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): September 9, 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 (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 26^th Annual Global Investment Conference beginning on September 9, 2024. 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 9, 2024	By:	/s/ Amro Albanna
		Amro Albanna
		Chief Executive Officer

 

 

2

Exhibit 99.1

 

MAKING PROMISING INNOVATIONS POSSIBLE, TOGETHER AMRO ALBANNA Co - Founder, Chairman & CEO

SAFE HARBOR STATEMENT & DISCLAIMERS This presentation contains forward - looking statements that are subject to many risks 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 have a reasonable basis for each forward - looking statement, we caution 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 Annual Report on Form 10 - K for the year ended December 31, 2023, that was filed with the U.S. Securities and Exchange Commission on April 16, 2024 as well as discussions of potential risk, uncertainties, and other essential 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 publicly update or revise any forward - looking statements, whether as a result of new information, future events, or otherwise. This Presentation includes specific projections and forward - looking statements provided by the Company, including concerning the Company's anticipated future performance and our ability to develop and commercialize products and obtain regulatory approvals. Such projections and forward - looking statements reflect various assumptions of management. They 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 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) the Company's ability to raise additional capital, which may not be available on acceptable terms, or at all; (ii) the Company's ability to finance and execute on its strategic M& A initiatives; (iii) future sales or issuances of substantial amounts of our common stock, including, potentially as a result of future acquisitions or strategic transactions could result in significant dilution; (iv) we have issued a significant number of shares of convertible preferred stock and warrants and may continue to do so in the future and the conversion and/or exercise of these securities and the sale of the shares of common stock issuable thereunder may dilute your percentage ownership interest and may also result in downward pressure on the price of our common stock; (v) we may encounter substantial delays in completing our clinical studies which in turn will require additional costs, or we may fail to demonstrate adequate safety and efficacy to the satisfaction of applicable regulatory authorities; (vi) we received the determination from Nasdaq that we regained compliance with the Nasdaq continued listing requirements, however, we remain subject to a panel monitor of our ongoing compliance until December 29, 2024 and if we fail to comply with such requirements during the panel monitor, it could result in the delisting of our securities by Nasdaq;(vii) our ability to enter strategic relationships for development or commercialization of our products; (viii) 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; (ix) our ability to obtain sufficient financing; and (x) 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 Aditxt in this Presentation is based only on information currently available to us and speaks only as of the date 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. © 2024 ADITXT, INC.

A PUBLIC COMPANY (Nasdaq: ADTX) WITH A MISSION TO ACCELERATE INNOVATIVE BUSINESSES TO ADDRESS THE MOST PRESSING HEALTH CHALLENGES AMRO ALBANNA Co - founder & CEO Together, we have the power to shape the future of innovation and make a lasting impact on global health. © 2024 ADITXT, INC.

BUSINESS MODEL Acquire disruptive innovative and scalable companies positioned for growth in targeted markets Leverage a dit X t’s evolving business acceleration platform to drive growth and achieve market penetration Monetize assets through mergers, sales, licenses, spin - offs, or IPOs to ensure long - term growth © 2024 ADITXT, INC. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

