SHPH 8-K
Shuttle Pharmaceuticals Holdings, Inc. (SHPH)
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, Shuttle Pharmaceuticals, Inc. (“Shuttle Pharma”), a wholly owned subsidiary of Shuttle Pharmaceuticals Holdings, Inc. (the “Company”), entered into a work order (the “Work Order”) with Theradex Systems, Inc., a New Jersey contract research organization (“CRO”), for purposes of supporting Shuttle Pharma’s “Phase 2 Study of Ropidoxuridine as a Radiation Sensitizing Agent During Radiotherapy in Patients with Newly Diagnosed IDH-Wildtype Glioblastoma with Unmethylated MGMT Promotor.” On January 23, 2025, Shuttle Pharma entered into a change order to the Work Order (the “Change Order”) effective as of February 1, 2025. Pursuant to the Change Order, the key changes include, among others, increasing the number of patients in Phase 2 from 15 to 16, due to inclusion of a replacement patient, increasing the number of sites in “Phase 2 - Start up” from four to six, and adding one more investigator site and safety teleconference per activity to allow for medical monitor review of safety data prior to the teleconference. Additionally, the Change Order includes several small increases in budget due to an increase in the number of sites within “Phase 2 – Start up” phase from four to six and a small increase in pass-through costs due to an increase in travel costs relating to additional site monitoring regulatory visits associated with the increased number of sites.
The foregoing description of the Change Order does not purport to be complete and is qualified in its entirety by reference to the full text of such agreement, the form of which is filed herewith as Exhibit 10.1 and is incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 10.1 | Change Order, dated January 23, 2025, between Shuttle Pharmaceuticals, Inc. and Theradex Systems, Inc.* | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
*Certain portions of this exhibit have been redacted because it (i) is not material and (ii) is the type of information that the company normally treats as private or confidential.
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. | ||
| Dated: January 28, 2025 | ||
| By: | /s/ Anatoly Dritschilo | |
| Name: | Anatoly Dritschilo | |
| Title: | Chief Executive Officer | |
Exhibit 10.1
Portions of this agreement have been redacted pursuant to Item 601(b)(10(iv).
Redactions are indicated with “[***]”
Change Order #1
to
Work Order #3
Theradex Systems, Inc. (hereinafter “Theradex Oncology”)
to assist
Shuttle Pharmaceuticals, Inc. (hereinafter “Shuttle”)
with the Scope of Work associated with:
Phase 2 Study of IPdR as a Radiation Sensitizing Agent During Radiotherapy in Patients with Newly Diagnosed IDH-Wildtype Glioblastoma with Unmethylated MGMT Promoter
17 January 2025
| Prepared For: | Michael Vander Hoek CFO and VP, Regulatory Shuttle Pharmaceuticals, Inc. 401 Professional Drive Suite 260 Gaithersburg, MD 20879 USA Email: [***] | |
| Prepared By: | [***] [***] The Pinnacle, Station Way Crawley West Sussex UK RH10 1JH Phone: [***] Email: [***] |
| Shuttle Pharmaceuticals, Inc. | |
| Work Order #3 Change Order #1: Phase 2 IPdR Glioblastoma study | 17 January 2025 |
Theradex Systems, Inc.
REQUEST FOR CHANGE ORDER #1 to
Work Order #3 to Master Service Agreement between
Shuttle Pharmaceuticals, Inc. and Theradex Systems, Inc.
