Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 40

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 40
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 as well as the global economy and financial markets, and lead to instability and
lack of liquidity in capital markets, potentially making it more difficult for us to obtain additional funds. Related sanctions,
export controls or other actions that may be initiated by nations including the United States, the European Union or Russia (e.g.,
potential cyberattacks, disruption of energy flows, etc.), which could adversely affect our business and/or our supply chain, our
CROs, CMOs and other third parties with which we conduct business. A severe or prolonged economic downturn, inflationary
environment, rising interest rates, or political unrest could result in a variety of risks to our business, including, weakened
demand for our product candidates and our ability to raise additional capital when needed on acceptable terms, if at all. A weak or
declining global economy could also strain our suppliers, possibly resulting in supply disruption. The extent and duration of the military action, sanctions, and resulting market disruptions are
impossible to predict, but could be substantial. Any such disruptions may also magnify the impact of other risks described in this
Annual Report on Form 10-K and the documents incorporated by reference herein.

Our
product candidates are in the early stages of development and may fail in development or suffer delays that materially adversely affect
their commercial viability.

We
have no products on the market and all of our product candidates are in the early stages of development. Our ability to achieve and sustain
profitability depends on obtaining regulatory approvals, including IRB approval, for and commercializing our product candidates, either
alone or with third parties. Before obtaining regulatory approval for the commercial distribution of our product candidates, we or one
of our collaborators must conduct extensive preclinical tests and clinical trials to demonstrate the safety and efficacy in humans of
our product candidates, the final determination of which rests solely in the authority of the FDA. Preclinical testing and clinical trials
are expensive, difficult to design and implement, can take many years to complete and are uncertain as to outcome. The start or end of
a clinical study is often delayed or halted due to changing regulatory requirements, manufacturing challenges, required clinical trial
administrative actions, slower than anticipated patient enrollment, changing standards of care, availability or prevalence of use of
a comparative drug or required prior therapy, clinical outcomes or financial constraints. For instance, delays or difficulties in patient
enrollment or difficulties in retaining trial participants can result in increased costs, longer development times or termination of
a clinical trial. Clinical trials of