SPRB Filings — Spruce Biosciences, Inc. - FilingSpy
SPRB
Spruce Biosciences, Inc.
A clinical-stage biopharmaceutical company developing drug therapies for rare endocrine (hormone) disorders. Its lead experimental medicine, tildacerfont, is being studied for people living with congenital adrenal hyperplasia, a rare genetic condition that disrupts the body's hormone production. Founded in 2013 and based in South San Francisco, the company went public on the US stock market in 2021.
Spruce Biosciences reports Q2 2026 net loss of $16.2M, plans BLA for TA-ERT in Q4 2026
Cash and cash equivalents were $96.3 million as of June 30, 2026, up from $48.9 million at December 31, 2025.
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Net loss was $16.2 million ($6.68 per share) for Q2 2026 and $28.5 million ($14.96 per share) for the first six months of 2026.
R&D expenses were $12.2 million in Q2 2026 and $19.7 million in the first half of 2026; G&A expenses were $4.3 million and $8.8 million, respectively.
BLA submission for TA-ERT for MPS IIIB is anticipated in Q4 2026, with the TrAnsform confirmatory study expected to initiate in Q4 2026.
Cure Sanfilippo Foundation and National MPS Society made a combined $5.5 million strategic investment to fund the TA-ERT Expanded Access Program.
Adrian Quartel, M.D., was appointed Chief Medical Officer effective July 27, 2026, and Jessica Cohen Pfeffer, M.D., was appointed VP of Clinical Development effective August 3, 2026.
2.02 Results of Operations and Financial Condition · 9.01 Financial Statements and Exhibits
Spruce Biosciences prices $60M public offering of common stock and pre-funded warrants
Spruce Biosciences entered into an underwriting agreement on April 20, 2026 to sell 1,150,000 shares of common stock at $50.00 per share and pre-funded warrants to purchase 50,000 shares at $49.99 per warrant.
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The underwriters exercised in full their option to purchase an additional 180,000 shares of common stock.
Gross proceeds from the offering are expected to be approximately $69.0 million before deducting underwriting discounts and commissions and estimated offering expenses.
The offering is expected to close on April 22, 2026, subject to customary closing conditions.
Leerink Partners, Guggenheim Securities, and Oppenheimer & Co. are acting as joint book-running managers, with Jones and Craig-Hallum as co-managers.
1.01 Entry into a Material Definitive Agreement · 8.01 Other Events · 9.01 Financial Statements and Exhibits
Spruce Biosciences terminates collaboration with Kaken on tildacerfont for CAH in Japan
On March 16, 2026, Spruce Biosciences entered into a Termination Agreement with Kaken Pharmaceutical to mutually terminate their Collaboration and License Agreement dated January 5, 2023.
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The Collaboration Agreement will terminate effective March 31, 2026, after which all licenses and rights granted to Kaken will end.
Under the original agreement, Kaken had made a non-refundable upfront payment of $15.0 million in April 2023 and could have paid up to $65.0 million in milestones plus royalties.
As of the Termination Date, Spruce will not be entitled to any previously disclosed unearned milestone payments or royalties from Kaken.
The termination follows a comprehensive assessment of the tildacerfont program for CAH, and no early termination penalties are incurred by Spruce.
1.02 Termination of a Material Definitive Agreement
Spruce Biosciences enters new equity sales agreement with Jefferies and reports 2025 results
Spruce Biosciences entered an Open Market Sale Agreement with Jefferies LLC to sell up to an unspecified maximum amount of common stock, replacing a prior 2022 agreement.
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The company reported a net loss of $39.0 million for 2025, with cash and equivalents of $48.9 million as of December 31, 2025.
BLA submission for TA-ERT (Sanfilippo syndrome type B) is on track for Q4 2026 following positive FDA Type B meetings.
Corwin Dale Hooks was appointed Chief Commercial Officer, effective March 9, 2026, with a base salary of $480,000 and an RSU award of 11,000 shares.
The company secured a loan facility of up to $50 million from Avenue Capital Group, with an initial $15 million tranche funded in January 2026.
1.01 Entry into a Material Definitive Agreement · 1.02 Termination of a Material Definitive Agreement · 2.02 Results of Operations and Financial Condition · 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements · 9.01 Financial Statements and Exhibits
Spruce Biosciences reports long-term TA-ERT data at WORLDSymposium showing preserved outcomes in MPS IIIB patients.
On February 5, 2026, Spruce Biosciences presented data at the 22nd Annual WORLDSymposium showing long-term tralesinidase alfa enzyme replacement therapy (TA-ERT) rapidly and durably reduced heparan sulfate and preserved cognitive and non-cognitive outcomes in MPS IIIB patients relative to natural history.
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An analysis of 22 patients followed up to six years showed TA-ERT stabilized cognitive function, cortical gray matter volume, and normalized liver and spleen volume, with approximately 6,000 doses administered.
A new VABS-II analysis showed TA-ERT stabilized receptive and expressive communication and fine and gross motor skills compared to declines in untreated natural history patients.
A case study of two siblings with severe MPS IIIB showed the treated sibling had higher cognitive, language, and motor functioning than the untreated sibling at similar ages.
The company stated its intent to advance TA-ERT through a biologics license application submission and potential U.S. FDA approval.
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7.01 Regulation FD Disclosure · 8.01 Other Events · 9.01 Financial Statements and Exhibits