▸ A limited number of CDMOs specialize in or have the expertise required to manufacture our product candidates or materials used in their manufacture. Moreover, our CDMOs have limited capacity at their facilities and require commitments to secure· · ● 1 ▸ Despite our workforce reduction in connection with the restructuring, we expect continued growth in the scope of our operations, particularly as we advance our product candidates into IND-enabling studies and clinical trials and continue to establish· · ● 1 ▸ Market and economic conditions may negatively impact our business, financial condition, and share price.· · ● 1 ▸ Our product candidates or technologies may be involved in investigator-sponsored clinical trials, and we will have limited or no control over the conduct of such trials.· · ● 1 ▸ Report for details on the amount of the potential Cobalt Success Payment and potential Cobalt Contingent Consideration if there is a change of control based on various thresholds for our market capitalization on such change of control date.· · ● 1 ▸ Third parties may challenge the inventorship or ownership of or otherwise assert rights in our patent and other intellectual property rights.· · ● 1 ▸ We may not realize the benefits of technologies that we have acquired or in-licensed, or will acquire or in-license in the future.· · ● 1 ▸ Confidentiality agreements with employees and third parties may not prevent unauthorized disclosure of trade secrets and other proprietary information.· ● ● 2 ▸ Future sales of our common stock in the public market could cause our common stock price to fall.· ● ● 2 ▸ If we are unable to successfully identify, develop, and commercialize any product candidates, or experience significant delays in doing so, our business, financial condition, and results of operations will be materially adversely affected.· ● ● 2 ▸ If we fail to maintain proper and effective internal controls over financial reporting, our ability to produce accurate and timely financial statements could be impaired.· ● ● 2 ▸ Intellectual property rights do not necessarily protect us from all potential threats to our competitive advantage.· ● ● 2 ▸ Our ability to develop our cell engineering platforms and product candidates and our future growth depend on retaining our key personnel and recruiting additional qualified personnel.· ● ● 2 rw ▸ Our business, financial condition, and results of operations could be materially adversely affected by any of the foregoing events.· ● ● 2 rw ▸ Our internal computer systems, or those used by third parties involved in our operations, such as research institution collaborators, CROs, CDMOs, and other service providers, contractors, or consultants, may fail or suffer security breaches.· ● ● 2 rw ▸ Our limited operating history may make it difficult to evaluate our prospects and likelihood of success.· ● ● 2 ▸ Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.· ● ● 2 ▸ Our success payment and contingent consideration obligations in our license and acquisition agreements may result in dilution to our stockholders, drain our cash resources, or require us to incur debt to satisfy the payment obligations.· ● ● 2 rw ▸ Raising additional capital may cause dilution to our stockholders, restrict our operations, or require us to relinquish rights to our technologies or product candidates.· ● ● 2 ▸ group Risks Related to Commercialization of Our Product Candidates· ● ● 2 ▸ group Risks Related to Intellectual Property and Information Technology· ● ● 2 ▸ Risks Related to Our Limited Operating History, Financial Condition, and Need for Additional Capital· ● ● 2 rw ▸ group Risks Related to Ownership of Our Common Stock· ● ● 2 ▸ Should any of these events occur, they could significantly harm our business, results of operations, and prospects.· ● ● 2 ▸ The requirements of being a public company may strain our resources, result in an increased risk of litigation, and divert management’s attention.· ● ● 2 ▸ The terms of our patents may not be sufficient to effectively protect our products and business.· ● ● 2 ▸ Third-party claims of intellectual property infringement against us or our collaborators may prevent or delay our product discovery, development, or commercialization efforts.· ● ● 2 ▸ We are an emerging growth company, and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors.· ● ● 2 ▸ We depend, in part, on our licensors to file, prosecute, maintain, defend, and enforce certain patents and patent applications that are material to our business.· ● ● 2 ▸ We do not currently intend to pay dividends on our common stock and, consequently, our stockholders’ ability to achieve a return on their investment will depend on appreciation of the value of our common stock.· ● ● 2 ▸ We may become exposed to costly and damaging liability claims, either when testing our product candidates in clinical trials or at the commercial stage, and our product liability insurance may not cover all damages arising from such claims.· ● ● 2 ▸ We may encounter difficulties in managing our growth as we expand our development and regulatory capabilities, which could disrupt our operations.· ● ● 2 rw ▸ 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.