Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 23

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 23
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 biomarker panel predictive of radiation
mediated late effects in patients treated for prostate cancer.

Through
collaboration with Georgetown University, patients treated with SBRT for prostate cancers were analyzed for urinary and rectal symptoms
and their blood was analyzed by mass spectroscopy for predictive biomarkers. The discovery and validation of metabolite panels to serve
as a predictive biomarker of patient outcomes following radiation therapy and supports future development and commercialization of a
diagnostic product through a Phase 2 SBIR effort.

17

The
development to commercialization of the metabolite predictive biomarker panel requires additional support through the SBIR funding mechanism.
We will be eligible to apply for Phase IIb SBIR funding for the next round of solicitation. A Phase IIb funding may help de-risk the
project by providing matching funds for performing the clinical validation trial for product development to commercialization. We intend
to apply for such government funding to advance this project. We also intend to raise capital through the public market for predictive
biomarker development through the Shuttle Diagnostics entity. Should we not be successful in obtaining SBIR IIb funding, we will terminate
this project.

Collaborative
Arrangements

While
we intend to enter into selective collaborative arrangements to further develop our drug candidates in the future, at present we have
not entered into any collaborative arrangements with third parties to develop our drug candidates as we are still completing clinical
trials and, as a result, there can be no assurance that we will be able to do so on commercially reasonable terms or otherwise.

Intellectual
Property

We
invest significant amounts of funds in research and development. Our research and development expenses before contract reimbursements
were $3,618,796 and $3,517,093 for the fiscal years ended December 31, 2024 and 2023 respectively, without receiving any reimbursements.

We
are seeking multifaceted protection for our intellectual property that includes licenses, confidentiality and non-disclosure agreements,
copyrights, patents, trademarks and common law rights, such as trade secrets. We enter into confidentiality and proprietary rights agreements
with our employees, consultants, collaborators, subcontractors and other third parties and generally control access to our documentation
and proprietary information.

As of the date of this Annual Report, we have 20 granted
patents overall, of which we have five core patents granted by the USPTO with respect to various aspects of our HDAC small molecule delivery
platform and one for Ropidoxuridine