8-K
Ernexa Therapeutics Inc. (ERNA)
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,<br> Suite 2100<br><br> <br>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<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 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<br><br> <br>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 |
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