| Date of Original Request: Nov 2024 | Change Order Number: 1 | Study: Phase 2 IPdR |
| Theradex Oncology Contact: Melchior Van De Visch | Theradex Client Code: 1274 | |
| Sponsor Contact: Michael Vander Hoek | ||
| Sponsor: Shuttle Pharmaceuticals, Inc. | ||
Theradex Oncology hereby requests the following changes to Shuttle Study Work Order #3 dated 30 July 2024, between Shuttle and Theradex Oncology:
This change order is submitted to account for changes in scope of the project described above. Where as WO#3 covered activities up to 31 January 2025 (Phase II Start up), CO#1 will cover activities up to 31 January 2026 (Phase II Start up and Phase II Year 2), with the total cost limited to $5,308,294. The following additional changes have been applied to the Theradex Oncology Project Budget compared with WO#3:
Key Changes:
| - | Number of patients in Phase II – Start up increased from 15 to 16, due to inclusion of a replacement patient. |
| - | Number of sites in “Phase II – Start up” increased from 4 to 6. |
| - | Investigator Site and Safety Teleconferences – Addition of 1 hour per activity to allow for medical monitor review of safety data prior to the teleconference. |
| - | Addition of activities relating to Protocol amendment version 2.0. |
| - | Addition of activities relating to Protocol amendment version 3.0. |
| - | Qualification visits (QVs): 1 On-Site QV removed from scope, 1 Remote QV added to scope in line with actuals. |
| - | Adjustment in the number of visits in Phase II – Year 2: |
|
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| Shuttle Pharmaceuticals, Inc. | |
| Work Order #3 Change Order #1: Phase 2 IPdR Glioblastoma study | 17 January 2025 |
| ○ | 1 Day On-Site RMV: Increased from 4 to 10. Overall an increase of 6, from 9 to 15. |
| ○ | 1 Day Remote RMV: Increased from 37 to 38. Overall an increase of 1, from 67 to 68. |
License fees:
| - | Small increase in budget due to increase in number of sites within Phase II – Start up phase from 4 to 6. This is due to two sites (UNC and Georgetown) being activated earlier than anticipated. |
Pass Through Costs:
| - | Small increase in Pass through costs due to increase in travel costs relating to additional RMV visits. |
Investigator Costs:
| - | Small increase in investigator fees. This increase is due to additional IRB fees and increase of one patient, as one patient had to be replaced in the study. |
The increase in labor cost associated with Change Order #1 has been incorporated into the milestone payment schedule. Three new milestones have been added to the schedule:
| - | Milestone 9: OOS items CO#1 (2 sites activated earlier in the study) |
| - | Milestone 9B: Protocol Amendment Version 2.0 |
| - | Milestone
10B: Protocol Amendment Version 3.0 |
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| Shuttle Pharmaceuticals, Inc. | |
| Work Order #3 Change Order #1: Phase 2 IPdR Glioblastoma study | 17 January 2025 |
Now, therefore, in consideration of the mutual promises contained in the agreement, in the WO#3 as modified from time to time and for other good and valuable consideration, the Parties hereto agree to enter into this Change Order #1 (“CO#1”) of the WO#3. This CO#1 is effective as of 1st of February 2025 (“CO#1 Effective Date”). Upon execution, this CO#1 shall be automatically incorporated into and subject to the terms of the Master Service Agreement.
The Parties agree that execution of this Change Order by industry standard electronic signature software and/or by exchanging PDF signatures shall have the same legal force and effect as the exchange of hand written signatures, and that in any proceeding arising under or relating to this Change Order, each Party hereby waives any right to raise any defense or waiver based upon execution of this Change Order by means of such electronic signatures or maintenance of the executed agreement electronically.
SIGNATURES
ON NEXT PAGE
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| Shuttle Pharmaceuticals, Inc. | |
| Work Order #3 Change Order #1: Phase 2 IPdR Glioblastoma study | 17 January 2025 |
ACKNOWLEDGED, ACCEPTED AND AGREED TO:
| Theradex Oncology: | ||
|
/s/ Margaret Valnoski |
||
Margaret Valnoski President / CEO Theradex Systems, Inc. |
Date
| |
|
Shuttle |
||
|
/s/ Michael P. Vander Hoek |
||
Michael P Vander Hoek VP, Regulatory Shuttle Pharmaceuticals, Inc. |
Date |
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| Work Order #3 Change Order #1: Phase 2 IPdR Glioblastoma study | 17 January 2025 |
Statement of Work
Section 1 – Project Assumptions:
| Lead-in Period | 5 months | |
| Enrollment Period | 24 months | |
| Average Duration of Patient Treatment | 2 months | |
| Data Lock | 2 months | |
| Clinical Study Report | 2 months | |
| Long-Term Follow Up | 18 months | |
| Total Study Duration | 53 months | |
| Number of Countries | 1 (US) | |
| Number of Sites | 6 sites | |
| Number of Patients Screened | 65 (20% screen failure rate) | |
| Number of Patients Enrolled | 55 |
Section 2 - Project Timeline:
| Task | Timeline | ||
| Estimated
Start Date |
Estimated
Completion Date | ||
| Start-up: Final Protocol to First Patient In (FPI) | 01 March 2024 | 31 July 2024 | |
| Recruitment: FPI to Last Patient In (LPI) | 01 August 2024 | 01 August 2026 | |
| Treatment: LPI to Last Patient Out (LPO) | 02 August 2026 | 01 October 2026 | |
| Database Lock: LPO to Database Lock | 02 October 2026 | 30 November 2026 | |
| Final Report: Draft Report to Final Report | 01 December 2026 | 31 January 2027 | |
| Long-Term Follow Up | 01 February 2027 | 31 July 2028 | |
| Total Timeline | 53 months | ||
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| Work Order #3 Change Order #1: Phase 2 IPdR Glioblastoma study | 17 January 2025 |
Theradex Oncology Project Budget
Budget Summary
[***]
Milestone Payment Schedule
[***]
Unit and Monthly Costs
[***]
License Fees
[***]
Pass Through Costs
[***]
Investigator Fees Overview
[***]
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