ADTX Aditxt Inc

 

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): December 11, 2024

 

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.)

 

2569 Wyandotte Street, Suite 101, Mountain View, CA		94043
(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:

 

☐	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 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

 

On December 12, 2024, Aditxt, Inc. (the “Company”) issued a press release announcing that its subsidiary, Adimune, Inc. (“Adimune”) has successfully completed preclinical efficacy and safety studies for its immune modulation therapeutic platform. A copy of the press release is furnished to this Current Report on Form 8-K as Exhibit 99.1

 

The Company has prepared presentation materials (the “Presentation”) regarding Adimune. The Presentation was posted to Adimune’s website on December 11, 2024 and is furnished to this Current Report on Form 8-K as Exhibit 99.2

 

The information in this Item 7.01 and Exhibit 99.1 and 99.2 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 and 99.2 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		Press release dated December 12, 2024
99.2		Adimune Presentation
104		Cover Page Interactive Data File (embedded within the XBRL document)

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities and Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: December 12, 2024

 

	Aditxt, Inc.
	By:	/s/ Amro Albanna
	Name:	Amro Albanna
	Title:	Chief Executive Officer

 

 

-2-

 

Exhibit 99.1

 

Aditxt’s Subsidiary Adimune Successfully Completes Preclinical Efficacy and Safety Studies for
its Immune Modulation Therapeutic ADI Platform, Advancing Toward

First-in-Human Clinical Trials

 

Submission for Regulatory Approval to Initiate Human Trials for Type 1 Diabetes, Psoriasis, and Stiff-Person Syndrome Targeted for H2 2025

 

MOUNTAIN VIEW, CA – (Dec. 12, 2024) – Aditxt, Inc. (NASDAQ: ADTX) (“Aditxt” or the “Company”), a social innovation platform dedicated to accelerating promising health innovations, today announced that its subsidiary, Adimune, Inc. (“Adimune”), has successfully completed all preclinical efficacy and safety studies for its antigen-specific gene therapy, ADI-100. This achievement represents a major milestone as Adimune prepares to submit a Clinical Trial Application (CTA)/Investigational New Drug (IND) application to initiate first-in-human clinical trials for ADI-100 in the treatment of Type 1 Diabetes (T1D), Psoriasis, and in collaboration with Mayo Clinic, Stiff-Person Syndrome (SPS).

 

Preclinical Data Highlight: Antigen specific immune tolerization without impairment of the overall immune responsiveness: ADI-100 is an innovative immune modulation therapy designed to restore immune tolerance in autoimmune diseases and induce tolerance for transplanted organs by leveraging the body’s natural immune homeostasis mechanisms. Preclinical studies demonstrated the therapy’s potential to achieve antigen-specific tolerization without impairing the immune system’s ability to fight infections or to suppress tumor growth.

 

In preclinical models, ADI-100 demonstrated efficacy in reversing hyperglycemia in Type 1 Diabetes, restoring islet cell mass, and transferring protective immune modulation to animals that were not treated with ADI-100. In separate preclinical experiments ADI-100 did not show any impairment of immune responses to infections or tumor growth. In Non-Obese Diabetic (NOD) mice (prone to spontaneous type 1 diabetes) treated with anti-PD-1 checkpoint inhibitors, which markedly hastened disease progression, ADI-100 prevented hyperglycemia in 70% of treated mice and provided durable protection lasting over 300 days. In a study conducted using tumor bearing mice, ADI-100 did not impede the ability of the checkpoint inhibitor, anti-PD1, to shrink the tumor.

 

Preclinical toxicology data confirmed the therapy’s safety, with no detectable persistence of plasmids in tissues and organs, no formation of anti-plasmid antibodies, and no significant adverse effects.

 

Advancing Toward IND Submission: Adimune has successfully completed all preclinical efficacy and safety studies for ADI-100, with GMP drug substances manufactured and stability studies underway. These steps position ADI-100 for first-in-human clinical trials, marking a significant milestone in transforming the treatment landscape for autoimmune diseases.

 

 

Dr. Friedrich Kapp, Co-CEO of Adimune commented, “The treatment of autoimmune diseases will see a fundamental change in the next few years, a paradigm shift, which has been awaited since the processes were understood by which immune tolerance normally is being maintained. Restoring immune tolerance will replace immunosuppressants in the treatment of autoimmune diseases, and insulin eventually will become a mere rescue medication in type 1 diabetes. With the recent deal between Roche/Genentech and Cour on autoimmune treatments, the race is on and will be won by the drug which best fulfils three main criteria: safety, effectiveness, and durability of response. Adimune’s ADI-100 is well positioned in this competitive endeavor. We are one of the front runners because we believe our drug candidate will meet all three criteria in a perfect manner.”

 

The autoimmune disease market represents a significant and growing unmet medical sector, with a total addressable market (TAM) of $84.12 billion. Autoimmune diseases affect approximately 8% of the U.S. population, with prevalence increasing year over year. Recent industry developments underscore the demand for innovative therapies in this space.

 

Adimune’s ADI-100 stands out in this competitive landscape with its innovative mechanism of action, broad therapeutic potential, and very strong preclinical data.