Current and Potential Programs and Subsidiaries © 2024 ADITXT, INC. Adimune - Immune Health A pre - clinical stage company that develops immune modulation therapies to advance immune health by naturally restoring immune tolerance. Women’s Health (Proposed Acquisition) On December 11, 2023, we entered into an Agreement and Plan of Merger with Adifem f/k/a Adicure , Inc., a majority owned subsidiary of the Company and Evofem Biosciences, Inc., pursuant to which we are seeking to acquire Evofem . The closing fo the transaction is subject to a number of closing conditions, including Aditxt securing sufficient financing to satisfy its obligations at closing, and approval by Evofem's stockholders. We can provide no assurance that the conditions to closing will be satisfied and that we will ultimately close. Evofem is the creator of an FDA - approved hormone - fee contraceptive gel, Phexxi ® and also recently acquired Solosec ®, an antimicrobial agent for bacterial vaginosis and trichomoniasis. Public Health (Proposed Acquisition) On April 1, 2024, we entered into an Arrangement Agreement with Adivir, Inc., a wholly owned subsidiary of the Company and Appili Therapeutics, Inc., pursuant to which we are seeking to acquire Appili . The closing of the transaction is subject to a number of conditions, including but not limited to, Aditxt securing sufficient financing to satisfy its obligations at closing, and approval of the transaction by Appili's stockholders. We can provide no assurance that the conditions to closing will be satisfied and that we will ultimately close. Appili has the following assets in its product pipeline: Likmez is a liquid formulation of metronidazole, a broad - spectrum antibiotic that is normally dispensed in a pill form. ATI - 1701 is a tularemia vaccine program that is fully funded by the U.S. Airforce. ATI - 1801 is a late - stage clinical program for topical treatment of cutaneous leishmaniasis, a painful and potentially disfiguring skin infection. Pearsanta - Precision Health A commercial - stage company developing precision diagnostic technologies. Their proprietary platforms include - Mitomic ® and Flow Cytometry technologies.

GLOBAL LEADERSHIP Amro Albanna Innovation & Entrepreneurship Co - Founder, Chairman & CEO Dr. Shahrokh Shabahang Innovation Co - Founder, Director & CIO Corinne Pankovcin Discovery CM&AO Rowena Albanna Operations COO Thomas Farley Finance CFO Jennifer Lee People VP of HR and Talent Acquisition Mary O’ Brien Communications Head of Communications INDEPENDENT BOARD MEMBERS Brian Brady Independent Director and Chair of Audit Committee Charles Nelson Independent Director and Chair of Compensation Committee Jeffrey Runge MD, FACEP Independent Director and Chair of Corporate Governance & Nominating Committee Team Locations: Silicon Valley | New York | Richmond © 2024 ADITXT, INC.

CURRENT PROGRAMS AND M&A PIPELINE

INTRODUCTION IMMUNE HEALTH CURRENT FOCUS AREAS & TAM Psoriasis ¹ • Affecting approximately 100 million people worldwide • Market size valued at USD 25.52 billion in 2023; projected to grow to USD 57.68 billion by 2032 Type 1 Diabetes (T1D) ² • In 2021, about 8.4 million individuals worldwide with T1D • Market valued at USD 5.6 billion in 2023; projected to grow to USD 9.4 billion by 2034 Stiff Person Syndrome (SPS) • Rare autoimmune disease of the central nervous system mediated by GAD • Estimated incidence: ~1 in 1 million individuals OVERVIEW . CHALLENGE Proprietary Product APOPTOTIC DNA IMMUNOTHERAPY (ADI - 100 ) Technology Overview & Nonclinical Findings Utilizes nucleic acid technology to deliver signals to induce tolerance using two DNA molecules: • Encode a protein (BAX) that promotes apoptosis • Encode a modified antigen to promote tolerance Mimics natural tolerance mechanisms In nonclinical studies, ADI - 100 has demonstrated significant prolongation of skin allografts, reversal of hyperglycemia in type 1 diabetes (T1D) and amelioration of psoriatic lesions The therapeutic effectiveness of ADI - 100 was not accompanied with any impairment of immune responsiveness against systemic infection, tumor growth or benefits of checkpoint inhibitors © 2024 ADITXT, INC. https:// www.fortunebusinessinsights.com/industry - reports/psoriasis - treatment - market - 100600 & Mehrmal S.: JJAD 2021 https://www.biospace.com/type - 1 - diabetes - market - estimated - to - reach - usd - 9 - 4 - billion - by - 2034 - impelled - by - increased - utilization - of - artificial - pancreas - systems#:~:text=The%20type%201%20diabetes%20market,4.84%25%20during%202024 %2D2034 & Gregory G.: The Lancet 2022 1. 2. Current treatments for autoimmune diseases and organ transplantation rely on long - term immunosuppression, leading to severe side effects and limited efficacy. This highlights the urgent need for innovative solutions for effective, long - term immune modulation without compromising overall health. Adimune is a pre - clinical stage company developing immune modulation therapies with a mission to advance immune health by naturally restoring immune tolerance, reducing dependency on immunosuppression, and transforming treatment for autoimmune diseases and organ transplantation

