Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 259

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1A
Chunk 259
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 Ropidoxuridine clinical testing and improved drug
formulation, to advance HDAC6 inhibitor (SP-2-225) preclinical development and explore application of the PC-RAD Test, predictive biomarkers
of radiation response. The clinical development of Ropidoxuridine has included completion of a Phase I clinical trial to establish drug
bioavailability and a maximum tolerated dose for use in Phase II clinical trials. TCG GreenChem, with whom we have contracted for process
research, development and cGMP compliant
manufacture of IPdR, has manufactured the API of Ropidoxuridine and the University of Iowa Pharmaceuticals has formulated the drug product
for use in the Company’s upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy. The drug product
(capsules) were shipped to CRO Theradex Oncology and distributed to clinical trial sites that are fully approved to enroll patients in
the trial. Shuttle received approval from the FDA to begin the clinical trial. The FDA made recommendations to expand the clinical trial
to include a randomized dose “optimization” step and we agreed with the recommendation. Meetings with engaged clinical sites
to review the protocol documents have occurred and FDA required IRB approvals have been received. With FDA recommended changes incorporated
into the revised protocol and the completion of site initiation visits, the Company has commenced its Phase II clinical study. The radiation
biomarker project and the health disparities project have been completed and the Company is proceeding with plans for clinical validation
and potential for commercialization of Ropidoxuridine as a radiation sensitizer.

57

Nasdaq
Listing Compliance

On
December 31, 2024, the Company received a letter from the Nasdaq Listing Qualifications Staff of The Nasdaq Stock Market LLC (“Nasdaq”)
stating that for the 30 consecutive business day period between November 15, 2024 to December 30, 2024 the Company’s common stock
had failed to maintain a minimum closing bid price of $1.00 per share, as required for continued listing on The Nasdaq Capital Market
pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). Pursuant to Nasdaq Listing Rule 5810(c)(3)(A),
the Company has until June 30, 2025 to regain compliance with the Minimum Bid Price Requirement. To regain compliance, the closing bid
price of the Company’s common stock must meet