Table of Contents FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-39594 Spruce Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 81-2154263 (State or other jurisdiction of incorp ...

Exhibit 99.1 Spruce Biosciences Reports Second Quarter 2025 Financial Results and Provides Corporate Updates Integrated Long-Term Clinical Data of Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) Demonstrates Profound and Durable Ef icacy and Safety in Patients with Sanfilippo Syndrome Type B (MPS IIIB) Biologics License Application Submission of TA-ERT for MPS IIIB Anticipated in First Quarter of 2026 First Patient Dosed in Phase 2 TAMARIND Trial of Tildacerfont for Major Depressive Disorder (MDD) wi ...

Tralesinidase Alfa (TA-ERT) for MPS IIIB - Tralesinidase Alfa 预计在 2026 年上半年提交 BLA 申请，该项目已准备就绪[8] - MPS IIIB 是一种影响 1/200,000 新生儿的常染色体隐性遗传病[14] - Tralesinidase Alfa 显著且持久地使脑脊液 HS 和 HS-NRE 水平正常化[22] - 早期使用 Tralesinidase Alfa 可稳定 MPS IIIB 患者的认知能力下降[29] - 在为期 48 周的初步研究及其扩展研究中，共进行了约 6,000 次给药，Tralesinidase Alfa 通常具有良好的耐受性[32] Tildacerfont + Cortibon for Major Depressive Disorder (MDD) - Tildacerfont + Cortibon 治疗重度抑郁症 (MDD) 的 2 期研究的顶线数据预计在 2026 年上半年公布[8] - Cortibon 是一种基因选择工具，可基于遗传标记识别 CRHR1 拮抗剂的应答者和非应答者[40] - Cortibon 挑选出约 50% 的显示 HPA 轴功能障碍迹象的 MDD 患者亚群[43] - 在 Cortibon 选择的 MDD 患者群体中，Cohen's d 效应量显著[46] SPR202 & SPR204 - SPR202 是一种用于治疗先天性肾上腺皮质增生症 (CAH) 的抗促肾上腺皮质激素释放激素 (CRH) 单克隆抗体，目前处于 IND 申报阶段[58, 63] - SPR204 是一种用于治疗减重手术后低血糖症的 GLP-1 受体拮抗剂单克隆抗体，目前处于 IND 申报阶段[64, 71] Financials - 截至 2025 年 3 月 31 日，公司拥有 2561.5 万美元的现金和现金等价物，以及 140.2 万美元的债务[74]

