Company: SPRB
Filing Date: 2025-08-14
Form Type: 10-Q
Source: 0000950170-25-108888
Chunk: 12

Company: SPRUCE BIOSCIENCES, INC.
Filing Date: 2025-08-14
Form: 10-Q
Item: Item 1
Chunk 12
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We face risks and uncertainties associated with our business, many of which are beyond our control. Some of the material risks associated with our business include the following:

•If we are unable to regain compliance with all applicable requirements of the Nasdaq Capital Market (“Nasdaq”), our delisting could adversely affect the market liquidity of our common stock and the market price of our common stock could decrease.

•We do not currently have sufficient working capital to fund our planned operations for the next twelve months and substantial doubt exists as to our ability to continue as a going concern.

•We will need substantial additional financing to develop our product candidates and implement our operating plan. If we fail to obtain additional financing, we may be forced to delay, reduce or eliminate our product development programs or commercialization efforts.

•We have a limited operating history, have incurred significant net losses since our inception, and anticipate that we will continue to incur significant net losses for the foreseeable future, and such net losses are expected to increase as we continue our clinical development of, and seek regulatory approvals for, our product candidates, tralesinidase alfa (“TA-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.

•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