Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 204

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1A
Chunk 204
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 approvals;

24

    ●
    terms
    of any approvals and the countries in which approvals are obtained;

    ●
    safety
    and efficacy of our product candidates, which are determinations solely within the authority of the FDA;

    ●
    prevalence
    and severity of any adverse side effects associated with our product candidates;

    ●
    warnings
    contained in any labeling approved by the FDA or other regulatory authority;

    ●
    convenience
    and ease of administration of our product candidates;

    ●
    success
    of our physician education programs;

    ●
    availability
    of adequate government and third-party payor reimbursement;

    ●
    pricing
    of our products, particularly as compared to alternative treatments; and

    ●
    availability
    of alternative effective products for indications our product candidates are intended to treat.

We
will require substantial additional financing in order to obtain marketing approval of our product candidates and commercialize our product
candidates; a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce
or terminate our product development, other operations or commercialization efforts.

Since
our inception, substantially all of our resources have been dedicated to the preclinical and clinical development of our HDAC small molecule
delivery platform and our initial product candidate, Ropidoxuridine. Our capital needs to date have been met by contributions from existing
stockholders, as well as through private offerings and IPO of our securities and our SBIR contracts. We believe that we will continue
to expend substantial resources for the foreseeable future on the completion of clinical development and regulatory preparedness of our
product candidates, preparations for a commercial launch of our product candidates, if approved, and development of any other current
or future product candidates we may choose to further develop. These expenditures will include costs associated with research and development,
conducting preclinical studies and clinical trials, obtaining marketing approvals, and, if we are not able to enter into planned collaborations,
manufacturing and supply as well as marketing and selling any products approved for sale. In addition, other unanticipated costs may
arise. Because the outcome of any drug development process is highly uncertain, we cannot reasonably estimate the actual amounts necessary
to complete the development and commercialization of our current product candidates, if approved, or future product candidates, if any.

We
believe that the proceeds we received in the $4.0 million, net of $0.5 million