Company: SHPH
Filing Date: 2025-05-08
Form Type: 10-Q
Source: 0001641172-25-009325
Chunk: 1

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-05-08
Form: 10-Q
Item: Item 2
Chunk 1
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 and development efforts to advance Ropidoxuridine clinical testing and improved drug formulation,
to advance HDAC6 inhibitor (SP-2-225) preclinical development and explore the 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 our 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 thereafter 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,
we commenced our Phase II clinical study in October 2024. The Company’s radiation biomarker project and the health disparities project
have been completed and we are proceeding with plans for clinical validation and potential for commercialization of Ropidoxuridine as
a radiation sensitizer.

Nasdaq Listing Compliance

On
December 31, 2024, we 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 our 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), we have a period
of 180 calendar days, or until June 30, 2025 (the “Compliance Period”), to regain compliance with the Minimum Bid Price Requirement.
To regain compliance