INTRODUCTION PRECISION HEALTH CURRENT FOCUS AREAS & TAM Prostate Cancer¹ According to the WHO, there were approximately 1,467,854 new cases of prostate cancer diagnosed worldwide in 2022. The prostate cancer diagnostics market was valued at USD 3.7 billion in 2022 and is projected to grow to USD 11.6 Billion in 20321 Ovarian Cancer² In 2022, there were more than 324,603 new cases of ovarian cancer worldwide, making it the 18th most common cancer globally and the 8th most common cancer among women. The ovarian cancer diagnostic market size was valued at around USD 1.54 billion in 2023 and is expected to grow to USD 2.71 billion in 20322 Endometriosis Testing³ The WHO estimates that 1 in 10 women suffer from endometriosis. The market was valued at approximately $1.27 billion and is projected to grow to USD 2.01 billion by 20283 OVERVIEW CHALLENGE Proprietary Product MITOMIC® TECHNOLOGY PLATFORM Planned Products: Mitomic® Endometriosis Test (MET ) MET is a diagnostic for endometriosis that has demonstrated accuracy in predicting surgical outcomes, significantly reducing the diagnostic delay. Early and precise diagnosis through MET leads to timely and effective treatment, improving patient outcomes and quality of life. Mitomic® Prostate Test (MPT ) MPT improves the detection of clinically significant prostate cancer, reducing reliance on PSA testing and its associated false positives and over - diagnosis. Accurately predicts prostate cancer, distinguishing between aggressive and non - aggressive forms, guiding treatment decisions, and reducing unnecessary interventions. Improves patient outcomes by ensuring only those with clinically significant prostate cancer receive treatment, avoiding side effects of unnecessary procedures. Mitomic® Ovarian Cancer Test (MOT ) MOT is an accurate and non - invasive diagnostic for ovarian cancer and has shown accuracy in detecting ovarian cancer early, which is essential for improving treatment outcomes and survival rates. The test can distinguish between benign and malignant ovarian tumors, thereby guiding appropriate treatment decisions. Early and precise diagnosis through MOT can lead to timely and effective treatment, significantly improving patient outcomes and quality of life. © 2024 ADITXT, INC. 1. https:// www.gminsights.com/industry - analysis/prostate - cancer - diagnostics - market#:~:text=Prostate%20Cancer%20Di agnostics%20Market%20size%20was%20valued%20at%20USD%203.7,CAGR%20from%202023%20to%202032. 2. https:// www.gminsights.com/industry - analysis/ovarian - cancer - diagnostic - market/market - size#:~:text=Ovarian%20Can cer%20Diagnostic%20Market%20size%20was%20valued%20at%20around%20USD,6.6%25%20between%202024%20an d%202032. & https://worldovariancancercoalition.org/about - ovarian - cancer/key - stats/ https:// www.researchandmarkets.com/report/endometriosis https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0276517 3. Late - stage cancer diagnoses lead to higher mortality rates and increased healthcare costs, highlighting the critical need for advanced early detection methods to improve survival rates and reduce economic burdens. Pearsanta is a commercial stage company developing technologies to empower individuals to achieve optimal health through precision diagnostics, enabling early disease detection, improving prognosis and monitoring, and ultimately enhancing lifelong well - being.

