SPRB 8-K
Spruce Biosciences, Inc. (SPRB)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
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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. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 12, 2026, Spruce Biosciences, Inc. (the "Company") issued a press release announcing its financial results for the second quarter ended June 30, 2026 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.
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Exhibit Description |
99.1 |
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Press Release of Spruce Biosciences, Inc., dated August 12, 2026. |
104 |
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Cover Page Interactive Data File (formatted as inline XBRL). |
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: August 12, 2026 |
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By: |
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/s/ Samir Gharib |
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Samir Gharib |
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President and Chief Financial Officer |
Exhibit 99.1
Spruce Biosciences Reports Second Quarter 2026 Financial Results and Provides Corporate Updates
Biologics License Application (BLA) for TA-ERT for the Treatment of MPS IIIB Anticipated in the Fourth Quarter of 2026
TrAnsform Confirmatory Study Required for Potential FDA Accelerated Approval of TA-ERT Expected to Initiate in the Fourth Quarter of 2026
Strengthened Leadership Team with the Appointments of Adrian Quartel, M.D., FFPM, as Chief Medical Officer and Jessica Cohen Pfeffer, M.D., as Vice President, Clinical Development
South San Francisco, Calif. — August 12, 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 second quarter ended June 30, 2026, and provided corporate updates.
“The second quarter was a period of significant execution as we advanced TA-ERT toward our planned BLA submission in the fourth quarter, which would be a transformative milestone for Spruce and for the children and families living with MPS IIIB,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “As we prepare for the submission, we are also preparing to initiate our TrAnsform confirmatory study in the fourth quarter of 2026. We are honored and grateful that Cure Sanfilippo Foundation and the National MPS Society have made a combined $5.5 million strategic investment to help broaden patient access to TA-ERT. We believe we are well positioned to advance TA-ERT through key regulatory milestones and prepare for a potential U.S. commercial launch next year.”
TA-ERT Program Updates
Strengthening Clinical Development and Medical Leadership
During and subsequent to the quarter, Spruce further strengthened its clinical development and medical leadership with two senior appointments to support the planned TA-ERT BLA submission, potential FDA approval and commercial readiness:
Strategic Investment from the Patient Advocacy Community
Today, Spruce separately announced that Cure Sanfilippo Foundation and the National MPS Society have made a combined $5.5 million strategic investment in Spruce. The proceeds will be used to partially fund the TA-ERT Expanded Access Program (EAP), helping to broaden patient access to investigational TA-ERT for the treatment of MPS IIIB. The planned open-label, single-arm EAP is designed to provide TA-ERT to children in the United States with attenuated and severe MPS IIIB who are not eligible to enroll in the TrAnsform confirmatory study. The EAP is expected to enroll approximately 10 participants across U.S. sites, with TA-ERT administered weekly via an ICV delivery device. The EAP is expected to initiate in the fourth quarter of 2026. More information about the EAP can be found at ClinicalTrials.gov. Additional information regarding the strategic investment is available in a separate press release available in the “News” section of the company’s website.
Second Quarter 2026 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. Spruce’s lead product candidate, tralesinidase alfa enzyme replacement therapy (TA-ERT), is in late-stage development for the treatment of mucopolysaccharidoses type IIIB (MPS IIIB), or Sanfilippo Syndrome Type B, a devastating pediatric neurodegenerative disorder for which there are no FDA-approved therapies. TA-ERT has received Breakthrough Therapy Designation, Rare Pediatric Disease Designation, Fast Track Designation and Orphan Drug Designation from the FDA, as well as Orphan Drug Designation in the European Union. 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 expected timing of a planned BLA submission for TA-ERT for the treatment of MPS IIIB and the pathway to potential accelerated approval; the expected timing, enrollment and conduct of the TrAnsform confirmatory study and the TA-ERT Expanded Access Program; the $5.5 million strategic investment from Cure Sanfilippo Foundation and the National MPS Society, including the expected use of proceeds; Spruce’s expectations regarding the sufficiency of its cash and cash equivalents to fund its planned operations and debt obligations into the second half of 2027; Spruce’s plans to advance TA-ERT through potential FDA approval and commercialization, if approved, including a potential U.S. commercial launch; the contributions and impact of recently appointed members of Spruce’s leadership team; and Spruce’s product candidate, strategy and regulatory matters. 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,” “plan,” “expect,” “believe” 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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June 30, |
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December 31, |
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2026 |
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2025 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
96,295 |
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$ |
48,906 |
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Prepaid expenses |
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4,625 |
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353 |
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Other current assets |
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234 |
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2,853 |
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Total current assets |
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101,154 |
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52,112 |
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Right-of-use assets |
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523 |
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666 |
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Other assets |
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1,175 |
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243 |
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Total assets |
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$ |
102,852 |
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$ |
53,021 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,209 |
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$ |
943 |
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Accrued expenses and other current liabilities |
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7,254 |
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9,143 |
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Debt, current portion |
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2,500 |
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— |
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Total current liabilities |
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10,963 |
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10,086 |
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Lease liabilities, net of current portion |
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245 |
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419 |
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Debt, net of current portion |
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4,591 |
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— |
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Warrant liability |
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3,323 |
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— |
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Total liabilities |
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19,122 |
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10,505 |
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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 |
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— |
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— |
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Common stock, $0.0001 par value; 200,000,000 shares authorized |
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— |
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— |
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Additional paid-in capital |
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401,459 |
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331,750 |
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Accumulated deficit |
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(317,729 |
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(289,234 |
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Total stockholders’ equity |
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83,730 |
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42,516 |
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Total liabilities and stockholders’ equity |
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$ |
102,852 |
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$ |
53,021 |
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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 June 30, |
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Six Months Ended June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Operating expenses: |
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Research and development |
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$ |
12,163 |
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$ |
(430 |
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$ |
19,738 |
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$ |
10,407 |
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General and administrative |
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4,349 |
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3,122 |
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8,761 |
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6,777 |
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Total operating expenses |
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16,512 |
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2,692 |
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28,499 |
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17,184 |
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Loss from operations |
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(16,512 |
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(2,692 |
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(28,499 |
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(17,184 |
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Interest expense |
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(1,097 |
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(29 |
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(1,771 |
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(65 |
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Interest and other income, net |
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765 |
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193 |
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1,251 |
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522 |
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Change in fair value of warrant and conversion option liabilities |
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615 |
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461 |
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524 |
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619 |
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Net loss and comprehensive loss |
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(16,229 |
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(2,067 |
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(28,495 |
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(16,108 |
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Net loss per share, basic and diluted |
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$ |
(6.68 |
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$ |
(3.50 |
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$ |
(14.96 |
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$ |
(27.36 |
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Weighted-average shares of common stock |
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2,431,075 |
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591,137 |
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1,904,505 |
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588,653 |
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