8-K
Spruce Biosciences, Inc. (SPRB)
UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, 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<br>of Incorporation) | (Commission File Number) | (IRS Employer<br>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<br>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<br><br>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) |
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<br>President and Chief Financial Officer |
EX-99.1
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)
| December 31, | |||||
|---|---|---|---|---|---|
| 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 |
All values are in US Dollars.
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, <br> 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