Proposed Acquisitions

LIKMEZ Metronidazole Oral Suspension 500MG/5ML Solution It is the only FDA - approved liquid oral suspension of metronidazole, which solves significant issues for patients who cannot swallow the current tablet formulation. U.S. patent coverage protects the composition and preparation methods through 2039 ATI - 1701 – Tularemia Vaccine ATI - 1701 is a novel, live - attenuated tularemia vaccine candidate addressing a top - priority biothreat (a Category A pathogen by the National Institutes of Health) . It is highly lethal ( 1 , 000 times more infectious than anthrax) and has no FDA - approved vaccine ATI - 1801 - Topical Treatment for Cutaneous Leishmaniasis (CL) An easy - to - use topical cream formulation of paromomycin repurposed for CL, which is a common and disfiguring disease without appropriate treatment options. ATI - 1801 has potent activity against both New - World and Old - World leishmaniasis specie s with low clinical risk and positive results in several Phase 2 and 3 studies © 2024 ADITXT, INC. INTRODUCTION PUBLIC HEALTH OVERVIEW The COVID - 19 pandemic has exposed systemic weaknesses in global health systems, emphasizing the urgent need for robust, resilient health infrastructure. Infectious diseases pose a critical global health challenge that carries significant morbidity and mortality rates. The rise of drug - resistant pathogens , neglected tropical diseases, and the threat of bioterrorism underscore the urgent need for new preventive and therapeutic approaches. CHALLENGE CURRENT FOCUS AREAS & TAM Francisella Tularensis ¹ This pathogen, associated with tularemia, poses significant bioterrorism threats (potentially 1,000 times more infectious than anthrax) and has substantial government interest. The tularemia market is anticipated to reach USD 482.5 million by 2030 Cutaneous Leishmaniasis ² The global cutaneous and systemic leishmaniasis market is projected to grow from USD 368.6 million in 2024 to USD 487.5 million by 2034 Antimicrobial Infections Proprietary Product Proposed acquisition, targeting November 16, 2024 closing https:// www.marketresearchfuture.com/reports/tularemia - market - 4120 https:// www.factmr.com/report/cutaneous - and - systemic - leishmaniasis - marke Appili is a commercial - stage company with a mission to advance the treatment of infectious diseases by developing innovative antivirals and vaccines to treat emerging, neglected, and resistant infectious diseases that address unmet medical needs, improve patient outcomes, and enhance global health security.

INTRODUCTION WOMEN’S HEALTH CURRENT THERAPEUTIC AREAS & TAM • Hormone - free contraception ¹ The U.S. contraceptive market was valued at approximately USD 8.3 billion in 2022 and is projected to grow at 5.16% CAGR.1 The global contraceptive market is valued at approximately USD 28.86 billion and is forecast to reach USD 47.77 billion by 2030.2 • Bacterial Vaginosis (BV) ² BV is the most common vaginal condition in women ages 15 to 44. It results from an overgrowth of bacteria, which upsets the balance of the natural vaginal microbiome and can lead to symptoms of odor and discharge. The global BV market is projected to grow from USD 4.06 billion in 2024 to USD 8.92 billion in 2031.3 • Trichomoniasis ³ Trichomoniasis is the most common non - viral STI in the world. The underlying parasite, Trichomonas vaginalis, affects both men and women. The global market is forecast to grow from USD 63.2 billion in 2022 to USD 90 billion by 2030.4 1. Grandview Research. U.S. Contraceptive Market Size, Share & Trends Analysis Report By Product (Pills, Intrauterine Devices (IUD), Condoms, Vaginal Ring, Subdermal Implants, Injectable), And Segment Forecasts, 2022 – 2030. 2. https:// www.transparencymarketresearch.com/women - health - therapeutics - market.html 3. https:// www.linkedin.com/pulse/bacterial - vaginosis - therapeutics - market - ed6yf/ 4. https:// www.databridgemarketresearch.com/reports/global - trichomoniasis - drugs - market OVERVIEW Options are sparse for women who do not want to use hormonal birth control products and would prefer to have more control with on - demand, topical products that do not exert systemic effects and are not impacted by other medications. CHALLENGE Proprietary Product • The only FDA - approved, hormone - free, on - demand prescription contraceptive vaginal gel • FDA - approved, single - dose antimicrobial agent • Complete course of therapy for bacterial vaginosis and Trichomoniasis © 2024 ADITXT, INC. Proposed acquisition, targeting late 2024 closing Evofem is a U.S. biopharma company commercializing innovative products to address unmet needs in women’s health.

THANK Y OU engagement@aditxt.com www.aditxt.com © 2 0 2 4 ADI T X T , IN C .

v3.24.2.u1

Cover	Sep. 09, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Sep. 09, 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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