▸ Changes to U.S. tariff and import/export regulations may have an adverse effect on our business, financial condition and results of operations.· · · ● 1 ▸ Competition for skilled personnel in our industry is intense and may limit our ability to hire and retain highly qualified personnel on acceptable terms or at all.· · · ● 1 ▸ Even if we receive regulatory approval of any product candidates, we will be subject to ongoing regulatory oversight and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to· · · ● 1 ▸ Our failure to meet the continued listing requirements of NASDAQ could result in the de-listing of our Class A common stock.· · · ● 1 ▸ Provisions in our corporate governance documents and Delaware law may prevent or delay an acquisition of our business, which could decrease the market price of our common stock.· · · ● 1 ▸ The global data protection landscape is rapidly evolving, and we may be or become subject to or affected by numerous federal, state and foreign laws and regulations, as well as regulatory guidance, governing the collection, use, disclosure, transfer,· · · ● 1 ▸ The stock market is volatile, and fluctuations in our operating results, removal from various indices and other factors could cause our stock price to decline.· · · ● 1 ▸ There have been significant changes and continue to be ongoing discussion and commentary regarding potential significant· · · ● 1 ▸ We currently have no marketing and sales organization and have no experience as a company in commercializing products, and we may have to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales· · · ● 1 ▸ We may not be successful in our efforts to identify or discover additional product candidates in the future.· ● ● ● 3 ▸ We rely upon cloud services to operate certain aspects of our business and any disruption of or interference with our use of cloud services would impact our operations and our business would be adversely impacted.· ● ● ● 3 ▸ Patent terms may be inadequate to protect our competitive position on rilparencel or our future product candidates for an adequate amount of time, and if we do not obtain protection under the Hatch-Waxman Amendments and similar non-United· · ● · 1 ▸ States legislation for extending the term of patents covering rilparencel or our future product candidates, our business may be materially harmed.· · ● · 1 ▸ Administration of autologous cell therapies is patient-specific and personalized medicine. The process requires careful handling of patient-specific products and fail-safe tracking to ensure that the tracking process is without error and that patient· ● · · 1 ▸ Disruptions at the FDA and other agencies may also slow the time necessary for new products to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years,· ● · · 1 ▸ Our business is highly dependent on the success of our lead product candidate, REACT, as well as any other future product candidates that we may advance into clinical development. REACT and our future product candidates will require significant· ● · · 1 ▸ Our monthly spending levels will vary based on new and ongoing development and corporate activities. Because the length of time and activities associated with development of REACT and any future product candidates is highly uncertain, we are unable· ● · · 1 ▸ To induce valuable employees to remain at our company, in addition to salary and cash incentives, we intend to provide equity awards that vest over time, some of which may be in the form of unregistered shares and may dilute the voting and· ● · · 1 ▸ Antitakeover provisions contained in our Charter, as well as provisions of Cayman Islands law, could impair a takeover attempt.● ● ● · 3 ▸ Because we are a “controlled company” within the meaning of the Nasdaq rules, our shareholders may not have certain corporate governance protections that are available to shareholders of companies that are not controlled companies.● ● ● · 3 ▸ Because we are incorporated under the laws of the Cayman Islands, you may face difficulties in protecting your interests, and your ability to protect your rights through the U.S. federal courts may be limited.● ● ● · 3 ▸ Cell therapies are complex and difficult to manufacture, and we could experience manufacturing problems that result in delays in the development or commercialization of REACT, our lead product candidate, or otherwise harm our business.● · · · 1 ▸ Changes in health care policies, laws and regulations, including legislative measures aimed at reducing health care costs, may impact our ability to obtain approval for, or commercialize REACT or any of our future product candidates, if approved.● ● · · 2 ▸ Competitor companies or hospitals may be able to take advantage of EU rules permitting sales of unlicensed medicines for individual patients to sell competing products without a marketing authorization.● ● · · 2 ▸ EU medicine marketing and reimbursement regulations may materially affect our ability to market and receive coverage for our products in the European member states.