8-K

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 20, 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, Suite 2100 Brooklyn, New York	11220
(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)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading symbol	Name of each exchange on which 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 20, 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 Number	Exhibit Description
99.1	Investor Presentation of Brooklyn ImmunoTherapeutics, Inc. dated September 20, 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 20, 2021	By:	/s/ Howard J. Federoff
		Howard J. Federoff
		Chief Executive Officer and President

EX-99.1

Exhibit 99.1

 September 20, 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, 8 and 20 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 uses synthetic mRNA with minimized immune response 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 technologySynthetic 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 with greater expansion allowing more consistent 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.) 

 Brooklyn’s Licensed mRNA-Based and LNP Technologies  5  Cell reprogramming  Gene editing  mRNA and LNP are toolsto make engineered cell medicine    Nucleic acid delivery  mRNA and LNP are the drugas in vivo gene-editing medicine   

 Fields of Medicine Addressable with BTX Technology  6 

 ToRNAdo™ Delivery Offers Superior Results  7  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 clinical testing of cellular products expected within 2 yearsBTX patent portfolio offers range of clinical applications at low cost and low 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  8 

 9  9    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  Some  No  No  N/A  No  mRNA Cell Reprogramming  Yes  N/A  N/A  N/A  N/A  N/A  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  N/A  N/A  N/A  N/A  N/A  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.  

 First Product Tier is a Stem Cell Product Platform   Mesenchymal Stem Cells (MSC)Multipotent stem cells capable of expansion and differentiation into different kinds of tissuesSources of trophic factors modulating the immune system and inducing repair of tissuesProduct development leveraging extensive adult-derived MSC precedentsLong history of clinical use and strong safety track recordInconsistent or insufficient efficacy has plagued field, due product inconsistency or poor choice of clinical indicationWell-described and long-practiced manufacturingMultiple capable CDMO options existA single Drug Product can be used across multiple and varied indicationsExploits homing/migration and anti-inflammatory properties of MSC   10 

 The iPSC Technology Addresses Issues with Adult Sources  11  iPSC-derived MSC advantagesAmenable to more scaled manufacturing due longer proliferative life-spanOne of the easiest iPSC-derived cell products to manufactureMore consistent characteristics and improved therapeutic properties relative to adult sourcesCan gene edit the iPSC to program additional properties into iMSC and broaden therapeutic use 

 First Targeted Clinical Indication for iMSC Products  12  Multiple clinical indications in setting of bone marrow transplant (BMT)Working with world class KOLs in BMT to focus on best clinical population(s) and trial designPreclinical development path elucidated by the iMSC program in ARDS (NoveCite partnership) 

 Developing Gene-edited Versions of iMSC Products Initially Targeting Poorly Addressed Solid Tumors  13  Rationale for gene-edited iMSC in oncologyHarnessing MSC homing to tumors to locally deliver immune stimulating proteinsAddition of specific cytokines counters the pro-tumor effect that sometimes observed (i.e. anti-inflammatory properties of MSC )Rationale for IL-7 and IL-15 (members of IL-2 family)IL-7/IL-15 used in vitro to enhance CAR-T tumor activity in vivo. Unlike IL-2, they will not induce proliferation of TregsLocal delivery to tumor sites should reduce toxicities associated with systemic administrationTargeting solid tumor clinical indications of high unmet need 

 Second Product Tier is a Genetic Medicine Product Platform   Proprietary lipid nanoparticle for nucleic acid deliveryProperties can be tuned to access different cell types and target tissuesCan deliver RNA or DNA; facilitates gene correction approachesDelivery of mRNA encoding for proprietary site-specific nucleaseNuclease can target any gene through design of protein binding domainsHigh specificity to target genomic siteAchieves high level but transient expression of nuclease, enhancing safety  14 

 Developing In Vivo Gene-editing Products Addressing Rare Disease Indications (Orphan Designation)  Direct gene editing in the liver, brain or eye for monogenic disordersAbility to knock-out or correct the target geneInitial gene targets includeTTR for Familial Transthyretin Amyloidosis (ATTR)ABCA4 for Stargardt Disease (monogenic form of macular degeneration)  15  ToRNAdo™ is a trademark of Factor Bioscience Inc. 