 

Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt and Co-CEO of Adimune, added, “Adimune represents an opportunity for a fundamental shift in the way we treat autoimmunity where reliance on immunosuppressants could be reduced or eliminated. With the successful completion of ADI-100’s preclinical efficacy and safety study, Adimune is closer to bringing this therapy to human trials advancing its mission of addressing autoimmune diseases as one of the most pressing health challenges we face.”

 

About ADI-100

 

ADI-100 is an innovative antigen-specific gene therapy that consists of two DNA molecules designed to restore immune tolerance in autoimmune diseases or to induce tolerance to transplanted organs. This approach should retrain the immune system to recognize antigens as “self” without relying on immunosuppression, offering the possibility of significant safety and efficacy benefits.

 

The therapy consists of a pro-apoptotic DNA molecule (BAX), which has been shown in preclinical models to induce localized apoptotic cell death combined with a methylated sGAD55 DNA molecule that encodes a modified form of GAD to retrain the immune system to become tolerant to the antigen.

 

ADI-100 is designed to work through precision immune reprogramming, downregulating pro-inflammatory cytokines while upregulating anti-inflammatory cytokines in an antigen-specific manner. It tolerizes to GAD, which is a target of autoimmunity, directly or indirectly involved in Type 1 Diabetes, Psoriasis, and certain CNS autoimmune disorders. In the mouse model for type 1 diabetes, ADI-100 demonstrated a reduction in the number of aggressive T cells directed against insulin, which is another antigen in the pancreas that is a target of autoimmune attack. This bystander effect is an important factor to counteract a phenomenon often observed where autoimmunity spreads to other regions of a protein or to other proteins in a cell. Another potential benefit of downregulating anti-GAD antibodies by ADI-100 is restoration of GABA levels, further enhancing the tolerization process.

 

To learn more and view the corporate presentation, please visit adimune.com.

 

 

About Aditxt, Inc.

 

Aditxt, Inc.® is a social innovation platform dedicated to accelerating promising health innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to “Make Promising Innovations Possible Together.” The innovation platform is the cornerstone of Aditxt’s strategy, where multiple disciplines drive disruptive growth and address significant societal challenges. Aditxt operates a unique model that democratizes innovation, ensures every stakeholder’s voice is heard and valued, and empowers collective progress.

 

Aditxt currently operates two programs focused on immune health and precision health. The Company plans to introduce two additional programs dedicated to public health and women’s health. For these, Aditxt has entered into an Arrangement Agreement with Appili Therapeutics, Inc. (“Appili”) (TSX: APLI; OTCPink: APLIF), which focuses on infectious diseases, and a Merger Agreement with Evofem Biosciences, Inc. (“Evofem”) (OTCQB: EVFM). Each program will be designed to function autonomously while collectively advancing Aditxt’s mission of discovering, developing, and deploying innovative health solutions to tackle some of the most urgent health challenges. The closing of each of the transactions with Appili and Evofem is subject to several conditions, including but not limited to approval of the transactions by the respective target shareholders and Aditxt raising sufficient capital to fund its obligations at closing. These obligations include cash payments of approximately $17 million for Appili and $17 million for Evofem, which includes approximately $15.2 million required to satisfy Evofem’s senior secured noteholder; should Aditxt fail to secure these funds, Evofem’s senior secured noteholder is expected to seek to prevent the closing of the merger with Evofem. No assurance can be provided that all of the conditions to closing will be obtained or satisfied or that either of the transactions will ultimately close.

 

For more information, www.aditxt.com.

 

Follow us on:

 

LinkedIn: https://www.linkedin.com/company/aditxt
Facebook: https://www.facebook.com/aditxtplatform/

 

 

Forward-Looking Statements

 

Certain statements in this press release constitute “forward-looking statements” within the meaning of federal securities laws. Forward-looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses, or current expectations concerning, among other things, the Company’s ongoing and planned product and business development; the Company’s ability to finance and execute its strategic M&A initiatives; the Company’s ability to obtain the necessary funding and partner to commence clinical trials; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth, and strategies; the Company’s ability to raise additional capital; expected usage of the Company’s ELOC and ATM facilities; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance, and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as market and other conditions and those risks more fully discussed in the section titled “Risk Factors” in Aditxt’s most recent Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s other filings with the 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, except as required by law.

 

Aditxt, Inc.

 

Investors:

 

Jeff Ramson, PCG Advisory, Inc.

T: 646-863-6893

contactus@aditxt.com

 

Corporate Communications:

 

Mary O’Brien

Mobrien@aditxt.com

 

 

Exhibit 99.2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

v3.24.3

Cover	Dec. 11, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Dec. 11, 2024
Entity File Number	001-39336
Entity Registrant Name	Aditxt, Inc.
Entity Central Index Key	0001726711
Entity Tax Identification Number	82-3204328
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	2569 Wyandotte Street
Entity Address, Address Line Two	Suite 101
Entity Address, City or Town	Mountain View
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94043
City Area Code	650
Local Phone Number	870-1200
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001
Trading Symbol	ADTX
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false

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