Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 946

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 5
Chunk 946
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 the goal of improving outcomes for cancer patients receiving radiation therapy. Shuttle has deployed its proprietary technology
to develop novel cancer immunotherapies, producing a pipeline of selective HDAC inhibitors for cancer and immunotherapy applications.
The Company’s HDAC platform is designed to target candidate molecules with potential roles in therapeutics beyond cancer, including
autoimmune, inflammatory, metabolic, neurological and infectious diseases. The Company’s Ropidoxuridine product, which is used
with radiation therapy to sensitize cancer cells, was initially funded by a Small Business Innovation Research (“SBIR”) contract
provided by the National Cancer Institute (“NCI”), a unit of the National Institutes of Health (“NIH”). Ropidoxuridine
has been further developed through the Company’s collaborations with scientists at the University of Virginia for use in combination
with proton therapy to improve patient survival. Historically, and prior to the Company’s initial public offering in September
2022, the Company had obtained funding to develop products through NIH grants, including a product to predict late effects of radiation
with metabolite biomarkers and develop prostate cancer cell lines in health disparities research.

The
production and marketing of the Company’s products and its ongoing research and development activities will be and are subject
to extensive regulation by numerous governmental authorities in the United States. Prior to marketing in the United States, any products
or combination of products developed by the Company must undergo rigorous preclinical (animal) and clinical (human) testing and an extensive
regulatory approval process implemented by the Food and Drug Administration (“FDA”) under the Food, Drug and Cosmetic Act.
There can be no assurance that the Company will not encounter problems in its clinical trials that will cause the Company or the FDA
to delay or suspend the clinical trials.

The
Company’s success will depend in part on its ability to obtain patents and product license rights, maintain trade secrets, and
operate without infringing on the proprietary rights of others, both in the United States and in other countries. There can be no assurance
that patents issued to or licensed by the Company will not be challenged, invalidated or circumvented, or that the rights granted thereunder
will provide proprietary protection or competitive advantages to the Company now or in the future.

    F-6

Liquidity
and Going Concern

Our
consolidated financial statements are prepared on a going concern basis, which contemplates the realization of assets and the satisfaction
of liabilities and commitments in the normal course of business. The Company has incurred losses since inception