Company: SPRB
Filing Date: 2025-10-29
Form Type: S-3
Source: 0001193125-25-256668
Chunk: 8

Company: SPRUCE BIOSCIENCES, INC.
Filing Date: 2025-10-29
Form: S-3
Chunk 8
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ERT, tildacerfont, and SPR202 and any future product candidates.

If we are unable to advance our product candidates in clinical development, obtain regulatory approval, and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.

Our clinical trials may fail to adequately demonstrate the safety and efficacy of our product candidates, which could prevent or delay regulatory approval and commercialization.

We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.

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Preclinical and clinical drug development involves a lengthy and expensive process with uncertain outcomes, and results of earlier studies and trials may not be predictive of future trial results. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of TA-ERT, tildacerfont and our other current and future product candidates.

If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

Any delays in the commencement or completion, or termination or suspension, of our clinical trials could result in increased costs to us, delay or limit our ability to generate revenue, and adversely affect our commercial prospects.

TA-ERT and tildacerfont are, and our other current and future product candidates will be, subject to extensive regulation and compliance obligations, which are costly and time-consuming, and such regulation may cause unanticipated delays or prevent the receipt of the required approvals to commercialize TA-ERT, tildacerfont and our other current and future product candidates.

Interim, topline, and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

If the market opportunities for TA-ERT, tildacerfont and our other current and future product candidates are smaller than we believe they are, our future revenue may be adversely affected and our business may suffer.

We currently have no marketing and sales organization and have yet to commercialize a product. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell TA-ERT, tildacerfont and our other current and future product candidates, we may not be able to generate product revenues.

Unfavorable U.S. and global economic and geopolitical conditions could adversely affect our business, financial condition or results of operations.

International trade policies