Company: SPRB
Filing Date: 2025-10-29
Form Type: S-3
Source: 0001193125-25-256668
Chunk: 9

Company: SPRUCE BIOSCIENCES, INC.
Filing Date: 2025-10-29
Form: S-3
Chunk 9
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, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.

We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.

Coverage and reimbursement may be limited or unavailable in certain market segments for TA-ERT, tildacerfont and our other current and future product candidates, which could make it difficult for us to sell TA-ERT, tildacerfont and our other current and future product candidates profitably.

If we fail to develop and commercialize additional product candidates, we may be unable to grow our business.

We depend on intellectual property licensed from others, the termination of which could result in the loss of significant rights, which would harm our business.

We rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize TA-ERT, tildacerfont, and our other product candidates.

We rely completely on third parties to manufacture our preclinical and clinical drug supplies and we intend to rely on third parties to produce commercial supplies of TA-ERT, tildacerfont and any future product

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candidates, if approved, and these third parties may fail to obtain and maintain regulatory approval for their facilities, fail to provide us with sufficient quantities of drug product or fail to do so at acceptable quality levels or prices.

If we are unable to obtain and maintain sufficient intellectual property protection for TA-ERT, tildacerfont, SPR202, any future product candidates, and other proprietary technologies we develop, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize TA-ERT, tildacerfont, and SPR202, if approved, any future product candidates, and other proprietary technologies if approved, may be adversely affected.

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. We may take advantage of certain exemptions from various public company reporting requirements, including not being required to have our internal control over financial reporting audited by our independent registered public accounting firm under Section 404 of the Sarbanes-Oxley Act of 2002 reduced disclosure obligations regarding executive compensation in our periodic