· ● ● 2 ▸ The ongoing COVID-19 pandemic could materially and adversely affect our preclinical studies and development, our manufacturing capabilities, any clinical trials we may commence, and our business, financial condition, and results of operations.· ● · 1 ▸ We may be involved in lawsuits to protect or enforce our patents or other intellectual property or the intellectual property of our licensors, which could be expensive, time-consuming, and unsuccessful.· ● · 1 ▸ We may be subject to claims challenging the inventorship or ownership of our patent and other intellectual property rights.· ● · 1 ▸ While we believe our pipeline will yield multiple INDs, we may not be able to submit INDs to commence clinical trials on the timelines we expect, and even if we are able to submit an IND, the FDA may not permit us to proceed with clinical trials.· ● · 1 ▸ A key to our strategy is operating our own manufacturing facility. We are investing early in building world class capabilities in key areas of● · · 1 ▸ Act, which brought into effect significant changes to the U.S. patent laws, including new procedures for challenging pending patent applications and issued patents.● · · 1 ▸ Adverse publicity due to ethical and social controversies surrounding the use of stem cells could lead to negative public opinion, difficulties enrolling patients in our clinical trials, increased regulation and stricter policies regarding the use● · · 1 ▸ All of our product candidates are in preclinical development and have not commenced clinical development. Preclinical and clinical drug development is a● · · 1 ▸ group Although the clinical trial process is designed to identify● · · 1 ▸ Although we maintain adequate product liability insurance for our product candidates, it is possible that our liabilities could exceed our● · · 1 ▸ Any adverse developments affecting manufacturing operations for our product candidates, if any are approved, may result in shipment delays,● · · 1 ▸ group Any clinical trial programs and research● · · 1 ▸ Any government investigation of alleged violations of law could require us to expend significant time and● · · 1 ▸ As a Delaware corporation, we will be subject to the anti-takeover provisions of Section 203 of the Delaware General Corporation Law,● · · 1 ▸ group As a public company, we will be subject● · · 1 ▸ As is the case with other biopharmaceutical companies, our success is heavily dependent on● · · 1 ▸ As of December 31, 2020, our executive officers, directors, holders of 5% or more of our capital stock and their respective affiliates● · · 1 ▸ As we continue to develop and scale our manufacturing process, we expect that we will need● · · 1 ▸ Assets Controls, the U.S. Foreign Corrupt Practices Act of 1977, as amended (FCPA), the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act, and other state and national anti-bribery and● · · 1 ▸ Because of the expense and uncertainty of litigation, we may conclude that even if a● · · 1 ▸ Because of the numerous risks and uncertainties associated with pharmaceutical products and biological development,● · · 1 ▸ Because the number of qualified clinical investigators and clinical trial● · · 1 ▸ group Because we have limited financial and● · · 1 ▸ group By disclosing information in this Annual Report on Form● · · 1 ▸ Certain aspects of our cell engineering platforms rely on the ability to edit genes. Public perception may be● · · 1 ▸ group Certain laws and regulations● · · 1 ▸ Certain of the research materials we use in our therapeutic research and development efforts, as well as stem cell lines used as starting● · · 1 ▸ group Certain patents relating to our● · · 1 ▸ China and India, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In those countries, we and our licensors may have limited remedies● · · 1 ▸ Clinical Health Act of 2009 (HITECH). Depending on the facts and circumstances, we could be subject to significant penalties if we violate HIPAA. For example, under HIPAA, we could potentially face substantial criminal or civil penalties if we● · · 1 ▸ Clinical trials must be conducted in accordance with the FDA and comparable foreign regulatory authorities’ legal requirements,● · · 1 ▸ Cobalt (Cobalt Success Payment) of $500.0 million is payable if, at pre-determined valuation measurement dates, our value is equal to or exceeds three● · · 1 ▸ Competitors may infringe our patents or other intellectual property or the intellectual property of our licensors. To cease such infringement● · · 1 ▸ Composition of matter patents for biological and pharmaceutical products such as● · · 1 ▸ group Confidentiality agreements with employees and third parties● · · 1 ▸ December 31, 2020, we had an accumulated deficit of $429.4 million. Our losses have resulted principally from expenses incurred for the research and development of our in vivo and ex vivo cell engineering platforms and from● · · 1 ▸ Despite the implementation of security measures (including edge technology designed to identify and protect our network from infiltration by● · · 1 ▸ Developing biopharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and● · · 1 ▸ Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain,● · · 1 ▸ group Ensuring that our internal operations and future