Spruce ends Kaken deal, narrows 2025 net loss
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Rhea-AI Filing Summary
Spruce Biosciences terminated its collaboration and license agreement with Kaken Pharmaceutical for tildacerfont in Japan, effective March 31, 2026, eliminating rights to up to approximately $65.0 million in potential milestone payments and future royalties, though no early termination penalties apply.
The company reported full-year 2025 net loss of $39.0 million, improved from $53.0 million in 2024, as total operating expenses fell to $36.5 million from $61.1 million, driven by ending tildacerfont development and focusing on tralesinidase alfa enzyme replacement therapy (TA-ERT) for Sanfilippo syndrome type B.
Cash and cash equivalents were $48.9 million as of December 31, 2025, and a loan facility with Avenue Capital provides up to $50 million, including an initial funded tranche of $15 million. Positive FDA Type B meetings support a planned biologics license application for TA-ERT in the fourth quarter of 2026, and new commercial and development leaders were added ahead of a potential launch.
Positive
- TA-ERT regulatory progress and clarity: The FDA confirmed that integrated TA-ERT clinical and natural history data could potentially support accelerated approval for MPS IIIB, with a biologics license application targeted for the fourth quarter of 2026 and eligibility for a Rare Pediatric Disease Priority Review Voucher if approved.
- Strengthened financial runway: Cash and cash equivalents were $48.9 million as of December 31, 2025, and a Avenue Capital loan facility of up to $50 million, including an initial $15 million tranche, supports advancement and potential launch of TA-ERT, with management expecting funding into early 2027.
- Improved cost profile and narrower loss: Total operating expenses declined to $36.5 million in 2025 from $61.1 million in 2024, reducing net loss to $39.0 million from $53.0 million, reflecting the shift away from tildacerfont and tighter spending while investing in TA-ERT and the acquisition of SPR202.
- Enhanced commercial and development leadership: The company appointed a Chief Commercial Officer and senior leaders in regulatory, quality, and clinical development operations, building capabilities ahead of a potential TA-ERT launch in a rare disease setting.
Negative
- Loss of tildacerfont partnership economics: Termination of the collaboration and license agreement with Kaken, effective March 31, 2026, ends Spruce’s rights to up to approximately $65.0 million in potential milestones and future royalties from tildacerfont in Japan.
- Elimination of collaboration revenue: Collaboration revenue fell to zero in 2025 from $4.9 million in 2024, reflecting the wind-down of partnered activities and increasing dependence on future TA-ERT and other pipeline milestones to offset ongoing operating losses.
Insights
Strategic pivot away from tildacerfont while advancing TA-ERT with strengthened finances.
Spruce Biosciences is exiting its Japanese tildacerfont collaboration with Kaken, giving up up to approximately $65.0 million in potential milestones and future royalties. This confirms a strategic refocus away from congenital adrenal hyperplasia toward tralesinidase alfa enzyme replacement therapy (TA-ERT) for MPS IIIB.
Financially, full-year 2025 net loss narrowed to $39.0 million from $53.0 million as total operating expenses fell to $36.5 million from $61.1 million, mainly from ending tildacerfont development. Cash and cash equivalents were $48.9 million, and a growth-capital facility provides up to $50 million, including a funded $15 million tranche.
On the pipeline side, successful Type B FDA meetings and a planned BLA filing in Q4 2026 for TA-ERT, combined with new commercial leadership and eligibility for a Rare Pediatric Disease Priority Review Voucher, position the program as the company’s main value driver. Actual impact will depend on execution toward the BLA submission, regulatory review, and drawdown of additional loan tranches under specified conditions.
8-K Event Classification
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What major agreement did Spruce Biosciences (SPRB) terminate with Kaken?
How did Spruce Biosciences (SPRB) perform financially in full-year 2025?
What is the cash position and funding outlook for Spruce Biosciences (SPRB)?
What are Spruce Biosciences’ (SPRB) plans for TA-ERT in MPS IIIB?
How large is Spruce Biosciences’ (SPRB) growth capital facility with Avenue Capital?
Why did Spruce Biosciences’ (SPRB) R&D expenses decline in 2025?
What leadership changes did Spruce Biosciences (SPRB) announce?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 1.02 Termination of a Material Definitive Agreement.
On March 16, 2026, Spruce Biosciences, Inc. (the “Company”) entered into a Termination Agreement (the “Termination Agreement”) with Kaken Pharmaceutical Co., Ltd. (“Kaken”) to terminate by mutual agreement that certain Collaboration and License Agreement, dated as of January 5, 2023, by and between the Company and Kaken (the “Collaboration Agreement”). The Collaboration Agreement will terminate effective as of March 31, 2026 (the “Termination Date”) pursuant to the Termination Agreement, and from and after the Termination Date, the Collaboration Agreement is of no further force or effect except as otherwise expressly set forth in such agreement.
