Pluri (PLUR) risk factors, FY2024 10-K

Risk Related to Our Business

1. 01It 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
2. 02Also, 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
3. 03If 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
4. 04We have not generated significant or consistent revenues to date, which raises doubts with respect to our ability to generate revenues in the future
5. 05Most 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
6. 06While 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

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

1. 07If 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. 08The 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. 09Favorable 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. 10Our product development programs are based on novel technologies and are inherently risky
5. 11Our cell therapy drug candidates represent new classes of therapy that the marketplace may not understand or accept
6. 12If 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 Food Business

1. 13Ever 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
2. 14Ever 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
3. 15Consumer 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
4. 16We expect that products utilizing Ever After Foods’ technologies will be subject to regulations that could adversely affect Ever After Foods’ business and operations
5. 17Our various new lines of business, including our cell-based coffee business vertical, PluriAgtech, 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
6. 18We may need to raise additional financing to support PluriAgtech’s and Coffeesai’s business verticals 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
7. 19Coffeesai’s products utilizing our 3D cell expansion technology may be subject to regulations that could adversely affect its business and results of operations

Risk Related to Commercialization of Our Product Candidates

1. 20We 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. 21Notwithstanding, we may not be able to further establish or maintain such licensing and collaboration arrangements necessary to develop and commercialize our product candidates
3. 22Our 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

Risk Related to Intellectual Property

1. 23Our 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. 24Third 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. 25The patent approval process is complex, and we cannot be sure that our pending patent applications or future patent applications will be approved

Risk Related to Our Common Shares

1. 26The price of our common shares may fluctuate significantly
2. 27We could fail 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
3. 28Future sales of our common shares may cause dilution

Risks Related to Foreign Exchange Rates

1. 29We are exposed to fluctuations in currency exchange rates
2. 30Our cash may be subject to a risk of loss

Risk Related to Our Industries

1. 31The trend towards consolidation in the pharmaceutical and biotechnology industries may adversely affect us
2. 32If 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. 33Some 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. 34Potential product liability claims could adversely affect our future earnings and financial condition

Risk Related to Our Dependence on Third Parties

1. 35We 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
2. 36A cybersecurity incident, other technology disruptions 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
3. 37Unsuccessful compliance with certain European privacy regulations could have an adverse effect on our business and reputation
4. 38We 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. 39Since we received grants from the IIA, we are subject to on-going restrictions
2. 40Recent global inflation may adversely affect our business results
3. 41Non-compliance with environmental, social, and governance, or ESG, practices could harm our reputation, or otherwise adversely impact our business, while increased attention to ESG initiatives could increase our costs
4. 42While we may, at times, engage in voluntary initiatives (such as voluntary disclosures, certifications, or goals, among others) or commitments to improve the ESG profile of our company and/or products, such initiatives or achievements of such commitments may not have the desired effect and may be costly
5. 43Since 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
6. 44Our principal research and development and manufacturing facilities are located in Israel and the unstable military and political conditions of Israel may cause interruption or suspension of our business operations without warning