business● · · 1 ▸ group Even if approved, our products may not gain market● · · 1 ▸ group Even if our product candidates obtain regulatory approval, we● · · 1 ▸ Even if the FDA or any comparable foreign regulatory authority approves the marketing of any product candidates that we develop, physicians,● · · 1 ▸ Even if we are able to commercialize any product candidate, coverage and adequate reimbursement may not be available or such product candidate may● · · 1 ▸ Even if we establish infringement, the court may decide not to grant an injunction against further● · · 1 ▸ Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects, and other supply disruptions. If microbial, viral, or other contaminations are discovered in our product candidates or in the● · · 1 ▸ Even successful defense against product liability claims would require significant financial and management resources. Regardless of the● · · 1 ▸ Exchange Act requires, among other things, that we file annual, quarterly, and current reports with respect to our business and operating results. The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls● · · 1 ▸ Executive Orders, that could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine oversight activities such as implementing statutes through rulemaking, issuance of guidance, and review and● · · 1 ▸ Factors that may lead to increases or decreases in the estimated fair value of contingent consideration include, among others, the estimated● · · 1 ▸ Failure to remedy any material weakness in our internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict our future access to the capital markets.● · · 1 ▸ From the beginning of 2021 (when the transitional period following the United Kingdom’s withdrawal from the European Union● · · 1 ▸ From time to time, we may also disclose preliminary or interim data from our preclinical studies and clinical trials. Preliminary or interim● · · 1 ▸ From time to time, we may publicly disclose interim, topline, or preliminary data from our preclinical studies and clinical trials, which is● · · 1 ▸ Future acquisitions or dispositions could result in potentially dilutive issuances of our equity securities, the incurrence of debt,● · · 1 ▸ Given the novelty of our technologies, we intend to work closely with the FDA and comparable foreign regulatory authorities to perform the● · · 1 ▸ Government agencies have provided and may in the future provide funding, facilities, personnel or other assistance in connection with the● · · 1 ▸ Healthcare providers, healthcare facilities and institutions, physicians, and third-party payors in the United States and elsewhere will play a● · · 1 ▸ IPO, together with our existing cash, cash equivalents and marketable securities at December 31, 2020, will be sufficient to fund our operating expenses and capital expenditure requirements for at least the next 36 months. We have based this● · · 1 ▸ If a natural disaster, power outage or other event occurred that prevented us from using all or a significant portion of our● · · 1 ▸ If a regulatory agency discovers previously unknown problems with a product, such as adverse● · · 1 ▸ group If any of these risks or uncertainties occur, we may not realize the● · · 1 ▸ group If any such actions are instituted against us, and● · · 1 ▸ If our product candidates fail to gain market acceptance, this will have a material adverse impact on our ability to generate● · · 1 ▸ If our quarterly operating results fall below the expectations of investors or securities analysts, the price of our common stock could● · · 1 ▸ group If securities or industry analysts either do not● · · 1 ▸ If the FDA or a comparable foreign regulatory authority approves any of our product candidates, the manufacturing processes, testing, labeling,● · · 1 ▸ If there are changes in the application of legislation or regulatory policies, or if problems are discovered with a product or our manufacture● · · 1 ▸ If we are unable to enter into these arrangements on acceptable terms or at all, we may not be able to successfully commercialize any approved● · · 1 ▸ If we are unable to obtain and maintain sufficient intellectual property protection for our platform● · · 1 ▸ If we are unable to obtain sufficient raw and intermediate materials on a timely basis or if we● · · 1 ▸ group If we are unable to successfully● · · 1 ▸ If we are unable to successfully identify, develop, and commercialize any product candidates, or experience significant delays in doing so, our● · · 1 ▸ If we fail to keep apprised of and comply with applicable international, federal, state, or● · · 1 ▸ If we fail to maintain proper and effective internal controls over financial reporting● · · 1 ▸ If we fail to receive positive results in preclinical studies or clinical trials of any product candidate, the development timeline and● · · 1 ▸ group If we license products or businesses, we● · · 1 ▸ If we or one of our licensing partners initiate legal proceedings against a third party to enforce a patent covering one of our product● · · 1 ▸ If we raise additional funds through collaborations, strategic alliances or marketing,● · · 1 ▸ If we were unable to find an adequate replacement or another acceptable solution in time, our