Spruce Biosciences reports TA-ERT MPS IIIB data

Spruce Biosciences filed a report describing new clinical data for its investigational enzyme replacement therapy tralesinidase alfa (TA-ERT) in Sanfilippo Syndrome Type B (MPS IIIB).

Rhea-AI Filing Summary

Spruce Biosciences filed a report describing new clinical data for its investigational enzyme replacement therapy tralesinidase alfa (TA-ERT) in Sanfilippo Syndrome Type B (MPS IIIB). Data presented at the 22nd Annual WORLDSymposium showed that long-term TA-ERT administration led to rapid and durable reductions in heparan sulfate, a key disease biomarker, and was associated with preserved cognitive and non-cognitive function versus natural history patients.

New analyses across one observational and three interventional studies using the validated VABS-II scale indicated that TA-ERT treatment was associated with stabilization of receptive and expressive communication and both fine and gross motor skills, in contrast to declines seen in untreated patients. The company also discussed plans and expectations around potential accelerated approval pathways, a future biologics license application, and the possibility that TA-ERT could become a first and best-in-class disease-modifying therapy for MPS IIIB, while emphasizing the significant risks and uncertainties that could cause actual outcomes to differ.

Insights

Clinical and regulatory strategy analyst

Spruce highlights encouraging TA-ERT data in MPS IIIB while outlining a potential accelerated approval path, subject to substantial regulatory risk.

Spruce Biosciences describes long-term data for tralesinidase alfa in Sanfilippo Syndrome Type B. The therapy reportedly produced rapid, durable heparan sulfate reductions and preserved cognitive and non-cognitive outcomes relative to natural history patients, which is notable in a disease that typically shows progressive decline.

The company also presents new pooled analyses from Observational Study 902 and Interventional Studies 250-201, 250-202, and 250-401, using the validated VABS-II scale. TA-ERT treatment was associated with stabilization of communication and motor skills, whereas untreated patients showed declines, suggesting a potential disease-modifying effect based on these measures.

Spruce states it may seek accelerated approval for TA-ERT based on existing data, advance toward a biologics license application, and pursue potential U.S. FDA approval. However, it underscores that these ambitions are forward-looking and subject to assumptions, broader business risks, and regulatory uncertainties that could materially change actual outcomes.

8-K Event Classification

Item 7.01 — Regulation FD Disclosure

1 item

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Spruce Biosciences (SPRB) report about TA-ERT in MPS IIIB?

Spruce Biosciences reported that long-term tralesinidase alfa (TA-ERT) treatment in Sanfilippo Syndrome Type B showed rapid, durable reductions in heparan sulfate and preserved cognitive and non-cognitive outcomes compared with natural history patients, based on data presented at the 22nd Annual WORLDSymposium.

How did TA-ERT affect communication and motor skills in Spruce Biosciences studies?

New analyses using the VABS-II scale showed TA-ERT was associated with stabilization of receptive and expressive communication, and both fine and gross motor skills, while untreated natural history patients experienced declines in these functional outcomes over time.

Which TA-ERT studies did Spruce Biosciences reference in its 8-K filing?

Spruce referenced final results from new analyses of existing data from Observational Study 902 and Interventional Studies 250-201, 250-202, and 250-401, all evaluating tralesinidase alfa enzyme replacement therapy for treating MPS IIIB patients.

What regulatory plans did Spruce Biosciences discuss for TA-ERT?

Spruce discussed the potential to seek accelerated approval for TA-ERT in MPS IIIB based on existing clinical data, advance the program through a biologics license application submission, and pursue potential U.S. FDA approval, while noting significant risks and uncertainties around these plans.

Why does Spruce Biosciences call TA-ERT potentially first and best-in-class?

Spruce states that TA-ERT has the potential to be the first and best-in-class disease-modifying therapy to treat MPS IIIB, reflecting its biomarker reductions and functional stabilization data, though this remains forward-looking and subject to regulatory review and future clinical outcomes.

What risks and uncertainties did Spruce Biosciences highlight about TA-ERT development?

Spruce cautioned that forward-looking statements on TA-ERT, including accelerated approval prospects and FDA decisions, may differ materially from expectations due to business risks, geopolitical and macroeconomic impacts, and other factors described in its Form 10-K and subsequent Form 10-Q filings.

AI-generated analysis. How Rhea-AI works. Not financial advice.

Understanding 8-K Material Events →

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Accepted by SEC EDGAR 02/05/2026 - 04:11 PM Learn about SEC filing dates

0001683553false00016835532026-02-052026-02-05

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): February 5, 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 7.01 Regulation FD Disclosure.

On February 5, 2026, Spruce Biosciences, Inc. (the “Company”) issued a press release announcing that data presented at the 22nd Annual WORLDSymposium™ (the “Conference”) demonstrate that the long-term administration of tralesinidase alfa enzyme replacement therapy (“TA-ERT”) resulted in rapid and durable reduction of heparan sulfate and preserved cognitive and non-cognitive outcomes in patients with Sanfilippo Syndrome Type B (“MPS IIIB”) relative to natural history patients (the “Presentation”). In addition, the press release announced that the Company presented a case study of two siblings at the Conference. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information contained in this Current Report on Form 8-K under Item 7.01, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section and will not be incorporated by reference into any filing by the Company under the Securities Act of 1933, or the Exchange Act, unless specifically identified as being incorporated therein by reference.

Item 8.01 Other Events.

The Presentation included final results from the Company’s new analyses of its existing data from Observational Study 902 and Interventional Studies 250-201, 250-202, and 250-401 for the treatment of MPS IIIB using the validated Vineland Adaptive Behavior Scales, Second Edition (“VABS-II”) scale. These new analyses showed that TA-ERT treatment was associated with a stabilization in receptive and expressive communication, as well as both fine and gross motor skills, compared to a decline in these outcomes in untreated natural history patients. An excerpt from the Presentation is attached hereto as Exhibit 99.2 and is incorporated herein by reference.

Forward Looking Statements

This Current Report on Form 8-K contains “forward-looking statements” within the meaning of the “safe harbor” provisions 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 timing and likelihood of regulatory filings and approvals for TA-ERT, including advancing this program through a biologics license application submission and potential U.S. FDA approval; the potentially transformative clinical impact for TA-ERT; and TA-ERT’s potential to be the first and best-in-class 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,” “will,” “potential,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the Company’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 the Company’s business in general, the impact of geopolitical and macroeconomic events, and other risks and uncertainties described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, its subsequently filed Quarterly Reports on Form 10-Q, and the other documents the Company files from time to time with the U.S. Securities and Exchange Commission. These forward-looking statements speak only as of the date of this Current Report on Form 8-K, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number		Description
99.1		Press Release of Spruce Biosciences, Inc., dated February 5, 2026.
99.2		Excerpt from Spruce Biosciences, Inc.’s Presentation, dated February 5, 2026.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

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: February 5, 2026				By:		/s/ Samir Gharib
						Samir Gharib
						President and Chief Financial Officer