Under the terms of the Collaboration Agreement, the Company granted Kaken the exclusive right to develop, manufacture and commercialize tildacerfont for the treatment of congenital adrenal hyperplasia (“CAH”) in Japan. Pursuant to the Collaboration Agreement, Kaken made a non-refundable upfront payment to the Company of $15.0 million in April 2023. In addition, the Company was entitled to receive up to an aggregate of approximately $65.0 million (at exchange rates in effect on the effective date of the Collaboration Agreement) upon the achievement of specified milestones related to the development, regulatory approval and commercialization of tildacerfont in Japan, and Kaken had agreed to pay the Company a non-creditable, non-refundable specified purchase price for each unit of Company-manufactured product supplied to Kaken for commercial sale. The Company was also entitled to receive a royalty for each unit of non-Company manufactured product sold in Japan. As of the Termination Date, the Collaboration Agreement will be terminated in its entirety, all licenses and other rights granted by the Company to Kaken will terminate and the Company will not be entitled to any previously disclosed and unearned milestone payments or royalties from Kaken. The parties mutually agreed to terminate the Collaboration Agreement following a comprehensive assessment of the tildacerfont program for the treatment of CAH. There are no early termination penalties incurred by the Company in connection with the Termination Agreement.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Spruce Biosciences, Inc. |
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Date: March 20, 2026 |
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By: |
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/s/ Samir Gharib |
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Samir Gharib |
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President and Chief Financial Officer |
Exhibit 99.1
Spruce Biosciences Reports Full Year 2025 Financial Results and Provides Corporate Updates
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. – March 9, 2026 – 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
Net Loss: Net loss for the year ended December 31, 2025 was $39.0 million compared to $53.0 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.
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.
Contacts
Media
Carolyn Hawley
Inizio Evoke Comms
Carolyn.Hawley@inizioevoke.com
media@sprucebio.com
Investors
Monique Kosse
Gilmartin Group
Monique@GilmartinIR.com
investors@sprucebio.com
SPRUCE BIOSCIENCES, INC.
BALANCE SHEETS
(in thousands, except share and per share amounts)
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December 31, |
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2025 |
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2024 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
48,906 |
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$ |
38,753 |
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Prepaid expenses |
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353 |
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3,177 |
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Other current assets |
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2,853 |
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2,276 |
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Total current assets |
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52,112 |
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44,206 |
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Right-of-use assets |
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666 |
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934 |
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Other assets |
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243 |
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69 |
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Total assets |
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$ |
53,021 |
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$ |
45,209 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
943 |
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$ |
1,295 |
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Accrued expenses and other current liabilities |
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9,143 |
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12,329 |
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Term loan, current portion |
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— |
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1,622 |
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Total current liabilities |
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10,086 |
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15,246 |
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Lease liabilities, net of current portion |
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419 |
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736 |
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Term loan, net of current portion |
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— |
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124 |
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Other liabilities |
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— |
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282 |
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Total liabilities |
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10,505 |
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16,388 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Preferred stock, $0.0001 par value; 10,000,000 shares authorized and |
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— |
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— |
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Common stock, $0.0001 par value; 200,000,000 shares authorized as of |
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— |
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— |
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Additional paid-in capital |
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331,750 |
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279,089 |
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Accumulated deficit |
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(289,234 |
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(250,268 |
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Total stockholders’ equity |
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42,516 |
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28,821 |
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Total liabilities and stockholders’ equity |
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$ |
53,021 |
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$ |
45,209 |
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SPRUCE BIOSCIENCES, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
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Year Ended December 31, |
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2025 |
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2024 |
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Collaboration revenue |
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$ |
— |
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$ |
4,911 |
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Operating expenses: |
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Research and development |
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19,522 |
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46,418 |
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General and administrative |
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16,991 |
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14,644 |
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Total operating expenses |
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36,513 |
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61,062 |
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Loss from operations |
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(36,513 |
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(56,151 |
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Interest expense |
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(90 |
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(307 |
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Change in fair value of warrant liability |
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(3,500 |
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— |
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Interest and other income, net |
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1,137 |
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3,422 |
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Net loss and comprehensive loss |
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(38,966 |
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(53,036 |
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Net loss per share, basic and diluted |
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$ |
(50.83 |
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$ |
(96.40 |
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Weighted-average shares of common stock outstanding, |
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766,598 |
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550,146 |
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