What changed in this filing

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Item 1A. Risk Factors

2021-11-12 compared with 2021-08-13 · 44 added, 58 removed, 3 unchanged (97% of the section changed)

2 unchanged sentences

You should consider carefully the risks and uncertainties

described below and in the “Risk Factors” section of our Current Report on Form 8-K filed with the SEC on May 11, 2021, together with all other information contained or incorporated by reference in this report, before you invest in common

If any of the risks described in this report or in such Current Report occur, our business, financial condition, results of operations and future growth prospects could be materially and adversely affected.

Under these circumstances, the

trading price of common stock could decline, and you may lose all or part of your investment.

Because our gene-editing and cell therapy product candidates are based on novel technologies, we cannot

assure you that we will be successful, or predict the related cost and time we will spend, in initiating, conducting and completing clinical development, and obtaining the necessary regulatory and reimbursement approvals, required for

commercialization.

Cell programming technology and platform for generating cell therapy products using allogenic MSCs derived from iPSCs

represent novel therapeutic approaches, and to our knowledge no iPSC-derived cell products are currently approved for commercial sale anywhere in the world.

As such, it is difficult to accurately predict the type and scope of challenges that we

will incur during development of our respective product candidates, and we thus face uncertainties associated with the preclinical and clinical development, manufacture, and regulatory compliance for the initiation and conduct of clinical

trials, regulatory approval, and reimbursement required for successful commercialization of product candidates.

In addition, because the iPSC-derived cell product candidates are in the pre-clinical stage, no human data are yet available to

assess the long-term effects of treatment.

Animal models and assays may not accurately predict the safety and efficacy of our product candidate in our target patient populations, and appropriate models and assays may not exist for demonstrating

the safety and purity of the product candidates, as required by the FDA and other regulatory authorities for ongoing clinical development and regulatory approval.

The pre-clinical and clinical development, manufacture, and regulatory requirements for approval of the product candidates

may be more expensive and take longer than for other more well-known or extensively studied pharmaceutical or biopharmaceutical product candidates due to a lack of prior experiences on the side of both developers and regulatory agencies.

Additionally, due to the uncertainties associated with the pre-clinical and clinical development, manufacture, and regulatory requirements for approval of the product candidates, we may be required to modify or change pre-clinical and clinical

development plans or manufacturing activities and plans, or be required to meet stricter regulatory requirements for approval.

Any such modifications or changes could delay or prevent our ability to develop, manufacture, obtain regulatory

approval or commercialize the product candidates, which would adversely affect our business, financial condition and results of operations.

Cellular immunotherapies, and stem cell therapies and iPSC-derived cell therapies in particular, represent relatively new

therapeutic areas, and the FDA has cautioned consumers about potential safety risks associated with cell therapies.

To date, there are relatively few approved cell therapies.

As a result, the regulatory approval process for a gene-editing or

cellular therapy product candidate is uncertain and may be more expensive and take longer than the approval process for product candidates based on other, better known or more extensively studied technologies and therapeutic approaches.

example, there are currently no FDA approved products with a label designation that supports the use of a product to treat and reduce the severity of ARDS in patients with COVID-19, which makes it difficult to determine the clinical endpoints

and data required to support an application or regulatory approval, and the time and cost required to obtain regulatory approval in the United States for our product candidate.

Regulatory requirements in the United States governing cell therapy products have changed frequently and the FDA or other

regulatory bodies may change the requirements, or identify different regulatory pathways, for approval of the product candidates.

For example, within the FDA, the Center for Biologics Evaluation and Research, or CBER, restructured and created a

new Office of Tissues and Advanced Therapies to better align its oversight activities with FDA Centers for Drugs and Medical Devices.

It is possible that over time new or different divisions may be established or be granted the responsibility

for regulating cell and/or gene therapy products, including iPSC-derived cell products.

As a result, we may be required to change its regulatory strategy or to modify its applications for regulatory approval, which could delay and impair its

ability to complete the pre-clinical and clinical development and manufacture of, and obtain regulatory approval for, our product candidates.

Changes in regulatory authorities and advisory groups, or any new requirements or guidelines they

promulgate, may lengthen the regulatory review process, require us to perform additional studies, increase its development and manufacturing costs, lead to changes in regulatory pathways, positions and interpretations, delay or prevent approval

and commercialization of the product candidates or lead to significant post-approval limitations or restrictions.

As we advance our product candidates, we will be required to consult with the FDA and other regulatory authorities, and our

product candidates will likely be reviewed by an FDA advisory committee.

We also must comply with applicable requirements, and if we fail to do so, we may be required to delay or discontinue development of our product candidates.

unexpected costs in obtaining, or the failure to obtain, the regulatory approval necessary to bring the product candidates to market could impair our ability to generate sufficient product revenues to maintain our respective businesses.

