Form 8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

     Date of Report (Date of earliest event reported): April 15, 2025

    

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: 415 294-1687

    

(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 2.02 Results of Operations and Financial Condition.

On April 15, 2025, Spruce Biosciences, Inc. (the “Company”) issued a press release providing a corporate update that included updates on its new corporate strategy and acquisition of tralesinidase alfa enzyme replacement therapy for the treatment of Sanfilippo Syndrome Type B, anticipated upcoming milestones, and its cash and cash equivalents balance of $38.8 million as of December 31, 2024 (the “Press Release”). The full text of the Press Release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

All of the information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended (“Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 7.01 Regulation FD Disclosure.

On April 15, 2025, the Company presented a slide presentation with an overview of the Company’s new corporate strategy and acquisition of tralesinidase alfa enzyme replacement therapy for the treatment of Sanfilippo Syndrome Type B entitled “Tralesinidase Alfa Enzyme Replacement Therapy for the Treatment of Sanfilippo Syndrome Type B (MPSIIIB)” (the “Presentation”). A copy of the Presentation is furnished as Exhibit 99.2.

All of the information furnished in this Item 7.01 and Item 9.01 (including Exhibit 99.2) shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act and shall not be incorporated by reference in any filing under the Securities Act, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.


Exhibit No.		Description
99.1		Press Release of Spruce Biosciences, Inc., dated April 15, 2025.
99.2		Presentation of Spruce Biosciences, Inc. entitled “Tralesinidase Alfa Enzyme Replacement Therapy for the Treatment of Sanfilippo Syndrome Type B (MPSIIIB).”
104		Cover Page Interactive Data File - the cover page XBRL tags are 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: April 15, 2025	By:	/s/ Samir Gharib
		Samir Gharib
		President and Chief Financial Officer

Spruce Biosciences Announces New Corporate Strategy and Acquisition of Tralesinidase Alfa for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB)

Biologics License Application (BLA) Submission to U.S. FDA for Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) Anticipated in 1H 2026

Spruce to Host Conference Call Today at 8:30 a.m. ET

South San Francisco, Calif. – April 15, 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 announced the company’s new corporate strategy and acquisition of tralesinidase alfa enzyme replacement therapy (TA-ERT) for the treatment of Sanfilippo Syndrome Type B (MPS IIIB).

“This is truly a transformative moment for Spruce as we focus our expertise in rare disease on a potential near-term commercial opportunity with TA-ERT in MPS IIIB,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce. “As a result of the strategic process initiated last year, Spruce acquired TA-ERT for the treatment of children with MPS IIIB, a neurodegenerative and ultimately fatal genetic disease. This new strategy opens a new chapter in our mission to provide transformative and life-changing therapies to patients affected by serious conditions with significant unmet medical need.”

Dr. Szwarcberg continued, “In clinical studies, TA-ERT has been shown to significantly and durably normalize cerebral spinal fluid (CSF) heparan sulfate non-reducing end (HS-NRE) levels over a five-year period. Alignment has been achieved with the U.S. Food and Drug Administration (FDA) that HS-NRE could be used as a biomarker that may reasonably predict clinical benefit and serve as a basis for accelerated approval. Based on the existing clinical and non-clinical data, we anticipate submitting a BLA for TA-ERT to the FDA in the first half of 2026. We extend our gratitude to the patient and caregiver advocates, clinicians and industry leaders who have contributed to the TA-ERT program. With no FDA-approved treatments currently available, TA-ERT has the potential to be a groundbreaking advancement for patients and families impacted by MPS IIIB.”

“The vision of the Spruce leadership team and their unrelenting commitment to serving patient communities with meaningful unmet need is on full display with the acquisition of TA-ERT,” said Mike Grey, Executive Chairman of Spruce. “The confidence and support shown by our Board underscore the immense potential of the company’s new portfolio and direction.”

Corporate Strategy

•

Seek regulatory approval and maximize the U.S. commercial potential of TA-ERT for the treatment of MPS IIIB. Spruce intends to seek U.S. accelerated approval of TA-ERT for MPS IIIB based on existing non-clinical and clinical data. As a condition of seeking such approval of a BLA from the FDA, Spruce will initiate a confirmatory trial. If the BLA is approved, Spruce intends to build a highly specialized commercial and medical affairs organization to support the commercialization of TA-ERT. Given that a relatively small number of clinicians and specialists treat most of the patients with MPS IIIB, we believe this market can be effectively addressed with a modest-sized and targeted patient-centric field team, alongside various high-touch patient initiatives.