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Unaudited Condensed Financial Statements](index=6&type=section&id=Item%201.%20Unaudited%20Condensed%20Financial%20Statements) The company reports a Q1 2025 net loss of $14.0 million and declining cash reserves, raising substantial doubt about its ability to continue as a going concern Condensed Balance Sheet Data (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $25,615 | $38,753 | | **Total current assets** | $30,576 | $44,206 | | **Total assets** | $31,649 | $45,209 | | **Total current liabilities** | $15,666 | $15,246 | | **Total liabilities** | $16,325 | $16,388 | | **Total stockholders' equity** | $15,324 | $28,821 | | **Accumulated deficit** | $(264,309) | $(250,268) | Condensed Statements of Operations (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Collaboration revenue | $0 | $2,002 | | Research and development | $10,837 | $10,317 | | General and administrative | $3,655 | $4,318 | | **Loss from operations** | **$(14,492)** | **$(12,633)** | | **Net loss** | **$(14,041)** | **$(11,625)** | | **Net loss per share** | **$(0.32)** | **$(0.28)** | - The company's cash and cash equivalents of **$25.6 million** as of March 31, 2025, are insufficient to fund planned operations for the next 12 months, raising **substantial doubt about its ability to continue as a going concern**[24](index=24&type=chunk) - On April 21, 2025, the company approved a **55% workforce reduction** to prioritize the development of tralesinidase alfa, expecting to incur approximately **$0.9 million** in related charges[97](index=97&type=chunk)[98](index=98&type=chunk) - On April 22, 2025, the company received a delisting notice from Nasdaq and its common stock began trading on the **OTC Pink Marketplace** on April 29, 2025[5](index=5&type=chunk)[101](index=101&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic shift to tralesinidase alfa, an increased Q1 net loss, and reiterates going concern doubts due to insufficient cash - The company has shifted its focus from tildacerfont to the development of **tralesinidase alfa ("TA-ERT")** for neurological disorders with significant unmet medical need[109](index=109&type=chunk)[110](index=110&type=chunk) Results of Operations Comparison (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $0 | $2,002 | $(2,002) | | Research and development | $10,837 | $10,317 | $520 | | General and administrative | $3,655 | $4,318 | $(663) | | **Net loss** | **$(14,041)** | **$(11,625)** | **$(2,416)** | - R&D expenses increased by $0.5 million, primarily due to a **$5.7 million cost for acquiring SPR202**, offset by a $3.4 million decrease in clinical activities for the discontinued tildacerfont CAH program and a $1.5 million decrease in personnel costs[136](index=136&type=chunk) - The company's cash and cash equivalents as of March 31, 2025, are **insufficient to fund operations** and debt obligations for at least 12 months, raising **substantial doubt about its ability to continue as a going concern**[142](index=142&type=chunk)[218](index=218&type=chunk) Cash Flow Summary (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(12,727) | $(14,958) | | Net cash used in financing activities | $(411) | $(227) | | **Net decrease in cash** | **$(13,138)** | **$(15,185)** | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate fluctuations, though management believes the potential impact on financial statements is not material - The company's primary market risk is **interest rate risk** on its cash equivalents and variable-rate term loan, but a hypothetical 1% change is not expected to have a material effect[162](index=162&type=chunk)[163](index=163&type=chunk) - Foreign currency exchange risk and inflation are not believed to have had a significant impact on the company's results of operations[164](index=164&type=chunk)[165](index=165&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of the end of the quarter, with no material changes - Management concluded that as of March 31, 2025, the company's **disclosure controls and procedures were effective**[166](index=166&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[167](index=167&type=chunk) [PART II. OTHER INFORMATION](index=39&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings but acknowledges that litigation can arise in the ordinary course of business - As of the filing date, the company is **not a party to any material legal proceedings**[170](index=170&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) The company outlines significant risks including Nasdaq delisting, ongoing financial losses, going concern doubts, and reliance on third parties [Risks Related to Ownership of Our Common Stock](index=39&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) Stockholder risks include reduced liquidity from Nasdaq delisting, high price volatility, and no anticipated dividends - The company's common stock was **delisted from Nasdaq** on April 29, 2025, and now trades on the OTC market, which could adversely affect liquidity and stock price[173](index=173&type=chunk)[175](index=175&type=chunk)[176](index=176&type=chunk) - The stock price is **highly volatile**, with a closing price range from $0.07 to $0.43 between January 1, 2025, and May 1, 2025[179](index=179&type=chunk) - The company has **never paid dividends** and does not anticipate doing so, with the Loan Agreement also prohibiting such payments without lender consent[184](index=184&type=chunk) [Risks Related to Our Business and Industry](index=50&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) The company faces fundamental business risks from its history of losses, insufficient capital, and uncertainty in clinical development and competition - The company has a history of significant net losses, reporting a **loss of $14.0 million for Q1 2025** and an **accumulated deficit of $264.3 million** as of March 31, 2025[211](index=211&type=chunk) - There is **substantial doubt about the company's ability to continue as a going concern**, as its cash of $25.6 million is insufficient to fund operations for the next twelve months[218](index=218&type=chunk) - The company intends to seek **accelerated approval for TA-ERT** for MPSIIIB based on a biomarker, but this pathway is not guaranteed and requires a confirmatory Phase 3 trial[225](index=225&type=chunk)[230](index=230&type=chunk) - The company faces **significant competition** from other biopharmaceutical companies with greater financial and technical resources[234](index=234&type=chunk) - Patient enrollment for clinical trials is challenging, especially for rare diseases like MPS-IIIB, which has an estimated **U.S. population of less than 200 patients**[241](index=241&type=chunk) [Risks Related to Our Reliance on Third Parties](index=103&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) The company's operations are highly dependent on third parties for intellectual property, clinical trials, and single-source manufacturing - The company is dependent on **intellectual property licensed from Eli Lilly, BioMarin, HBM, and Twist**, and termination of these licenses could halt product development[373](index=373&type=chunk) - The company relies on third-party CROs to conduct its clinical trials and is responsible for ensuring their compliance with GCPs, with failures potentially delaying development[375](index=375&type=chunk) - The company relies completely on **third-party manufacturers**, including single-source suppliers for drug substance and product, for its clinical supplies[380](index=380&type=chunk)[381](index=381&type=chunk) [Risks Related to Our Intellectual Property](index=107&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Success depends on obtaining and defending patents, a complex and uncertain process, with risks of infringement claims and challenges to existing IP - The company's ability to commercialize its products depends on obtaining and maintaining **sufficient patent protection**, a highly uncertain and complex process[387](index=387&type=chunk)[388](index=388&type=chunk)[389](index=389&type=chunk) - The company may not be able to protect its intellectual property rights throughout the world, as **patent laws and enforcement vary significantly** by country[415](index=415&type=chunk) - The company may be subject to **third-party claims of patent infringement**, which could result in costly litigation and block commercialization of its product candidates[430](index=430&type=chunk)[432](index=432&type=chunk) - The company is currently a party to **post-grant reviews and opposition proceedings** challenging the validity of its patents, which could result in the loss of exclusivity[449](index=449&type=chunk) - The company relies on **trade secrets and confidentiality agreements**, but these may not provide adequate protection against unauthorized disclosure[454](index=454&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=136&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company's Loan Agreement with Silicon Valley Bank prohibits the payment of cash dividends without prior written consent - The company is **prohibited from paying cash dividends** without the prior written consent of Silicon Valley Bank, as per the terms of its Loan Agreement[462](index=462&type=chunk) [Item 3. Defaults Upon Senior Securities](index=136&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports that this item is not applicable - Not Applicable[463](index=463&type=chunk) [Item 4. Mine Safety Disclosures](index=136&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reports that this item is not applicable - Not Applicable[464](index=464&type=chunk) [Item 5. Other Information](index=136&type=section&id=Item%205.%20Other%20Information) The company reports no other information for disclosure under this item - None[465](index=465&type=chunk) [Item 6. Exhibits](index=137&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the report, including corporate governance documents, agreements, and officer certifications

