News Release Details

Granted Breakthrough Therapy Designation for Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) for the Treatment of Sanfillipo Syndrome Type B (MPS IIIB)

Biologics License Application Submission of TA-ERT for the Treatment of MPS IIIB on Track for the First Quarter of 2026

Completed $50.0 Million Private Placement Financing Backed by Dedicated Healthcare Investors

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nov. 10, 2025-- 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

• $50.0 Million Private Placement Financing Backed by Dedicated Healthcare Investors. In October 2025, the company entered into a definitive securities purchase agreement for a private placement that resulted in gross proceeds of approximately $50.0 million, before deducting offering expenses. Under the securities purchase agreement, the investors purchased 502,181 shares of the company’s common stock. In lieu of shares of common stock, as a portion of their investment, certain investors purchased prefunded warrants to purchase up to 233,144 shares of common stock. The prefunded warrants are exercisable for a period of five years following the date of issuance.

• U.S. FDA Breakthrough Therapy Designation Granted to TA-ERT for the Treatment of MPS IIIB. Granted to Spruce in October 2025, the FDA Breakthrough Therapy Designation is designed to expedite the development and regulatory review of promising therapies for serious or life-threatening conditions where preliminary clinical evidence suggests the potential for substantial improvement over existing treatments. The designation facilitates more intensive FDA guidance, cross-disciplinary collaboration, and eligibility for rolling submission and priority review.

• Relisted “SPRB” on the Nasdaq Capital Market. In September 2025, the company resumed trading on the Nasdaq Capital Market under the ticker symbol “SPRB” and CUSIP 85209E 208, following a one-for-75 reverse stock split.

Third Quarter 2025 Financial Results

• Cash and Cash Equivalents: Cash and cash equivalents as of September 30, 2025, were $10.7 million, which does not include approximately $50.0 million in gross proceeds from the October 2025 private placement financing. Cash and cash equivalents as of September 30, 2025, plus proceeds from the October 2025 private placement financing are expected to fund the company’s current operating plan into the fourth quarter of 2026.

• Research and Development (R&D) Expenses: R&D expenses for the three and nine months ended September 30, 2025, were $5.0 million and $15.4 million, respectively, compared to $6.6 million and $25.0 million for the same periods in 2024. The decrease in R&D expenses was primarily related to the cessation of development activities of tildacerfont for the treatment of congenital adrenal hyperplasia (CAH), offset by development activities related to TA-ERT for the treatment of MPS IIIB.

• General and Administrative (G&A) Expenses: G&A expenses for the three and nine months ended September 30, 2025, were $3.2 million and $10.0 million, respectively, compared to $3.5 million and $11.3 million for the same periods in 2024, primarily driven by a decrease in stock-based compensation expense.

• Total Operating Expenses: Total operating expenses for the three and nine months ended September 30, 2025, were $8.2 million and $25.4 million, respectively, compared to $10.0 million and $36.3 million for the same periods in 2024. Operating expenses include non-cash stock-based compensation expenses of $0.4 million and $0.9 million for the three and nine months ended September 30, 2025, respectively, compared to $1.1 million and $4.4 million for the same periods in 2024.

• Net Loss: Net loss for the three and nine months ended September 30, 2025, was $8.2 million and $24.3 million, respectively, compared to $8.7 million and $29.5 million for the same periods in 2024.

• Capital Structure: Common shares outstanding as of September 30, 2025, were 563,491, which excludes 25,512 outstanding restricted stock units and 28,118 outstanding prefunded warrants to purchase common stock. In connection with the October 2025 private placement financing, 502,181 shares of common stock and 233,144 prefunded warrants to purchase common stock were issued to certain investors.

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.

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Media
Carolyn Hawley
Inizio Evoke Comms
Carolyn.Hawley@inizioevoke.com
media@sprucebio.com

Investors
Samir Gharib
President and CFO
Spruce Biosciences, Inc.
investors@sprucebio.com

Source: Spruce Biosciences, Inc.