false000168355300016835532026-03-092026-03-09
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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Date of Report (Date of earliest event reported): March 9, 2026 |
Spruce Biosciences, Inc.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
001-39594 |
81-2154263 |
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
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611 Gateway Boulevard, Suite 740 |
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South San Francisco, California |
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94080 |
(Address of Principal Executive Offices) |
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(Zip Code) |
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Registrant’s Telephone Number, Including Area Code: 415-343-5986 |
(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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:
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Title of each class
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Trading Symbol(s) |
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Name of each exchange on which registered
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Common Stock, par value $0.0001 per share |
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SPRB |
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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 1.01 Entry into a Material Definitive Agreement.
On March 9, 2026, Spruce Biosciences, Inc. (the “Company”) entered into an Open Market Sale AgreementSM (the “Sales Agreement”) with Jefferies LLC (“Jefferies”). Under the Sales Agreement, the Company may offer and sell, from time to time, through Jefferies as its sales agent and/or principal, shares (the “Shares”) of its common stock, par value $0.0001 per share (the “Common Stock”), having an aggregate offering amount not exceeding the Maximum Program Amount, as such term is defined in the Sales Agreement. The Sales Agreement replaces the prior Open Market Sale AgreementSM, dated February 25, 2022, by and between the Company and Jefferies (the “Prior Sales Agreement’), which was terminated as of March 9, 2026 pursuant to the terms of the Sales Agreement.
The Company is not obligated to sell any Shares under the Sales Agreement. Upon delivery of an issuance notice and subject to the terms and conditions of the Sales Agreement, Jefferies will use commercially reasonable efforts, consistent with its normal trading and sales practices and applicable laws and regulations, to sell Shares from time to time based upon the Company’s instructions, including any price, time or size limits or other customary parameters or conditions the Company may specify, subject to certain limitations. Under the Sales Agreement, Jefferies may sell Shares in negotiated transactions, including block trades or block sales, or by any method that is deemed to be an “at-the-market offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended (the “Securities Act”), including without limitation sales made through the Nasdaq Capital Market or on any other existing trading market for the Common Stock, or by any other method permitted by law. The Company will pay Jefferies a commission of up to 3.0% of the gross sales proceeds of any Shares sold through Jefferies under the Sales Agreement. The Company has also provided Jefferies with customary indemnification and contribution rights. The Sales Agreement contains customary representations and warranties and conditions to the placements of Shares pursuant thereto. The Sales Agreement may be terminated by the Company or Jefferies upon written notice to the other party in accordance with the terms of the Sales Agreement. The offering of Shares pursuant to the Sales Agreement will terminate upon the termination of the Sales Agreement in accordance with its terms.
The issuance and sale, if any, of Shares under the Sales Agreement will be made pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-291152), filed with the U.S. Securities and Exchange Commission (the “SEC”) on October 29, 2025, including the prospectus, dated October 29, 2025, and the Company’s prospectus supplement, dated March 9, 2026. This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy any Shares under the Sales Agreement nor shall there be any offer, solicitation or sale of such Shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.
Cooley LLP, counsel to the Company, has issued a legal opinion relating to the validity of the Shares. A copy of such legal opinion, including the consent included therein, is filed as Exhibit 5.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The foregoing description of the material terms of the Sales Agreement is qualified in its entirety by reference to the full text of the Sales Agreement, which is attached as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 1.02 Termination of a Material Definitive Agreement.
The information set forth above in Item 1.01 with respect to the termination of the Prior Sales Agreement is hereby incorporated by reference into this Item 1.02.
Item 2.02 Results of Operations and Financial Condition.
On March 9, 2026, the Company issued a press release announcing its financial results for the full year ended December 31, 2025 and providing corporate updates (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 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 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Appointment of Corwin Dale Hooks as Chief Commercial Officer
On March 9, 2026, the Company announced the appointment of Corwin Dale Hooks as the Company’s Chief Commercial Officer, effective March 9, 2026.
