0001683553false00016835532025-05-062025-05-06

 

 

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): May 6, 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: 415-655-4168

 

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

 

*

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.

* The registrant’s common stock began trading exclusively on the OTC Pink Marketplace on April 29, 2025 under the symbol “SPRB”.

 

 

 


 

Item 2.02 Results of Operations and Financial Condition.

On May 6, 2025, Spruce Biosciences, Inc. (the "Company") issued a press release announcing its financial results for the first quarter ended March 31, 2025 and providing corporate updates. 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 (the "Exchange Act"), and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, 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

Number

 

Description

 

 

 

99.1

Press Release of Spruce Biosciences, Inc., dated May 6, 2025

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

1


 

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 thereunto duly authorized.

 

 

 

SPRUCE BIOSCIENCES, INC.

 

 

 

 

Date:

May 6, 2025

By:

/s/ Samir Gharib

 

 

 

Samir Gharib
President and Chief Financial Officer

 

2


Exhibit 99.1

Spruce Biosciences Reports First Quarter 2025 Financial Results and Provides Corporate Updates

 

Acquisition of Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB)

Biologics License Application (BLA) Submission to U.S. FDA for TA-ERT Expected in 1H 2026

 

South San Francisco, Calif. – May 6, 2025 – Spruce Biosciences, Inc. (OTC: 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 first quarter ended March 31, 2025 and provided corporate updates.

“With no FDA-approved treatments currently available to treat MPS IIIB, TA-ERT has the potential to be a groundbreaking advancement for patients and families impacted by this devastating disease,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce. “Across the landscape, this is an incredibly important and exciting time for patients and families affected by neuropathic MPS diseases. Looking ahead, we remain focused on pursuing accelerated approval of TA-ERT and filing the BLA in the first half of 2026. We also plan to initiate a confirmatory study prior to potential accelerated approval of TA-ERT and enable expanded access programs to ensure that patients have access to therapy.”

 

Corporate Updates

TA-ERT for the Treatment of MPSIIIB. Spruce entered into an Asset Purchase Agreement under which the company acquired an exclusive worldwide license agreement 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 non-clinical 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.
Tildacerfont and Cortibon for the Treatment of MDD. Spruce entered into a license, development and option agreement (the “HMNC Agreement”) with HMNC Holding GmbH (“HMNC”). Under the terms of the HMNC Agreement, HMNC will fund and conduct a Phase 2 proof-of-concept study of tildacerfont, a potent and highly selective, oral, small-molecule antagonist of the CRF1 receptor, in patients with MDD who will be screened using Cortibon, HMNC’s proprietary genetic test. HMNC has initiated the Phase 2 TAMARIND study, which will explore the efficacy of 400mg twice-daily tildacerfont versus placebo in improving depressive symptoms in MDD patients. Topline results from TAMARIND are anticipated in the first half of 2026.

 

First Quarter 2025 Financial Results

Cash and Cash Equivalents: Cash and cash equivalents as of March 31, 2025 were $25.6 million. Cash and cash equivalents are expected to allow the company to fund its current operating plan through the end of 2025.
Research and Development (R&D) Expenses: R&D expenses for the three months ended March 31, 2025 were $10.8 million compared to $10.3 million for the same period in 2024. R&D expenses for the three months ended March 31, 2025 include $5.7 million in costs related to the acquisition of SPR202, an anti-corticotrophin releasing hormone monoclonal antibody for the treatment of congenital adrenal hyperplasia.
General and Administrative (G&A) Expenses: G&A expenses for the three months ended March 31, 2025 were $3.7 million compared to $4.3 million for the same period in 2024, primarily driven by a decrease in stock-based compensation expense.
Total Operating Expenses: Total operating expenses for the three months ended March 31, 2025 were $14.5 million compared to $14.6 million for the same period in 2024. Operating expenses include non-cash stock-based

 


 

compensation expenses of $0.5 million for the three months ended March 31, 2025 compared to $1.6 million for the same period in 2024.
Net Loss: Net loss for the three months ended March 31, 2025 was $14.0 million compared to $11.6 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 @Spruce_Bio, 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 Spruce’s confirmatory trial for TA-ERT; the timing and likelihood of regulatory filings and approvals for TA-ERT, including the anticipated BLA Submission of TA-ERT for MPS IIIB in the first half of 2026; Spruce’s expectation that topline results from the TAMARIND study will be available in the first half of 2026; and Spruce’s intended focus on serious diseases with significant unmet medical need and clear biology, 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”, “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.

