Commitments & Contingencies |
3 Months Ended | |||||||||||||||||||||||||||
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Mar. 31, 2026 | ||||||||||||||||||||||||||||
| Commitments & Contingencies [Abstract] | ||||||||||||||||||||||||||||
| COMMITMENTS & CONTINGENCIES | NOTE 10 – COMMITMENTS & CONTINGENCIES
License Agreement with Loma Linda University
On March 15, 2018, as amended on July 1, 2020, we entered into a LLU License Agreement directly with Loma Linda University.
Pursuant to the LLU License Agreement, we obtained the exclusive royalty-bearing worldwide license in and to all intellectual property, including patents, technical information, trade secrets, proprietary rights, technology, know-how, data, formulas, drawings, and specifications, owned or controlled by LLU and/or any of its affiliates (the “LLU Patent and Technology Rights”) and related to therapy for immune-mediated inflammatory diseases (the ADI™ technology). In consideration for the LLU License Agreement, we issued 1 share of common stock to LLU.
Pursuant to the LLU License Agreement, we are required to pay an annual license fee to LLU. Also, we paid LLU $455,000 in July 2020 for outstanding milestone payments and license fees. We are also required to pay to LLU milestone payments in connection with certain development milestones. Specifically, we are required to make the following milestone payments to LLU: $175,000 on June 30, 2022; $100,000 on September 30, 2024; $500,000 on September 30, 2026; and $500,000 on September 30, 2027. In lieu of the $175,000 milestone payment due on September 30, 2023, the Company paid LLU an extension fee of $100,000. The Company did not make the September 30, 2024 payment; the Company intends to obtain an extension for this payment. Upon payment of this extension fee, an additional year will be added for the September 30, 2023 milestone. Additionally, as consideration for prior expenses incurred by LLU to prosecute, maintain and defend the LLU Patent and Technology Rights, we made the following payments to LLU: $70,000 at the end of December 2018, and a final payment of $60,000 at the end of March 2019. We are required to defend the LLU Patent and Technology Rights during the term of the LLU License Agreement. Additionally, we will owe royalty payments of (i) 1.5% of Net Product Sales (as such terms are defined under the LLU License Agreement) and Net Service Sales on any Licensed Products (defined as any finished pharmaceutical products which utilizes the LLU Patent and Technology Rights in its development, manufacture or supply), and (ii) 0.75% of Net Product Sales and Net Service Sales for Licensed Products and Licensed Services (as such terms are defined under the LLU License Agreement) not covered by a valid patent claim for technology rights and know-how for a three (3) year period beyond the expiration of all valid patent claims. We also are required to produce a written progress report to LLU, discussing our development and commercialization efforts, within 45 days following the end of each year. All intellectual property rights in and to LLU Patent and Technology Rights shall remain with LLU (other than improvements developed by or on our behalf).
The LLU License Agreement shall terminate on the last day that a patent granted to us by LLU is valid and enforceable or the day that the last patent application licensed to us is abandoned. The LLU License Agreement may be terminated by mutual agreement or by us upon 90 days written notice to LLU. LLU may terminate the LLU License Agreement in the event of (i) non-payments or late payments of royalty, milestone and license maintenance fees not cured within 90 days after delivery of written notice by LLU, (ii) a breach of any non-payment provision (including the provision that requires us to meet certain deadlines for milestone events (each, a “Milestone Deadline”)) not cured within 90 days after delivery of written notice by LLU and (iii) LLU delivers notice to us of three or more actual breaches of the LLU License Agreement by us in any 12-month period. Additional Milestone Deadlines include: (i) the requirement to have regulatory approval of an IND application to initiate first-in-human clinical trials on or before September 30, 2023, which will be extended to September 30, 2024 with a payment of a $100,000 extension fee, (ii) the completion of first-in-human (phase I/II) clinical trials by September 30, 2024, which the Company is actively pursuing an extension, (iii) the completion of Phase III clinical trials by September 30, 2026 and (iv) biologic licensing approval by the FDA by September 30, 2027. The Company has not initiated clinical trials to date and the Company intends to obtain an extension to commence human trials. License Agreement with Leland Stanford Junior University
On February 3, 2020, we entered into an exclusive license agreement (the “February 2020 License Agreement”) with Stanford regarding a patent concerning a method for detection and measurement of specific cellular responses. Pursuant to the February 2020 License Agreement, we received an exclusive worldwide license to Stanford’s patent regarding use, import, offer, and sale of Licensed Products (as defined in the agreement). The license to the patented technology is exclusive, including the right to sublicense, beginning on the effective date of the agreement, and ending when the patent expires. Under the exclusivity agreement, we acknowledged that Stanford had already granted a non-exclusive license in the Nonexclusive Field of Use, under the Licensed Patents in the Licensed Field of Use in the Licensed Territory (as those terms are defined in the February 2020 License Agreement). However, Stanford agreed to not grant further licenses under the Licensed Patents in the Licensed Field of Use in the Licensed Territory. On December 29, 2021, we entered into an amendment to the February 2020 License Agreement which extended our exclusive right to license the technology deployed in AditxtScoreTM and securing worldwide exclusivity in all fields of use of the licensed technology.
