UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 1.01. Entry into a Material Definitive Agreement.
As previously disclosed by the Company in its Current Report on Form 8-K, filed with the U.S. Securities and Exchange Commission (the “SEC”) on October 21, 2025, on October 15, 2025, Shuttle Pharmaceuticals Holdings, Inc. (the “Company”) received a letter from Theradex Systems, Inc. (“Theradex”), providing written notice of termination of the master agreement, dated November 1, 2018 (the “Master Agreement”), between Shuttle Pharmaceuticals, Inc. (the Company’s wholly-owned subsidiary) and Theradex, and all work orders thereunder.
Pursuant to the notice of termination, on November 20, 2025, the Company and Theradex entered into a release and settlement agreement (the “Settlement Agreement”), pursuant to which the Company will pay a partial payment of $300,000 to Theradex as full and final payment of any and all claims relating to the debt or obligation previously owed by the Company to Theradex, totalling approximately $557,000 (the “Outstanding Liabilities”) and in consideration of such payment, each party will release, acquit and discharge each other from all claims arising from the Outstanding Liabilities and Theradex will properly wind down the Clinical Trials (as defined below) in a manner compliant with the Food and Drug Administration. After the payments pursuant to the Settlement Agreement, the Company will still owe amounts, under five separate research site agreements between the Company and various hospitals, as disclosed in the Settlement Agreement. The Company currently estimates these amounts to be approximately $750,000.
Item 1.02. Termination of a Material Definitive Agreement.
The information set forth above under Item 1.01 of this Current Report on Form 8-K is incorporated herein by reference.
Item 2.05. Costs Associated with Exit or Disposal Activities.
The information set forth above under Item 1.01 of this Current Report on Form 8-K is incorporated herein by reference.
On November 20, 2025, in light of the foregoing, the Company committed to a plan to discontinue its clinical trials of Ropidoxuridine (the “Clinical Trials”), as provided for under the Master Agreement. The Company expects to immediately end enrollment and initiate winddown activities for the Clinical Trials, with full completion of winddown activities expected to occur as soon as practicable in a manner compliant with the requirements of the Food and Drug Administration.
As a result of the termination of the Clinical Trials, the Company expects to incur additional expenses related to trial closeout activities. The Company is currently assessing and estimating these costs and expects that the vast majority of these charges will be recorded in the fourth quarter of 2025.
The costs that the Company expects to incur in connection with the foregoing are subject to a number of assumptions, and actual results may materially differ. The Company may also incur other costs or charges not currently contemplated as a result of, or associated with, the foregoing events.
Item 2.05 contains “forward-looking” statements and estimates, including anticipated winddown costs. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether the Company will successfully winddown the Clinical Trials and other risks detailed in the “Risk Factors” section of the Company’s most recent periodic report filed with the SEC. These statements represent the Company’s estimates and assumptions only as of the date of this Current Report on Form 8-K. The Company does not undertake any obligation to update publicly any such forward-looking statements, even if new information becomes available.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
Description | |
| 10.1 | Release and Settlement Agreement, by and between Shuttle Pharmaceuticals Holding, Inc. and Theradex Systems, Inc., dated November 20, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the inline 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.
| SHUTTLE PHARMACEUTICALS HOLDINGS, INC. | ||
| Date: November 21, 2025 | By: | /s/ Christopher Cooper |
| Christopher Cooper | ||
| Interim Chief Executive Officer | ||
Exhibit 10.1
RELEASE AND SETTLEMENT AGREEMENT
(Partial Payment Accepted as Payment in Full)
This Release and Settlement Agreement (“Agreement”) is made and entered into on the day of November 20, 2025, by and between:
Creditor: Theradex Systems, Inc.
Address: 4365 Rte. 1 South, Ste 101, Princeton, NJ 08540
and
Debtor: Shuttle Pharmaceuticals Holding, Inc.
Address: 401 Professional Dr., Ste 260 Gaithersburg, MD 20879
Each referred to as a “Party” and Collectively referred to as the “Parties.”