clinical trials could be● · · 1 ▸ In order to satisfy our obligations to make these success payments, if and when they are triggered, we may issue equity or convertible debt● · · 1 ▸ In the United States and other jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory● · · 1 ▸ In the United States, numerous federal and state laws and regulations, including state data breach notification laws and● · · 1 ▸ In the past, securities class action litigation has often been instituted against companies following periods of volatility in the● · · 1 ▸ group Index to Financial Statements● · · 1 ▸ group Interim reimbursement levels for new drug products, if● · · 1 ▸ Interim, topline, or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data becomes● · · 1 ▸ Investing in shares of our common stock involves a high degree of risk. You should carefully consider the following risks and uncertainties,● · · 1 ▸ group Issued patents covering our● · · 1 ▸ group Jurisdictions in addition to● · · 1 ▸ Leahy-Smith Act, signed into law on September 16, 2011, could increase those uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. The Leahy-Smith Act includes a● · · 1 ▸ Licensing of intellectual property is of critical importance to our business● · · 1 ▸ Manufacturers and manufacturers’ facilities are required to comply with extensive FDA and comparable foreign regulatory authority● · · 1 ▸ Manufacturing our product candidates is highly complex and requires sourcing specialty materials. Many of the risks associated with the● · · 1 ▸ Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The● · · 1 ▸ March 1, 2021, the holders of approximately 134.1 million shares, or 71.5% of our outstanding shares, of our common stock will have rights, subject to some conditions, to require us to file registration statements covering the sale of● · · 1 ▸ March 10, 2020 the FDA announced its intention to postpone most inspections of foreign manufacturing facilities, and on March 18, 2020, the FDA temporarily postponed routine surveillance inspections of domestic manufacturing facilities.● · · 1 ▸ Misconduct by employees could include failures to comply with FDA regulations, provide accurate information to the FDA, comply with manufacturing standards we may establish, comply with federal and state healthcare fraud and abuse laws and● · · 1 ▸ Negative public opinion and increased regulatory scrutiny of research and● · · 1 ▸ Numerous U.S. and foreign issued patents and pending patent applications● · · 1 ▸ Obtaining and enforcing patents is expensive and time-consuming, and we may not be able to file and prosecute all necessary or● · · 1 ▸ Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements● · · 1 ▸ group One aspect of the determination of patentability● · · 1 ▸ group One particularly sensitive issue under these European Union data● · · 1 ▸ Our CROs have the right to terminate their agreements with us in the event of an uncured material breach. In● · · 1 ▸ group Our ability to commercialize any products successfully● · · 1 ▸ group Our ability to develop our cell engineering platforms and● · · 1 ▸ group Our ability to generate revenue● · · 1 ▸ Our ability to raise additional funds will depend on financial, economic, political and market conditions and other factors, over which we may● · · 1 ▸ Our amended and restated certificate of incorporation and amended and restated bylaws contain provisions that could depress the market price of● · · 1 ▸ Our amended and restated certificate of incorporation provide that, unless we consent in writing to the selection of● · · 1 ▸ group Our business operations and current and future● · · 1 ▸ Our clinical trials may fail to demonstrate substantial evidence of the safety and efficacy of our product candidates or any future product candidates,● · · 1 ▸ group Our clinical trials will compete with other clinical● · · 1 ▸ Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. There is a● · · 1 ▸ group Our corporate headquarters and other● · · 1 ▸ Our current certificate of incorporation provides, and our amended and restated certificate of incorporation will provide that the Court of Chancery of● · · 1 ▸ Our current or future trademarks or trade names may be challenged, infringed,● · · 1 ▸ Our employees, independent contractors, principal investigators, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.● ● · 2 rw ▸ Our in vivo and ex vivo cell engineering technology represents an aggregation of years of● · · 1 ▸ group Our internal computer systems, or those used by our● · · 1 ▸ Our management team has broad discretion to use the net proceeds from our IPO and its● · · 1 ▸ Our management will have broad discretion over the use of net proceeds from our IPO, and could spend the net proceeds in ways our stockholders● · · 1 ▸ Our manufacturing processes requires many reagents, which are drug substance intermediates used in our manufacturing processes to bring about● · · 1 ▸ Our patents or pending patent applications may be challenged in the courts or patent offices in the United States and abroad. For example, we● · · 1 ▸ Our product candidates may also require specific components to work effectively and efficiently, and rights● · · 1 ▸ group Our product candidates may have● · · 1 ▸ group Our research and development● · · 1 ▸ Our stock price may be volatile or may decline regardless of our operating performance, resulting in substantial losses for investors.