Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 203

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1A
Chunk 203
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 either directly or through collaborative relationships;

    ●
    establish
    and maintain supply and manufacturing relationships with third parties, and ensure adequate and legally compliant manufacturing of
    bulk drug substances and drug products to maintain that supply;

    ●
    obtain
    regulatory approval from relevant regulatory authorities in jurisdictions where we intend to market our product candidates, either
    directly or through collaborative relationships;

    ●
    launch
    and commercialize future product candidates for which we obtain marketing approval, if any, through collaborative partners;

    ●
    obtain
    coverage and adequate product reimbursement from third-party payors, including government payors;

    ●
    achieve
    market acceptance for our products, if any;

    ●
    establish,
    maintain and protect our intellectual property rights; and

    ●
    attract,
    hire and retain qualified personnel.

In
addition, because of the numerous risks and uncertainties associated with clinical product development, including that our product candidates
may not advance through development or achieve the endpoints of applicable clinical trials, we are unable to predict the timing or amount
of any potential future product sales revenues. Our expenses also could increase beyond expectations if we decide to or are required
by the FDA, or comparable foreign regulatory authorities, to perform studies or trials in addition to those that we currently anticipate.
Even if we complete the development and regulatory processes described above, we anticipate incurring significant costs associated with
launching and commercializing these products.

The
market may not be receptive to our product candidates based on our novel therapeutic modality, and we may not generate any future revenue
from the sale or licensing of product candidates.

Even
if approval is obtained for a product candidate, we may not generate or sustain revenue from sales of the product due to factors such
as whether the product can be sold at a competitive cost and otherwise accepted in the market. The product candidates that we are developing
are based on new delivery platform therapeutic approaches (there currently is no drug which has FDA approval for indications of radiation
sensitization). Market participants with significant influence over acceptance of new treatments, such as physicians and third-party
payors, may not accept our delivery platform, and we may not be able to convince the medical community and third-party payors to accept
and use, or to provide favorable reimbursement for, any product candidates developed by us. Market acceptance of our product candidates
will depend on, among other factors:

    ●
    timing
    of our receipt of any marketing and commercialization