▸ Our business could be materially adversely affected by the effects of health pandemics or epidemics in regions where we or third parties on which we rely have concentrations of clinical trial sites or other business operations.· · ● 1 ▸ We are dependent on patents, know-how and proprietary technology, both our own and licensed from others.· · ● 1 ▸ We cannot assure you that the recent reverse stock split will increase our stock price, marketability or our liquidity.· · ● 1 ▸ We have material weakness in our internal control over financial reporting, which could adversely affect our business, financial condition and operating results.· · ● 1 ▸ We will rely on licensed gene editing technology for future cell therapy product candidates.· · ● 1 ▸ A variety of risks associated with conducting research and clinical trials abroad and marketing our therapeutic candidates internationally could materially adversely affect our business.· ● ● 2 ▸ Fluctuations in the cost and availability of raw materials, equipment, labor, and transportation could cause manufacturing delays or increase our costs.· ● ● 2 ▸ Our collection, use, processing, and cross-border transfer of personal information, including individually identifiable health information, is governed by restrictive regulations.· ● ● 2 ▸ Our organizational changes and cost cutting measures may not be successful.· ● ● 2 rw ▸ We may experience difficulties in managing the growth of our business.· ● ● 2 ▸ We may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our therapeutic candidates are safe and effective for any of their proposed indications;· ● · 1 ▸ Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations and prospects.● ● · 2 ▸ We rely on CAR-T viral vectors from Sorrento Therapeutics, Inc. for our CYCART-19 therapeutic candidate and termination of this license, or any future licenses, could result in the loss of significant rights, which would harm our business.● ● · 2 ▸ We will need to continue to grow the size of our organization, and we may experience difficulties in managing this growth.● · · 1 ▸ Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors, which may adversely affect our future profitability.● ● ● 3 ▸ Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.● ● ● 3 ▸ Cell-based therapies rely on the availability of specialty raw materials, which may not be available to us on acceptable terms or at all.● ● ● 3 ▸ Changes in patent law, including recent patent reform legislation, could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.● ● ● 3 ▸ Changes in tax law could adversely affect our business and financial condition.● ● ● 3 ▸ Clinical trials are expensive, time-consuming and difficult to design and implement.● ● ● 3 ▸ Confidentiality agreements with employees and third parties may not prevent unauthorized disclosure of trade secrets and other proprietary information.● ● ● 3 ▸ Coverage and reimbursement may be limited or unavailable in certain market segments for our therapeutic candidates, which could make it difficult for us to sell our cell therapies, if approved, profitably.● ● ● 3 ▸ Even if we obtain regulatory approval of our therapeutic candidates, the cell therapies may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community.● ● ● 3 ▸ If our efforts to protect the proprietary nature of the intellectual property related to our technologies is not adequate, we may not be able to compete effectively in our market.● ● ● 3 ▸ If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our therapeutic candidates.● ● ● 3 rw ▸ If we do not obtain and maintain federal and state licenses and registrations required for our current and future operations, our ability to generate revenue will be limited.● ● ● 3 ▸ If we fail to develop additional therapeutic candidates, our commercial opportunity will be limited.● ● ● 3 ▸ If we or third party suppliers acting on our behalf use hazardous, non-hazardous, biological or other materials in a manner that causes injury or violates applicable law, we may be liable for damages.● ● ● 3 ▸ Intellectual property rights do not necessarily address all potential threats to our competitive advantage.● ● ● 3 ▸ Monitoring and managing toxicities in patients receiving therapeutic candidates is challenging, which could adversely affect our ability to obtain regulatory approval and commercialize our therapeutic candidates.● ● ● 3 ▸ Obtaining and maintaining regulatory approval of our therapeutic candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our therapeutic candidates in other jurisdictions.● ● ● 3 ▸ Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.● ● ● 3 ▸ Our clinical trials may fail to demonstrate the safety and efficacy of any of our therapeutic candidates, which would prevent or delay regulatory approval and commercialization.