•

Commercialize globally through a patient-focused organization. Spruce seeks to commercialize TA-ERT and its other investigational products throughout the developed world,

including North America, the European Union (EU), the United Kingdom, Latin America, Turkey, Asia, and other international markets. We intend to establish our own commercial organization in the United States, EU, and the United Kingdom, and seek regional strategic collaborations and a network of third-party distributors in other international markets.

•

Focus on serious diseases with significant unmet medical need and clear biology. Spruce focuses on diseases that have biology that is well understood. The company believes that developing drugs that directly impact known disease pathways will increase the probability of success of its development programs.

TA-ERT for the Treatment of MPS IIIB

Spruce entered into an Asset Purchase Agreement under which we acquired an exclusive worldwide license agreement with BioMarin Pharmaceutical Inc. 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 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 nonclinical 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.

Financial Update

Spruce Biosciences also reported financial results for the year ended December 31, 2024.

As of December 31, 2024, Spruce had cash and cash equivalents of $38.8 million. The company expects its cash runway to fund its current operating plan through the end of 2025. 42.2 million shares of common stock are issued and outstanding and 21.4 million shares of common stock are reserved for issuance of warrants and equity securities as of December 31, 2024.

Please refer to Spruce’s 2024 Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission today for our full annual 2024 financial results.

Conference Call Details

Spruce’s management team will host a conference call today at 8:30 a.m. ET to discuss the business update. Analysts and investors can participate in the conference call by registering here.

An archived replay of the call will be available on the events section of the company’s investor relations website for approximately 90 days.

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 anticipated timing and conduct of our confirmatory trial for TA-ERT; the timing and likelihood of regulatory filings and approvals for TA-ERT, including our anticipated BLA Submission of TA-ERT for MPS IIIB in the first half of 2026; our ability to commercialize TA-ERT, if approved, in the United Sates and in international markets; the anticipated market opportunity and level of sales for TA-ERT for MPS IIIB, if approved; our ability to establish a commercial organization in the United States and leverage regional partnerships and a network of third-party distributors in international markets; our intended focus on serious diseases with significant unmet medical need and clear biology; and our expected future financing needs, are forward-looking statements. 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”, “continue”, “will”, “potential”, “on track”, “can”, “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.

Media  

Katie Beach Oltsik

Inizio Evoke Comms 
(937) 232-4889

katie.beach@inizioevoke.com
media@sprucebio.com  

Investors   

Samir Gharib  
President and CFO 

Spruce Biosciences, Inc.

investors@sprucebio.com   

Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB) Conference Call April 15, 2025 Javier Szwarcberg, M.D., M.P.H., CEO Samir Gharib, M.B.A., President & CFO Kirk Ways, M.D., Ph.D., CMO

Forward Looking Statements This presentation contains forward-looking statements about Spruce Biosciences, Inc. (“we,” “Spruce” or the “Company”). All statements other than statements of historical facts contained in this presentation are forward-looking statements, including statements about our strategy, our expectations regarding the timing and achievement of our product candidates' development activities and ongoing and planned clinical trials, the timing or likelihood of regulatory filings and approvals for any of our product candidates, amount and sufficiency of our cash and cash equivalents to achieve our projected milestones and to fund our planned operations, and plans and expectations for future operations. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: our limited operating history; our expectation that we will incur net losses for the foreseeable future, and that we may never be profitable; our ability to continue as a going concern; our need for additional funding and related risks for our business, product development programs and future commercialization activities; the timing and success of clinical trials we conduct; the ability to obtain and maintain regulatory approval of our product candidates; the ability to commercialize our product candidates; our ability to compete in the marketplace; risks regarding our license agreement; our ability to obtain and maintain intellectual property protection for our product candidates; and our ability to manage our growth. We operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this presentation to conform these statements to actual results or to changes in our expectations. Certain information contained in this presentation and statements made orally during this presentation relate to or are based on studies, publications, surveys and other data obtained from third-party sources and Spruce’s own internal estimates and research. While Spruce believes these third-party studies, publications, surveys and other data to be reliable as of the date of this presentation, it has not independently verified, and makes no representations as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, no independent source has evaluated the reasonableness or accuracy of Spruce’s internal estimates or research and no reliance should be made on any information or statements made in this presentation relating to or based on such internal estimates and research. This presentation discusses product candidates that are under clinical study and which have not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of these product candidates for the use for which they are being studied. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy securities, nor shall there be any sale of securities in any state of jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. You agree to keep any information provided herein confidential and not to disclose any of the information to any other parties without our prior express written permission. Neither the information contained in this presentation nor any further information made available by us or any of our affiliates or employees, directors, representatives, officers, agents or advisers in connection with this presentation will form the basis of, or be construed as, a contract or any other legal obligation. 2