● · · 1 ▸ Our success depends in large part on our ability to obtain and maintain patent protection in the United States and other countries with● · · 1 ▸ Our success payment and contingent consideration obligations in our license and acquisition agreements may result in dilution to our stockholders, may● · · 1 ▸ Patents are of national or regional effect, and filing, prosecuting, maintaining and defending patents on product candidates in all countries● · · 1 ▸ Patents have a limited lifespan. In● · · 1 ▸ Periodic maintenance fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime● · · 1 ▸ group Pharmaceutical manufacturers are also subject to● · · 1 ▸ Pharmaceutical manufacturers are required to register their facilities and products manufactured at the● · · 1 ▸ group Preclinical studies and clinical testing are expensive● · · 1 ▸ Provisions in our amended and restated certificate of incorporation and our● · · 1 ▸ group Pursuant to Section 404 of the● · · 1 ▸ Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured product candidates ourselves,● · · 1 ▸ Report on Form 10-K are subject to significant uncertainty and are based on assumptions and estimates. These estimates, which have been derived from a variety of sources, including scientific literature,● · · 1 ▸ Results of our clinical trials could reveal a high and unacceptable severity and prevalence● · · 1 ▸ Results of preclinical studies of any product candidates may not be predictive of the results of future preclinical studies or clinical trials.● · · 1 ▸ Sarbanes-Oxley Act, our management will be required to report upon the effectiveness of our internal control over financial reporting beginning with the annual report for our fiscal year ending December 31, 2021. When we lose our status as an● · · 1 ▸ group Separately, in response to the COVID-19 pandemic, on● · · 1 ▸ Since a significant proportion of the regulatory framework in the United Kingdom applicable to our business and our product candidates is● · · 1 ▸ Since its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA, and we expect● · · 1 ▸ Smaller and other early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with● · · 1 ▸ States a patent’s life can be increased based on certain delays caused by the USPTO, this increase can be reduced or eliminated based on certain delays caused by the patent applicant during patent prosecution. A patent term extension based on● · · 1 ▸ Subsequently, on July 10, 2020, the FDA announced its intention to resume certain on-site inspections of domestic manufacturing facilities subject to a risk-based prioritization system. The FDA intends to● · · 1 ▸ Substantially all shares of common stock sold in our IPO (excluding any shares sold to our directors or officers in the directed share● · · 1 ▸ Successful and timely completion of clinical trials will require that we enroll and retain a● · · 1 ▸ Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial● · · 1 ▸ group Supply sources could be interrupted● · · 1 ▸ Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents● · · 1 ▸ The ACA includes a subtitle called the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which created an● · · 1 ▸ group The COVID-19 global pandemic continues to rapidly● · · 1 ▸ The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding● · · 1 ▸ The biotechnology and pharmaceutical industries are highly competitive and● · · 1 ▸ The clinical development, manufacturing, labeling, packaging, storage, recordkeeping, advertising, promotion, export,● · · 1 ▸ The contingent consideration and success payment obligations in our license and acquisition agreements may cause operating results to fluctuate● · · 1 ▸ The development and commercialization of biopharmaceutical products is subject to extensive regulation, and the regulatory approval processes of the FDA● · · 1 ▸ The development and potential commercialization of our product candidates will require substantial additional capital to fund expenses. We may● · · 1 ▸ The estimates of market opportunity and forecasts of market growth included in this Annual Report on● · · 1 ▸ The increased likelihood of biosimilar competition has increased the risk of loss of innovators’ market exclusivity. Due to this risk,● · · 1 ▸ The licensing and acquisition of third-party intellectual property rights is a competitive practice, and companies that may be more● · · 1 ▸ The manufacture of biopharmaceutical products is complex and requires significant expertise, including the development of advanced● · · 1 ▸ group The manufacture of certain of our● · · 1 ▸ The manufacture of our product candidates is complex. Our third-party manufacturers may encounter difficulties in production, which could delay or● · · 1 ▸ The market price of our common stock may be highly volatile and may fluctuate substantially as a result of a variety of factors, some of which● · · 1 ▸ The outbreak of the novel coronavirus disease, COVID-19, could materially and adversely affect our preclinical● · · 1 ▸ The pharmaceutical and biotechnology