Spruce Biosciences filings document the regulatory, financing and governance record of a late-stage biopharmaceutical company developing TA-ERT for Sanfilippo Syndrome Type B (MPS IIIB). Form 8-K disclosures cover material agreements, including loan and security arrangements, at-the-market equity sale agreements, collaboration and license matters, and furnished clinical data updates related to the TA-ERT program.
Proxy materials describe shareholder voting matters, director elections, board committee changes, executive compensation and equity incentive plan matters. The filing record also includes capital-structure disclosures tied to common stock, equity awards, financing arrangements, risk factors and public-company governance.
Spruce Biosciences, Inc. reported a $52.5 million net loss for the nine months ended September 30, 2026, versus $24.3 million in 2025, and used $44.6 million of operating cash, versus $26.9 million. Cash and cash equivalents were $87.7 million as of September 30, 2026. Spruce said this cash would be insufficient to fund planned operations and debt obligations for at least 12 months following issuance absent alternative financing. It stated substantial doubt exists about its ability to continue as a going concern.
The company is developing TA-ERT for MPS IIIB and anticipates a BLA submission seeking accelerated approval in December 2026. Its TrAnsform confirmatory study is on track to begin in December 2026 and is expected to enroll approximately 14 participants; an expanded access program began in November 2026 and is expected to enroll approximately 10. Spruce has no approved products or product revenue.
On November 6, 2026, Spruce's board approved separating CRHX-101 into Adrenyx; a pro rata distribution is expected in the first half of 2027, but the board had not yet approved the distribution. An Avenue amendment extended the interest-only period through March 31, 2027; further extensions are subject to conditions.
Spruce Biosciences, Inc. said its planned December 2026 biologics license application (BLA) for TA-ERT remains on track to seek accelerated approval for MPS IIIB based on CSF HS-NRE reduction. The TrAnsform confirmatory study is expected to start in December with approximately 14 participants; FDA requested initiation during BLA review as a condition of potential accelerated approval.
An Avenue amendment makes up to $15.0 million available under Tranche 2 for draws from January 1 through March 31, 2027, subject to conditions, and extends the interest-only period through March 31, 2027. Spruce separated CRHX-101 into wholly owned Adrenyx on November 6 and intends a pro rata distribution, expected in the first half of 2027 subject to conditions and board approval. Adrenyx issued $5.0 million of secured convertible notes and may issue up to $10.0 million in aggregate principal; a private placement with up to $50 million funded by the notes investor, inclusive of note funding, is expected at distribution. Spruce cannot use note proceeds for its operations.
Cash and cash equivalents were $87.7 million as of September 30, 2026, and Q3 net loss was $24.0 million, versus $8.2 million in Q3 2025. Spruce believes its cash will fund planned operations and debt obligations into the second half of 2027.
OrbiMed Advisors LLC and OrbiMed Capital LLC report institutional ownership in Spruce Biosciences, Inc. The filing states that OrbiMed Advisors beneficially owns 132,200 shares of Spruce’s common stock, representing 4.8% of the outstanding class, while OrbiMed Capital beneficially owns 67,800 shares, representing 2.5%.
OrbiMed Advisors has shared voting and dispositive power over 132,200 shares, and OrbiMed Capital has sole voting and dispositive power over 67,800 shares. The reporting persons hold 7.3% of Spruce’s common stock in the aggregate on behalf of other persons who are entitled to dividends and sale proceeds. Investment and voting power are exercised through a management committee, whose members disclaim beneficial ownership.
Spruce Biosciences, Inc. is the issuer of common stock, par value $0.0001 per share, covered by this Schedule 13G/A. As of June 30, 2026, ADAR1 Capital Management, LLC, a Texas investment adviser, and Daniel Schneeberger, a Swiss citizen, each report beneficial ownership of 67,717 shares of Spruce Biosciences common stock, representing 2.5% of the outstanding class. These shares include 47,652 held by ADAR1 Partners, LP, 9,916 held by Spearhead Insurance Solutions IDF, LLC, and 10,149 held by other separately managed accounts. ADAR1 Capital Management and Mr. Schneeberger report no sole voting or dispositive power and shared voting and dispositive power over all 67,717 shares, with beneficial ownership attributed through their roles as investment manager, sub-advisor, or manager for the referenced entities and accounts.
Citadel-affiliated entities and Kenneth Griffin report a sub‑5% passive stake in Spruce Biosciences, Inc. They may be deemed to beneficially own various blocks of common stock, with Mr. Griffin associated with 51,919 Shares, representing 1.9% of Spruce’s common stock outstanding.
