UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
|
(I.R.S. Employer Identification No.) |
(Address of principal executive offices, including ZIP code)
(
(Registrant’s telephone number, including area code)
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 | ||
| The |
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 1.01 Entry into a Material Definitive Agreement
On March 5, 2025, Aditxt, Inc. (the "Company") entered into a Settlement Agreement (the "Settlement Agreement") with Aldevron, LLC to resolve certain disputes arising from previously issued invoices under existing services agreements. Pursuant to the Settlement Agreement, the Company will pay $1 million and issue a Promissory Note (the “Note”) in the principal amount of $824,371.06 (the “Principal Amount”). The Principal Amount will not bear interest unless it is not repaid in full by its maturity date on May 16, 2025, in which case interest will accrue at a rate of one and one-half percent (1.5%) per annum.
The foregoing descriptions of the Settlement Agreement and the Note are not complete and are qualified in their entirety by reference to the full text of the Settlement Agreement and the form of Note, copies of which are filed as Exhibit 10.1 and Exhibit 10.2, respectively, to this Current Report on Form 8-K and are incorporated by reference herein.
Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant
The information relating to the Note included in Item 1.01 is incorporated by reference in this item to the extent required.
Item 7.01 Regulation FD Disclosure
On March 6, 2025, the Company issued a press release announcing an update on its subsidiary, Adimune, Inc. and its progress in advancing ADI-100. A copy of the press release is furnished to this Current Report on Form 8-K as Exhibit 99.1.
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 | |
| 10.1 | Settlement Agreement dated March 5, 2025 | |
| 10.2 | Form of Promissory Note | |
| 99.1 | Press release dated March 6, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the XBRL document) |
-1-
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: March 6, 2025
| Aditxt, Inc. | ||
| By: | /s/ Amro Albanna | |
| Name: | Amro Albanna | |
| Title: | Chief Executive Officer | |
-2-
Exhibit 10.1
SETTLEMENT AGREEMENT
This Settlement Agreement (the “Settlement Agreement”) is entered into as of the date of the last party’s signature below (“Effective Date”), between Aditxt, Inc. (“Aditxt”) and Aldevron, LLC (“Aldevron”) (collectively, referred to as the “Parties”).
WHEREAS, Aditxt and Aldevron entered into a Services Agreement, dated March 28, 2022, as amended (“MSA” and together with any amendments thereto and proposals and statements of work thereunder, and any other agreements between the Parties, the “Agreements”); and
WHEREAS, the Parties desire to settle Invoice IF071391: $1,766,529.06 and Invoice IF083791: $57,842 issued under the Agreements (the “Invoices”).
NOW THEREFORE, in consideration of the mutual covenants and agreements contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
AGREEMENT
| 1. | Amount Owed: The Parties agree that Aditxt owes Aldevron a total of $1,824,371 (“Amount Owed”) under the Invoices. |
| 2. | Return of Materials: Aldevron agrees to ship all vials of GMP materials 159822 and 159823, including any unused stability vials (the “Materials”) within fourteen days of the Cash Payment date, as defined below, via overnight courier with tracking and insurance, at Aldevron's expense and risk until delivery to Aditxt's designated facility. |
| 3. | Payment Terms: The Amount Owed shall be paid by (1) a payment of $1 million (the “Cash Payment”) and (2) a promissory note in the form attached hereto as Exhibit A in the amount of $824,371 (the “Promissory Note”). The Cash Payment shall be made within one (1) business day of the Effective Date. The Promissory Note shall be executed and delivered by Aditxt within five (5) business days of receipt of the Materials, after satisfactory inspection by Aditxt has taken place. |
| 4. | Completion of Work: Aldevron agrees to deliver the stability and quality testing data deliverables pursuant to invoice IF083791 within ten (10) days of repayment of the Promissory Note. Failure to make such delivery will require Aldevron to repay Aditxt the full amount of $57,842 within fifteen (15) days of repayment of the Promissory Note. |