aj Topline data anticipated in 1H 2026 Precision Psychiatry Program Novel mAb Pipeline Tildacerfont + Cortibon (Companion Diagnostic) for Major Depressive Disorder (MDD) Development partner (HMNC Brain Health) funding Phase 2 study Topline data anticipated in 1H 2026 CRH Antagonist mAb for Congenital Adrenal Hyperplasia GLP-1R Antagonist mAb for Post-Bariatric Hypoglycemia U.S. FDA Alignment on HS-NRE1 as Valid Surrogate for Accelerated Approval Potential PRV Eligibility Upon U.S. FDA Approval2 First-to-Market Potential | IP Exclusivity to 2037 | Orphan Drug Designations in US + EU Measured Investment Required for Launch | Commercial Team of ~10 Fatal pediatric neurodegenerative genetic disorder with no approved therapies Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) for MPS IIIB Expected BLA Filing anticipated in 1H 2026 BLA-Ready Program Heparan sulfate non-reducing end. Contingent upon reauthorization of Rare Pediatric Disease PRV Program and U.S. FDA approval. 3 Spruce Bio: Global Neuro Biopharma Company

Program Overview

Autosomal recessive disorder affecting 1 in 200,000 newborns 1 A deficiency in alpha-N-acetylglucosaminidase (NAGLU) leads to lysosomal accumulation of Heparan Sulfate (HS)2 HS buildup impairs neuronal development ultimately leading to neurodegeneration and death Sources: 1. Disease modeling for Mucopolysaccharidosis type IIIB using patient derived induced pluripotent stem cells Huang et al. -Experimental Cell Research 2021; 2. https://curesanfilippofoundation.org 2 5 Mucopolysaccharidosis IIIB (MPS IIIB): Progressive Fatal Neurodegenerative Pediatric Disorder

HS-NRE is deemed to be a biomarker1 reasonably likely to predict clinical benefit and serve as basis for accelerated approval (AA) HS based AA in other MPS subtypes are being pursued (RARE,2 DNLI3, RGNX4 ) Prior agreement with FDA on the tralesinidase program on: Acceptability of HS based biomarker as the primary endpoint for BLA submission The completed clinical and nonclinical studies are sufficient for BLA filing The key design elements of a confirmatory trial (placebo-controlled 5-year study with a 2-year interim analysis in 14 patients) can be initiated prior to potential approval Potential Priority Review Voucher (PRV) eligibility upon approval5 Well-Defined Regulatory Pathway to Approval for Tralesinidase Alfa Sources: 1. Reagan-Udall Foundation Qualifying Biomarkers to Support Rare Disease Regulatory Pathways Workshop Feb 21, 2024; 2. Ultragenyx Pharmaceutical Inc. – Investor Relations https://ir.ultragenyx.com; 3. Denali Therapeutics Inc. – Investor Relations; https://investors.denalitherapeutics.com; 4. Regenxbio Inc. – Investor Relations https://www.regenxbio.com/investors; 5. Contingent upon reauthorization of Rare Pediatric Disease PRV Program. 6