Mr. Hooks, age 60, previously served as Chief Commercial Officer of Applied Therapeutics, Inc. from April 2024 until February 2026. Mr. Hooks has over 30 years of experience in the biopharma industry, leading numerous product launches and managing global brands. Mr. Hooks previously served as Vice President of Global Commercial Operations at Reata Pharmaceuticals, Inc. from February 2019 to November 2023. Prior to that, Mr. Hooks was the Chief Commercial Officer at Clovis Oncology, Inc. from January 2016 to October 2018, where he was responsible for building their global commercial organization. From 1992 to 2014, Mr. Hooks held positions of increasing responsibility at Genentech, Galderma, Novartis, and GSK. Mr. Hooks has a B.S. degree in Marketing and Finance from Stephen F. Austin University and an M.B.A. from the University of North Carolina at Chapel Hill.
In connection with Mr. Hooks’s appointment, the Company entered into an offer letter with Mr. Hooks dated February 18, 2026 (the “Offer Letter”). Under the terms of the Offer Letter, Mr. Hooks will receive an annual base salary of $480,000 per year. He is eligible to receive an annual performance bonus of up to 40% of his base salary based on the attainment of corporate performance metrics and individual performance objectives, in each case established and evaluated by the board of directors of the Company (the “Board”) or the Compensation Committee of the Board (the “Compensation Committee”) in its sole good faith discretion. Pursuant to the Offer Letter, Mr. Hooks will be granted a restricted stock unit award for 11,000 shares of the Company’s common stock (the “RSU”). The RSU will vest in equal annual installments over a period of four years subject to Mr. Hooks’s continuous service through the applicable vesting dates. The RSU constitutes an inducement award in accordance with Nasdaq Listing Rule 5635(c)(4) and was granted outside the Company’s 2020 Equity Incentive Plan (the “Plan”) but pursuant to the terms of the Plan as if such awards were made under the Plan. In connection with such awards, the Board adopted a form of inducement RSU award grant notice and award agreement (the “Inducement RSU Grant Package”).
Mr. Hooks will be eligible to participate in the Company’s Severance and Change in Control Plan (the “Severance Plan,” a copy of which is incorporated by reference as Exhibit 10.9 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 22, 2021). Mr. Hooks entered into the Company’s standard form of Indemnity Agreement for directors and executive officers of the Company.
There is no arrangement or understanding between Mr. Hooks and any other person pursuant to which he was selected as an executive officer of the Company, and there are no family relationships between Mr. Hooks and any of the Company’s directors or executive officers. There are no transactions to which the Company is a party and in which Mr. Hooks has a direct or indirect material interest that would be required to be disclosed under Item 404(a) of Regulation S-K.
The foregoing descriptions of the Offer Letter and the Inducement RSU Grant Package are not complete and are qualified in their entirety by reference to the text of the Offer Letter and the Inducement RSU Grant Package, which are filed as Exhibits 10.1 and 10.2, respectively, to this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit Number |
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Description |
1.1 |
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Open Market Sales AgreementSM, dated March 9, 2026, by and between Spruce Biosciences, Inc. and Jefferies LLC. |
5.1 |
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Legal Opinion of Cooley LLP. |
10.1 |
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Offer Letter, by and between Spruce Biosciences, Inc. and Corwin Dale Hooks, dated February 18, 2026. |
10.2 |
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Form of Restricted Stock Unit Grant Notice and Award Agreement for Inducement Grant Outside of the Spruce Biosciences, Inc. 2020 Equity Incentive Plan. |
23.1 |
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Consent of Cooley LLP (included in Exhibit 5.1). |
99.1 |
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Press Release of Spruce Biosciences, Inc., dated March 9, 2026. |
104 |
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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 hereunto duly authorized.
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Spruce Biosciences, Inc. |
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Date: March 9, 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 Full Year 2025 Financial Results and Provides Corporate Updates
Following Positive Type B Meetings with the FDA, BLA Submission for TA-ERT for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB) on Track for the Fourth Quarter of 2026
Appoints Dale Hooks as Chief Commercial Officer, Strengthening the Company’s Commercial Capabilities in Preparation for a Potential Launch of TA-ERT
Secured up to $50 Million in Growth Capital from Avenue Capital Group
South San Francisco, Calif. – March 9, 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 year ended December 31, 2025 and provided corporate updates.
