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What changed 10-Q

Item 1A. Risk Factors

2021-08-13 compared with 2021-05-17 · 57 added, 76 removed, 4 unchanged (97% of the section changed)

2 unchanged sentences

You should consider carefully the risks and uncertainties

described 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 stock.

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.

Incorporated By Reference

Restated Certificate of Incorporation

Exhibit to Form 10-Q filed on August 14, 2013

Certificate of Amendment to the Restated Certificate of Incorporation (reverse/forward split)

Exhibit to Form 8-K filed on June 17, 2016

Certificate of Decrease of the Series A Convertible Preferred Stock

Exhibit to Form 8-K filed on April 12, 2017

Certificate of Amendment to the Restated Certificate of Incorporation (decrease in authorized capital stock)

Exhibit to Form 8-K filed on June 9, 2017

Certificate of Amendment to Restated Certificate of Amendment, dated March 25, 2021 (Reverse Stock Split)

Exhibit to Form 8-K filed on March 31, 2021

Certificate of Amendment to Restated Certificate of Amendment, dated March 25, 2021 (Authorized Share Increase)

Exhibit to Form 8-K filed on March 31, 2021

Certificate of Amendment to Restated Certificate of Amendment, dated March 25, 2021 (Name Change)

Exhibit to Form 8-K filed on March 31, 2021

Amended and Restated Bylaws

Exhibit to Form 8-K filed on March 31, 2021

Amended and Restated Royalty Agreement and Distribution Agreement, dated March 22, 2021

Exhibit to Form 8-K filed on March 31, 2021

Brooklyn ImmunoTherapeutics, Inc.

2020 Stock Incentive Plan

Exhibit to Form 8-K filed on March 31, 2021

Assignment and Assumption of Employment Agreement dated March 30, 2021 among Brooklyn ImmunoTherapeutics, LLC, Brooklyn ImmunoTherapeutics, Inc.

and Ronald Guido

Exhibit to Form 8-K filed on March 31, 2021

Assignment and Assumption of Employment Agreement dated March 30, 2021 among Brooklyn ImmunoTherapeutics, LLC, Brooklyn ImmunoTherapeutics, Inc.

and Lynn Sadowski Mason

Exhibit to Form 8-K filed on March 31, 2021

Executive Employment Agreement, dated as of April 1, 2021 and effective as of April 16, 2021, between Brooklyn ImmunoTherapeutics, Inc.

and Howard J.

Exhibit to Form 8-K filed on April 7, 2021

Form of Indemnification Agreement

Exhibit to Form 8-K filed on April 16, 2021

Schedule identifying agreements substantially identical to the form of indemnification agreement filed as Exhibit 10.6

Exhibit to Form 8-K filed on May 11, 2021

Purchase Agreement, dates as of April 26, 2021, between Brooklyn ImmunoTherapeutics, Inc.

and Lincoln Park Capital Fund, LLC

Exhibit to Form 8-K filed on April 30, 2021

Registration Rights Agreement, dated as of April 26, 2021, between Brooklyn ImmunoTherapeutics, Inc.

and Lincoln Park Capital Fund, LLC

Exhibit to Form 8-K filed on April 30, 2021

Exclusive License Agreement, dated as of April 26, 2021, between Factor Bioscience Limited, Novellus Therapeutics Limited and Brooklyn ImmunoTherapeutics LLC

Exhibit to Form 8-K filed on April 30, 2021

Certification of Principal Executive and Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

Filed herewith

Certification of Principal Executive Officer and Financial pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Furnished herewith

XBRL Instance Document

Filed herewith

XBRL Taxonomy Extension Schema Document

Filed herewith

XBRL Taxonomy Extension Calculation Linkbase Document

Filed herewith

XBRL Taxonomy Extension Definition Linkbase Document

Filed herewith

XBRL Taxonomy Extension Label Linkbase Document

Filed herewith

Certain information redacted and replaced with “[***]”.

Indicates management contract or compensatory plan.

Certain addenda have been omitted pursuant to Item 601(a)(5) of Regulation S-K.

We hereby undertake to furnish copies of the omitted addenda upon request by the Securities and Exchange Commission, provided

that we may request confidential treatment pursuant to Rule 24b‑2 of the Securities Exchange Act of 1934 for the addenda so furnished.

Certain exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K.

A copy of any omitted exhibit will be furnished to the Securities and Exchange Commission or its staff upon request.

This certification is being furnished solely to accompany this report pursuant to U.S.C.

§ 1350, and it is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and is not to be incorporated herein by

reference into any filing of the registrant whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the

undersigned hereunto duly authorized.

BROOKLYN IMMUNOTHERAPEUTICS, INC.

/s/ Howard J.

Chief Executive Officer and President

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.

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.