Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 202

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1A
Chunk 202
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Report could affect our ability to commercialize product candidates, which could impact our ability to earn sufficient revenues to
transition from a developmental stage company and continue our business. If we do not obtain marketing approval of and
commercialization of our product candidates, or are significantly delayed in doing so, our business will be materially harmed. We
have a limited operating history and have incurred significant losses since our inception, and we anticipate that we will continue
to incur losses for the foreseeable future and may never achieve or maintain profitability.

We
are a clinical stage pharmaceutical company, have only recently commenced our Phase II clinical trials of our lead drug candidate,
and have a limited operating history upon which you can evaluate our business and prospects. Specialty pharmaceutical product
development is a highly speculative undertaking and involves a substantial degree of risk. We do not currently have any product
candidates in advanced clinical trials or approved for sale, and we continue to incur significant research and development and
general and administrative expenses related to our operations. In addition, we have limited experience and have not yet demonstrated
an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly
evolving fields, particularly in the specialty pharmaceutical industry. We have not generated any revenue to date and have incurred
losses in each year since our founding in December 2012. Our accumulated deficit as of December 31, 2024 was $34.6 million. We
expect to continue to incur significant losses for the foreseeable future. Even if we achieve profitability in the future, we may
not be able to sustain profitability in subsequent periods.

23

We
currently have no source of product sales revenue.

We
have not yet completed clinical trials and thus do not yet have commercial sales of our products and have not yet generated any
revenues from commercial sales of our product candidates. Our ability to generate product revenue depends upon our ability to
develop and commercialize products, including any of our current product candidates or other product candidates that we may develop,
in-license or acquire in the future. We do not anticipate generating revenue from the sale of products for the foreseeable future and are reliant on our ability to raise financing through third parties, including the sale of securities.
Our ability to generate future product revenue from our current or future product candidates also depends on a number of additional
factors, including our ability to:

    ●
    our
    ability to raise funds to enable us to finance and complete research and clinical development of current and future product
    candidates,