▸ Any of the foregoing could materially adversely affect our business, financial condition, results of operations, and prospects, as well as the market price of our common shares.· · ● 1 ▸ As discussed elsewhere in this Risk Factors section, we may enter into various kinds of collaborative research and development and product marketing agreements to develop and commercialize our product candidates. We are· · ● 1 ▸ FDA requirements with respect to HCT/Ps are still evolving, and FDA could increase and/or expand requirements for keeping and/or maintaining marketing approval; and· · ● 1 ▸ Our decisions regarding whether to advance our programs internally or through strategic relationships may not maximize the value of our pipeline for our shareholders, and misjudgments in these decisions could materially adversely affect our business.· · ● 1 ▸ Our research and development activities are costly, time consuming, and their results are uncertain. We incurred research and development expenses amounting to approximately $17.7 million and $12.5 million during the fiscal· · ● 1 ▸ group Risks Related to Commercialization of our Product Candidates· · ● 1 ▸ group Risks Related to Ownership of Our Common Shares· · ● 1 ▸ Risks Related to the Development and Clinical Testing of Our Product Candidates· · ● 1 ▸ Roche may not dedicate the resources necessary to carry OpRegen through clinical development, regulatory approval, or commercialization;· · ● 1 ▸ The use of social media platforms present risks and challenges.· · ● 1 ▸ We may seek additional capital through a variety of means, including equity offerings, debt financings or other third-party funding, including grants or new strategic alliances and licensing or collaborations. To the extent that we· · ● 1 ▸ Confidentiality agreements with employees and third parties may not prevent disclosure of trade secrets and other proprietary information.· ● ● 2 ▸ Roche may conclude that clinical supply of OpRegen does not meet its internal standards;· ● ● 2 ▸ The issuance of common shares upon exercise of warrants would cause immediate and substantial dilution to existing shareholders.· ● ● 2 ▸ If we, or our personnel or third parties upon whom rely, fail, or are perceived to have failed, to address or comply with applicable data privacy, security, protection and transfer requirements, we could face significant consequences.· ● · 1 ▸ Political uncertainty may have an adverse impact on our operating performance and results of operations.· ● · 1 ▸ We currently rely, and plan to continue to rely, on third parties such as CROs, data management companies, contract clinical research associates, medical institutions, clinical investigators and contract laboratories to assist with· ● · 1 ▸ We or our collaborators, suppliers, CROs, other service providers, or other third parties on which we rely may experience interruptions to our operations, including the conduct of our research and development programs, clinical· ● · 1 ▸ Data obtained from preclinical and clinical studies is susceptible to varying interpretations and regulatory changes that could delay, limit, or prevent regulatory agency approvals.● ● · 2 ▸ Disruptions at the FDA and other government agencies caused by funding shortages or other events or conditions outside of their control could negatively impact our business.● ● · 2 ▸ If we or our strategic collaborators do not receive regulatory approvals, our product candidates may not be marketed or sold.● ● · 2 ▸ Insiders continue to have substantial influence over our company, which could limit your ability to influence the outcome of key transactions, including a change of control.● ● · 2 ▸ group Risks Pertaining to Our Common Shares● ● · 2 ▸ group Risks Related to Our Clinical Development and Commercial Operations● ● · 2 ▸ Roche may believe that data generated in clinical trials for OpRegen may be negative, inconclusive, or do not otherwise demonstrate adequate safety, efficacy or clinical benefit to warrant further development or commercialization;● ● · 2 rw ▸ We enter into agreements with our employees pursuant to which they agree that any inventions created in the scope of their employment are assigned to us or owned exclusively by us, without the employee retaining any rights.● · · 1 ▸ We or our collaborators will face similar regulatory issues in foreign countries.● ● · 2 ▸ Adverse litigation judgments or settlements resulting from legal proceedings in which we may be involved could expose us to monetary damages or limit our ability to operate our business.● ● ● 3 ▸ Because a portion of our expenses are incurred in currencies other than the U.S. Dollar, our results of operations may be harmed by currency fluctuations.● ● ● 3 ▸ Because we do not intend to pay cash dividends, our common shares may not be a suitable investment for anyone who needs to earn dividend income.● ● ● 3 ▸ Changes in or disruptions to our manufacturing operations could materially and adversely affect our business.● ● ● 3 ▸ Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations.● ● ● 3 ▸ Clinical development of new therapeutic products is a lengthy and expensive process with a high level of uncertainty as to timing and ultimate outcome.● ● ● 3 ▸ Even if we receive approval to market a product candidate, we may be subject to extensive post-approval regulatory obligations that may have a significant adverse effect on our business, results of operations, financial condition and reputation.● ● ● 3 ▸ Failure of our internal control over financial reporting could harm our business and financial results.● ● ● 3 ▸ Government-imposed bans or restrictions and religious, moral, and ethical concerns about the use of hES cells could prevent us from developing and successfully marketing stem cell products.● ● ● 3 ▸ HIPAA, which created new federal criminal statutes that prohibit, among other things, executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters;● ● ● 3 ▸ If the market opportunities for our product candidates prove to be significantly smaller than we estimate, our business prospects may suffer.