Pluri (PLUR) risk factors, FY2026 10-K

Risks Related to Our Business

1. 01If 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
2. 02We 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
3. 03Also, 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
4. 04If 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
5. 05We have not generated significant or consistent revenues to date, which raises doubts with respect to our ability to generate revenues in the future
6. 06Failure to reach an agreement with the EIB about the repayment of the EIB Loan could adversely affect our financial condition and liquidity69% rewritten
7. 07If 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 concernNew
8. 08Most 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
9. 09While 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 so27% rewritten
10. 10Changes in U.S. trade policy and tariffs may have an adverse impact on our business

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

1. 11If 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
2. 12The 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
3. 13Favorable 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
4. 14Our product development programs are based on novel technologies and are inherently risky
5. 15Our cell therapy drug candidates represent new classes of therapy that the marketplace may not understand or accept
6. 16If 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

Risks Related to Our Cultivated FoodTech Business

1. 17Ever 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
2. 18Consumer 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
3. 19We expect that products utilizing Ever After Foods’ technologies will be subject to regulations that could adversely affect Ever After Foods’ business and operations
4. 20Our 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
5. 21We 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 terminated51% rewritten
6. 22Cultivated plant-based products utilizing our 3D cell expansion technology may be subject to regulations that could adversely affect its business and results of operations

Risks Related to Commercialization of Our Product Candidates

1. 23We may not successfully establish new collaborations, joint ventures or licensing arrangements, which could adversely affect our ability to develop and commercialize our product candidates
2. 24Notwithstanding, we may not be able to further establish or maintain such licensing and collaboration arrangements necessary to develop and commercialize our product candidates
3. 25Our 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

Risks Related to Intellectual Property

1. 26Our 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
2. 27Third 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
3. 28The patent approval process is complex, and we cannot be sure that our pending patent applications or future patent applications will be approved

Risks Related to Our Common Shares

1. 29The price of our common shares may fluctuate significantly35% rewritten
2. 30We 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 transaction93% rewritten
3. 31The 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”New
4. 32We 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 thereafterNew
5. 33Future sales of our common shares may cause dilution68% rewritten
6. 34Beneficial ownership information may be incomplete, delayed or inaccurate because it depends on information reported by our shareholders and in SEC filingsNew

Risks Related to Foreign Exchange Rates

1. 35We are exposed to fluctuations in currency exchange rates
2. 36Our cash may be subject to a risk of loss25% rewritten

Risks Related to Our Industries

1. 37Consolidation and other strategic transactions in the pharmaceutical and biotechnology industries may adversely affect us99% rewritten
2. 38If 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
3. 39Some 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
4. 40Potential product liability claims could adversely affect our future earnings and financial condition

Risks Related to Our Dependence on Third Parties

1. 41A 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 reputation63% rewritten
2. 42Failure to comply with certain European privacy regulations could have an adverse effect on our business and reputation72% rewritten
3. 43We may be exposed to liabilities under the Foreign Corrupt Practices Act, and any determination that we violated the Foreign Corrupt Practices Act could have a material adverse effect on our business

Other Risks

1. 44Since we received grants from the IIA, we are subject to on-going restrictions
2. 45Recent global inflation may adversely affect our business results
3. 46Non-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 costs92% rewritten
4. 47Since 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 activities43% rewritten