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].

Spruce Biosciences, Inc. (SPRB) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Since a changin ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ____________ Commission File Number: 001-39594 Spruce Biosciences, Inc. (Exact name of registrant as specified in its cha ...

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]

Spruce Biosciences, Inc. (SPRB) came out with a quarterly loss of $0.21 per share versus the Zacks Consensus Estimate of a loss of $0.27. This compares to loss of $0.30 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 22.22%. A quarter ago, it was expected that this company would post a loss of $0.33 per share when it actually produced a loss of $0.22, delivering a surprise of 33.33%.Over the last four quarters, the company has ...

Spruce Biosciences, Inc. (SPRB) came out with a quarterly loss of $0.22 per share versus the Zacks Consensus Estimate of a loss of $0.33. This compares to loss of $0.32 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 33.33%. A quarter ago, it was expected that this company would post a loss of $0.32 per share when it actually produced a loss of $0.28, delivering a surprise of 12.50%. Over the last four quarters, the company h ...

Clinical Development - Tildacerfont, an oral antagonist of the CRF1 receptor, is being developed for classic congenital adrenal hyperplasia (CAH), polycystic ovary syndrome (PCOS), and major depressive disorder (MDD) with over 400 subjects administered in clinical trials[49] - In the CAHmelia-203 trial, 96 subjects had a mean baseline androstenedione (A4) level of 1,151 ng/dL, but the primary efficacy endpoint was not achieved, showing a placebo-adjusted reduction of -2.6% at week 12[49] - The CAHmelia-204 trial is ongoing with 100 adult patients, and topline results are expected in Q4 2024, with a mean baseline A4 level of 224 ng/dL[50] - The CAHptain-205 trial for pediatric patients showed that 73% of 30 children met the efficacy endpoint of A4 or glucocorticoid reduction at 12 weeks[50] - Tildacerfont demonstrated significant reduction in DHEAS levels in women with PCOS, with a p-value of 0.020, and an increase in sex hormone binding globulin (SHBG) with a p-value of 0.012[50] - A license agreement with HMNC Holding GmbH will fund a Phase 2 study of tildacerfont in MDD patients, utilizing the Cortibon Genetic Selection Tool for patient screening[50] - The company is advancing clinical development of tildacerfont in additional indications, including PCOS and MDD, and plans to build a specialized commercial organization if approved[51] Financial Performance - The company has no products approved for commercial sale and has not generated any product revenue to date, continuing to incur significant research and development expenses[50] - The company incurred net losses of $20.8 million and $25.6 million for the six months ended June 30, 2024 and 2023, respectively, with cash used in operations of $26.1 million and $9.8 million[51] - As of June 30, 2024, the company had an accumulated deficit of $218.0 million, up from $197.2 million as of December 31, 2023[51] - The company raised aggregate gross proceeds of $293.1 million since inception, including $15.0 million from the Kaken License Agreement in April 2023[51] - The company expects to continue incurring significant losses and does not anticipate positive cash flows from operations for the foreseeable future[51] - The company has cash and cash equivalents of $69.7 million as of June 30, 2024, which is projected to fund operations for at least 12 months[51] - The company has not generated any revenues from the commercial sale of approved products and does not expect to do so in the foreseeable future[57] - Collaboration revenue for the three months ended June 30, 2024, was $1.6 million, down from $2.2 million in the same period of 2023, a decrease of 26%[62] - Research and development expenses decreased by $5.0 million to $8.1 million for the three months ended June 30, 2024, compared to $13.1 million in 2023, a reduction of 38%[62] - General and administrative expenses increased by $0.5 million to $3.6 million for the three months ended June 30, 2024, compared to $3.0 million in 2023, an increase of 18%[63] - Net loss for the three months ended June 30, 2024, was $9.2 million, improved from a net loss of $12.8 million in the same period of 2023, a reduction of 28%[61] - Total operating expenses for the three months ended June 30, 2024, were $11.6 million, down from $16.1 million in 2023, a decrease of 28%[61] - For the six months ended June 30, 2024, collaboration revenue was $3.6 million, down from $4.1 million in 2023, a decrease of 12%[65] - Research and development expenses for the six months ended June 30, 2024, were $18.4 million, down from $24.8 million in 2023, a decrease of 26%[65] - General and administrative expenses increased by $1.4 million to $7.9 million for the six months ended June 30, 2024, compared to $6.5 million in 2023, an increase of 22%[66] - As of June 30, 2024, the company had cash and cash equivalents of $69.7 million, down from $96.3 million as of December 31, 2023[69] - The company expects its cash and cash equivalents will be sufficient to fund operations for at least 12 months following the issuance date of the financial statements[69] - Net cash used in operating activities increased by $16.3 million for the six months ended June 30, 2024, compared to the same period in 2023[76] - The company anticipates significant increases in research and development expenses as it continues to invest in tildacerfont[72] Licensing and Royalties - Under the Kaken License Agreement, the company is entitled to receive up to approximately $65.0 million upon achieving specified milestones related to tildacerfont in Japan[54] - The company will receive tiered double-digit royalties on net sales of tildacerfont in Japan, with rates based on annual sales[54] - The company is obligated to make up to $23.0 million in milestone payments under the Lilly License Agreement[75] Debt and Financing - The company has entered into a Loan Agreement with Silicon Valley Bank, with an outstanding principal of $2.6 million as of June 30, 2024[56] - Future payments of principal and interest on the Term Loan as of June 30, 2024, were $2.8 million[74] - The company has total undiscounted lease payments for its non-cancelable operating lease of $1.3 million as of June 30, 2024[75] - The SEC declared effective a Shelf Registration covering the sale of up to $200.0 million of securities in February 2022[70] - In February 2023, the company sold 16,116,000 shares of common stock and warrants for gross proceeds of $53.6 million[71] Economic Factors - The company does not expect anticipated changes in inflation to have a material effect on its business or financial condition[85] - Inflation has increased costs related to labor and clinical trials, but is not expected to have a significant impact on future financial results[85] - The company anticipates continued record inflation due to geopolitical and macroeconomic events, but does not expect it to materially affect business operations[85] - There was no material impact on operating results due to foreign currency exchange rate fluctuations[84] - A hypothetical 1% change in interest rates would not have a material effect on the financial statements as of June 30, 2024, and December 31, 2023[83] - The company does not currently engage in hedging transactions to manage exposure to interest rate risk[83]