Financial Position - Spruce Biosciences reported a cash and cash equivalents balance of $38.8 million as of December 31, 2024[6] Corporate Developments - The company announced the acquisition of tralesinidase alfa enzyme replacement therapy for the treatment of Sanfilippo Syndrome Type B[6] - A corporate update was provided, highlighting new corporate strategies and anticipated upcoming milestones[6] - The presentation titled "Tralesinidase Alfa Enzyme Replacement Therapy for the Treatment of Sanfilippo Syndrome Type B (MPSIIIB)" was shared to outline the new strategy[8]

Filing Information - Spruce Biosciences, Inc. filed a Notification of Late Filing on Form 12b-25 regarding its Annual Report for the fiscal year ended December 31, 2024[6]. - The Notification of Late Filing was submitted to the SEC on March 31, 2025[6]. - The report emphasizes that the information provided is not deemed "filed" under the Exchange Act[7]. Financial Estimates - The filing includes certain estimates about the Company's results of operations and financial condition for the fiscal year ended December 31, 2024[6]. - The filing does not include specific financial metrics or performance data for the fiscal year ended December 31, 2024[6]. - The Company has not yet provided detailed guidance or future outlook in this filing[6]. Company Classification and Trading - The Company is classified as an emerging growth company under the Securities Act of 1933[5]. - The Company’s common stock is traded on the Nasdaq Capital Market under the symbol SPRB[5]. Company Information - The Company’s principal executive offices are located in South San Francisco, California[2]. - There are no mentions of new products, technologies, market expansions, or acquisitions in the current report[6].

