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): March 19, 2021

 

Aditx Therapeutics, 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.)

 

2569 Wyandotte St., Suite 101

Mountain View, CA

  94043
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (909) 488-0844

 

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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

Appointment of Principal Accounting Officer

 

On March 19, 2021, the board of directors of Aditx Therapeutics, Inc. (the “Company”) appointed Thomas J. Farley as Principal Accounting Officer of the Company. Mr. Farley currently serves as the Controller of the Company.

 

Set forth below is the biographical information of Mr. Farley, age 47, as required by Item 401 of Regulation S-K.

 

Since October 2020, Mr. Farley has been the Controller on the Company. From December 2015 to April 2020, Mr. Farley was the Senior Controller and Treasurer of Business Development Corporation of America (“BDCA”), a business development company. Prior thereto, from January 2011 to August 2015, Mr. Farley was the Senior Controller of Blackrock Capital Investment Corporation (NASDAQ: BKCC). Prior to joining BlackRock, Mr. Farley was a Senior Controller for PineBridge Investments. Mr. Farley began his career with PricewaterhouseCoopers LLP, from 1991 to 2001. Mr. Farley earned his B.S. in Accounting from Long Island University. He is a Certified Public Accountant.

 

Item 7.01 Regulation FD Disclosure.

 

Attached as Exhibit 99.1 to this Current Report on Form 8-K is an updated version of the Company’s investor presentation, which may be used in presentations to investors from time to time in the future.

 

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

 

Exhibits

 

Exhibit No.   Description
99.1   Investor Presentation

 

-1-

 

 

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.

 

  ADITX THERAPEUTICS, INC.
     
Date: March 24, 2021 By: /s/ Corinne Pankovcin
    Corinne Pankovcin
    Chief Financial Officer

 

 

-2-

 

Exhibit 99.1

 

Aditxt Corporate Overview NASDAQ: ADTX March, 2021 1

 

 

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. 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 prospectus, dated June 29, 2020, that was filed with the U.S. Securities and Exchange Commission under File No. 333 - 235933, 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. SAFE HARBOR DISCLAIMER

 

 

Highlights A unique strategic combination of therapeutics and healthTech Two key milestones in 2021 Attractive valuation NASDAQ: ADTX - Mkt. Cap.: Approx. $44M ( as of 03/23/2021)

 

 

 

 

Silicon Valley, CA Hub of discovery and product development Richmond, VA CLIA - certified Ad i t x tS c o r e Πoperation New York City, NY Hub of capital markets, investor and media relations, and business development STRATEGICALLY LOCATED

 

 

AditxtReprogramming tm

 

 

AditxtReprogramming Œ Immune reprogramming (immune tolerance) therapies reprogram the immune system so that disease - causing immune responses are stopped while maintaining the immune system’s ability to combat pathogenic infection. Tolerance is achievable as demonstrated clinically via chimerism and cell - based therapy but there is a need for more practical and cost - effective approaches which: x Can be made into a product x Do not require additional hospitalization x Are simple to produce and ship

 

 

AditxtReprogramming Œ technologies are protected by 7 patent families, including: • 8 U.S. patents, 4 U.S. pending patent applications, 86 foreign patents, and 14 foreign pending patent applications (EU, Australia, Canada, Japan, China, India, Hong Kong) AditxtReprogramming Œ patents are broadly categorized into 3 groups: • Autoimmune diseases and type 1 diabetes • Organ transplantation and a method of producing plasmid DNA that is mammalian - like to prevent immune activation • Composition of matter for a tolerance delivery system for antigens of interest (basis for a platform allowing development of a new class of immunotherapeutics for various indications) The projected expiration dates for the ADi Œ patents range from 2021 to 2032. We also possess and/or in - license substantial know - how and trade secrets relating to the development and commercialization of our product candidates, including related manufacturing processes and technologies. Current Innovation Platform IP

 

 

21 Days 58 Days Immunosuppression alone Allograft lost in 21 days on average ADi Πwith minimal immunosuppression 3 - fold increase in the longevity of the skin allografts IMMUNOSUPRESSION ALONE TREATMENT WITH AditxtReprogramming TM TECHNOLOGY (minimal immunosuppression) Skin Graft Survival Time ADi TM Increases Skin Allograft Survival Rate in Recipient Mice ADi TM tripled graft survival time vs. IS alone in a completely mis - matched skin allograft model * Low - level immunosuppression provided for the first 5 weeks in the experimental group.

