Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
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Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
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We
are a clinical stage pharmaceutical company leveraging our proprietary technology to develop novel therapies designed to cure cancers.
Our goal is to extend the benefits of cancer treatments with surgery, radiation therapy, chemotherapy and immunotherapy. Radiation therapy
(“RT”) is one of the most effective modalities for treating cancers. We are developing a pipeline of products designed to
address the limitations of the current cancer therapies as well as to extend to the new applications of RT. 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.

The
corporate structure is based on Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq SHPH – a Delaware company) serving as a holding
company with drug discovery and development performed in the Company’s wholly-owned subsidiary Shuttle Pharmaceuticals, Inc. (a
Maryland Company) and diagnostics performed in the Company’s wholly-owned subsidiary Shuttle Diagnostics, Inc. (a Maryland Company).
Our product candidates include Ropidoxuridine, a Phase II clinical-stage radiation sensitizer, a platform of HDAC inhibitors (SP-1-161,
SP-2-225 and SP-1-303), and two preclinical, prostate cancer-oriented diagnostics assets – the PC-RAD Test, a blood test to predict
clinical response to radiation therapy and the PSMA-B ligand for potential use as a theranostic agent.

In
December 2023, we submitted an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”)
to support the next phase of development of Ropidoxuridine. In January 2024, we received the ‘Safe to Proceed’ letter from
the FDA for our IND application for the Phase II study of Ropidoxuridine (IPdR) as a radiation sensitizing agent during radiotherapy
in patients with newly diagnosed IDH-wildtype glioblastoma with unmethylated MGMT promoter. Receipt of the letter allows us to commence
the Phase II study of Ropidoxuridine (IPdR). We have applied for and received FDA approval of Orphan designation for Ropidoxuridine and
RT for treating brain cancer (glioblastoma).

We
believe our management team’s expertise in radiation therapy, combined modality cancer treatment and immuno-oncology will help
drive the development and, if approved, the commercialization of these potentially curative