industries have produced a considerable number of patents, and it may not always be clear to industry● · · 1 ▸ The process of manufacturing our biologic product candidates is extremely susceptible to● · · 1 ▸ The regulations that govern regulatory approvals, pricing, and reimbursement for drug products vary widely from country to country. Some● · · 1 ▸ group The requirements of being a public company may● · · 1 ▸ The trading market for our common stock will be influenced in part by the research and reports that securities or● · · 1 ▸ The use of human stem cells exposes us to a number of risks in the development of our human stem cell derived products, including restrictions on● · · 1 ▸ The withdrawal of the United Kingdom from the European Union, commonly referred to as “Brexit,” may adversely impact our● · · 1 ▸ There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal, and state levels● · · 1 ▸ group There is a limited number of third-party service providers that● · · 1 ▸ There may be significant delays in obtaining reimbursement for newly-approved drug products, and coverage may be more limited than the● · · 1 ▸ These factors may make it difficult for us to enroll enough patients to complete● · · 1 ▸ These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. For example, our directors or executive officers could inadvertently fail to disclose● · · 1 ▸ These new rules and regulations may make it more expensive for us to obtain director and officer liability insurance and, in the future, we● · · 1 ▸ These organizations may have significantly greater resources than we do and conduct similar research, seek patent protection and establish collaborative arrangements for research, development, manufacturing, and marketing of products that compete● · · 1 ▸ Third parties asserting their patent or other intellectual property rights against us may seek and obtain injunctive or other equitable● · · 1 ▸ This lengthy approval process, as well as the unpredictability of future clinical trial results, may result in our failing to obtain● · · 1 ▸ To become and remain profitable, we must succeed in identifying, developing, getting regulatory approval for and eventually commercializing● · · 1 ▸ To date, we have not commenced any clinical trials required for the approval of a product candidate. We do not know whether planned clinical● · · 1 ▸ To manage our anticipated future growth, we will continue to implement and improve our managerial, operational, and financial systems, expand● · · 1 ▸ group To obtain the requisite regulatory● · · 1 ▸ To obtain the requisite regulatory approvals to market and sell any of our product candidates, we or any collaborator for such● · · 1 ▸ Under the JOBS Act, emerging growth companies can also delay adopting new or● · · 1 ▸ Under the Tax Cuts and Jobs Act of 2017, as modified by the Coronavirus Aid, Relief, and Economic Stability Act, or CARES Act, our federal net● · · 1 ▸ United States, including in the locations of our offices and those of key vendors and partners. As a result of the COVID-19 pandemic, or similar pandemics, and related “shelter in place” orders and● · · 1 ▸ Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations with our existing cash, cash● · · 1 ▸ We and our partners and vendors are subject to various federal, state, and foreign data protection laws and regulations. If we fail to comply● · · 1 ▸ We are a preclinical-stage biotechnology company and have incurred significant losses since our inception, and we expect to incur losses for● · · 1 ▸ We are dependent on patents, know-how, and proprietary technology, both our own and licensed from others. We are a● · · 1 ▸ group We are exposed to the risk of employee● · · 1 ▸ We are increasingly dependent upon information technology systems, infrastructure and data to operate our business. In the ordinary course of● · · 1 ▸ We are likely to be required to expend significant capital and other resources to ensure ongoing● · · 1 ▸ We are seeking to identify and develop a broad pipeline of product candidates using our in vivo and ex vivo cell engineering● · · 1 ▸ group We are subject to U.S. and● · · 1 ▸ We are subject to the periodic reporting requirements of the Exchange Act. We must design our disclosure controls and procedures to reasonably● · · 1 ▸ We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors, and other collaborators, even if we do not explicitly authorize or have actual knowledge of such activities. Any violations of the laws and● · · 1 ▸ We can face criminal liability and other serious consequences for violations, which can harm our business.● · · 1 ▸ We cannot assure you that there will not be material weaknesses or significant deficiencies in our internal control● · · 1 ▸ We cannot be certain that our licensors will allocate sufficient resources or prioritize their or our enforcement of such patents or defense of such claims to protect our interests in the licensed patents. Even if we are not a party to these legal● · · 1 ▸ We cannot predict if investors will find our common stock less attractive if● · · 1 ▸ We could be an emerging growth company for up to five years following the completion of our● · · 1 ▸ We could be subject to securities class action litigation.