NATURAL HISTORY TREATMENT Natural History Study 1-10 years of age DQ > 50 Concurrent Natural History Study 0-18 years of age No DQ requirement COMPLETED STUDIES SUPPORTING A POTENTIAL ACCELERATED APPROVAL (AA3) PLANNED STUDY FOR FULL APPROVAL 250-301 Ph 4 Confirmatory Trial N~14 (Initiating Anticipated 1H 26) No further clinical or non-clinical studies are required for BLA submission Tralesinidase Alfa Anticipated Development Roadmap 250-401 Extension 140 wks N=5 250-202 Extension 240 wks N=20 250-201 (Part 2) 48 wks N=22 250-201 (Part 1) Dose Finding N=3 250-902 up to 192 wks N=44 250-901 48 wks N=22 Potential Accelerated Approval Based on Reduction in HS Biomarker1, 2 Confirmatory Trial Anticipated to Support Full Approval Sources: 1. Community consensus for Heparan sulfate as a biomarker to support accelerated approval in Neuronopathic Mucopolysaccharidoses Muenzer et al. -Molecular Genetics and Metabolism 2024 2. FDA Guidance to Industry: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products 2019 3. Data from completed studies 250-201, 250-202 and 250-401 provide expected sufficient data for BLA filing in 2026. 7

Normalization of pathogenic substrate in CSF is the goal of therapy Sources: 1. Internal data on file; 2. J Clin Invest. 2023;133(2):e165076. https://www.jci.org/articles/view/165076 Tralesinidase alfa is designed to target lysosomal delivery and correct NAGLU deficiency Tralesinidase alfa, 300 mg was ICV administered by a 10-minute infusion via an Ommaya reservoir weekly for 48 weeks and either weekly or every other week thereafter 2 8 CSF HS Levels¹ CSF HS-NRE Levels¹ 2 2 Tralesinidase Alfa Was Shown to Significantly and Durably Normalize CSF HS and HS-NRE Levels

Reflective of tralesinidase alfa removal of HS deposits in target organs Source: 1. J Clin Invest. 2023;133(2):e165076. https://www.jci.org/articles/view/165076 Tralesinidase alfa, 300 mg was ICV administered by a 10-minute infusion via an Ommaya reservoir weekly for 48 weeks Liver Volume 1 Cortical Gray Matter Volume 1 9 Tralesinidase Alfa Was Shown to Normalize Liver and Stabilize Cortical Grey Matter Volume

Tralesinidase alfa treatment was associated with stable cognitive function more frequently in patients with early disease, relative to patents with late disease Early and late disease groups based on baseline cognition score3 Disease stability: No meaningful loss of cognitive function4 at endpoint evaluation Natural History: Progressive Irreversible Cognitive Decline2 Bayley and Kaufman Assessments: Most Benefit in Patients with Early Disease Early Disease Late Disease Baseline (N=22) 10 12 Stable Disease at Endpoint (%) 7/10 (70%) 3/12 (25%) 1 1 Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) or the Kaufman Assessment Battery for Children, Second Edition (KABC-II) Cognition Age Equivalent Score (AEq); 2 J Pediatr. 2022 Oct;249:50-58.e2.; 3 Cognition BSID-III/KABC-11 AEq >40 months or Cognitive Disease Quotient>75 = early stage; 3 BSID-III/KABC-11 cognition AEq ≥6 change from baseline defined as stable disease ;4 Data on file Alignment with U.S. FDA on Bayley’s Cognition Raw Score as Primary Endpoint for Confirmatory Trial Early Intervention with Tralesinidase Alfa Stabilizes Cognitive Decline in MPS IIIB

22 patients enrolled in the 48-week initial study and extension studies lasting up to 6 years ~6,000 total infusions have been delivered in the 48-week initial study and its extensions Tralesinidase alfa was generally well tolerated with no discontinuations due to drug or device related adverse events and no deaths occurred in the study 1 Device-related adverse events occurred at 0.02 per infusion with serious adverse events occurring; at 0.01 per infusion 1 Hypersensitivity related adverse events reported at <0.01 per infusion and none were severe 1 Anti-drug and neutralizing antibodies occurred but did not affect CSF tralesinidase or CSF HS levels2 Tralesinidase Alfa – Safety Profile and Immunogenicity1 Source: 1 Internal data on file from 250-201 clinical study report; 2 J Pediatr. 2022 Oct;249:50-58.e2. 11