 

 

0 . 2 0 . 3 Psoriasis Induced - ADI treated Psoriasis Induced - Untreated 0 0.1 Change in thickness (mm) Skin Thickness Evaluation ADi TM Reduces Skin Thickening and Scaling in A Psoriasis Mouse Model* Psoriasis Induced - Untreated Psoriasis Induced - ADI Treated 0 0 .2 0 .4 0 .6 0 .8 1 1 .2 1 .4 Scaling Score Evaluation Psoriasis Induced - Untreated Psoriasis Induced - ADI Treated 0 0.2 0.4 0.6 0.8 1 Scaling Score (range = 0 - 4) 1.2 1.4 * Imiquimod - induced model ADi TM treatment resulted in a 69% reduction in skin thickening and 38% reduction in scaling over the 10 - day study period

 

 

ADi TM Reverses Hyperglycemia and Suppresses Development of Type 1 Diabetes Delivery of ADi TM using sGAD over an 8 - wk period in NOD mice restored insulin production and reversed hyperglycemia

 

 

AditxtReprogramming ΠCandidate Pipeline

 

 

Potential for Expansion Our ADi ΠProgram can be Engineered to Address a Wide Variety of Indications Meaningful Potential Exis t s Across Man y O t her Indications Illustrative Autoimmune Disease Organ Transplant Allergy Dermatology Other Potential Appl i ca t io n s

 

 

Notable Recent Licensing Transactions Significant Value in a Partner - Centric Approach Significant upside potential in low saturated indication Source: Cortellis Health Intelligence Source: Cortellis Health Intelligence Significant opportunity in pharma backed indications Deal Date Licensor Licensee Phase of D e velo p ment Indication(s) Deal Type Upfront Payment (M) Milestone Payment (M) Total Deal Value (M) 13 - Nov - 2019 Exicure Allergan Discovery Alopecia License - Collaboration (option) $25 $725 $770 30 - Oct - 2019 Pandion Therapeutics Astellas Pharma Discovery Type 1 Diabetes License - Collaboration $45 $750 $795 29 - Oct - 2018 Denali Therapeutics Sanofi Genzyme Phase 1 Clinical Psoriasis and other CNS indications License - Collaboration (option) $125 $1,095 $1,220 02 - Dec - 2016 Exicure Purdue Pharma Phase 1 Clinical Psoriasis License - Collaboration (option) $10 $777 $787 02 - Jun - 2015 Anokion Astellas Pharma Discovery Type 1 Diabetes and Celiac disease License - Collaboration Undisclosed Undisclosed $760

 

 

IMMUNE MONITORING: ADITXTSCORE TM IMMUNE MONITORING PLATFORM 15

 

 

• A proprietary platform that provides a personalized comprehensive profile of the immune system which can assist the medical community in anticipating responses and possible reaction to viruses, bacteria, allergens, and transplanted organs. • Can be useful in anticipating attacks on the body by having the ability to determine its potential response and for developing a plan to deal with an undesirable reaction by the immune system. • Initial technology was licensed from, invented and used at Stanford University. It encompasses methods, systems and kits for detection and measurement of specific immune responses as described within the company’s U.S. Patent. AditxtScore Œ technologies are protected by 2 patent families, including: • 1 U.S. patent, 1 U.S. provisional patent application with plans to file foreign patent applications (EU, Australia, Canada, Japan, China, India, Hong Kong) We also possess and/or in - license substantial know - how and trade secrets relating to the development and commercialization of our product candidates, including related manufacturing processes and technologies. ADITXTSCORE Œ – IMMUNE MONITORING AS A SERVICE

 

 

Adit x tScor e ΠGeneral Health Drug / Vaccine Response Allergies Infectio u s Diseases Organ Fai l ure Disease Susceptib i lity Diverse applications of AditxtScore TM may be applied to a variety of therapeutic indications. AditxtScore ΠApplications

 

 

1 ST COMMERCIAL APPLICATION: 18

 

 

AditxtScore ̻ Monitoring: COVID - 19 Past: Early Stage of Pandemic Do I have the virus? Protect yourself and others Seek medical attention Isolate/quarantine Have I been exposed? Is there evidence of an immune response? Is the immune response protective? Pre - Vaccine Information to help you make a decision about the vaccine During - Vaccine Early Follow - Up Is the vaccine working to protect me from contracting COVID - 19? Long - term Follow - Up Have I developed a cellular immune response that will protect me long term? Is there evidence that I have developed long - term immunity Am I developing antibodies in response to the vaccine? If so, are the antibodies protective? Questions and Actions Change as the Time Continuum of COVID - 19 Progresses

 

 

MONITORING SERVICE Sample Collection 1 TH E I MMUN E Implement AditxtScore Πimmune monitoring into an existing clinical workflow or at - home as follows: Capture tube of blood during a traditional lab blood draw. Or consumers use our AditxtScore Πat - home collection kit with fingerstick.

 

 

MONITORING SERVICE TH E I MMUN E Send the sample to the AditxtScore ΠImmune Monitoring Center for processing 2 Processing

 

 

AditxtScore Report combines knowledge and clinical experience in its proprietary algorithm 3 Reporting

 

 

Summary A unique strategic combination of therapeutics and healthTech Two key milestones in 2021 Attractive valuation NASDAQ: ADTX - Mkt. Cap.: Approx. $44M ( as of 03/23/2021)

 

 

FOR MORE INFORMATION CONTACT: Email: IR@aditxt.com Pho n e: 6 5 0 - 870 - 1200 Thank You