Company: SHPH
Filing Date: 2025-01-24
Form Type: 424B3
Source: 0001493152-25-003508
Chunk: 237

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-01-24
Form: 424B3
Chunk 237
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 Nasdaq informing the Company that it has regained compliance with the Bid Price Requirement for continued listing on the Nasdaq Capital Market.

FDA Approval to Proceed with Phase II study of Ropidoxuridine (IPdR)

On January 8, 2024, Shuttle Pharmaceuticals Holdings, Inc., a Delaware corporation (the “Company”), issued a press release announcing that the Company had received the “Safe to Proceed” letter from the U.S. Food and Drug Administration for the Company’s investigational new drug (IND) application for its Phase II study of Ropidoxuridine (IPdR) as a radiation sensitizing agent during radiotherapy in patients with newly diagnosed IDH-wildtype glioblastoma with unmethylated MGMT promoter. Receipt of the letter allows Shuttle to commence the Phase II study and, as a result, the Company is currently finalizing site enrollment with “first patient, first dose” expected in the coming months.The Phase II clinical trial was also approved by the Institutional Review Board “IRB”
on June 21, 2024.

On August 8, 2024, 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 the Company’s Phase II Study of Ropidoxuridine as a Radiation Sensitizing Agent During Radiotherapy in
Patients with Newly Diagnosed IDH-Wildtype Glioblastoma with Unmethylated MGMT Promotor.” As such, Shuttle Pharma is now in the
process of signing up six clinical sites where the clinical studies will be performed – two of which have completed initial site
initiation visits and one of which is ready to enroll patients – and where the CRO will oversee such studies.

Under the terms of the Work
Order, the CRO will oversee the studies for a period of 53 months (the “Term”), including overseeing and monitoring the regulatory
aspects of the Phase II clinical trial, and managing the documentation surrounding the clinical trial in exchange for a fee of approximately
$2.3 million, payable in stages and based upon services performed during the Term of the study.

Rights Offering

Effective February 7, 2024, the Company and its wholly-owned subsidiary, Shuttle Diagnostics, Inc., entered into a securities purchase agreement (the “Purchase Agreement”) with SRO, LLC, a Nevada limited liability company, pursuant to which SRO LLC agreed to commit