Financial Performance - Spruce Biosciences reported cash and cash equivalents of $69.7 million as of June 30, 2024, which is expected to fund operations through the end of 2025[4] - Collaboration revenue for Q2 2024 was $1.6 million, a decrease from $2.2 million in Q2 2023, while total collaboration revenue for the first half of 2024 was $3.6 million compared to $4.1 million in the same period last year[4] - Research and Development (R&D) expenses decreased to $8.1 million for Q2 2024 from $13.1 million in Q2 2023, primarily due to reduced clinical development costs[4] - General and Administrative (G&A) expenses increased to $3.6 million for Q2 2024 from $3.0 million in Q2 2023[4] - Total operating expenses for Q2 2024 were $11.6 million, down from $16.1 million in Q2 2023[4] - The net loss for Q2 2024 was $9.2 million, compared to a net loss of $12.8 million in Q2 2023[4] Strategic Collaborations - Spruce announced a strategic collaboration with HMNC to develop tildacerfont for Major Depressive Disorder (MDD), with HMNC funding a Phase 2 study[2] Clinical Development - Topline data from the CAHmelia-204 study of tildacerfont is anticipated in Q4 2024, along with data from the CAHptain-205 study[1] - The company plans to meet with the U.S. FDA in the first half of 2025 to discuss the potential registrational path for tildacerfont[4] - Tildacerfont demonstrated the ability to reduce dehydroepiandrosterone sulfate levels in women with Polycystic Ovary Syndrome (PCOS) during the Phase 2 POWER study[2]