Financials and Commercial

Financial Snapshot 13 Capital Structure and Summary Financials as of December 31, 2024 Capital Structure Shares (M) Common Shares Outstanding 42.2 Equity Awards Issued and Outstanding1 5.8 Common Stock Warrants2 12.7 Fully Diluted Shares Outstanding 60.7 Cash and Debt 000’s Cash & Cash Equivalents $38,753 Debt3 $1,757 Includes 3.5 million common stock options issued and outstanding, with a weighted-average exercise price of $3.27 per share, and 2.2 million restricted stock units outstanding (summation rounds up to 5.8 million equity awards issued and outstanding). Common stock warrants issued in February 2023 in connection with private placement financing; 5-year term with strike price of $3.96 per share. Term loan, gross balance as of December 31, 2024. Up to $122.5 million in total milestones, including up to $22.5 million due upon the achievement of certain development and regulatory milestones and up to $100 million due upon the achievement of certain sales milestones. Subject to the applicable royalty term and certain customary reductions and floors. TA-ERT Exclusive Worldwide License Terms with BioMarin Pharmaceutical, Inc. Term Milestones4 $122,500,000 Royalties on Worldwide Net Sales5 High-single digit to low-teens

Consistent Growth Trajectories: Patient-centric commercial strategy linking awareness, diagnosis, and reimbursement using a small field team has generated multiple high-value markets Small patient numbers results in low overall payer burden: Multiple approved MPS ERTs confirm long-term potential Premium Pricing & Reimbursement: High unmet need and measurable clinical benefit support favorable payer coverage and sustainable pricing models Year-Over-Year Growth Reflective of Improved Diagnosis and Awareness Post-Launch Market Benchmark: Enzyme Replacement in MPS Driving Robust Growth Product Indication1 Approval1 Incidence2 Annual Cost 2024 Annual Worldwide Net Sales Brineura® CLN2 2017 0.5 in 100K $400-$500K4 $169M5 Vimizim® MPS IVA 2014 1 in 200K $450–$600K3 $740M5 Mepsevii® MPS VII 2017 1 in 1M $400–$600K3 $30M6 Aldurazyme® MPS I 2003 1 in 100K $200–$250K3 $311M7 Elaprase® MPS II 2006 1 in 160K (males)* $300–$400K3 $635M8 Naglazyme® MPS VI 2005 1 in 250-600K $400–$500K3 $480M5 Brineura, Naglazyme, Aldurazyme & Mepsevii Annual Sales <$200M) Vimizim and Elaprese Annual Sales (>$200M) *MPS II (Hunter Syndrome) exclusively affects males Net Sales ($M) by Launch Year9 Sources: 1. Approval Dates & Indications: U.S. Food and Drug Administration (FDA), Drugs@FDA Database (www.fda.gov); 2. National Organization for Rare Disorders (NORD); Christina L. Grant, Jaime López-Valdez, Deborah Marsden, Fatih Ezgü, Mucopolysaccharidosis type VII (Sly syndrome) - What do we know?, Molecular Genetics and Metabolism, Volume 141, Issue 3, 2024, 108145, ISSN 1096-7192.; 3. https://doi.org/10.1016/j.bbmt.2019.02.012; 4. https://www.fiercepharma.com/pharma/biomarin-picks-up-fda-approval-for-orphan-drug-brineura 5. Biomarin Pharmaceutical, Inc. 2024 Annual Report on Form 10-K (page 5); Evaluate Pharma; 6. Ultragenyx, Inc. 2024 Annual Report on Form 10-K (page 75); 7. https://www.sanofi.com/assets/dotcom/pressreleases/2025/2025-01-30-06-30-00-3017713-en.pdf; converted from 297 million EUR to $311 million as of 12/31/24; 8. Takeda Pharmaceutical Company Limited FY2024 Annual Securities Report; 91.6 Billion JPY converted to $635M as of 3/31/24; 9. Evaluate Pharma Uptake Reports (by product). YoY sales trajectories MPS therapies, highlight earlier diagnosis and improved awareness contribute to strong market uptake. 14

Document and Entity Information	Apr. 15, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Apr. 15, 2025
Entity Registrant Name	Spruce Biosciences, Inc.
Entity Central Index Key	0001683553
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity File Number	001-39594
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	81-2154263
Entity Address, Address Line One	611 Gateway Boulevard
Entity Address, Address Line Two	Suite 740
Entity Address, City or Town	South San Francisco
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94080
City Area Code	415
Local Phone Number	294-1687
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	SPRB
Security Exchange Name	NASDAQ