Spruce Biosciences (Nasdaq: SPRB) cuts 2025 loss, exits Kaken pact to focus TA-ERT

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

Biopharma & Financial Analyst

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.

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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

Date of Report (Date of earliest event reported): March 16, 2026

Spruce Biosciences, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware			001-39594	81-2154263
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
611 Gateway Boulevard, Suite 740
South San Francisco, California				94080
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: 415-343-5986

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

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)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	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:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		SPRB		Nasdaq Capital Market

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.

				Spruce Biosciences, Inc.
Date: March 20, 2026				By:		/s/ Samir Gharib
						Samir Gharib
						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

•Held Positive Type B Meetings with the FDA. In February 2026, the company announced the successful completion of two Type B meetings with the FDA regarding its planned upcoming BLA submission for TA-ERT for the treatment of MPS IIIB. The FDA confirmed that the integrated study data from interventional clinical studies of TA-ERT and the available natural history data could potentially serve as an adequate and well-controlled study for purposes of the FDA’s review of the effects of TA-ERT on cerebral spinal fluid heparan sulfate non-reducing end, which could serve as a reasonably likely surrogate endpoint of clinical benefit supporting an accelerated approval. The BLA submission for TA-ERT is anticipated in the fourth quarter of 2026.

•Appointed Dale Hooks, an Accomplished Rare Disease Commercial Leader, as Chief Commercial Officer. Today, the company announced the appointment of Dale Hooks as Chief Commercial Officer, who brings over three decades of biopharmaceutical marketing and commercialization expertise to drive the potential commercial launch of TA-ERT.

•Secured Up to $50 million in Growth Capital from Avenue Capital. In January 2026, the company entered into a loan facility for up to $50 million in growth capital to support the continued advancement and potential commercial launch of TA-ERT. The loan facility has a 42-month term and includes an initial tranche of $15 million, which was fully funded in January 2026, and three additional tranches totaling up to $35 million, subject to the satisfaction of certain terms and conditions of the loan and security agreement.

•Presented Long-term Data of TA-ERT at the 22nd Annual WORLDSymposium™. In February 2026, data from two different analyses were presented highlighting TA-ERT as potentially the first disease-modifying treatment option for MPS IIIB. One presentation showed that long-term administration of TA-ERT resulted in rapid and durable reduction of heparan sulfate and preserved cognitive and non-cognitive clinical outcomes in patients with MPS IIIB relative to natural history patients. The second presentation included analyses of two siblings

diagnosed with MPS IIIB showing that, in an age-matched comparison, one sibling treated with TA-ERT appeared to display higher cognitive, language, and motor functioning relative to the untreated sibling at a similar age. For more information, the two poster presentations can be found on the Spruce Biosciences website at https://investors.sprucebio.com/news-and-events/presentations.

•Added Regulatory and Clinical Development Expertise to the Executive Leadership Team. In February 2026, the company appointed Daven Mody, Pharm.D., as Senior Vice President, Regulatory and Quality, and Bruno Gagnon, B.Pharm., M.Sc., as Senior Vice President, Clinical Development Operations.

•Reauthorization of the Rare Pediatric Disease Priority Review Voucher (PRV) Program. In February 2026, the PRV program was reauthorized through September 30, 2029. This five-year extension restores a key incentive to develop therapies for rare pediatric diseases, allowing companies to receive a fast-track review voucher for approved drugs. TA-ERT has secured Rare Pediatric Disease Designation and is eligible for a PRV, if approved by the FDA.

•Appointed Keli Walbert, a Proven Pharmaceutical Commercial Leader, to the Board of Directors. In December 2025, the company appointed Keli Walbert to its Board of Directors. Ms. Walbert has decades of commercial leadership experience and a proven track record of successful product launches in rare diseases.

Full Year 2025 Financial Results

•Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2025 were $48.9 million, which excludes the receipt of $15.0 million in gross proceeds under the loan facility with Avenue Capital. The company expects its cash and cash equivalents to fund its current operating plan into early 2027, beyond the anticipated BLA submission for TA-ERT.

•Research and Development (R&D) Expenses: R&D expenses for the year ended December 31, 2025 were $19.5 million compared to $46.4 million for the same period 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 and the acquisition of SPR202, an anti-corticotropin releasing hormone monoclonal antibody for the treatment of CAH.

•General and Administrative (G&A) Expenses: G&A expenses for the year ended December 31, 2025 were $17.0 million compared to $14.6 million for the same period in 2024, primarily driven by increased professional service fees, offset by a decrease in stock-based compensation expense.

•Total Operating Expenses: Total operating expenses for the year ended December 31, 2025 were $36.5 million compared to $61.1 million for the same period in 2024. Operating expenses include non-cash stock-based compensation expenses of $2.6 million for the year ended December 31, 2025 compared to $5.3 million for the same period in 2024.

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)

		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

FAQ

What major agreement did Spruce Biosciences (SPRB) terminate with Kaken?

Spruce Biosciences and Kaken mutually agreed to terminate their January 2023 collaboration and license agreement for tildacerfont in Japan, effective March 31, 2026. All licenses and rights granted to Kaken will end, and Spruce will forgo unearned milestones and future royalties tied to that program.

How did Spruce Biosciences (SPRB) perform financially in full-year 2025?

Spruce reported a 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. Expense reductions mainly came from stopping tildacerfont development while continuing investment in TA-ERT and related programs.

What is the cash position and funding outlook for Spruce Biosciences (SPRB)?

Cash and cash equivalents were $48.9 million as of December 31, 2025, excluding $15.0 million of gross proceeds from a Avenue Capital loan facility. Management expects existing cash to fund the current operating plan into early 2027, beyond the anticipated TA-ERT BLA submission.

What are Spruce Biosciences’ (SPRB) plans for TA-ERT in MPS IIIB?

Spruce plans to submit a biologics license application for TA-ERT in the fourth quarter of 2026, following positive Type B FDA meetings. The agency indicated existing integrated clinical and natural history data could potentially support an accelerated approval pathway based on a surrogate biomarker endpoint.

How large is Spruce Biosciences’ (SPRB) growth capital facility with Avenue Capital?

Spruce entered a loan facility of up to $50 million with Avenue Capital, featuring a 42‑month term. An initial tranche of $15 million was fully funded in January 2026, with three additional tranches totaling up to $35 million available upon meeting agreed conditions.

Why did Spruce Biosciences’ (SPRB) R&D expenses decline in 2025?

Research and development expenses fell to $19.5 million in 2025 from $46.4 million in 2024, primarily because Spruce ceased development of tildacerfont for congenital adrenal hyperplasia. This decrease was partially offset by spending on TA-ERT for MPS IIIB and the acquisition of SPR202.

What leadership changes did Spruce Biosciences (SPRB) announce?

Spruce appointed Dale Hooks as Chief Commercial Officer to prepare for a potential TA-ERT launch and added senior leaders for regulatory, quality, and clinical development operations. It also appointed experienced commercial executive Keli Walbert to its Board of Directors in December 2025.

Filing Exhibits & Attachments

2 documents

Press Releases

• EX-99.1 EX-99.1 181.5 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA WITH EMBEDDED LINKBASES DOCUMENT 31.2 KB