We own only a 25% interest in NoveCite, Inc., and that interest may be diluted unless we invest

additional funds.

In July 2021, we acquired 25% of the outstanding common stock of NoveCite, Inc.

As a result, we will only be entitled to a

portion of any benefits that flow from the development by NoveCite, Inc.

of any product candidates.

In the event that NoveCite, Inc.

issues additional equity securities in the future, our percentage ownership would be diluted unless we were to

invest additional funds.

Dilution of our equity ownership would decrease our portion of any benefit that might be derived from a NoveCite, Inc.

drug candidate’s successful development.

If we were to determine that it would be in the best

interests of our company and stockholders to invest additional amounts in NoveCite, Inc.

to prevent dilution of our interests, the required funds may not be available to us on reasonable terms, or at all.

described below and in the “Risk Factors” section of our Current Report on Form 8-K filed with the SEC on May 11, 2021, and our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021, filed with the SEC on August 13, 2021,

together with all other information contained or incorporated by reference in this report.

If any of the risks described in this report or in such Current Report or Quarterly Report occur, our business, financial condition, results of operations

and future growth prospects could be materially and adversely affected.

Under these circumstances, the trading price of common stock could decline, and you may lose all or part of your investment.

We can provide no assurance that claims will not be made to challenge the validity of the ratification

of the filing and effectiveness of the certificate of amendment to our restated certificate of incorporation filed with the Secretary of State of the State of Delaware on March 25, 2021 with respect to the increase in the number of authorized

shares of common stock pursuant to Section 204 of the Delaware General Corporation Law.

On September 3, 2021, our stockholders a pproved the

ratification, which we refer to as the Share Increase Ratification, of the amendment to our restated certificate of incorporation filed with the Secretary of State of the State of Delaware on March 25, 2021, which effected an increase

in the number of authorized shares of common stock by 85,000,000, from 15,000,000 shares to 100,000,000 shares, and which we refer to as the Share Increase Amendment.

We subsequently filed a certificate of validation with respect to the Share

Increase Amendment with the Secretary of State of the State of Delaware, which we refer to as the Certificate of Validation, on September 3, 2021.

Even though we filed the Certificate of Validation, any claim that (i) the

increase in the number of authorized shares of common stock and related issuance of such shares ratified pursuant to the Share Increase Ratification is void or voidable due to a failure of authorization, or (ii) the Delaware Court of Chancery

should declare in its discretion that the Share Increase Ratification not be effective or be effective only on certain conditions, which we refer to collectively as the Subsequent Claims, may still be brought within 120 days from the time that

the filing of the Certificate of Validation with the Secretary of State of the State of Delaware becomes effective in accordance with the DGCL.

We can provide no assurance that Subsequent Claims will not be made within the available time period for making such claims

or what the resolution of such Subsequent Claims would be.

If Subsequent Claims are made, it could have a material adverse effect on our liquidity, which could result in our filing for bankruptcy or an involuntary petition for bankruptcy being

filed against us.

We may not generate the expected benefits of the Acquisition and the Acquisition could disrupt our ongoing

business, distract our management and increase our expenses.

We entered into the Acquisition Agreement to acquire all of the outstanding equity interests of Novellus, Inc.

and Novellus,

Ltd., which we collectively refer to as Novellus, with the expectation that the Acquisition will result in various benefits, including accelerating our research and development efforts in the gene editing and mRNA spaces.

Achieving the anticipated

benefits of the Acquisition is subject to a number of uncertainties, including whether our business and the business of Novellus can be integrated in an efficient and effective manner.

We cannot assure you that we will be able to accurately

forecast the performance or ultimate impact of the Acquisition.

It is possible that the integration process following the Acquisition could take longer than anticipated and could result in

unforeseen expenses, the disruption of our ongoing business, processes and systems, or inconsistencies in standards, controls, procedures, practices, policies and compensation arrangements, any of which could adversely affect our ability to achieve

the anticipated benefits of the Acquisition.

There may be increased risk due to integrating financial reporting and internal control systems.

The integration process is subject to a number of uncertainties, and no assurance can be given that the

anticipated benefits, expense savings and synergies of the Acquisition will be realized or, if realized, the timing of their realization.

Failure to achieve these anticipated benefits could result in increased costs or decreases in the amount of

expected revenues and could adversely affect our future business, financial condition, operating results and prospects.

We have incurred and will continue to incur non-recurring expenses in connection with the Acquisition, including legal,

accounting and other expenses.

Additional unanticipated costs may be incurred following consummation of the Acquisition in the course of the integration of the business of Novellus into our business.

We cannot be certain that the realization of

efficiencies related to the integration of Novellus will offset in the near term, or at all, the transaction and integration costs of the Acquisition and any losses from undiscovered liabilities not covered by indemnification provisions from the

sellers of Novellus under the Acquisition Agreement or otherwise.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1A. Risk Factors