We were obligated to pay and paid a fee of $25,000 to Stanford within 60 days of February 3, 2020. We also issued 1 share of the Company’s common stock to Stanford. An annual licensing maintenance fee is payable by us on the first anniversary of the February 2020 License Agreement in the amount of $40,000 for 2021 through 2024 and $60,000 starting in 2025 until the license expires upon the expiration of the patent. The Company is required to pay and has paid $25,000 for the issuances of certain patents. The Company will pay milestone fees of $50,000 on the first commercial sales of a licensed product and $25,000 at the beginning of any clinical study for regulatory clearance of an in vitro diagnostic product developed and a potential licensed product. The Company paid a milestone fee for a clinical study for regulatory clearance of an in vitro diagnostic product developed and a potential licensed product of $25,000 in March of 2022. We are also required to: (i) provide a listing of the management team or a schedule for the recruitment of key management positions by June 30, 2020 (which has been completed), (ii) provide a business plan covering projected product development, markets and sales forecasts, manufacturing and operations, and financial forecasts until at least $10,000,000 in revenue by June 30, 2020 (which has been completed), (iii) conduct validation studies by September 30, 2020 (which has been completed), (iv) hold a pre-submission meeting with the FDA by September 30, 2020 (which has been completed), (iv) submit a 510(k) application to the FDA, Emergency Use Authorization (“EUA”), or a Laboratory Developed Test (“LDT”) by March 31, 2021 (which has been completed), (vi) develop a prototype assay for human profiling by December 31, 2021 (which has been completed), (vii) execute at least one partnership for use of the technology for transplant, autoimmunity, or infectious disease purposes by March 31, 2022 (which has been completed) and (viii) provided further development and commercialization milestones for specific fields of use in writing prior to December 31, 2022.
In addition to the annual license maintenance fees outlined above, we will pay Stanford royalties on Net Sales (as such term is defined in the February 2020 License Agreement) during the term of the agreement as follows: 4% when Net Sales are below or equal to $5 million annually or 6% when Net Sales are above $5 million annually. The February 2020 License Agreement may be terminated upon our election on at least 30 days advance notice to Stanford, or by Stanford if we: (i) are delinquent on any report or payment; (ii) are not diligently developing and commercializing Licensed Product; (iii) miss certain performance milestones; (iv) are in breach of any provision of the February 2020 License Agreement; or (v) provide any false report to Stanford. Should any events in the preceding sentence occur, we have a thirty (30) day cure period to remedy such violation.
Appili Termination
The Parties terminated the Arrangement Agreement effective May 31, 2025. In connection with the termination of the Arrangement Agreement, the Company is required to pay a $1,250,000 termination fee (the “Appili Termination Fee”). As of March 31, 2026, there is $650,000 remaining of the Appili Termination Fee. The Appili Termination Fee is recorded in general and administrative expenses. Acquisition of Ignite Proteomics, LLC
On March 11, 2026, the Company entered into a Securities Purchase Agreement (the “Ignite Agreement”) with IMAC Holdings, Inc. (“IMAC”) and the several investors listed on the Schedule of Buyers attached to the Agreement (collectively, the “Ignite Buyers”) whereby the Ignite Buyers sold 100% of their equity interests in Ignite Proteomics, LLC, a Delaware limited liability company (“Ignite”) and formerly a wholly owned subsidiary of IMAC plus $475,000 in cash, for a total consideration of 36,000 shares of the Company’s newly created Preferred A-2 Shares. The stated value of the Preferred A-2 Shares is $1,000 per share for a total of $36,000,000 in preferred stock. The equity interests of Ignite purchased by the Company under the Ignite Agreement represent 100% of the issued and outstanding equity of Ignite. As of the date of this filing, the Company is still determining the financial statement impact of the transaction. (Note 6)
The Preferred A-2 Shares are convertible into shares of Common Stock. If, as of the first anniversary of the Closing Date (as defined in the Ignite Agreement), the Conversion Price (as defined in the Certificate of Designation for the Preferred A-2 Shares) is less than the Market Price (as defined in the Ignite Agreement), the Company shall provide each stockholder entitled to vote at the next annual meeting of stockholders of the Company a proxy statement soliciting each such stockholder’s affirmative vote at the stockholder meeting for approval to change the amount of the Conversion Price to such lower number. If the stockholders do not approve changing the Conversion Price, the Company will again recommend approval of the new Conversion Price at each succeeding annual meeting of stockholders until such approval is obtained.
Following the closing of the transaction, Ignite’s financial statements as of the closing date were consolidated with the Consolidated Financial Statements of the Company.
The following presents the consideration paid for the acquisition of Ignite and the purchase price allocation.
Legal Proceedings
The Company is party to various actions and claims arising in the normal course of business, including the below Vertalo Action. The Company does not believe that the final outcome of these matters will have a material adverse effect on the Company’s financial position or results of operations. In addition, the Company maintains what it believes is adequate insurance coverage to further mitigate risk. However, no assurance can be given that the final outcome of such proceedings will not materially impact the Company’s financial condition or results of operations. Further, no assurance can be given that the amount or scope of existing insurance coverage will be sufficient to cover losses arising from such matters.
Vertalo Action
On February 3, 2026, Vertalo, Inc. (“Vertalo”) filed an Original Petition against the Company in the District Court of Travis County, Texas (98th Judicial District), Cause No. D-1-GN-26-000795. The complaint follows Aditxt terminating their agreement with Vertalo for material breach. Vertalo’s complaint asserts claims for breach of contract and seeks, among other relief, alleged unpaid fees of $300,000, warrants to acquire 6,250 shares of Aditxt common stock, $26,000 of alleged travel-related costs, additional alleged damages of at least $500,000, attorneys’ fees, and interest. Notably, Vertalo did not serve the Company in this matter and thus proceedings have not commenced. Aditxt disputes the allegations and in the event proceedings do commence, Aditxt intends to defend the matter vigorously, pursue counterclaims and pursue available claims and defenses. Based on information available to the Company at present, the Company cannot reasonably estimate a range of loss for this potential action We cannot predict the outcome of this dispute with certainty. Regardless of the outcome, this action could have an adverse impact on the Company due to legal costs, diversion of management resources, and other factors. |
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