● · · 1 ▸ We currently have no marketing, sales, or distribution infrastructure and we intend to either establish a sales and marketing infrastructure or● · · 1 ▸ We currently rely on certain independent organizations, advisors, and consultants to provide certain services, including strategic, financial,● · · 1 ▸ We depend on intellectual property licensed from third parties and if we breach our obligations under these agreements or if any of these agreements is● · · 1 ▸ group We depend, in part, on our licensors to file, prosecute, maintain,● · · 1 ▸ We do not currently intend to pay dividends on our common stock and, consequently, our● · · 1 ▸ We do not currently own or operate any GMP manufacturing facilities nor do we have any● · · 1 ▸ We expect to continue to expand our development and regulatory capabilities, and as a result, we● · · 1 ▸ We face potential liability related to the privacy of personal information, including health information we utilize in the development of products● · · 1 ▸ group We have devoted a significant portion of our financial resources and● · · 1 ▸ group We have experienced delays in the● · · 1 ▸ group We have experienced rapid growth since our● · · 1 ▸ We have never declared or paid cash dividends on our common stock. We currently intend to retain all available funds and any future earnings to● · · 1 ▸ We have not previously submitted a BLA to the FDA or similar regulatory approval filings to● · · 1 ▸ We have received confidential and proprietary information from third parties. In addition, we employ● · · 1 ▸ group We have relied upon and plan to continue to rely upon third● · · 1 ▸ We intend to initially focus our product candidate development on treatments for various diseases caused by missing or damaged cells. Our● · · 1 ▸ We may be dependent on intellectual property licensed or sublicensed to us from, or for which development was funded or otherwise assisted by,● · · 1 ▸ We may be involved in lawsuits to protect or enforce our patents or other● · · 1 ▸ We may become exposed to costly and damaging liability claims, either when testing our product candidates in● · · 1 ▸ We may not be successful in obtaining or maintaining necessary rights to product components and processes for● · · 1 ▸ We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or● · · 1 ▸ We may not realize the benefits of any collaborative or licensing arrangement, and if we fail to enter into new strategic relationships our business,● · · 1 ▸ We may not realize the benefits of technologies that we have acquired, or will acquire in the future, or other strategic transactions that we have or will consummate.● ● · 2 rw ▸ We or our licensors may have relied on third-party consultants or collaborators or on funds from third parties, such as the U.S. government,● · · 1 ▸ We or the third parties upon whom we depend may be adversely affected by earthquakes or other natural disasters, and our business● · · 1 ▸ We own or license from third parties certain intellectual property rights necessary to develop our product candidates. The growth of our● · · 1 ▸ We rely on our manufacturers to purchase from third-party suppliers the materials necessary to produce our product candidates for our● · · 1 ▸ We rely on third-parties to manufacture our product candidates. Any failure by a third-party manufacturer to produce acceptable raw materials or product● · · 1 ▸ We rely, and expect to continue to rely, on third parties, including independent clinical investigators and CROs, to conduct our preclinical studies and● · · 1 ▸ We use human stem cells in our research and development, including embryonic stem cells (ESCs), and one or more● · · 1 ▸ group We will depend on enrollment and retention of patients in our● · · 1 ▸ group We will require additional funding in order to● · · 1 ▸ Changes in United States and foreign patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.● ● ● 3 rw ▸ If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.● ● ● 3 rw ▸ Market opportunity and market growth for our product candidates may prove to be smaller than we initially estimated, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.● ● ● 3 rw ▸ Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.● ● ● 3 ▸ Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.● ● ● 3 ▸ Our product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.● ● ● 3 rw ▸ group Risks Related to Our Business and Industry● ● ● 3 rw ▸ group Risks Related to Our Dependence on Third Parties● ● ● 3 ▸ group Risks Related to Our Regulatory Environment● ● ● 3 ▸ Risks Related to the Development and Clinical Testing of Our Product Candidates● ● ● 3 ▸ We are exposed to a number of risks related to the supply chain for the materials required to manufacture our product candidates.● ● ● 3 rw ▸ We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties.● ● ● 3 rw ▸ 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.● ● ● 3 rw ▸ We may not be able to protect our intellectual property rights throughout the world.● ● ● 3 ▸ We operate in highly competitive and rapidly changing industries, which may result in others discovering, developing, or commercializing competing products before or more successfully than we do.● ● ● 3 rw 
