Spruce Biosciences Reports Third Quarter 2025 Financial Results and Provides Corporate Updates
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 third quarter ended September 30, 2025 and provided corporate updates.
“We have made significant progress this year with the receipt of Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for our tralesinidase alfa enzyme replacement therapy (TA-ERT), followed by the syndication of a $50 million private placement financing backed by an impressive group of healthcare investors. These important corporate milestones underscore the transformative moments in our collective efforts to advance TA-ERT as potentially the first disease-modifying therapy to treat children with MPS IIIB,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “The recent financing provides the capital resources to advance TA-ERT well beyond a biologics license application (BLA) submission expected in the first quarter of 2026.”
Dr. Szwarcberg continued, “I am very proud of our team for the advancements we have made this year, appreciative of the unwavering support from our Board and investors, and grateful to the patients and families who took part in the TA-ERT clinical trials. We look forward to an impactful 2026 as we move towards bringing to market a new, life-changing treatment option for children affected by MPS IIIB.”
Corporate Updates
Third Quarter 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, visit www.sprucebio.com and follow us on X, LinkedIn, Facebook and YouTube.
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 timing and likelihood of regulatory filings and approvals for TA-ERT, including the anticipated biologics license application submission of TA-ERT for MPS IIIB in the first quarter of 2026; TA-ERT’s potential to be the first disease-modifying therapy to treat MPS IIIB; TA-ERT’s potential to be a new, life-changing treatment option for children affected by MPS IIIB; and the Company’s ability to fund its operating plan into the fourth quarter of 2026. 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”, “will”, “potential”, “intend”, “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 undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
SPRUCE BIOSCIENCES, INC.
CONDENSED BALANCE SHEETS
(unaudited)
(in thousands, except share and per share amounts)
September 30,
December 31,
2025
2024
ASSETS
Current assets:
Cash and cash equivalents
$
10,669
$
38,753
Prepaid expenses
932
3,177
Other current assets
2,915
2,276
Total current assets
14,516
44,206
Right-of-use assets
735
934
Other assets
62
69
Total assets
$
15,313
$
45,209
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
1,386
$
1,295
Accrued expenses and other current liabilities
7,502
12,329
Term loan, current portion
539
1,622
Total current liabilities
9,427
15,246
Lease liabilities, net of current portion
500
736
Term loan, net of current portion
—
124
Other liabilities
—
282
Total liabilities
9,927
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 September 30, 2025 and December 31, 2024
—
—
Common stock, $0.0001 par value; 200,000,000 shares authorized as of September 30, 2025 and December 31, 2024; 563,491 and 563,042 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively
—
—
Additional paid-in capital
279,974
279,089
Accumulated deficit
(274,588
)
(250,268
)
Total stockholders’ equity
5,386
28,821
Total liabilities and stockholders’ equity
$
15,313
$
45,209
SPRUCE BIOSCIENCES, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
(in thousands, except share and per share amounts)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025
2024
2025
2024
Collaboration revenue
$
—
$
602
$
—
$
4,214
Operating expenses:
Research and development
5,011
6,554
15,418
24,961
General and administrative
3,218
3,456
9,995
11,330
Total operating expenses
8,229
10,010
25,413
36,291
Loss from operations
(8,229
)
(9,408
)
(25,413
)
(32,077
)
Interest expense
(19
)
(71
)
(84
)
(251
)
Interest and other income, net
36
808
1,177
2,851
Net loss and comprehensive loss
(8,212
)
(8,671
)
(24,320
)
(29,477
)
Net loss per share, basic and diluted
$
(14.58
)
$
(15.75
)
$
(41.25
)
$
(53.68
)
Weighted-average shares of common stock outstanding, basic and diluted
563,066
550,645
589,520
549,116