 


 

SPRUCE BIOSCIENCES, INC.

CONDENSED BALANCE SHEETS

(unaudited)

(in thousands, except share and per share amounts)

 

 

 

 

 

March 31,

 

 

December 31,

 

 

 

2025

 

 

2024

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

25,615

 

 

$

38,753

 

Prepaid expenses

 

 

2,899

 

 

 

3,177

 

Other current assets

 

 

2,062

 

 

 

2,276

 

Total current assets

 

 

30,576

 

 

 

44,206

 

Right-of-use assets

 

 

869

 

 

 

934

 

Other assets

 

 

204

 

 

 

69

 

Total assets

 

$

31,649

 

 

$

45,209

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,879

 

 

$

1,295

 

Accrued expenses and other current liabilities

 

 

12,442

 

 

 

12,329

 

Term loan, current portion

 

 

1,345

 

 

 

1,622

 

Total current liabilities

 

 

15,666

 

 

 

15,246

 

Lease liabilities, net of current portion

 

 

659

 

 

 

736

 

Term loan, net of current portion

 

 

 

 

 

124

 

Other liabilities

 

 

 

 

 

282

 

Total liabilities

 

 

16,325

 

 

 

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 March 31, 2025 and December 31, 2024

 

 

 

 

 

 

Common stock, $0.0001 par value; 200,000,000 shares authorized as of
   March 31, 2025 and December 31, 2024; 42,231,285 shares issued and
   outstanding as of March 31, 2025 and December 31, 2024

 

 

4

 

 

 

4

 

Additional paid-in capital

 

 

279,629

 

 

 

279,085

 

Accumulated deficit

 

 

(264,309

)

 

 

(250,268

)

Total stockholders’ equity

 

 

15,324

 

 

 

28,821

 

Total liabilities and stockholders’ equity

 

$

31,649

 

 

$

45,209

 

 

 


 

SPRUCE BIOSCIENCES, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(unaudited)

(in thousands, except share and per share amounts)

 

 

 

 

 

Three Months Ended March 31,

 

 

 

2025

 

 

2024

 

Collaboration revenue

 

$

 

 

$

2,002

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

 

10,837

 

 

 

10,317

 

General and administrative

 

 

3,655

 

 

 

4,318

 

Total operating expenses

 

 

14,492

 

 

 

14,635

 

Loss from operations

 

 

(14,492

)

 

 

(12,633

)

Interest expense

 

 

(36

)

 

 

(97

)

Interest and other income, net

 

 

487

 

 

 

1,105

 

Net loss and comprehensive loss

 

 

(14,041

)

 

 

(11,625

)

Net loss per share, basic and diluted

 

$

(0.32

)

 

$

(0.28

)

Weighted-average shares of common stock outstanding,
   basic and diluted

 

 

43,944,946

 

 

 

41,096,231

 

 

 


 

Contacts

Media

Katie Beach Oltsik
Inizio Evoke Comms
(937) 232-4889
Katherine.Beach@inizioevoke.com
media@sprucebio.com

 

Investors

Samir Gharib
President and CFO

Spruce Biosciences, Inc.

investors@sprucebio.com

 

 


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May 06, 2025
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Entity Registrant Name Spruce Biosciences, Inc.
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Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 81-2154263
Entity Address, Address Line One 611 Gateway Boulevard
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Title of 12(b) Security Common Stock, par value $0.0001 per share
Trading Symbol SPRB

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