| 5. | No Admission of Liability: This Settlement Agreement reflects the Parties’ compromise and settlement of all differences, disagreements, and disputes arising out of or relating to the Parties’ respective rights, obligations, and performances under the Invoices. No part of this Settlement Agreement constitutes, or shall be deemed to constitute, an admission or recognition in any way by any Party, or any of their parents, subsidiaries, or affiliates, that they have breached any contractual obligation, committed any violation of any law, or engaged in any other type of improper conduct. This Settlement Agreement, its provisions, and all related drafts, communications, and discussions, cannot be construed as or deemed to be evidence of an admission or concession by any Party of any wrongdoing, and cannot be offered or received into evidence or requested in discovery in any action or proceeding (including, but not limited to any civil, criminal, or administrative proceeding) as evidence of an admission, concession, or presumption regarding such matters. |
| 6. | Governing Law: This Agreement shall be governed and construed in accordance with the procedural and substantive laws of the state of New York. Any litigation arising under this Agreement shall be brought only in the courts of the city and state of New York or the courts of the United States which are situated in the city and state of New York and Parties consent to and confer personal jurisdiction upon the courts of the State of New York or the courts of the United States which are situated in the State of New York, and expressly waives any objections as to venue in any such courts. |
| 7. | Confidentiality: The provisions of this Settlement Agreement will be held in strictest confidence by the Parties and will not be publicized or disclosed by the Parties in any manner whatsoever; provided, however, that: (a) either Party may disclose this Settlement Agreement in confidence to its attorneys, accountants, tax preparers, and financial advisors; (b) either Party may disclose this Settlement Agreement insofar as such disclosure may be necessary to enforce the terms of the Settlement Agreement or as otherwise required by law; and (c) and Aditxt may make any disclosures required by securities laws or regulations, including SEC filing requirements. |
| 8. | Miscellaneous: It is understood and expressly agreed by both Parties that this is a compromise settlement of a dispute, the liability of which has been and hereby is expressly denied by both. This Settlement Agreement contains the entire agreement between the Parties with respect to the settlement of the dispute related to the Invoices, and no representations not contained herein shall be admissible to establish the inducement of this settlement or the execution of this Settlement Agreement. In the event of any conflict between the Agreements with regard to the Invoices and the terms set forth in this Settlement Agreement, the terms of this Settlement Agreement shall prevail. |
| 9. | Authorization: The Parties have all the necessary power and authority to execute, deliver, perform, and comply with all terms of this Settlement Agreement. |
| 10. | Counterparts: This Settlement Agreement may be executed in counterparts, each of which constitutes an original, but all of which together constitute one and the same instrument. Several signature pages may be collected and annexed to one or more documents to form a complete counterpart. Photocopies, facsimiles, and/or PDFs of executed copies of this Settlement Agreement may be treated as originals. |
[Rest of page intentionally left blank]
2
IN WITNESS WHEREOF, the Parties have duly authorized and caused this Settlement Agreement to be executed as of the Effective Date by their duly authorized representatives.
| Aditxt, Inc. |
Aldevron, LLC | |||
| By: | /s/ Amro Albanna | By: | /s/ Courtney Dubois | |
| Name: | Amro Albanna | Name: | Courtney Dubois | |
| Title: | Chief Executive Officer | Title: | Chief Financial Officer | |
| Date: | March 5, 2025 | Date: | March 5, 2025 | |
3
Exhibit A
Promissory Note
4
Exhibit 10.2
PROMISSORY NOTE
| $824,371.06 | Date: [ ], 2025 |
FOR VALUE RECEIVED, Aditxt, Inc., a Delaware corporation, (“Maker”) promises to pay to Aldevron, LLC a Delaware corporation, the principal sum of Eight Hundred Twenty Four Thousand Dollars and Six Cents ($824,371.06) (the “Principal Amount”), at the terms set forth below:
1. Interest. The Principal Amount shall not bear interest unless the Principal Amount is not repaid by the Maturity Date, in which case interest shall accrue from and after the Maturity Date at the rate of 1.5% per annum. All interest payable under this Note shall be computed on the basis of a three hundred sixty five (365) day year for the actual number of days elapsed.
2. Term and Manner of Payments. The Principal Amount under this Note shall be due and payable in full on May 16, 2025 (the “Maturity Date”).