● ● · · 2 ▸ Governmental authorities may question our intercompany transfer pricing policies or change their laws in a manner that could increase our effective tax rate or otherwise harm our business.● ● ● · 3 ▸ Managing an autologous ex vivo cell therapy supply chain is highly complex. We must identify, engage, and coordinate with treatment centers where patients’ cellular source material must be collected, prepared and transported to the manufacturing● · · · 1 ▸ Obtaining and maintaining regulatory approval of REACT or any of our future product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of REACT or future product candidates in other jurisdictions.● ● · · 2 ▸ Our business and operations may be adversely affected by the evolving and ongoing COVID-19 global pandemic.● · · · 1 ▸ We are a limited partner of PKLP but may, in certain circumstances, lose the benefit of limited liability.● ● ● · 3 ▸ We are a limited partner of PKLP, a limited partnership registered under the laws of Ireland.● ● ● · 3 ▸ We may be a passive foreign investment company, or “PFIC,” which could result in adverse U.S. federal income tax consequences to U.S. investors.● ● ● · 3 ▸ Any of the above events, should they happen, could adversely affect our development timelines and our business, financial condition, results of operations and prospects.● ● ● ● 4 ▸ Any trademarks we have obtained or may obtain may be infringed or otherwise violated, or successfully challenged, resulting in harm to our business.● ● ● ● 4 ▸ Certain patents covering rilparencel could be found invalid or unenforceable if challenged in court or the USPTO.● ● ● ● 4 rw ▸ Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.● ● ● ● 4 ▸ Changes in patent law in the United States, changes in the administration’s interpretation of the law, or changes in the law in other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.● ● ● ● 4 ▸ Contract development and manufacturing organizations have a finite cell manufacturing capacity, which could inhibit the long-term growth prospects of our business.● ● ● ● 4 ▸ Coverage and reimbursement may be limited or unavailable in certain market segments for rilparencel or our future product candidates, if approved, which could make it difficult for us to sell any product candidates profitably.● ● ● ● 4 rw ▸ Due to our limited resources and access to capital, we must make decisions on the allocation of resources to certain programs and product candidates; these decisions may prove to be wrong and may adversely affect our business.● ● ● ● 4 ▸ Geopolitical risks could result in increased market volatility and uncertainty, which could negatively impact our business, financial condition, and results of operations.● ● ● ● 4 rw ▸ If product liability lawsuits are brought against us, we may incur substantial financial or other liabilities and may be required to limit commercialization of rilparencel or our future product candidates.● ● ● ● 4 rw ▸ If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be negatively impacted, and our business and competitive position would be harmed.● ● ● ● 4 ▸ If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our products may be delayed or never achieved.● ● ● ● 4 ▸ In certain cases, payments under the Tax Receivable Agreement may exceed the actual tax benefits we realize or may be accelerated.● ● ● ● 4 ▸ In certain circumstances, PK Holdings will be required to make distributions to us and the other holders of ProKidney Common Units, and the distributions that PK Holdings will be required to make may be substantial.● ● ● ● 4 rw ▸ Increased prices and inflation could negatively impact our margin performance and our financial results.● ● ● ● 4 ▸ Legal, political and economic uncertainty relating to our international operations could negatively impact or restrict our operations.● ● ● ● 4 ▸ Negative public opinion and increased regulatory scrutiny of autologous cell therapy using rilparencel may adversely impact the development or commercial success of our current and future product candidates.● ● ● ● 4 rw ▸ Our autologous cell therapy products are patient-specific, and we need to ensure that the correct product is administered to the correct patient.● ● ● ● 4 ▸ Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts.● ● ● ● 4 ▸ Our employees, independent contractors, consultants, collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.● ● ● ● 4 ▸ Our executive officers, directors, security holders and their respective affiliates may have competitive pecuniary interests that conflict with our interests.● ● ● ● 4 ▸ Our internal computer systems, or those of our collaborators or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs.● ● ● ● 4 ▸ Rilparencel and our future product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated, and our operating results will suffer if we fail to compete effectively.● ● ● ● 4 rw ▸ Rilparencel is based on a novel technology, which makes it difficult to predict the time and cost of product development and of subsequently obtaining regulatory approval.● ● ● ● 4 rw ▸ Rilparencel requires cryopreservation with specific storage, handling and administration at the clinical sites.