“2025 was a very productive year, and our team continues to execute and drive towards key milestones with our tralesinidase alfa enzyme replacement therapy (TA-ERT) program, especially our planned biologics license application (BLA) submission in the fourth quarter of this year and potential commercial launch in MPS IIIB,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “Our recent productive interactions with the FDA have provided clear next steps that strengthen our conviction in the development of TA-ERT for patients and families living with MPS IIIB, for which currently there are no approved therapies. Our appointment of Dale Hooks as Chief Commercial Officer further reflects our conviction and commitment to building our capabilities and commercial infrastructure, as we position ourselves to capitalize on the next chapter of growth at Spruce.”
Recent Corporate Updates
•Held Positive Type B Meetings with the FDA. In February 2026, the company announced the successful completion of two Type B meetings with the FDA regarding its planned upcoming BLA submission for TA-ERT for the treatment of MPS IIIB. The FDA confirmed that the integrated study data from interventional clinical studies of TA-ERT and the available natural history data could potentially serve as an adequate and well-controlled study for purposes of the FDA’s review of the effects of TA-ERT on cerebral spinal fluid heparan sulfate non-reducing end, which could serve as a reasonably likely surrogate endpoint of clinical benefit supporting an accelerated approval. The BLA submission for TA-ERT is anticipated in the fourth quarter of 2026.
•Appointed Dale Hooks, an Accomplished Rare Disease Commercial Leader, as Chief Commercial Officer. Today, the company announced the appointment of Dale Hooks as Chief Commercial Officer, who brings over three decades of biopharmaceutical marketing and commercialization expertise to drive the potential commercial launch of TA-ERT.
•Secured Up to $50 million in Growth Capital from Avenue Capital. In January 2026, the company entered into a loan facility for up to $50 million in growth capital to support the continued advancement and potential commercial launch of TA-ERT. The loan facility has a 42-month term and includes an initial tranche of $15 million, which was fully funded in January 2026, and three additional tranches totaling up to $35 million, subject to the satisfaction of certain terms and conditions of the loan and security agreement.
•Presented Long-term Data of TA-ERT at the 22nd Annual WORLDSymposium. In February 2026, data from two different analyses were presented highlighting TA-ERT as potentially the first disease-modifying treatment option for MPS IIIB. One presentation showed that long-term administration of TA-ERT resulted in rapid and durable reduction of heparan sulfate and preserved cognitive and non-cognitive clinical outcomes in patients with MPS IIIB relative to natural history patients. The second presentation included analyses of two siblings
diagnosed with MPS IIIB showing that, in an age-matched comparison, one sibling treated with TA-ERT appeared to display higher cognitive, language, and motor functioning relative to the untreated sibling at a similar age. For more information, the two poster presentations can be found on the Spruce Biosciences website at https://investors.sprucebio.com/news-and-events/presentations.
•Added Regulatory and Clinical Development Expertise to the Executive Leadership Team. In February 2026, the company appointed Daven Mody, Pharm.D., as Senior Vice President, Regulatory and Quality, and Bruno Gagnon, B.Pharm., M.Sc., as Senior Vice President, Clinical Development Operations.
•Reauthorization of the Rare Pediatric Disease Priority Review Voucher (PRV) Program. In February 2026, the PRV program was reauthorized through September 30, 2029. This five-year extension restores a key incentive to develop therapies for rare pediatric diseases, allowing companies to receive a fast-track review voucher for approved drugs. TA-ERT has secured Rare Pediatric Disease Designation and is eligible for a PRV, if approved by the FDA.
•Appointed Keli Walbert, a Proven Pharmaceutical Commercial Leader, to the Board of Directors. In December 2025, the company appointed Keli Walbert to its Board of Directors. Ms. Walbert has decades of commercial leadership experience and a proven track record of successful product launches in rare diseases.
Full Year 2025 Financial Results
•Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2025 were $48.9 million, which excludes the receipt of $15.0 million in gross proceeds under the loan facility with Avenue Capital. The company expects its cash and cash equivalents to fund its current operating plan into early 2027, beyond the anticipated BLA submission for TA-ERT.