3. Event of Default. The Maker shall not be considered in default under this Note until sixty (60) days after the Maturity Date.
4. Representations and Warranties of Holder
In order to induce the Maker to enter into and issue this Note to the Holder, the Holder hereby represents and warrants to, and agrees with, the Maker that:
(a) The Note will be acquired for investment for the Holder’s own account, not as a nominee or agent, and not with a view to the public resale or distribution thereof within the meaning of the 1933 Act, and the Holder has no present intention of selling, granting any participation in, or otherwise distributing the same.
(b) The Holder is an “accredited investor” under Rule 501 of Regulation D promulgated under the Act.
5. Subordination.
(a) Anything in this Note to the contrary notwithstanding, the payment of the principal amount of and interest on this Note and all other amounts payable by Maker hereunder (all of the foregoing, the “Subordinated Obligations”) shall be subordinate and junior to and subject in right of payment to the payment in full of all other debt for borrowed money of Maker (the “Senior Debt”).
(b) Anything in this Note to the contrary notwithstanding, in the event of the institution of any bankruptcy or other insolvency proceeding relative to Maker, then (i) the holders of Senior Debt shall be entitled to receive payment in full of all Senior Debt before any payments are made on account of the Subordinated Obligations; and (ii) any payment or distribution of any kind or character and from whatever source, whether in cash, property or securities, by setoff or otherwise, which may be payable or deliverable in such proceedings in respect of the Subordinated Obligations shall (notwithstanding any other provision of this Note) be paid or delivered by the maker of such payment or distribution, whether a trustee in bankruptcy, a receiver, a liquidating trustee, or otherwise, directly to the holders of the Senior Debt to the extent necessary to make payment in full of all Senior Debt remaining unpaid.
6. Governing Law. This Note shall be governed by and construed under the laws of the State of New York, without reference to principles of conflict of laws or choice of laws. Any litigation arising under this Note shall be brought only in the courts of the city and state of New York or the courts of the United States which are situated in the city and state of New York and Parties consent to and confer personal jurisdiction upon the courts of the State of New York or the courts of the United States which are situated in the State of New York, and expressly waives any objections as to venue in any such courts.
7. Transfer. Neither this Note nor any rights hereunder may be assigned, conveyed or transferred, in whole or in part, without the Maker’s prior written consent, which the Maker may withhold in its sole discretion. Subject to the foregoing, the rights and obligations of the Maker and Holder under this Note shall be binding upon and benefit their respective permitted successors, assigns, heirs, administrators and transferees.
| MAKER: | ||
| Aditxt, Inc., | ||
| a Delaware corporation | ||
| By: | ||
| Name: | Amro Albanna | |
| Title: | Chief Executive Officer | |
| HOLDER: | ||
| Aldevron, LLC, | ||
| a New Hampshire limited liability company | ||
| By: | ||
| Name: | Courtney Tornow | |
| Title: | Chief Financial Officer | |
Exhibit 99.1
Aditxt Subsidiary Adimune to Ship Drug Substances for Final Drug Product Formulation of ADI-100 Ahead of Planned Clinical Trials in Type 1 Diabetes and Psoriasis in Germany, and Stiff Person Syndrome at the Mayo Clinic in the U.S.
MOUNTAIN VIEW, Calif., March 6, 2025--(BUSINESS WIRE)--Aditxt, Inc. (NASDAQ: ADTX) (“Aditxt” or the “Company”), a social innovation platform dedicated to accelerating promising health innovations, today provided an update on its subsidiary, Adimune, Inc., (“Adimune”) and its progress in advancing ADI-100, an investigational product candidate to be studied in patients with Psoriasis, Type I Diabetes (T1D) and Stiff Person Syndrome.
Adimune’s mission is to address the root causes of autoimmune diseases. By harnessing the body’s natural ability to restore and maintain immune tolerance, Adimune strives to deliver innovative solutions that improve lives without the risks of immunosuppression.
