Company: SPRB
Filing Date: 2025-11-10
Form Type: 10-Q
Source: 0001193125-25-274234
Chunk: 3

Company: SPRUCE BIOSCIENCES, INC.
Filing Date: 2025-11-10
Form: 10-Q
Item: Item 2
Chunk 3
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 team experienced in the development and commercialization of groundbreaking therapeutics.

Since our inception in November 2014, we have focused primarily on raising capital, establishing and protecting our intellectual property portfolio, organizing and staffing our company, business planning, and conducting preclinical and clinical development of, and manufacturing development for, our product candidate, tildacerfont. While tildacerfont remains in development, since November 2024 we have shifted our focus to the development of tralesinidase alfa (“TA-ERT”), an investigational treatment for mucopolysaccharidoses type IIIB (“MPS IIIB”), or Sanfillipo Syndrome Type B. In October 2025, TA-ERT received breakthrough therapy designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of Sanfilippo Syndrome Type B. We anticipate submitting a biologics license application of TA-ERT for the treatment of Sanfilippo Syndrome Type B in the first quarter of 2026. Currently, there is no U.S. FDA-approved therapy for the treatment of MPS IIIB, and disease management consists of limited palliative care. 

We have no products approved for commercial sale and have not generated any product revenue to date, and we continue to incur significant research and development and other expenses related to our ongoing operations. Our ability to generate product revenue sufficient to achieve profitability, if ever, will depend on the successful development of tildacerfont and any future product candidates. 

Since inception, we have incurred significant losses and negative cash flows from operations. During the nine months ended September 30, 2025 and 2024, we incurred net losses of $24.3 million and $29.5 million, respectively, and used $26.9 million and $35.3 million of cash in operations, respectively. As of September 30, 2025, we had an accumulated deficit of $274.6 million, and we do not expect positive cash flows from operations for the foreseeable future. We expect to continue to incur significant and increasing losses for the foreseeable future, and our net losses may fluctuate significantly from period to period, depending on the timing of expenditures on our planned research and development activities.

Since inception through September 30, 2025, we have raised aggregate gross proceeds of $293.1 million, including $103.5 million from our initial public offering (“IPO”) in October 2020, $116.0 million from the sale of our redeemable convertible preferred stock, $