•Research and Development (R&D) Expenses: R&D expenses for the year ended December 31, 2025 were $19.5 million compared to $46.4 million for the same period in 2024. The decrease in R&D expenses was primarily related to the cessation of development activities of tildacerfont for the treatment of congenital adrenal hyperplasia (CAH), offset by development activities related to TA-ERT for the treatment of MPS IIIB and the acquisition of SPR202, an anti-corticotropin releasing hormone monoclonal antibody for the treatment of CAH.
•General and Administrative (G&A) Expenses: G&A expenses for the year ended December 31, 2025 were $17.0 million compared to $14.6 million for the same period in 2024, primarily driven by increased professional service fees, offset by a decrease in stock-based compensation expense.
•Total Operating Expenses: Total operating expenses for the year ended December 31, 2025 were $36.5 million compared to $61.1 million for the same period in 2024. Operating expenses include non-cash stock-based compensation expenses of $2.6 million for the year ended December 31, 2025 compared to $5.3 million for the same period in 2024.
Net Loss: Net loss for the year ended December 31, 2025 was $39.0 million compared to $53.0 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, 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 content, timing and likelihood of regulatory filings and approvals for TA-ERT, including advancing this program through a BLA submission and potential FDA approval; the potentially transformative clinical impact for TA-ERT; TA-ERT’s eligibility for a PRV; and TA-ERT’s potential to be the first disease-modifying therapy to treat MPS IIIB. 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,” “could,” “potential,” “on track,” “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.
Contacts
Media
Carolyn Hawley
Inizio Evoke Comms
Carolyn.Hawley@inizioevoke.com
media@sprucebio.com
Investors
Monique Kosse
Gilmartin Group
Monique@GilmartinIR.com
investors@sprucebio.com
SPRUCE BIOSCIENCES, INC.
BALANCE SHEETS
(in thousands, except share and per share amounts)
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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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$ |
48,906 |
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$ |
38,753 |
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Prepaid expenses |
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353 |
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3,177 |
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Other current assets |
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2,853 |
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2,276 |
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Total current assets |
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52,112 |
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44,206 |
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Right-of-use assets |
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666 |
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934 |
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Other assets |
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243 |
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69 |
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Total assets |
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$ |
53,021 |
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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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$ |
943 |
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$ |
1,295 |
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Accrued expenses and other current liabilities |
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9,143 |
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12,329 |
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Term loan, current portion |
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— |
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1,622 |
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Total current liabilities |
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10,086 |
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15,246 |
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Lease liabilities, net of current portion |
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419 |
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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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10,505 |
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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 no shares issued or outstanding as of December 31, 2025 and 2024 |
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— |
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— |
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Common stock, $0.0001 par value; 200,000,000 shares authorized as of December 31, 2025 and 2024; 1,372,043 and 563,042 shares issued and outstanding as of December 31, 2025 and 2024, respectively |
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— |
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— |
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Additional paid-in capital |
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331,750 |
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279,089 |
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Accumulated deficit |
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(289,234 |
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(250,268 |
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Total stockholders’ equity |
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42,516 |
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28,821 |
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Total liabilities and stockholders’ equity |
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$ |
53,021 |
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$ |
45,209 |
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SPRUCE BIOSCIENCES, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
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Year Ended December 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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$ |
4,911 |
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Operating expenses: |
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Research and development |
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19,522 |
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46,418 |
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General and administrative |
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16,991 |
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14,644 |
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Total operating expenses |
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36,513 |
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61,062 |
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Loss from operations |
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(36,513 |
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(56,151 |
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Interest expense |
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(90 |
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(307 |
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Change in fair value of warrant liability |
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(3,500 |
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— |
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Interest and other income, net |
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1,137 |
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3,422 |
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Net loss and comprehensive loss |
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(38,966 |
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(53,036 |
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Net loss per share, basic and diluted |
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$ |
(50.83 |
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$ |
(96.40 |
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Weighted-average shares of common stock outstanding, basic and diluted |
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766,598 |
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550,146 |
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