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): May 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 5.03 Amendment to Articles of Incorporation or Bylaws; Change in Fiscal Year.

 

On May 24, 2021, Aditx Therapeutics, Inc. (the “Company”) increased the number of authorized shares of the Company’s common stock, par value $0.001 per share, from 27,000,000 to 100,000,000 (the “Authorized Shares Increase”) by filing a Certificate of Amendment (the “Certificate of Amendment”) to its Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware. In accordance with the General Corporation Law of the State of Delaware, the stockholders of the Company approved the Authorized Shares Increase and the Certificate of Amendment at its Annual Meeting of Stockholders (the “Annual Meeting”) held on May 19, 2021.

 

The foregoing description of the Certificate of Amendment is not complete and is qualified in its entirety by reference to the full text of the Certificate of Amendment, a copy of which is filed as Exhibit 3.1 to this Current Report on Form 8-K and is hereby incorporated by reference.

 

Item 5.07 Submission of Matters to a Vote of Security Holders.

 

On May 19, 2021, the Company held its Annual Meeting. A total of 8,255,916 shares of common stock were present or represented by proxy at the Annual Meeting, representing approximately 56.97% of the Company’s issued and outstanding common stock as of the March 25, 2021 record date. The following are the voting results for the proposals considered and voted upon at the Annual Meeting, each of which were described in the Company’s Definitive Proxy Statement on Schedule 14A filed with the Securities and Exchange Commission on April 5, 2021.

 

Item 1 – Election of six (6) persons as members of the board of directors, to hold office until the 2022 annual meeting of stockholders and until their respective successors have been duly elected and qualified.

 

NOMINEE   Votes FOR     Votes WITHHELD     Broker Non-Votes  
Amro Albanna     4,999,256       76,830       3,179,830  
Shahrokh Shabahang, MS, Ph.D.     4,981,683       94,403       3,179,830  
Brian Brady     4,967,125       108,961       3,179,830  
Namvar Kiaie     4,978,736       97,350       3,179,830  
Laura Anthony     4,974,577       101,509       3,179,830  
Jeffrey Runge, M.D.     4,985,935       90,151       3,179,830  

  

Item 2 – Ratification of the appointment of dbbmckennon as the Company’s independent registered accounting firm for the fiscal year ending December 31, 2021.

 

Votes FOR   Votes AGAINST   Votes ABSTAINED   Broker Non-Votes
7,968,354   63,243   224,319   0

 

Item 3 – Approval of the Company’s 2021 Omnibus Equity Incentive Plan and the reservation of 3,000,000 shares of common stock for issuance thereunder.

 

Votes FOR   Votes AGAINST   Votes ABSTAINED   Broker Non-Votes
4,643,978   393,259   38,849   3,179,830

 

Item 4 – Approval of an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of shares of authorized common stock from 27,000,000 to 100,000,000.

 

Votes FOR   Votes AGAINST   Votes ABSTAINED   Broker Non-Votes
7,346,025   765,577   144,314   0

 

Item 5 – Approval, for the purposes of Listing Rule 5635 of The Nasdaq Stock Market LLC, of the issuance of shares of common stock underlying a Senior Secured Convertible Promissory Note and an accompanying warrant issued by the Company in January 2021.

 

Votes FOR   Votes AGAINST   Votes ABSTAINED   Broker Non-Votes
4,861,368   175,633   39,805   3,179,830

 

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Item 7.01 Regulation FD Disclosure.

 

On May 21, 2021, the Company made available a shareholders letter (“Shareholders Letter”) on its website at https://aditxt.com/investor-relations/shareholders-letter-20210521/. A copy of the Shareholders Letter is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

 

The information contained in this Current Report on Form 8-K (including the Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities under that Section, and shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly provided by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description
3.1   Certificate of Amendment, filed with the Secretary of State of the State of Delaware on May 24, 2021
99.1   Shareholders Letter, dated May 21, 2021

 

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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: May 25, 2021 By: /s/ Corinne Pankovcin
    Corinne Pankovcin
    Chief Financial Officer

 

 

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Exhibit 3.1

  

 

 

 

 

Exhibit 99.1

 

 

A Letter from Amro Albanna

 

I am proud of our accomplishments since the completion of our IPO in July 2020. Guided by our mission is to improve the health of the immune system, we are developing innovations in two key areas. Immune Monitoring and Immune Retraining.

 

The two significant milestones that we set for Aditxt this year, 2021, are transitioning the company from pre-revenue to revenue and transitioning our therapeutic program from pre-clinical to clinical. Revenue growth will be driven by our immune monitoring segment, which is branded AditxtScore™. Our clinical expansion will be driven through our Aditxt Reprogramming and therapeutic segment. The following is a review of the actions we’ve taken towards those stated goals. 

