Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 593

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 2
Chunk 593
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 our proprietary technology to develop novel therapies that are designed to cure cancer. Originally
formed as Shuttle Pharmaceuticals, LLC in 2012, our goal is to extend the benefits of cancer treatments by leveraging insights into cancer
therapy with surgery, radiation therapy, chemotherapy and immunotherapy. While there are several therapies being developed with the goal
of curing cancer, one of the most effective and proven approaches to this is RT. The Company is developing a pipeline of products designed
to address the limitations of the current standard of cancer therapies. We believe that our product candidates will enable us to deliver
cancer treatments that are safer, more reliable and at a greater scale than that of the current standard of care.

Operations
to date have focused on continuing our research 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, 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