1. Purpose of Agreement
The Parties desire to settle and fully resolve any and all claims relating to the debt or obligation previously owed by Debtor to Creditor, which the Parties agree had an outstanding balance of more than $ 557,000. USD
2. Settlement Payment
Creditor acknowledges receipt, or agrees to accept, a partial payment of $300,000 USD (“Settlement Payment”) from Debtor.
Creditor agrees that this Settlement Payment is accepted as full and final payment of the entire debt or obligation referenced above.
3. Release of Claims
In consideration of Settlement Payment, the Theradex hereby fully and forever releases, acquits, and discharges Shuttle, its officers and directors, management current and previous from:
| ● | any and all amounts previously owed relating to the debt; | |
| ● | any future claims, demands, damages, liabilities, actions, or causes of action of any kind relating to the debt; | |
| ● | all rights to further collection or enforcement of the debt. |
In consideration of the Settlement Payment, Theradex agrees to properly wind down and close the Clinical Trial attached to this debt in an FDA compliant manner within their capabilities as the sponsor representative, including, but not limited to:
| ● | IRB payment & notification, and Primary Investigator notifications, site closure, list of unfinished tasks outside the scope of this agreement that Shuttle shall handle and database transfer to Shuttle with all actions completed in an FDA compliant manner. | |
| ● | Theradex will complete these obligations within 75 days, any FDA responsibilities extending beyond 75 days will solely be the responsibility of Shuttle Pharmaceuticals Holding, Inc. | |
| ● | After 75 days, Shuttle Pharmaceutical Holding, Inc. will be responsible for all communications with FDA. | |
| ● | Shuttle Pharmaceuticals Holding, Inc. will direct Theradex where to destroy or ship the remaining drug supply or incur additional storage costs after 75 days. | |
| ● | Shuttle will be responsible to close or inactivate their IND after the study and investigational sites are closed. |
In consideration of the Settlement Payment, Shuttle hereby fully and forever releases, acquits, and discharges Theradex, its officers and directors, management current and previous from:
| ● | any and all amounts previously owed relating to the debt; | |
| ● | any future claims, demands, damages, liabilities, actions, or causes of action of any kind relating to the debt; | |
| ● | all rights to further collection or enforcement of the debt. |
This release is intended to be complete. This Agreement excludes the five hospital research site agreements directly between Shuttle and the hospital research sites:
| ● | Hackensack University Medical Center / John Theurer Cancer Center |
| ○ | Deric Park, MD, FACP |
| ● | Miami Cancer Institute |
| ○ | Robert Press, MD |
| ● | Allegheny General Hospital |
| ○ | Rodney E. Wegner |
| ● | University of Virginia |
| ○ | David Schiff, MD |
| ● | Georgetown University/ Lombardi Cancer Center |
| ○ | Matthew Witek, MD |
| ● | University of North Carolina |
| ○ | Collette Shen, MD |
4. No Admission of Liability
This Agreement does not constitute an admission of fault or liability by either Party. It is entered into solely for the purpose of compromise and settlement.
5. Binding Effect
This Agreement is binding upon and shall inure to the benefit of the Parties and their respective heirs, successors, and assigns.
6. Entire Agreement
This document contains the entire agreement between the Parties concerning the matters described herein and supersedes all prior discussions or agreements.
7. Governing Law
This Agreement shall be governed by and interpreted in accordance with the laws of the State of New York.
8. Acknowledgment
Each Party acknowledges that they have read and understand this Agreement, voluntarily accept its terms, and have had the opportunity to obtain legal counsel. Each Party participated in the negotiation and drafting of this Agreement, assisted by such legal counsel as it desired, and contributed to its revisions. Any ambiguities with respect to any provision of this Agreement will be construed fairly as to all Parties and not in favor of or against any Party. The headings of Sections are provided for convenience only and will not affect the construction or interpretation of this Agreement.
9. Intellectual property and Ownership
No transfer of ownership or intellectual property shall occur under this agreement, and each party shall retain all rights to its respective intellectual property. Title and ownership of intellectual property and all property shall remain with the party that owns it.
Signatures
| Theradex: |
| Signature: _________________________________________ |
| Printed Name: ______________________________________ |
| Date: _____________________________________________ |
| Shuttle: |
| Signature: _________________________________________ |
| Printed Name: ______________________________________ |
|
Date: _____________________________________________ |