Clinical Trials and Development - Tildacerfont is being developed as a potential first non-steroidal therapy for classic congenital adrenal hyperplasia (CAH), with over 200 subjects administered in clinical trials and no serious adverse events reported[76]. - The CAHmelia-203 trial enrolled 96 adult patients with a mean baseline androstenedione level of 1,151 ng/dL, but did not achieve the primary efficacy endpoint, showing a placebo-adjusted reduction of -2.6%[77]. - The CAHmelia-204 trial is ongoing with 100 adult patients, and topline results are expected in Q3 2024[78]. - The CAHptain-205 trial for children aged 2 to 17 years showed that 73% of patients met the efficacy endpoint of A4 or glucocorticoid reduction at 12 weeks[79]. - A pediatric investigational plan for tildacerfont has been submitted to the European Medicines Agency, with a waiver granted for patients under one year[81]. - The company is exploring tildacerfont's potential in treating polycystic ovary syndrome (PCOS) and has completed a Phase 2 trial showing promising interim results[82]. Financial Performance - As of March 31, 2024, the company reported net losses of $11.6 million and an accumulated deficit of $208.9 million[86]. - Cash and cash equivalents as of March 31, 2024, were $81.2 million, expected to fund operations for at least 12 months[89]. - Collaboration revenue for Q1 2024 was $2.0 million, a slight increase from $1.964 million in Q1 2023, reflecting a change of $38,000[119]. - Total operating expenses decreased to $14.635 million in Q1 2024 from $15.163 million in Q1 2023, a reduction of $528,000[119]. - Research and development expenses were $10.317 million in Q1 2024, down from $11.712 million in Q1 2023, showing a decrease of $1.395 million[119]. - General and administrative expenses increased to $4.318 million in Q1 2024 from $3.451 million in Q1 2023, an increase of $867,000[119]. - Net loss for Q1 2024 was $11.625 million, an improvement compared to a net loss of $12.791 million in Q1 2023, reflecting a decrease in loss of $1.166 million[119]. - Interest expense decreased to $97,000 in Q1 2024 from $131,000 in Q1 2023, a reduction of $34,000[119]. - Interest and other income, net increased to $1.105 million in Q1 2024 from $539,000 in Q1 2023, an increase of $566,000[119]. - As of March 31, 2024, the accumulated deficit was $208.9 million, up from $197.2 million as of December 31, 2023[125]. - Cash and cash equivalents decreased to $81.2 million as of March 31, 2024, from $96.3 million as of December 31, 2023[125]. - Net cash used in operating activities increased by $3.2 million to $15.0 million for the three months ended March 31, 2024, compared to $11.8 million in the same period of 2023[141]. - Net cash provided by investing activities was nil for the three months ended March 31, 2024, compared to $10.5 million in the same period of 2023[143]. - Net cash used in financing activities was $0.2 million for the three months ended March 31, 2024, primarily due to principal payments on the Term Loan[144]. - The company anticipates needing additional capital to fund operations and develop tildacerfont, with future funding requirements dependent on various factors[130]. - For the three months ended March 31, 2023, net cash provided by financing activities was $50.5 million, primarily from a private placement of $51.0 million, offset by principal payments on the Term Loan of $0.4 million[145]. - As of March 31, 2024, cash and cash equivalents totaled $81.2 million in bank deposits and money market funds, with no excessive risk anticipated[151]. - The company does not expect a hypothetical 1% change in interest rates to have a material effect on its financial statements as of March 31, 2024[152]. - There was no material impact on the company's results of operations from foreign currency exchange rate changes for any periods presented[153]. - Inflation has increased costs related to labor and clinical trials, but the company does not expect significant future impacts on its financial condition or results of operations due to anticipated changes in inflation[154]. Funding and Partnerships - The company has raised a total of $293.1 million since inception, including $15.0 million from Kaken Pharmaceutical for the development of tildacerfont in Japan[88]. - The Kaken License Agreement includes potential milestone payments of up to approximately $65.0 million upon achieving specified milestones related to tildacerfont in Japan[98]. - The company has retained all rights to tildacerfont in all geographies outside Japan, while Kaken is responsible for regulatory approvals in Japan[96]. - The company expects significant additional spending to progress tildacerfont through clinical development and potential regulatory approval[113].