8-K - ERNA - Equibles

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 9, 2021

BROOKLYN IMMUNOTHERAPEUTICS, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware	001-11460	31-1103425
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)
140 58th Street, Building A,<br> Suite 2100<br><br> <br>Brooklyn, New York	11220
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(Address of Principal Executive Offices)	(Zip Code)

Registrant’s telephone number, including area code: (212) 582-1199

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading symbol	Name of each exchange on which<br><br> <br>registered
Common Stock, par value $0.005 per share	BTX	NYSE American

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934:

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01	Regulation FD Disclosure.

On September 9, 2021, we are posting an investor presentation to our website (https://www.brooklynitx.com). A copy of this investor presentation is furnished as Exhibit 99.1 to this Current Report on Form 8‑K and is incorporated herein by reference.

The information contained herein, including the exhibit furnished hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except as expressly set forth by specific reference in such filing.

Item 9.01	Financial Statements and Exhibits.
Exhibit<br><br> <br>Number	Exhibit Description
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99.1	Investor Presentation of Brooklyn ImmunoTherapeutics, Inc. dated September 9, 2021
104	Cover Page Interactive Data File (embedded within the XBRL document)

SIGNATURE

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.
Dated: September 9, 2021	By:	/s/ Howard J. Federoff
		Howard J. Federoff
		Chief Executive Officer and President

Exhibit 99.1

September 2021 mRNA Engineered Cell & Cytokine Medicines A platform company in cell, gene-editing & cytokine therapies

Disclaimer This presentation is intended to provide summary information about the business of Brooklyn ImmunoTherapeutics, Inc. (“BTX”). The information in this presentation is in no respects complete, comprehensive or exhaustive, and it should be read in conjunction with BTX’s public filings with the Securities and Exchange Commission, including information set forth in those filings under “Risk Factors” and similar headings. ‎Forward-Looking Statements. Certain statements presented below on pages 3, 4, 7 and 8 are forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are any statements that are not statements of historical fact and may be identified by terminology such as “expect,” “plan,” “potential,” “project” or “will” or other similar words. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results may vary significantly from BTX’s expectations based on a number of risks and uncertainties, including but not limited to the following: (i) the evolution of BTX’s business model into a platform company focused on cellular, gene editing and cytokine programs; (ii) BTX’s ability to successfully, cost effectively and efficiently develop its technology and products; (iii) BTX’s ability to successfully commence clinical trials of any products on a timely basis or at all; (iv) BTX’s ability to successfully fund and manage the growth of its development activities; (v) BTX’s ability to obtain regulatory approvals of its products for commercialization; and (vi) uncertainties related to the impact of the COVID-19 pandemic on the business and financial condition of BTX, including on the timing and cost of its clinical trials. BTX cannot guarantee any future results, levels of activity, performance or achievements. The industry in which BTX operates is subject to a high degree of uncertainty and risk due to variety of factors, including those described in BTX’s public filings with the Securities and Exchange Commission, including its Current Report on Form 8-K filed with the Securities and Exchange Commission on May 11, 2021 and its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021 for a more complete discussion of these factors and other risks, particularly under the heading “Risk Factors.” BTX expressly disclaims any obligation to update forward-looking statements after the date of this presentation. 2

BTX: World’s Only mRNA Cell-Engineering Platform What is mRNA cell-engineering? Messenger RNA (“mRNA”) is a special class of molecules that contain the instructions that determine how cells function. BTX’s platform is being designed to harness mRNA to engineer cells to treat disease by repairing disease-causing mutations and directing the formation of stem cells.BTX is developing a platform of gene-editing and cell therapies based on exclusively in-licensed mRNA technologyEngineered mRNA allows gene editing without provoking an immune responsemRNA therapeutics are safe and highly effective in patientsFast to market – mRNA products have proven accelerated entry into clinical development Low cost of goods sold – mRNA products avoid complex and costly viral-vector manufacturingCan target any geneNo limit to the number or complexity of cellular modifications that can be madeEnables high-potency mRNA and precision cell therapiesEngineered cells are fully rejuvenated allowing longer-lasting treatments BTX’s in-licensed vehicle safely delivers mRNA to cells inside and outside the body 3

BTX: Leveraging In-licensed Patent Portfolio to Advance Medicine BTX has an exclusive license from Factor Bioscience to a portfolio of granted patents around mRNA-based cell engineering that will provide BTX with a competitive advantageBTX’s major platform components:mRNA Cell Reprogramming (25 patents, extensive cellular data)mRNA Gene Editing (15 patents, extensive cellular data)NoveSlice™ Gene-Editing Protein (15 patents, extensive cellular data)ToRNAdo™ mRNA Delivery Vehicle (4 patents, extensive cell and animal data) 4 NoveSlice and ToRNAdo are trademarks of Factor Bioscience Limited. 2022 2023 Reverse Merger with NTN Buzztime (NYSE American: BTX) 2021 Established R&D Center in Cambridge, MA In-Licensed mRNA Patents Acquired Novellus Therapeutics IND-Enabling Pre-Clinical Studies IND – Indication 1 (est.)

Fields of Medicine Addressable with BTX Technology 5

ToRNAdo™ Delivery Offers Superior Results 6 Vector toxicity

An Investment in BTX Today Offers Future Value Breadth and depth of BTX technology offer numerous opportunities for successful clinical resultsBTX in-licensed patent portfolio offers potential for licensing and royalty revenue in coming yearsBTX technology platform offers predictable path to clinical development, with initial cellular products expected within 2 yearsBTX patent portfolio offers range of clinical applications at lower cost and lower riskBTX legacy cytokine portfolio and completed Phase 2b trial offer additional valueOpportunity for partnering in the Ph3 registration studyOpportunity for advancing another Ph2 study in a different oncologic indication 7

8 8 BTX CRISPR1 TALENs2 Zinc-Finger Nucleases3 mRNA Vaccines4 CAR-T5 Primary Technologies mRNA Cell ReprogrammingmRNA Gene EditingNoveSlice™ToRNAdo™ CRISPR(including base-editing) TALENs Zinc-Finger Nucleases None Viral Vectors for CAR-T mRNA Gene Editing Yes No No No No No mRNA Cell Reprogramming Yes No No No No No mRNA Delivery Yes Electroporation (limited to ex-vivo) Electroporation (limited to ex-vivo) Electroporation (limited to ex-vivo) Vaccines N/A High Off-Target Effects No Yes(short gRNA recognition sequence) Yes(based on plant-pathogen sequences) Yes(requires extensive screening) N/A N/A Immune response No Yes(bacterial protein) Possible(plant- pathogen sequences) Possible Yes(desired for vaccines) N/A On-Target Efficiency High Medium Medium Medium N/A N/A Cell Rejuvenation Yes No No No No No BTX Technology: Competitive Landscape Example Companies: 1 Beam Therapeutics, CRISPR Therapeutics, Editas Medicine, Intellia Therapeutics. 2 Allogene Therapeutics, Cellectis, Iovance Biotherapeutics. 3 Sangamo Therapeutics. 4 BioNTech, Moderna. 5 Juno Therapeutics, Kite.

September 2021 A platform company in cell, gene-editing & cytokine therapies mRNA Engineered Cell & Cytokine Medicines