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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
13, 2023
ADITXT,
INC.
(Exact name of registrant as specified in its charter)
Delaware |
|
001-39336 |
|
82-3204328 |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
737 N. Fifth Street, Suite 200 Richmond, VA |
|
23219 |
(Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number, including
area code: (650) 870-1200
N/A
(Former name or former address, if changed since
last report)
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 (see General
Instruction A.2. below):
| ☐ | 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(s) |
|
Name of each exchange on which registered |
Common Stock, par value $0.001 |
|
ADTX |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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.
Aditxt,
Inc. (the “Company”) has prepared presentation materials (the “Presentation Materials”) that management intends
to use from time to time in presentations about the Company’s operations and performance, including during the Company’s presentation
at the H.C. Wainwright 25th Annual Global Investment Conference on September 13, 2023. The Presentation Materials are
furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The
information in this Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K is furnished and shall not be deemed to be “filed”
for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject
to the liabilities of that section. The information in this Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K shall not be
incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after
the date of this Current Report, regardless of any general incorporation language in any such filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
Exhibit No. |
|
Exhibit |
99.1 |
|
Investor Presentation |
104 |
|
Cover Page Interactive Data File (embedded within the XBRL document) |
SIGNATURES
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.
|
ADITXT, INC. |
|
|
|
Date: September 13, 2023 |
By: |
/s/ Amro Albanna |
|
|
Amro Albanna |
|
|
Chief Executive Officer |
2
Exhibit 99.1
ADITXT (NASDAQ: ADTX) MAKING PROMISING INNOVATIONS POSSIBLE, TOGETHER…
This presentation contains forward - looking statements that are subject to many risk and uncertainties. Forward - looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned product development; our intellectual property position; our ability to develop commercial functions; expectations regarding project launch and revenue; our results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which we operate; and the trends that may affect the industry or us. Although we believe we have a reasonable basis for each forward - looking statement, we caution you that forward looking statements are not guarantees of future performance. ADTX | Aditxt.com | Innovation in monitoring and treatment of the immune system 2 Actual results may differ materially from those indicated by these forward - looking statements as a result of various important factors, as well as those risks more fully discussed in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10 - K for the year ended December 31, 2021, that was filed with the U.S. Securities and Exchange Commission on March 25, 2021 as well as discussions of potential risk, uncertainties, and other important factors in the Company’s subsequent filings with the U.S. Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward - looking statements, whether as a result of new information, future events or otherwise. This Presentation includes certain projections and forward - looking statements provided by the Company, including with respect to the anticipated future performance of the Company, and our ability to develop and commercialize products and obtain regulatory approvals. Such projections and forward - looking statements reflect various assumptions of management, and are subject to significant business, regulatory, economic and competitive uncertainties and contingencies, many of which are beyond the control of the Company. Accordingly, there can be no assurance that such projections or forward - looking statements will be realized. Actual results may vary from anticipated results and such variations may be material. Therefore, you should not rely on any of these projections or forward - looking statements. Important factors that could cause our actual results to differ materially from those indicated in the projections or forward - looking statements include, among others: (i) risks associated with the regulatory approval process; (ii) our ability to enter strategic relationships for development or commercialization of our products; (iii) patents may not issue from our patent applications, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; (iv) our ability to obtain sufficient financing; and (v) our ability to consummate on terms that are favorable to us or at all any potential strategic transactions. Any projection or forward - looking statement made by us in this Presentation is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any projection or forward - looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Safe Harbor Statement & Disclaimers
3 ADTX | A ditxt.com | Innovation in monitoring and treatment of the immune system Focus on Innovations in the Field of Precision Medicine Precision Monitoring • Lab Tests • Personalized screenings and recommendations • Point of Care • At - home monitoring • A.I. • Targeted therapeutics, technologies and treatments Precision Prevention and Treatment • Immune Tolerance • Antivirals • Immune Modulators • Nutraceuticals • Supplements • Regenerative Medicine • Stem Cells Applications • Autoimmune • Organ Transplantation • Oncology • Infectious Diseases • Central Nervous System • Dermatology
OUR 3D APPROACH • IP • Early to late - stage companies Discover • Innovation • Operation • Commercialization • Corporation Develop • IPO • M&A Deploy
ADVANTAGES D IVERSIFIED E FFICIENT L IQUID T RANSPARENT Growing diversified portfolio of innovative subsidiaries Shared innovation, operational, commercialization, and corporate resources to support all subsidiaries Approximately $4B traded to date Fully SEC reporting and NASDAQ listed Access to breakthrough innovations developed by leading institutions and corporations A CCESS Scalable business infrastructure to support exponential growth S CALABLE
Amro Albanna Co - founder, CEO, and Chairman Dr. Shahrokh Shabahang Co - founder, Chief Innovation Officer, Board Member Rowena Albanna Chief Operations Officer Corinne Pankovcin Chief Commercialization Officer Thomas Farley Chief Financial Officer Jennifer Lee Chief People Officer Maureen Connolly Chief Content and Engagement Officer Silicon Valley, CA - New York, NY - Richmond, VA – Berlin, Germany – Dubai, UAE - Milan, Italy | | | | | | | | | Investment Bank Securities Counsel Exchange M&A Counsel
CURRENT PROGRAMS AND OPPORTUNITIES PRECISION PREVENTION/TREATMENT Immune Modulation Therapeutic COLLABORATORS Pearsanta PRECISION MONITORING Immunological Monitoring
REAL TIME, RAPID TEST, LAB - QUALITY SCREENING & MONITORING » Launch of Test2Treat.me Platform in major markets » Revenue growth organically and via M&A MARKET 2024 MILESTONE PROGRAM HIGHLIGHTS » Established CLIA/CAP Immune Monitoring Center in Richmond, VA » Medicare reimbursed » Initiated operations and became revenue - generating » FedEx signs as key logistics partner Test2Treat.me Lab tests are used in more than: 14 billion lab tests ordered in the U.S. every year ( CDC ). 70 % of medical diagnoses The projected value of global clinical direct - to - consumer (DTC) and point - of - care (POC) by 2030 testing markets combined are estimated to hit $ 429B Which test do you have? SHOP
PRECISION THERAPEUTICS ADDRESSING ORGAN REJECTION, AUTOIMMUNITY, CENTRAL NERVOUS SYSTEM DISORDERS, AND ALLERGIES 02 MARKET » Mayo Clinic Human trial initial results » Psoriasis human trial in Germany » T1D human trial » ADI - 100 restores immune tolerance in an antigen - specific manner without impairment of immune response » 2024 MILESTONE » PROGRAM HIGHLIGHTS » 100+ issued patents » Drug substance manufacturing completed » Signed a clinical trial agreement with Mayo Clinic to test ADI - 100 in patients with Stiff - Person Syndrome » ADI - 100 prevented checkpoint - inhibitor - induced T1D in animal models without diminishing effectiveness in reducing cancer tumor size
2024 ANTICIPATED MILESTONES Adimune • Sales channels expansion • Offerings expansion • 2 - 4 Clinical Trials (Psoriasis, SPS, T1D, Skin Allograft Pearsanta
Silicon Valley, CA - New York, NY - Richmond, VA – Berlin, Germany – Dubai, UAE - Milan, Italy | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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