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Spruce Biosciences (SPRB) investor relations material

Spruce Biosciences Q2 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q2 2025 earnings summary14 Aug, 2025

Executive summary

  • Focused on developing therapies for neurological disorders with unmet medical need, with primary focus on tralesinidase alfa (TA-ERT) for MPSIIIB since November 2024.

  • Integrated five-year clinical data for TA-ERT shows significant and durable efficacy and safety in MPS IIIB patients, with BLA submission planned for Q1 2026.

  • Workforce reduced by 55% in April 2025 to prioritize TA-ERT development.

  • Common stock delisted from Nasdaq in April 2025, began trading on OTCQB in August 2025 after a 1:75 reverse stock split; Nasdaq relisting anticipated after compliance.

  • First patient dosed in Phase 2 TAMARIND trial for tildacerfont in MDD; topline results expected in 1H 2026.

Financial highlights

  • Net loss of $2.1 million for Q2 2025 and $16.1 million for the six months ended June 30, 2025, both improved from $9.2 million and $20.8 million in 2024.

  • Cash and cash equivalents were $16.4 million as of June 30, 2025, down from $38.8 million at year-end 2024, expected to fund operations through year-end 2025.

  • R&D expenses for Q2 2025 were $(0.4) million, reflecting reductions in liabilities and increased receivables from TA-ERT acquisition; six-month R&D expenses were $10.4 million.

  • G&A expenses for Q2 2025 were $3.1 million, down from $3.6 million in Q2 2024, mainly due to lower stock-based compensation.

  • Total operating expenses for Q2 2025 were $2.7 million, down from $11.6 million in Q2 2024.

Outlook and guidance

  • Cash and cash equivalents are insufficient to fund operations and debt obligations for at least 12 months from the financial statement issuance date; substantial doubt exists about ability to continue as a going concern.

  • Biologics License Application for TA-ERT in MPS IIIB planned for submission in Q1 2026 under accelerated approval pathway.

  • Topline results from the TAMARIND Phase 2 trial in MDD expected in the first half of 2026.

  • Will require substantial additional capital to fund operations and product development; may seek equity, debt, or out-licensing agreements.

  • Cash runway expected to last through the end of 2025.

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Frequently asked questions

Spruce Biosciences Inc. is a biopharmaceutical company developing and commercializing therapies for rare endocrine disorders. The company's leading product candidate, tildacerfont, is a non-steroidal therapy designed to improve disease control and reduce steroid dependency in patients suffering from congenital adrenal hyperplasia (CAH). Tildacerfont is under clinical trial for both adult and pediatric classic CAH, as well as for females with polycystic ovary syndrome in a separateclinical trial. Spruce Biosciences has entered into strategic partnerships, including a license agreement with Eli Lilly and Company for research, development, and commercialization of compounds, and a collaboration and license agreement with Kaken Pharmaceutical for the treatment of CAH in Japan. The company is headquartered in South San Francisco, California, and its shares are listed on the NASDAQ under the ticker symbol SPRB.

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