SPRB 8-K
Spruce Biosciences, Inc. (SPRB)
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:
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.
* 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 |
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Description |
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99.1 |
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Press Release of Spruce Biosciences, Inc., dated May 6, 2025 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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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.
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SPRUCE BIOSCIENCES, INC. |
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Date: |
May 6, 2025 |
By: |
/s/ Samir Gharib |
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Samir Gharib |
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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
First Quarter 2025 Financial Results
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)
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March 31, |
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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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$ |
25,615 |
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$ |
38,753 |
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Prepaid expenses |
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2,899 |
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3,177 |
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Other current assets |
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2,062 |
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2,276 |
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Total current assets |
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30,576 |
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44,206 |
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Right-of-use assets |
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869 |
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934 |
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Other assets |
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204 |
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69 |
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Total assets |
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$ |
31,649 |
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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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$ |
1,879 |
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$ |
1,295 |
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Accrued expenses and other current liabilities |
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12,442 |
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12,329 |
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Term loan, current portion |
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1,345 |
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1,622 |
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Total current liabilities |
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15,666 |
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15,246 |
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Lease liabilities, net of current portion |
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659 |
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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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16,325 |
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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, $0.0001 par value; 200,000,000 shares authorized as of |
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4 |
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4 |
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Additional paid-in capital |
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279,629 |
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279,085 |
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Accumulated deficit |
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(264,309 |
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(250,268 |
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Total stockholders’ equity |
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15,324 |
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28,821 |
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Total liabilities and stockholders’ equity |
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$ |
31,649 |
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$ |
45,209 |
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SPRUCE BIOSCIENCES, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended March 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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2,002 |
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Operating expenses: |
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Research and development |
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10,837 |
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10,317 |
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General and administrative |
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3,655 |
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4,318 |
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Total operating expenses |
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14,492 |
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14,635 |
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Loss from operations |
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(14,492 |
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(12,633 |
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Interest expense |
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(36 |
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(97 |
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Interest and other income, net |
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487 |
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1,105 |
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Net loss and comprehensive loss |
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(14,041 |
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(11,625 |
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Net loss per share, basic and diluted |
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$ |
(0.32 |
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$ |
(0.28 |
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Weighted-average shares of common stock outstanding, |
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43,944,946 |
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41,096,231 |
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Contacts
Media
Katie Beach Oltsik
Inizio Evoke Comms
(937) 232-4889
[email protected]
[email protected]
Investors
Samir Gharib
President and CFO
Spruce Biosciences, Inc.