Full Press Release Details
Following Positive Type B Meetings with the FDA, BLA Submission for TA-ERT for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB) on Track for the Fourth Quarter of 2026
Appoints Dale Hooks as Chief Commercial Officer, Strengthening the Company’s Commercial Capabilities in Preparation for a Potential Launch of TA-ERT
Secured up to $50 Million in Growth Capital from Avenue Capital Group
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Spruce Biosciences, Inc.(Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today reported financial results for the year ended December 31, 2025 and provided corporate updates.
“2025 was a very productive year, and our team continues to execute and drive towards key milestones with our tralesinidase alfa enzyme replacement therapy (TA-ERT) program, especially our planned biologics license application (BLA) submission in the fourth quarter of this year and potential commercial launch in MPS IIIB,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “Our recent productive interactions with the FDA have provided clear next steps that strengthen our conviction in the development of TA-ERT for patients and families living with MPS IIIB, for which currently there are no approved therapies. Our appointment of Dale Hooks as Chief Commercial Officer further reflects our conviction and commitment to building our capabilities and commercial infrastructure, as we position ourselves to capitalize on the next chapter of growth at Spruce.”
Recent Corporate Updates
Full Year 2025 Financial Results
About Spruce Biosciences
Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need. To learn more, visitwww.sprucebio.comand follow us onX,LinkedIn,FacebookandYouTube.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the ability to seek accelerated approval of TA-ERT for MPS IIIB based on existing clinical data; the content, timing and likelihood of regulatory filings and approvals for TA-ERT, including advancing this program through a BLA submission and potential FDA approval; the potentially transformative clinical impact for TA-ERT; TA-ERT’s eligibility for a PRV; and TA-ERT’s potential to be the first disease-modifying therapy to treat MPS IIIB. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “could,” “potential,” “on track,” “expect,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Spruce’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Spruce’s business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Spruce’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date.
| SPRUCE BIOSCIENCES, INC. | ||||||||
| BALANCE SHEETS | ||||||||
| (in thousands, except share and per share amounts) | ||||||||
| December 31, | ||||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 48,906 | $ | 38,753 | ||||
| Prepaid expenses | 353 | 3,177 | ||||||
| Other current assets | 2,853 | 2,276 | ||||||
| Total current assets | 52,112 | 44,206 | ||||||
| Right-of-use assets | 666 | 934 | ||||||
| Other assets | 243 | 69 | ||||||
| Total assets | $ | 53,021 | $ | 45,209 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 943 | $ | 1,295 | ||||
| Accrued expenses and other current liabilities | 9,143 | 12,329 | ||||||
| Term loan, current portion | — | 1,622 | ||||||
| Total current liabilities | 10,086 | 15,246 | ||||||
| Lease liabilities, net of current portion | 419 | 736 | ||||||
| Term loan, net of current portion | — | 124 | ||||||
| Other liabilities | — | 282 | ||||||
| Total liabilities | 10,505 | 16,388 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $0.0001 par value; 10,000,000 shares authorized and no shares issued or outstanding as of December 31, 2025 and 2024 | — | — | ||||||
| Common stock, $0.0001 par value; 200,000,000 shares authorized as of December 31, 2025 and 2024; 1,372,043 and 563,042 shares issued and outstanding as of December 31, 2025 and 2024, respectively | — | — | ||||||
| Additional paid-in capital | 331,750 | 279,089 | ||||||
| Accumulated deficit | (289,234 | ) | (250,268 | ) | ||||
| Total stockholders’ equity | 42,516 | 28,821 | ||||||
| Total liabilities and stockholders’ equity | $ | 53,021 | $ | 45,209 | ||||
| SPRUCE BIOSCIENCES, INC. | ||||||||
| STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
| (in thousands, except share and per share amounts) | ||||||||
| Year Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Collaboration revenue | $ | — | $ | 4,911 | ||||
| Operating expenses: | ||||||||
| Research and development | 19,522 | 46,418 | ||||||
| General and administrative | 16,991 | 14,644 | ||||||
| Total operating expenses | 36,513 | 61,062 | ||||||
| Loss from operations | (36,513 | ) | (56,151 | ) | ||||
| Interest expense | (90 | ) | (307 | ) | ||||
| Change in fair value of warrant liability | (3,500 | ) | — | |||||
| Interest and other income, net | 1,137 | 3,422 | ||||||
| Net loss and comprehensive loss | (38,966 | ) | (53,036 | ) | ||||
| Net loss per share, basic and diluted | $ | (50.83 | ) | $ | (96.40 | ) | ||
| Weighted-average shares of common stock outstanding, basic and diluted | 766,598 | 550,146 |
MediaCarolyn HawleyInizio Evoke CommsCarolyn.Hawley@inizioevoke.commedia@sprucebio.comInvestorsMonique KosseGilmartin GroupMonique@GilmartinIR.cominvestors@sprucebio.com