● ● ● ● 4 rw ▸ group Risks Related to Legal and Regulatory Compliance Matters● ● ● ● 4 ▸ group Risks Related to Managing Our Business and Operations● ● ● ● 4 ▸ Risks Related to Our Financial Position and Need for Additional Capital● ● ● ● 4 ▸ group Risks Related to Our Intellectual Property● ● ● ● 4 ▸ group Risks Related to Our Reliance on Third Parties● ● ● ● 4 ▸ Risks Related to Research and Development of Rilparencel and Our Future Product Candidates● ● ● ● 4 rw ▸ group Risks Related to our Organizational Structure● ● ● ● 4 ▸ Risks Related to the Commercialization of Rilparencel and Our Future Product Candidates● ● ● ● 4 rw ▸ Risks Related to the Manufacturing of Rilparencel and Our Future Product Candidates● ● ● ● 4 rw ▸ The JOBS Act permits “emerging growth companies” like us to take advantage of certain exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies.● ● ● ● 4 ▸ The affected populations for rilparencel or any of our future product candidates may be smaller than we or third parties currently project, which may affect the addressable markets for rilparencel or our future product candidates.● ● ● ● 4 rw ▸ The design or execution of our ongoing and future clinical trials may not support marketing approval.● ● ● ● 4 ▸ These factors could cause the delay of clinical trials, regulatory submissions, required approvals or commercialization of rilparencel, cause us to incur higher costs and prevent us from commercializing rilparencel successfully, if approved.● ● ● ● 4 rw ▸ Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.● ● ● ● 4 ▸ Third parties may assert that we are employing their proprietary technology without authorization.● ● ● ● 4 ▸ Third-party claims of intellectual property infringement may be costly and time consuming to defend and could prevent or delay our product discovery, development and commercialization efforts.● ● ● ● 4 ▸ Unanticipated changes in effective tax rates or adverse outcomes resulting from examination of our income or other tax returns could adversely affect our financial condition and results of operations.● ● ● ● 4 ▸ We are a holding company, and our only material asset is our interest in PK Holdings, and we are accordingly dependent upon distributions made by our subsidiaries to pay taxes, make payments under the Tax Receivable Agreement and pay dividends.● ● ● ● 4 rw ▸ We are conducting our first Phase 3 clinical trial and may be unable to successfully complete it or any future clinical trials.● ● ● ● 4 rw ▸ We cannot be certain that we were the first to file any patent application related to our technology, including rilparencel, and, if we were not, we may be precluded from obtaining patent protection for our technology, including rilparencel.● ● ● ● 4 rw ▸ We do not have experience as a company managing a complex supply chain or satisfying manufacturing-related regulatory requirements.● ● ● ● 4 ▸ We have a limited operating history and have not generated any revenue to date, and may never become profitable.● ● ● ● 4 ▸ We have and may continue to encounter difficulties enrolling patients in our clinical trials, and our clinical development activities have been and may continue to be delayed or otherwise adversely affected.● ● ● ● 4 rw ▸ We have incurred significant net losses since inception and we expect to continue to incur significant net losses for the foreseeable future.● ● ● ● 4 ▸ We have limited foreign intellectual property rights and may not be able to protect and enforce our intellectual property rights throughout the world.● ● ● ● 4 ▸ We have our own manufacturing capabilities, which may result in increased costs being incurred by us.● ● ● ● 4 ▸ We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, or challenging the patent rights of others, which could be expensive, time-consuming and unsuccessful.● ● ● ● 4 ▸ We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.● ● ● ● 4 ▸ We may fail to demonstrate with substantial evidence from adequate and well-controlled trials, and to the satisfaction of the FDA or comparable foreign regulatory authorities, that rilparencel is safe and potent for its intended uses.● ● ● ● 4 rw ▸ We may incur substantial costs in our efforts to comply with evolving global data protection laws and regulations, and any failure or perceived failure by us to comply with such laws and regulations may harm our business and operations.● ● ● ● 4 ▸ We may not be successful in obtaining or maintaining necessary intellectual property rights to develop any future product candidates on acceptable terms.● ● ● ● 4 ▸ We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent which might adversely affect our ability to develop and market our products.● ● ● ● 4 ▸ We must be able to overcome these challenges in order for us to develop, commercialize and manufacture rilparencel.● ● ● ● 4 rw ▸ We rely on third parties for materials, including tissue samples, required for our research and development activities, and if we are unable to reach agreements with these third parties our research and development activities would be delayed.● ● ● ● 4 