The reported percentages are based on 2,752,278 Shares outstanding as of May 11, 2026, as referenced from Spruce’s Form 10‑Q. All reporting persons disclose no sole voting or dispositive power, only shared voting and dispositive power over their respective share amounts, and confirm ownership of 5 percent or less of the class.
Spruce Biosciences, Inc. reports that AWM Investment Company, Inc., a Delaware corporation acting as investment adviser to three Special Situations funds, has filed as a beneficial owner of its common stock. AWM reports beneficial ownership of 146,988 shares of common stock, representing 5.1% of the class as of June 30, 2026.
AWM has sole voting and dispositive power over all 146,988 shares, held across Special Situations Cayman Fund, L.P. (29,033 shares), Special Situations Fund III QP, L.P. (99,618 shares) and Special Situations Life Sciences Fund, L.P. (18,337 shares). The filing identifies David M. Greenhouse and Adam C. Stettner as controlling principals of AWM and as members of the entities serving as general partners of the funds.
Spruce Biosciences, Inc. is a late-stage biopharmaceutical company developing tralesinidase alfa (TA-ERT) for mucopolysaccharidosis type IIIB (Sanfilippo B), which has no approved therapies. TA-ERT holds multiple U.S. and EU regulatory designations, and a BLA filing is anticipated in Q4 2026.
For the six months ended June 30, 2026, Spruce reported a net loss of $28.5 million versus $16.1 million in 2025, driven by higher TA-ERT spending. Research and development expenses rose to $19.7 million from $10.4 million, and general and administrative expenses to $8.8 million from $6.8 million. Cash and cash equivalents increased to $96.3 million from $48.9 million, primarily from a $64.4 million April 2026 equity offering and a $15.0 million Avenue term loan. Management believes existing cash plus a subsequent $5.5 million August 2026 private placement will fund operations and debt obligations for at least 12 months, but the company remains pre-revenue and expects continued losses as it advances TA-ERT and builds commercialization capabilities.
Spruce Biosciences reported second quarter 2026 results and outlined late-stage plans for its lead therapy tralesinidase alfa enzyme replacement therapy (TA-ERT) in mucopolysaccharidoses type IIIB (MPS IIIB), a pediatric neurodegenerative disorder with no FDA‑approved treatments. A Biologics License Application for TA‑ERT is anticipated in the fourth quarter of 2026, seeking accelerated approval using cerebrospinal fluid heparan sulfate non‑reducing end as a surrogate endpoint. A randomized, single‑blind TrAnsform confirmatory study in approximately 14 children with severe MPS IIIB is also expected to start in the fourth quarter of 2026.
Patient advocacy groups Cure Sanfilippo Foundation and the National MPS Society made a combined $5.5 million strategic investment to help fund a TA‑ERT Expanded Access Program for about 10 U.S. participants, planned to begin in the fourth quarter of 2026. Cash and cash equivalents were $96.3 million as of June 30 2026, up from $48.9 million at year‑end 2025, which the company believes will fund planned operations and debt obligations into the second half of 2027. Total operating expenses were $16.5 million in the quarter, leading to a net loss of $16.2 million, or $(6.68) per share, and a six‑month net loss of $28.5 million, or $(14.96) per share. The company also strengthened its leadership with a new Chief Medical Officer and Vice President of Clinical Development.
Spruce Biosciences, Inc. is reported as the issuer of Common Stock, par value $0.0001 per share. Integrated Core Strategies (US) LLC, Millennium Management LLC, Millennium Group Management LLC and Israel A. Englander jointly report beneficial ownership of 160,981 shares of Spruce Biosciences common stock, with shared voting power and shared dispositive power over 160,981 shares and no sole voting or dispositive power. Each reporting person’s cover information reflects this same share amount and a stated ownership of 5.8% of the class.
The filers state that, as of the relevant date, they have ceased to beneficially own more than 5 percent of Spruce Biosciences’ common stock, and they characterize their holdings accordingly under the “Ownership of 5 Percent or Less of a Class” item. A joint filing agreement among the four reporting persons is referenced as an exhibit.
BlackRock, Inc. reports beneficial ownership of common stock of Spruce Biosciences Inc.. BlackRock and certain of its subsidiaries and affiliates collectively beneficially own 187,836 shares of Spruce Biosciences common stock, representing 6.8% of the outstanding class.
BlackRock has sole voting power over 185,907 shares and sole dispositive power over 187,836 shares, with no shared voting or dispositive power reported. Various underlying clients and accounts have rights to dividends or sale proceeds from these shares, but no single such person holds more than five percent of Spruce Biosciences’ outstanding common shares. The filing is made on a Schedule 13G basis as a large institutional holder.