SHPH Shuttle Pharmaceuticals Holdings 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): January 23, 2025

 

SHUTTLE PHARMACEUTICALS HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware		001-41488		82-5089826
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

401 Professional Drive, Suite 260

Gaithersburg, MD 20879

(Address of principal executive offices) (Zip Code)

 

(240) 430-4212

(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
Common Stock $0.00001 per share		SHPH		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 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 1^st 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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Shuttle Pharmaceuticals, Inc.
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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Shuttle Pharmaceuticals, Inc.
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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v3.24.4

Cover	Jan. 23, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 23, 2025
Entity File Number	001-41488
Entity Registrant Name	SHUTTLE PHARMACEUTICALS HOLDINGS, INC.
Entity Central Index Key	0001757499
Entity Tax Identification Number	82-5089826
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	401 Professional Drive
Entity Address, Address Line Two	Suite 260
Entity Address, City or Town	Gaithersburg
Entity Address, State or Province	MD
Entity Address, Postal Zip Code	20879
City Area Code	(240)
Local Phone Number	430-4212
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock $0.00001 per share
Trading Symbol	SHPH
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false

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