Spruce Biosciences(SPRB) - 2025 Q2 - Quarterly Results

Executive Summary & Recent Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Recent%20Highlights) This section provides an overview of Q2 2025 financial results, corporate updates, and key strategic advancements Overview of Q2 2025 Results and Corporate Updates Spruce Biosciences reported financial results for the second quarter ended June 30, 2025, and provided key corporate updates, including significant progress on its lead programs and efforts towards Nasdaq relisting - Spruce Biosciences reported Q2 2025 financial results and provided corporate updates, including progress on TA-ERT for Sanfilippo Syndrome Type B (MPS IIIB), initiation of the TAMARIND trial for Tildacerfont in Major Depressive Disorder (MDD), and efforts for Nasdaq relisting[1] CEO's Statement The CEO highlighted the company's commitment to advancing TA-ERT as a potential first-to-market, disease-modifying treatment for MPS IIIB, with a Biologics License Application (BLA) submission anticipated in Q1 2026 - CEO Javier Szwarcberg emphasized the company's commitment to advancing TA-ERT as a potential first-to-market treatment for children diagnosed with Sanfilippo Syndrome Type B (MPS IIIB)[2] - The company remains on track to submit the biologics license application for TA-ERT under the accelerated approval pathway in the first quarter of 2026[2] - TA-ERT has the potential to be the first disease-modifying therapy to treat MPS IIIB, offering a novel option for affected families[2] Corporate Updates](index=1&type=section&id=Corporate%20Updates) This section details clinical trial progress for TA-ERT and Tildacerfont, along with corporate actions like Nasdaq relisting TA-ERT Clinical Data and Regulatory Pathway Integrated long-term clinical data for TA-ERT demonstrated profound and durable efficacy and safety in patients with MPS IIIB, supporting its potential as a transformative treatment - Integrated long-term clinical data of TA-ERT demonstrated profound and durable efficacy and safety in patients with MPS IIIB over a five-year period from clinical studies 201, 202, and 401[3] - Biologics License Application (BLA) submission of TA-ERT for MPS IIIB is anticipated in the first quarter of 2026[1] Efficacy and Safety in MPS IIIB This section presents clinical data on the efficacy and safety profile of TA-ERT in patients with MPS IIIB | Metric | Change/Observation | Timeframe | p-value | | :----- | :----------------- | :-------- | :------ | | CSF HS-NRE | Decreased 91.5 ng/mL from baseline | 240 weeks | <0.0001 | | Cognition (BSID-C) | Remained stable in treated group; significantly higher mean BSID-C in treated vs. untreated children | 6-10 years of age | 0.005 (at 6 yrs), <0.0001 (at 10 yrs) | | CGMV | Stabilized from weeks 48 to 240 after initial decrease | 48-240 weeks | N/A | | Safety | Adequate safety profile demonstrated over up to 7.3 years | Up to 7.3 years | N/A | Tildacerfont (TAMARIND Trial) for MDD The first patient was dosed in the Phase 2 TAMARIND trial of Tildacerfont for Major Depressive Disorder (MDD), a study funded and conducted by HMNC Holding GmbH, with topline results expected in 1H 2026 - The first patient was dosed in the Phase 2 TAMARIND trial of Tildacerfont for Major Depressive Disorder (MDD)[1][6] - HMNC Holding GmbH will fund and conduct the Phase 2 proof-of-concept study, exploring the efficacy of 400mg twice-daily tildacerfont versus placebo in MDD patients screened using HMNC's proprietary genetic test, Cortibon[7] - Topline results from the TAMARIND trial are anticipated in the first half of 2026[1][7] Nasdaq Capital Market Relisting Spruce Biosciences implemented a 1-for-75 reverse stock split to meet Nasdaq's minimum bid price requirement, with relisting anticipated upon sustained compliance - The company implemented a 1-for-75 reverse stock split of its common stock to comply with the minimum bid price requirement for continued listing on the Nasdaq Capital Market[7] - Nasdaq Capital Market relisting is anticipated following compliance with the minimum bid price for 20 consecutive trading days[1][7] Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) This section presents the company's financial performance for Q2 2025, highlighting key income statement and balance sheet figures Key Financial Highlights Spruce Biosciences reported a net loss of $2.1 million for Q2 2025, a significant improvement from Q2 2024, driven by reduced R&D and G&A expenses, with cash and cash equivalents expected to fund operations through the end of 2025 | Financial Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | H1 2025 (in thousands) | H1 2024 (in thousands) | | :--------------- | :--------------------- | :--------------------- | :--------------------- | :--------------------- | | Cash & Cash Equivalents (as of June 30) | $16,387 | N/A | N/A | N/A | | R&D Expenses | $(430) | $8,090 | $10,407 | $18,407 | | G&A Expenses | $3,122 | $3,556 | $6,777 | $7,874 | | Total Operating Expenses | $2,692 | $11,646 | $17,184 | $26,281 | | Net Loss | $(2,067) | $(9,181) | $(16,108) | $(20,806) | | Net Loss Per Share (Basic & Diluted) | $(3.50) | $(16.73) | $(27.36) | $(37.94) | - Cash and cash equivalents as of June 30, 2025, were $16.4 million, expected to fund the current operating plan through the end of 2025[8] - R&D expenses for Q2 2025 included a reduction in recorded liabilities of $3.3 million and an increase in receivables of $0.7 million associated with the acquisition of TA-ERT[8] - G&A expenses decreased primarily due to a decrease in stock-based compensation expense[8] About Spruce Biosciences](index=3&type=section&id=About%20Spruce%20Biosciences) This section provides a brief overview of Spruce Biosciences, its mission, and therapeutic focus Company Overview Spruce Biosciences is a late-stage biopharmaceutical company dedicated to developing and commercializing novel therapies for neurological disorders with significant unmet medical needs - Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need[9] Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section includes a standard disclaimer regarding forward-looking statements and associated risks and uncertainties Disclaimer This section serves as a standard disclaimer, indicating that statements regarding future events are forward-looking and subject to various risks and uncertainties, which may cause actual results to differ materially - Statements in the press release regarding matters that are not historical facts are 'forward-looking statements' subject to risks and uncertainties, and actual results may differ materially[10] - Forward-looking statements include those related to the ability to seek accelerated approval for TA-ERT, timing of regulatory filings, clinical impact, and the resumption of Nasdaq trading[10] Financial Statements](index=4&type=section&id=Financial%20Statements) This section presents the condensed balance sheets and statements of operations for the reported periods Condensed Balance Sheets The condensed balance sheets provide a snapshot of Spruce Biosciences' financial position as of June 30, 2025, compared to December 31, 2024, showing changes in assets, liabilities, and stockholders' equity | ASSETS (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Cash and cash equivalents | $16,387 | $38,753 | | Prepaid expenses | $1,868 | $3,177 | | Other current assets | $2,698 | $2,276 | | Total current assets | $20,953 | $44,206 | | Right-of-use assets | $803 | $934 | | Other assets | $64 | $69 | | Total assets | $21,820 | $45,209 | | LIABILITIES (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Accounts payable | $807 | $1,295 | | Accrued expenses and other current liabilities | $6,310 | $12,329 | | Term loan, current portion | $943 | $1,622 | | Total current liabilities | $8,060 | $15,246 | | Lease liabilities, net of current portion | $580 | $736 | | Term loan, net of current portion | $0 | $124 | | Other liabilities | $0 | $282 | | Total liabilities | $8,640 | $16,388 | | STOCKHOLDERS' EQUITY (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Additional paid-in capital | $279,556 | $279,089 | | Accumulated deficit | $(266,376) | $(250,268) | | Total stockholders' equity | $13,180 | $28,821 | Condensed Statements of Operations and Comprehensive Loss The condensed statements of operations detail the company's financial performance for the three and six months ended June 30, 2025, showing a reduced net loss compared to the same periods in 2024 | (in thousands, except per share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Collaboration revenue | $0 | $1,610 | $0 | $3,612 | | Research and development | $(430) | $8,090 | $10,407 | $18,407 | | General and administrative | $3,122 | $3,556 | $6,777 | $7,874 | | Total operating expenses | $2,692 | $11,646 | $17,184 | $26,281 | | Loss from operations | $(2,692) | $(10,036) | $(17,184) | $(22,669) | | Interest expense | $(29) | $(83) | $(65) | $(180) | | Interest and other income, net | $654 | $938 | $1,141 | $2,043 | | Net loss and comprehensive loss | $(2,067) | $(9,181) | $(16,108) | $(20,806) | | Net loss per share, basic and diluted | $(3.50) | $(16.73) | $(27.36) | $(37.94) | | Weighted-average shares of common stock outstanding, basic and diluted | 591,137 | 548,789 | 588,653 | 548,344 | Contacts](index=6&type=section&id=Contacts) This section provides contact information for media and investor relations inquiries Media and Investor Relations This section provides contact information for media and investor inquiries - Contact information for media inquiries is provided via Katie Beach Oltsik at Inizio Evoke Comms and media@sprucebio.com[14] - Contact information for investor inquiries is provided via Samir Gharib, President and CFO of Spruce Biosciences, Inc., at investors@sprucebio.com[14]