 Third Product Tier is a Personalized Cell Therapy Platform   Licensed technology is the safest, most efficient, and fastest method for iPSC derivation Safe: Non-integrating method using synthetic mRNA to produce reprogramming factorsEfficient: Uses LNP for repeated in vitro delivery with low toxicityEfficient: Can combine reprogramming and gene editing in single step derivationFast: Reprogramming and iPSC colony formation within 2 weeksThe safety, reliability and speed enable autologous iPSC programsEfficiency of reprogramming permits low quantity of cells from biopsy and simultaneous correction of gene defects Can quickly produce multiple iPSC clones per patientAbsence of genome integration facilitates screening to identify and characterize a safe clone  16 

 Autologous Cell Therapy Applications of Licensed Technology  Autologous iPSC / Gene-modified autologous iPSC for: Genetic disease (e.g. Sickle cell disease)Infectious disease (e.g. HIV)Other cell therapy indicationsAutologous programs represent opportunities for future BTX expansion or partnering  17 

 BTX Cytokine, Cell Therapy, and Gene Editing Pipeline  18  Indication  Approach  Discovery  Preclinical  IND-enabling  Early clinical  Late clinical  Comments   IRX-2: human cell-derived mixed cytokine                Head & Neck Cancer  SubQ injections            Phase 2b  Various IST  SubQ injections            Phase 1/2   iMSC: iPSC-derived mesenchymal stem cells                ARDS  I.V. injection            NoveCite program  BMT failure  I.V. injection              TBD(inflammation, autoimmunity)   I.V. injection              TBD(inflammation, autoimmunity)   other than I.V.              Solid tumors  Gene-edited(IL-7 + IL-15)               In vivo gene editing                Transthyretin Amyloidosis  I.V. or CNS              Stargardt Disease  Retinal injection                               

 IRX-2 Mixed Cytokine Product Invigorates the Immune Response to Tumors  Multiple cytokines in mixture can act locally and potentially in systemic fashionHuman cell-derived source addresses toxicity observed with other IL-2 cancer therapiesCurrently in Phase 2b for Neoadjuvant Head and Neck Cancer, data readout in 1H-2022  19  Cold tumor  Hot tumor  Cytokine mixture attractsimmune cells 

   BTX Most Advanced Asset: IRX-2 Human-Derived Cytokines   Phase 2 Company Sponsored Study in 1 IST Indication targeted to begin in 2022Phase 3 Study in Neoadjuvant Head and Neck Cancer targeted to begin in 2023  20  Renal Cell CancerLiver CancerHead and Neck CancerGastrointestinal Cancer    Currently in Phase 2b for Neoadjuvant Head and Neck Cancer  Final data readout expected in 1H2022  Additional Investigator Sponsored Trials (ISTs) in:     Future Planned Studies:    Strong IP and Patent Position    Cervical/Vulvar Interstitial NeoplasiaTriple Negative Breast CancerEarly Stage Breast Cancer 

 September 20, 2021  A platform company in cell, gene-editing & cytokine therapies   mRNA Engineered Cell & Cytokine Medicines 

XML

Document and Entity Information	Sep. 20, 2021
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Sep. 20, 2021
Entity Registrant Name	BROOKLYN IMMUNOTHERAPEUTICS, INC.
Entity Incorporation, State or Country Code	DE
Entity File Number	001-11460
Entity Tax Identification Number	31-1103425
Entity Address, Address Line One	140 58th Street, Building A
Entity Address, Address Line Two	Suite 2100
Entity Address, City or Town	Brooklyn
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	11220
City Area Code	212
Local Phone Number	582-1199
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	false
Entity Central Index Key	0000748592
Title of 12(b) Security	Common Stock, par value $0.005 per share
Trading Symbol	BTX
Security Exchange Name	NYSEAMER