● ● ● 3 ▸ Our historical operating results indicate substantial doubt exists related to our ability to continue as a going concern.● ● ● 3 rw ▸ Our internal computer systems, or those used by our CROs, collaborators or other contractors or consultants, may fail or suffer security breaches.● ● ● 3 ▸ Our placental-derived cellular therapy candidates represent a novel approach to cancer, infectious and degenerative disease treatments that creates significant challenges.● ● ● 3 ▸ Our therapeutic candidates are based on novel technologies, which makes it difficult to predict the time and cost of therapeutic candidate development and obtaining regulatory approval.● ● ● 3 ▸ Our therapeutic candidates may cause undesirable side effects or have other properties that could halt our clinical development, prevent our regulatory approval, limit our commercial potential or result in significant negative consequences.● ● ● 3 ▸ group Risks Related to Business and Industry● ● ● 3 ▸ group Risks Related to Government Regulation● ● ● 3 ▸ group Risks Related to Our Intellectual Property● ● ● 3 ▸ group Risks Related to Our Reliance on Third Parties● ● ● 3 ▸ group Risks Related to Ownership of Our Class A Common Stock● ● ● 3 ▸ The FDA may disagree with our future regulatory plans and we may fail to obtain regulatory approval of our cell therapeutic candidates.● ● ● 3 rw ▸ The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our future therapeutic candidates.● ● ● 3 rw ▸ The advancement of healthcare reform may negatively impact our ability to sell our therapeutic candidates, if approved, profitably.● ● ● 3 rw ▸ The distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing, storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products.● ● ● 3 ▸ The gene-editing technology we use is relatively new, and if we are unable to use this technology in our intended therapeutic candidates, our revenue opportunities will be materially limited.● ● ● 3 ▸ The lives of our patents may not be sufficient to effectively protect our products and business.● ● ● 3 ▸ The market price of our securities may be volatile, which could cause the value of an investment to decline.● ● ● 3 ▸ There may not be an active trading market for our securities, which may make it difficult to sell shares of Class A common stock.● ● ● 3 ▸ These and other risks associated with our international operations may materially adversely affect our ability to attain or maintain profitable operations.● ● ● 3 rw ▸ Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts and our ability to commercialize our therapeutic candidates.● ● ● 3 ▸ This provision would not apply to suits brought to enforce a duty or liability created by the Exchange Act or any other claim for which the U.S. federal courts have exclusive jurisdiction.● ● ● 3 ▸ To the extent our Biovance and Interfyl products do not qualify for regulation as HCT/P solely under Section 361 of the PHSA, this could result in removal of these products from the market.● ● ● 3 ▸ Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.● ● ● 3 ▸ We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.● ● ● 3 ▸ We do not intend to pay cash dividends for the foreseeable future.● ● ● 3 ▸ We expect the cell therapy therapeutic candidates we develop will be regulated as biological products, or biologics, and they may be subject to competition sooner than anticipated.● ● ● 3 rw ▸ We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.● ● ● 3 ▸ We have incurred net losses in every period since our inception, have no cellular therapeutics approved for commercial sale and anticipate that we will incur substantial net losses in the future.● ● ● 3 rw ▸ We may be involved in lawsuits or other legal proceedings to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.● ● ● 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 encounter substantial delays in our clinical trials or may not be able to conduct our trials on the timelines we expect.● ● ● 3 ▸ We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.● ● ● 3 ▸ We may not be able to protect our intellectual property rights throughout the world.● ● ● 3 ▸ We may not be able to submit INDs to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit such trials to proceed.● ● ● 3 ▸ We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.● ● ● 3 ▸ We may not elect or be able to take advantage of any expedited development or regulatory review and approval processes available to therapeutic candidates granted breakthrough therapy or fast track designation by the FDA.● ● ● 3 ▸ We may not realize the benefits of acquired assets or other strategic transactions.● ● ● 3 ▸ We or our licensors may be subject to claims challenging the inventorship of our patents and other intellectual property.● ● ● 3