Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 2

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 2
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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 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, Inc. (“TCG GreenChem”),
with whom we have contracted for process research, development and Good
Manufacturing Practices (“cGMP”) compliant manufacture of IPdR, has manufactured the
active pharmaceutical ingredient (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)
was shipped to contract research organization (CRO) Theradex Oncology and distributed to clinical trial sites that are fully approved
to enroll patients in the trial. The Company received approval from the FDA to begin the clinical trial, after which time 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 Institutional Review Board, or 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.

We
also worked with University of Iowa Pharmaceuticals to develop the formulation, produce the capsules, and which have been shipped to
Contract Research Organization (CRO) Theradex Oncology for distribution to clinical trial sites. Both activities have now been completed.
In addition, we received approval from the FDA to begin the clinical trial. The FDA made recommendations to expand the clinical trial
and the Company agreed with the recommendation. With this change incorporated into the revised protocol, the Company commenced its Phase
II clinical study with finalized agreements with all six of the planned site enrollment locations to administer the Phase II clinical
trial of Ropidoxuridine and has enrolled the first three patients in October 2024.

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