Core Viewpoint - Spruce Biosciences, Inc. (SPRB) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to institutional investors adjusting their valuations, resulting in buying or selling actions that affect stock prices [4]. Company Performance Indicators - For the fiscal year ending December 2024, Spruce Biosciences is expected to earn -$1.03 per share, reflecting a 16.9% change from the previous year [8]. - Over the past three months, the Zacks Consensus Estimate for Spruce Biosciences has increased by 8.3%, indicating a positive trend in earnings expectations [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [7]. - The upgrade to Zacks Rank 2 places Spruce Biosciences in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10][11].

Financial Performance - Collaboration revenue for Q3 2024 was $0.6 million, a decrease of 80.5% compared to $3.1 million in Q3 2023[5] - Research and development (R&D) expenses for Q3 2024 were $6.6 million, down 51.3% from $13.5 million in Q3 2023[5] - General and administrative (G&A) expenses for Q3 2024 were $3.5 million, an increase of 9.4% compared to $3.2 million in Q3 2023[5] - Total operating expenses for Q3 2024 were $10.0 million, a decrease of 40.0% from $16.7 million in Q3 2023[5] - Net loss for Q3 2024 was $8.7 million, a reduction of 30.0% compared to $12.4 million in Q3 2023[5] Cash Position - Cash and cash equivalents as of September 30, 2024, were $60.1 million, expected to fund operations through the end of 2025[4] Clinical Trials - Topline data from the CAHmelia-204 study of tildacerfont in adult congenital adrenal hyperplasia (CAH) is anticipated in December 2024[1] - Topline results from the CAHptain-205 clinical trial are also anticipated in December 2024[3] - The end of Phase 2 meeting with the U.S. FDA is anticipated in the first half of 2025[3] Product Development - The company is developing tildacerfont for the treatment of CAH, polycystic ovary syndrome (PCOS), and major depressive disorder (MDD)[7]

Group 1 - Spruce Biosciences reported a quarterly loss of $0.21 per share, better than the Zacks Consensus Estimate of a loss of $0.27, and an improvement from a loss of $0.30 per share a year ago, resulting in an earnings surprise of 22.22% [1] - The company posted revenues of $0.6 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 66.56%, and a significant decline from year-ago revenues of $3.07 million [2] - Spruce Biosciences shares have declined approximately 81.7% since the beginning of the year, contrasting with the S&P 500's gain of 25.7% [3] Group 2 - The current consensus EPS estimate for the upcoming quarter is -$0.28 on revenues of $1.55 million, and for the current fiscal year, it is -$1.12 on revenues of $5.8 million [7] - The Medical - Biomedical and Genetics industry, to which Spruce Biosciences belongs, is currently ranked in the top 31% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8]

Group 1 - Spruce Biosciences reported a quarterly loss of $0.22 per share, better than the Zacks Consensus Estimate of a loss of $0.33, representing an earnings surprise of 33.33% [1] - The company posted revenues of $1.61 million for the quarter ended June 2024, surpassing the Zacks Consensus Estimate by 3.87%, although this is a decline from $2.17 million in the same quarter last year [2] - Spruce Biosciences has surpassed consensus EPS estimates for four consecutive quarters [2] Group 2 - The stock has underperformed significantly, losing about 85.1% since the beginning of the year, while the S&P 500 has gained 12% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.32 on revenues of $1.8 million, and for the current fiscal year, it is -$1.24 on revenues of $5.27 million [7] - The Medical - Biomedical and Genetics industry, to which Spruce Biosciences belongs, is currently in the top 30% of Zacks industries, indicating a favorable outlook for the sector [8]