● ● ● 3 ▸ If we are unable to obtain and enforce patents and to protect our trade secrets, others could use our technology to compete with us, which could limit opportunities for us to generate revenues by licensing our technology and selling products.● ● ● 3 ▸ If we fail to comply with the extensive legal and regulatory requirements affecting the healthcare industry, we could face increased costs, penalties and loss of business.● ● ● 3 ▸ If we fail to meet our obligations under our in-license agreements, we may lose our rights to key technologies on which our business depends.● ● ● 3 ▸ If we or our subsidiaries issue additional common shares or preferred shares, investors in our common shares may experience dilution of their ownership interests.● ● ● 3 ▸ Intellectual property we may develop using grants received from governmental entities are subject to rights maintained by those governments.● ● ● 3 ▸ Legislation and legislative, executive and regulatory proposals intended to contain health care costs may adversely affect our business.● ● ● 3 ▸ Our ability to raise capital through equity or convertible debt financings may be limited by applicable rules of the SEC and NYSE American.● ● ● 3 ▸ Our ability to use our net operating losses and other tax attributes to offset future taxable income or taxes may be limited, which may effectively increase our future income tax obligations.● ● ● 3 rw ▸ Our business could be adversely affected if we lose the services of the key personnel upon whom we depend or if we fail to attract and retain senior management and key scientific personnel.● ● ● 3 ▸ Our business could be materially and adversely affected in the future by the effects of a public health crisis.● ● ● 3 ▸ Our business could be negatively affected as a result of actions of activist shareholders, and such activism could affect the trading value of our securities.● ● ● 3 ▸ Our business could be negatively impacted by environmental, social and corporate governance (“ESG”) matters or our reporting of such matters.● ● ● 3 ▸ Our intellectual property may be insufficient to protect our products.● ● ● 3 ▸ Our international business exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.● ● ● 3 ▸ Raising additional capital may cause dilution to our existing shareholders, restrict our operations, or require us to relinquish rights to or dilute our economic interest in our product candidates or technology on terms unfavorable to us.● ● ● 3 ▸ Regenerative Medicine Advanced Therapydesignation may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that a product candidate will receive marketing approval.● ● ● 3 ▸ group Risks Related to Government Regulation● ● ● 3 ▸ group Risks Related to Our Business Operations and Capital Requirements● ● ● 3 ▸ group Risks Related to our Dependence on Third Parties● ● ● 3 ▸ group Risks Related to our Intellectual Property● ● ● 3 ▸ Securities analysts may not initiate coverage or continue to cover our common shares, and this may have a negative impact on the market price of our common shares.● ● ● 3 ▸ Some of our product candidates, may be considered combination products by the FDA and other regulatory authorities, which could increase the complexity, cost and timeline for their development and regulatory approval.● ● ● 3 ▸ Taxing authorities could reallocate our taxable income among our subsidiaries, which could increase our overall tax liability.● ● ● 3 ▸ The ACA and future changes to that law may adversely affect our business.● ● ● 3 ▸ The commercial success of any of our current or future product candidates will depend upon the degree of market acceptance by physicians, patients, third-party payors, other healthcare providers and others in the medical community.● ● ● 3 ▸ The market price of our common shares has been and may continue to be volatile, and you could lose all or part of your investment.● ● ● 3 ▸ There is no certainty that our pending or future patent applications will result in the issuance of patents.● ● ● 3 ▸ There is no certainty that we will be able to obtain licenses to intellectual property rights owned by third parties.● ● ● 3 ▸ They or their third-party manufacturers may not obtain or maintain intellectual property rights necessary for the development, manufacture and, if approved, commercialization of the systems or devices.● ● ● 3 ▸ They or their third-party manufacturers might not manufacture in a timely manner the device, systems or components in the quantity or quality required to meet our clinical trial needs and, if approved, commercial needs.● ● ● 3 ▸ Unfavorable macroeconomic conditions and wars or armed conflicts could have an adverse impact on our business, financial condition and results of operations, including our clinical trials.● ● ● 3 ▸ We have incurred operating losses since inception, and we do not know if or when we will attain profitability.● ● ● 3 ▸ We may be subject to product liability exposure arising out of use of the systems or devices to administer our product candidates in clinical trials or, if approved, for commercial use, and our insurance may not cover all potential claims.● ● ● 3 ▸ We may become dependent on possible future collaborations to develop and commercialize many of our product candidates and to provide the regulatory compliance, sales, marketing and distribution capabilities required for the success of our business.● ● ● 3 ▸ We may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could result in litigation and adversely affect our business.● ● ● 3 ▸ We may expend our limited resources to pursue particular product candidates and fail to capitalize on other product candidates that may be more profitable or for which there is a greater likelihood of success.● ● ● 3 ▸ We will continue to spend a substantial amount of our capital on research and development, but we might not succeed in identifying or developing product candidates that are safe and effective for their target indications or are commercially viable.● ● ● 3 rw 