 

Let’s start with immune monitoring. It is now more apparent than ever, given the challenge the world has faced with the COVID-19 pandemic, that we must understand immunity status at an individual level, not only at a population level. We have been developing AditxtScore as an immune monitoring service with a vision to transform reactive testing into proactive monitoring. Since the IPO, we’ve made the following progress towards commercializing AditxtScore from a promising innovation into a commercial product:

 

To begin, we established AditxtScore as a health tech brand with a vision focused on personalized health.

 

We expanded on the original IP we licensed from Stanford University by preparing and filing additional patent applications in the U.S. and internationally.

 

We established an R&D facility in Silicon Valley near Stanford University to develop applications based on the AditxtScore platform in areas including infectious diseases, organ rejection, disease susceptibility, and drug response. 

 

Our team leaped into action in response to the COVID-19 event and rapidly launched the first AditxtScore application, AditxtScore for COVID-19. We also developed an application for providing information about levels of immunity for SARS-CoV-2 whether that immunity was acquired via natural exposure or vaccination. This will be essential information as more of the world’s population gets vaccinated.

 

The Stanford Blood Center validated the AditxtScore for COVID-19.

 

With the above accomplished, our focus turned to operation. Given our business model of processing biological samples in our AditxtScore Centers, we decided to operate as CLIA lab and launch AditxtScore current and future applications as Lab Developed Tests (LDT). Our regulatory and product development team is continuing in parallel to pursue EUA and ultimately 510K. 

 

 

 

 

We established an interim CLIA certified laboratory in Richmond, VA, in collaboration with one of our partners. This was an interim step while we were planning for a longer-term facility.

 

As we recently announced in a joint press conference with the Governor of Virginia and the Mayor of Richmond, we are in the process of establishing our first high-capacity AditxtScore Center with a targeted annual capacity of 10M AditxtScores per year by the end of 2023. This facility will be up and running on July 1st. 

 

We’ve also recruited a team of industry experts with deep clinical and operational backgrounds, including several people with extensive experience at the Mayo Clinic and Quest Diagnostics. They bring the clinical and operational knowledge we need to manage and operate our AditxtScore Centers.

 

We also recruited business development and P&L team members to focus on securing channel partners. Our channel partners are vital in getting AditxtScore into key industries, including healthcare, travel and tourism, and general wellness.

 

Our plan moving forward is to work with current and future channel partners on joint marketing to create awareness for AditxtScore and AditxtScore for COVID-19. This is going to be a cornerstone in our efforts to capture market share. As you’ve seen recently, we recruited a Chief Communications Officer who came from BMS and brings significant experience in biotech and consumer health.

 

The steps above have gotten us significantly closer to our first goal of making AditxtScore commercially available. 

 

Now let me address our second segment, Aditxt Reprogramming which is the therapeutics side of our business. We are developing a new class of therapeutics designed to retrain the immune system to potentially address organ rejection, autoimmune diseases, and allergies. 

 

Our first therapeutic technology platform is referred to as ADi, which stands for Apoptotic DNA Immunotherapy. We’ve taken the following steps towards getting ADi into clinical trials, which is our second goal in 2021:

 

We expanded on the original IP we licensed from Loma Linda University by filing additional patent applications. We now have approximately 95 issued patents in the U.S. and internationally.

 

We established an R&D facility in Silicon Valley, which I previously mentioned, to advance the work necessary to get into clinical trials. 

 

We brought in a team from the industry with scientific, clinical, and commercialization expertise in autoimmunity and organ transplantation. 

 

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This team is currently working on pre-IND enabling activities, including GMP manufacturing and tox studies which are required for IND submission.

 

We are now targeting the 4th quarter of this year to start the first-in-human trials, which will be in Germany, pending regulatory approvals. The trial will be focused on psoriasis as a POC in autoimmunity. 

 

With clinical trials nearing, our business development team is working on mapping out our strategy for partnering with big pharma in the form of co-development and licensing sometime in 2022.

 

To recap, in just 10 months since our IPO, we have expanded our IP portfolio, recruited key team members, built the necessary infrastructure to advance development and deployment for AditxtScore and AditxtReprogramming, and positioned the company for the commercialization of AditxtScore and clinical trials for AditxtReprogramming -- all in just 300 calendar days.

 

I hope this brief update provided a clear roadmap of our goals and significant progress to date. I believe in Aditxt and its team, and I am tremendously excited about our prospects. We are well-positioned to deliver innovations that could potentially address significant health challenges. Our current market cap hovers around $30M-40M depending on the day. I know we would all enjoy a much higher market cap, but our focus is on building the company and its market share, as I believe that will ultimately drive the value of Aditxt.

 

We are here today because of the many stakeholders who believed in us and our mission. I want to take this opportunity to thank you as our shareholders. I would also like to recognize and thank our team and our partners who have been working practically seven days a week to pursue our mission and reach the goals we set for Aditxt.

 

Thank you.

 

Amro Albanna

Co-Founder and Chief Executive Officer

 

 

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