previous report

We have relied on and utilized services provided by third parties in connection with our clinical trials, which services involve the collection, use, storage and analysis of personal health information. While we receive assurances from these vendors that their services are compliant with the Health Insurance Portability and Accountability Act, and other applicable privacy laws, there can be no assurance that such third parties will comply with applicable laws or regulations. Non-compliance by such vendors may result in liability for us, which would have a material adverse effect on our business, financial conditions and results of operations.

Previous report

We use AI tools in certain administrative functions and are evaluating suitability of these technologies for broader administrative and data-processing applications. These technologies are not embedded in our core operations or product development systems. Potential risks include inaccuracies or biases in AI-generated analyses, compliance challenges with emerging AI regulations, and cybersecurity vulnerabilities. We continue to monitor and assess AI technologies to mitigate potential impacts on our business.

Previous report

Expectations around a company’s management of ESG matters continue to evolve rapidly, in many instances due to factors that are out of our control. To the extent ESG matters negatively impact our reputation, it may also impede our ability to compete as effectively to attract and retain employees or customers, which may adversely impact our operations.
Reworded paragraphs (45)

Previous wording

As of June 30, 2025, our cash balances (cash and cash equivalents, short-term bank deposits, , restricted cash and restricted bank deposits) totaled to $21,914,000. According to management estimates, we do not have sufficient resources to meet our operating obligations for at least twelve 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.

Current wording

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.

Previous wording

It is highly likely that 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.

Current wording

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.

Previous wording

It is likely that we will need to raise additional funds in the future 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.

Current wording

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.

Previous wording

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 the loss of some or all of one’s investment in our common shares.

Current wording

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.

Previous wording

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 successfully, or are unable to obtain the necessary regulatory approvals, our likelihood of profitability will be limited severely.

Current wording

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.

Previous wording

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 cell-based products and/or licensing of our products, which will require additional research and development.

Current wording

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.

Previous wording

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 tranche in the amount of €20 million. The amount received is 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, 2025, the interest accrued was in the amount of approximately €3.27 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, 2025, we had an accrued royalty in the amount of $12 thousand.

Current wording

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.

Previous wording

If we fail to reach an agreement with the EIB about the repayment of the EIB Loan, or if we are unable to repay the EIB Loan when due, our financial condition and liquidity would be materially affected and it could impact our ability to continue as a going concern.

Current wording

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.

Previous wording

To date, we have focused our efforts primarily in the regenerative medicine field, in the food tech field, in the CDMO field, and in the agriculture field, 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 food tech, CDMO and agriculture fields, 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.*** ***

Current wording

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.* *

Previous wording

Ever After Foods has a limited operating history in the field of cultivated or cultured meat (hereinafter, “cultivated meat”) to date and its prospects will be dependent on its ability to meet a number of challenges.

Current wording

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.

Previous wording

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 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.

Current wording

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

Previous wording

In addition, Ever After Foods will be subject to changing laws, rules and regulations in the United States, Israeli, Asia Pacific, the European Union and other jurisdictions relating to the food tech industry. Such laws and regulations may negatively impact its 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.

Current wording

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.

Previous wording

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 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.

Current wording

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.

Previous wording

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 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.

Current wording

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.

Previous wording

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 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.

Current wording

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.

Previous wording

In addition, certain of our lines of business, such as our Agtech 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.

Current wording

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.

Previous wording

We may need to raise additional financing to support our 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.

Current wording

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.

Previous wording

It is highly likely that we will need to raise significant additional capital from investors in the future to finance our plant-based business vertical operations. Our current capital may not be sufficient to finance our AgTech lines of business and the plant-based operations until we are able to complete the development of a high-quality coffee and cacao. If we are not able to attract investors and obtain additional financing, PluriAgTech’s and the plant-based operations may be adversely affected or terminated.

Current wording

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.

Previous wording

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 undisclosed leading international agriculture corporation to enhance the global sustainable vegetable supply.

Current wording

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.

Previous wording

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. In particular, 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.

Current wording

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.

Previous wording

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 AgTech 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.

Current wording

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.

Previous wording

Risk Related to Our Common Shares

Current wording

Risks Related to Our Common Shares

Previous wording

The market for 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:

Current wording

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:

Previous wording

In addition, a global pandemic, such as the COVID-19 pandemic and a market downturn in general and/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.

Current wording

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.

Previous wording

We could fail to maintain compliance with the Audit Committee Requirements 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.

Current wording

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.

Previous wording

On November 25, 2024, we received a deficiency letter (the “Nasdaq Letter”) from the Listing Qualifications Department of The Nasdaq Stock Market LLC (the “Nasdaq”), notifying us that we are not in compliance with the Stockholders’ Equity Requirement, which requires us to maintain a minimum of $2.5 million in stockholders’ equity, nor were in compliance with either of the alternative listing standards, market value of listed securities of at least $35 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.

Current wording

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.

Previous wording

We intend to take all reasonable measures available to maintain compliance with the Nasdaq’s listing Requirements 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.

Current wording

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.

Previous wording

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 company.

Current wording

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.

Previous wording

Our assets include a significant component of cash and cash equivalents and bank deposits. We adhere to an investment policy set by our investment committee 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, 2025. 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, or 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.

Current wording

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.

Previous wording

The trend towards consolidation in the pharmaceutical and biotechnology industries may adversely affect us.

Current wording

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

Previous wording

We are dependent upon third party suppliers for raw materials needed to manufacture PLX; if any of these third parties fails or is unable to perform in a timely manner, our ability to manufacture and deliver will be compromised.

Current wording

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.

Previous wording

In addition to the placenta used in the clinical manufacturing process of PLX, we require certain raw materials. These items must be manufactured and supplied to us in sufficient quantities and in compliance with current GMP. To meet these requirements, we have entered into supply agreements with firms that manufacture these raw materials to current GMP standards. Our requirements for these items are expected to increase if and when we transition to the manufacture of commercial quantities of our cell-based drug candidates.

Current wording

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.

Previous wording

In addition, as we proceed with our trial efforts, 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 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.

Current wording

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.

Previous wording

A cybersecurity incident, other technology disruptions, potential risks associated with 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.

Current wording

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.

Previous wording

Future security breaches or any material system failure events could result in a material disruption of 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 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. We are constantly exploring new and advanced security protection measures to prevent future cybersecurity incidents. See Item 1C. “Cybersecurity”, for additional information.

Current wording

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.

Previous wording

In addition, we are subject to laws, rules and regulations in the Israeli, United States, the EU 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.

Current wording

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.

Previous wording

Unsuccessful compliance with certain European privacy regulations could have an adverse effect on our business and reputation.

Current wording

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

Previous wording

The collection and use of personal health data in the EU is governed by the provisions of the General Data Protection Regulation (“GDPR”). This directive imposes several requirements relating to the consent of the individuals to whom the personal data relates, the information provided to the individuals, notification of data processing obligations to the competent national data protection authorities and the security and confidentiality of the personal data. The GPDR 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. 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 and other administrative penalties. 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 regulations impose additional responsibility and liability in relation to personal data that we process, and we intend to put in place additional mechanisms ensuring compliance with these and/or new data protection rules.

Current wording

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.

Previous wording

Changes to these European privacy regulations and unsuccessful compliance may be onerous and adversely affect our business, financial condition, prospects, results of operations and reputation.

Current wording

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.

Previous wording

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 discourage these practices 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 for Any failure by us to adopt appropriate compliance procedures and 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.

Current wording

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.

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