As a subsidiary of Aditxt, Adimune continues to advance its novel immune modulation therapy, the ADI platform, for autoimmune diseases toward first-in-human clinical trials. Aditxt provides critical support, resources, and infrastructure to drive regulatory and clinical progress, helping move ADI-100, its first product candidate based on the ADI platform, into its next phase of development with a focus on demonstrating safety and efficacy in autoimmune disease treatment.
Status Update
All preclinical studies of Adimune’s first product candidate, ADI-100, have been completed, and the shipment of the drug substances for final drug product formulation are planned for March. These studies have provided several data points supporting the potential effectiveness of ADI-100 in restoring durable tolerance over the 10-month duration of the T1D studies both in prevention and treatment study designs. Preclinical safety and toxicology studies have shown absence of drug toxicity, no antibody formation to the drug product, and a lack of persistence in all organs evaluated. Furthermore, Adimune has demonstrated in three separate preclinical studies that ADI-100 does not impair the responsiveness of the immune system to combat infection, cancer, or the tumor fighting capabilities of checkpoint inhibitors.
Good Manufacturing Process (GMP) clinical-grade drug substances have been successfully manufactured by a qualified contract manufacturer. Upon shipment, the clinical grade drug substances will be formulated into the final drug product, ready for stability testing, and use in the clinical trials pending required regulatory submissions. Lastly, two remaining drug product release assays specifically designed for ADI-100 are in the final stages of validation to be used once the final drug product is ready.
Preclinical and manufacturing data, including the clinical-grade drug substance, are essential components of the complete dossier that we intend to submit to the regulatory agencies, which evaluate the safety and quality of the final drug product to be administered in the clinical trials. Adimune has had pre-submission meetings with the regulatory agency in Germany and has completed the additional studies requested.
For the clinical trials that are planned in Germany, Adimune has engaged with a Contract Research Organization (CRO) to manage the process, including site selection. In parallel, Adimune is working with the Mayo Clinic to prepare the IND package for FDA submission and is awaiting a pre-IND meeting expected in the second quarter of this year to review the package before full submission.
“Adimune is committed to developing a transformative approach to autoimmunity—one that focuses on restoring immune tolerance rather than suppressing the immune system,” said Dr. Friedrich Kapp, Co-CEO of Adimune. “With the shipment of ADI-100 drug substance soon underway, we are moving toward clinical trials and remain focused on executing the necessary steps to ensure the highest standards of safety, efficacy and regulatory compliance. We are completing key milestones that will allow us to advance the ADI-100 drug product into human studies and bring us closer to a potential paradigm shift in autoimmune disease treatment.”
Amro Albanna, Co-Founder, Chairman and CEO of Aditxt, added, “This milestone underscores the significant progress Adimune has made in bringing ADI and ADI-100 to the clinic, with the shipment of the drug substance marking a critical step in that journey. Adimune exemplifies Aditxt’s mission of identifying and accelerating disruptive health innovations. By providing the support and infrastructure needed to advance ADI-100 toward clinical trials, we are reinforcing our commitment to addressing autoimmune diseases as one of the most pressing health challenges we face today.”
About ADI-100
ADI-100 is an investigational, 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. A key target of ADI-100 is Glutamic Acid Decarboxylase (GAD), an enzyme implicated in Type 1 Diabetes, Stiff Person Syndrome, and several other autoimmune conditions. This approach is designed to 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 DNA molecule that encodes a pro-apoptotic protein (BAX), which has been shown in preclinical models to induce localized apoptotic cell death leading to recruitment of key immune cells called dendritic cells combined with a methylated 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 is designed to tolerize to GAD, which is a target of autoimmunity, directly or indirectly involved in Type 1 diabetes, psoriasis, and certain central nervous system 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, 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.
-2-
About Aditxt
Aditxt, Inc.® is a social innovation platform dedicated to accelerating promising health innovations. Aditxt’s ecosystem of research institutions, industry partners and shareholders collaboratively drive 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. On Dec. 23, 2024, Evofem announced the cancellation of its special stockholders meeting and the withdrawal of the merger proposal with Aditxt from consideration by the stockholders. 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.
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.
Corporate Communications
Jeff Ramson, PCG Advisory
T: 646-863-6893
jramson@pcgadvisory.com
-3-