Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 14

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 14
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requested and received FDA orphan drug status for Ropidoxuridine as a clinical radiation sensitizer for treatment of glioblastoma and
pre-operative treatment of soft tissue sarcomas. As a result, the application for “orphan” designation for Ropidoxuridine
with RT for glioblastoma has been approved. The application for sarcomas, however, was not approved and will require addressing certain
FDA comments and resubmission. The IPdR/TPI formulation clinical plan will focus on resectable stage II and III rectal cancer patients.

Our
clinical plan for Ropidoxuridine development as implemented to date, includes:

    ●
    GMP
    manufacture and formulation of 24 kg of Ropidoxuridine for use in clinical trials has been completed.

    ●
    The
    IND for a Phase II clinical trial of Ropidoxuridine and RT in glioblastoma has been approved for the study to proceed.

    ●
    The
    contract research organizations (CRO), Theradex Oncology has been engaged to assist in the performance the Phase II clinical trial.

    ●
    Completion
    of the Phase II clinical trial in glioblastomas to determine appropriate dosing, effectiveness and tolerability of the treatment.

The
data obtained from the NIH/NCI SBIR funded Phase I clinical trial supported efforts to raise capital to enable performing the Phase II
clinical trials of Ropidoxuridine. We aim to conduct and complete the Phase II clinical trial so that we may present data to the FDA
for its determination of efficacy. We believe this will support our efforts to raise the additional required capital to complete Phase
II and to fund the Phase III clinical trials and seek FDA approval of an NDA with “orphan” designation.

The
clinical plan for the IPdR/TPI formulation will focus on resectable Stage II and Stage III rectal cancer patients and on recurrent glioblastoma
treated with proton therapy. Nonetheless, we cannot guarantee the successful completion of any of these trials. Our inability to meet
any of the aforementioned milestones in the Phase II or Phase III clinical trials will cause us to be unable to proceed with our present
efforts and will likely cause us to be unable to raise additional funds.

11

Our
HDAC Small Molecule Delivery Platform

General

Since
the founding of Shuttle Pharma, our discovery research and development efforts have been focused on our