Spruce Biosciences Reports First Quarter 2025 Financial Results and Provides Corporate Updates

Acquisition of Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB)

Biologics License Application (BLA) Submission to U.S. FDA for TA-ERT Expected in 1H 2026

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Spruce Biosciences, Inc. (OTC: 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 first quarter ended March 31, 2025 and provided corporate updates.

“With no FDA-approved treatments currently available to treat MPS IIIB, TA-ERT has the potential to be a groundbreaking advancement for patients and families impacted by this devastating disease,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce. “Across the landscape, this is an incredibly important and exciting time for patients and families affected by neuropathic MPS diseases. Looking ahead, we remain focused on pursuing accelerated approval of TA-ERT and filing the BLA in the first half of 2026. We also plan to initiate a confirmatory study prior to potential accelerated approval of TA-ERT and enable expanded access programs to ensure that patients have access to therapy.”

Corporate Updates

• TA-ERT for the Treatment of MPS IIIB. Spruce entered into an Asset Purchase Agreement under which the company acquired an exclusive worldwide license agreement for TA-ERT and other enzyme replacement therapy products. TA-ERT is a fusion protein comprised of recombinant human alpha-N-acetylglucosaminidase (rhNAGLU) with modified human insulin-like growth factor 2 via an amino acid linker. TA-ERT is intended as an enzyme replacement therapy for the treatment of patients with MPS IIIB who lack rhNAGLU enzyme activity. In March 2024, in a Type C meeting with the U.S. Food and Drug Administration (FDA), the FDA confirmed that HS-NRE is deemed to be a surrogate biomarker reasonably likely to predict clinical benefit and could serve as a basis for accelerated approval. The FDA also confirmed that the completed clinical and non-clinical studies of TA-ERT were sufficient for a BLA submission and provided guidance around key design elements of a confirmatory trial, which must be initiated prior to potential accelerated approval of TA-ERT. TA-ERT has received Fast Track Designation, Rare Pediatric Disease Designation, and Orphan Drug Designation in the U.S. and EU. Spruce intends to submit the BLA of TA-ERT for the treatment of MPS IIIB in the first half of 2026.
• Tildacerfont and Cortibon for the Treatment ***of Major Depressive Disorder (MDD).***Spruce entered into a license, development and option agreement (the “HMNC Agreement”) with HMNC Holding GmbH (“HMNC”). Under the terms of the HMNC Agreement, HMNC will fund and conduct a Phase 2 proof-of-concept study of tildacerfont, a potent and highly selective, oral, small-molecule antagonist of the CRF1 receptor, in patients with MDD who will be screened using Cortibon, HMNC’s proprietary genetic test. HMNC has initiated the Phase 2 TAMARIND study, which will explore the efficacy of 400mg twice-daily tildacerfont versus placebo in improving depressive symptoms in MDD patients. Topline results from TAMARIND are anticipated in the first half of 2026.

First Quarter 2025 Financial Results

• Cash and Cash Equivalents: Cash and cash equivalents as of March 31, 2025 were $25.6 million. Cash and cash equivalents are expected to allow the company to fund its current operating plan through the end of 2025.
• Research and Development (R&D) Expenses: R&D expenses for the three months ended March 31, 2025 were $10.8 million compared to $10.3 million for the same period in 2024. R&D expenses for the three months ended March 31, 2025 include $5.7 million in costs related to the acquisition of SPR202, an anti-corticotrophin releasing hormone monoclonal antibody for the treatment of congenital adrenal hyperplasia.
• General and Administrative (G&A) Expenses: G&A expenses for the three months ended March 31, 2025 were $3.7 million compared to $4.3 million for the same period in 2024, primarily driven by a decrease in stock-based compensation expense.
• Total Operating Expenses: Total operating expenses for the three months ended March 31, 2025 were $14.5 million compared to $14.6 million for the same period in 2024. Operating expenses include non-cash stock-based compensation expenses of $0.5 million for the three months ended March 31, 2025 compared to $1.6 million for the same period in 2024.
• Net Loss: Net loss for the three months ended March 31, 2025 was $14.0 million compared to $11.6 million for the same period in 2024.

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.

SPRUCE BIOSCIENCES, INC. CONDENSED BALANCE SHEETS (unaudited) (in thousands, except share and per share amounts)

March 31,

December 31,

2025

2024

ASSETS

Current assets:

Cash and cash equivalents

$

25,615

$

38,753

Prepaid expenses

2,899

3,177

Other current assets

2,062

2,276

Total current assets

30,576

44,206

Right-of-use assets

869

934

Other assets

204

69

Total assets

$

31,649

$

45,209

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable

$

1,879

$

1,295

Accrued expenses and other current liabilities

12,442

12,329

Term loan, current portion

1,345

1,622

Total current liabilities

15,666

15,246

Lease liabilities, net of current portion

659

736

Term loan, net of current portion

—

124

Other liabilities

—

282

Total liabilities

16,325

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 March 31, 2025 and December 31, 2024

—

—

Common stock, $0.0001 par value; 200,000,000 shares authorized as of March 31, 2025 and December 31, 2024; 42,231,285 shares issued and outstanding as of March 31, 2025 and December 31, 2024

4

4

Additional paid-in capital

279,629

279,085

Accumulated deficit

(264,309

)

(250,268

)

Total stockholders’ equity

15,324

28,821

Total liabilities and stockholders’ equity

$

31,649

$

45,209

SPRUCE BIOSCIENCES, INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) (in thousands, except share and per share amounts)

Three Months Ended March 31,

2025

2024

Collaboration revenue

$

—

$

2,002

Operating expenses:

Research and development

10,837

10,317

General and administrative

3,655

4,318

Total operating expenses

14,492

14,635

Loss from operations

(14,492

)

(12,633

)

Interest expense

(36

)

(97

)

Interest and other income, net

487

1,105

Net loss and comprehensive loss

(14,041

)

(11,625

)

Net loss per share, basic and diluted

$

(0.32

)

$

(0.28

)

Weighted-average shares of common stock outstanding, basic and diluted

43,944,946

41,096,231

Contacts

Media

Katie Beach Oltsik Inizio Evoke Comms (937) 232-4889 [email protected] [email protected]

Investors

Samir Gharib President and CFO Spruce Biosciences, Inc. [email protected]