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].

Financial Performance - Cash and cash equivalents as of March 31, 2024, were $81.2 million, expected to fund operations through the end of 2025[13] - Collaboration revenue for Q1 2024 was $2.0 million, consistent with Q1 2023, reflecting partial recognition of a $15.0 million upfront payment from Kaken Pharmaceutical[13] - Research and development expenses decreased to $10.3 million in Q1 2024 from $11.7 million in Q1 2023, primarily due to completion of enrollment in CAH programs[13] - General and administrative expenses increased to $4.3 million in Q1 2024 from $3.5 million in Q1 2023[13] - Total operating expenses for Q1 2024 were $14.6 million, a slight decrease from $15.2 million in Q1 2023[13] - Net loss for Q1 2024 was $11.6 million, compared to a net loss of $12.8 million in Q1 2023[13] Clinical Trials and Research - The CAHmelia-203 study showed a maximum mean reduction in ACTH of 45% at week 64, indicating effective treatment engagement[2] - Patients with a baseline GC dose of 55 mg HCe experienced a mean placebo-adjusted decrease in A4 of 27% after 12 weeks of treatment with tildacerfont[3] - Topline results from the CAHmelia-204 clinical trial are anticipated in Q3 2024, focusing on adult classic CAH patients[8] - The company plans to hold an End of Phase 2 meeting with the FDA in Q1 2025 to discuss the potential registrational path for tildacerfont[8]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 Charter) Delaware 81-2154263 (State or ...

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, 2023 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 charter) Delaware 81- ...

(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, 2023 OR UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☐ 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 charter) Delaware 81-21542 ...

Focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need Certain information contained in this presentation and statements made orally during this presentation relate to or are based on studies, publications, surveys and other data obtained from third-party sources and Spruce's own internal estimates and research. While Spruce believes these third-party studies, publications, surveys and other data to be reliable as of the date of this presen ...

☐ 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 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 March 31, 2023 OR Spruce Biosciences, Inc. (Exact name of registrant as specified in its charter ...

Financial Performance - The company reported a net loss of $46.180 million for the year ended December 31, 2022, compared to a net loss of $42.292 million in 2021, indicating an increase in losses of about 9.0%[651] - For the year ended December 31, 2022, the company reported a net loss of $46.2 million, compared to a net loss of $42.3 million in 2021, reflecting an increase in losses of approximately 2.1%[658] - The basic and diluted net loss per share for the year ended December 31, 2022, was $(1.96), compared to $(1.81) in 2021, with a net loss of $46.18 million in 2022[759] Assets and Liabilities - As of December 31, 2022, total assets decreased to $85.648 million from $126.486 million in 2021, reflecting a decline of approximately 32.3%[648] - As of December 31, 2022, the company had total liabilities of $17.162 million, an increase from $15.115 million in 2021[648] - As of December 31, 2022, the company had an accumulated deficit of $149.3 million, up from $103.1 million at the end of 2021, representing a 44.8% increase[664] Cash Flow - Cash and cash equivalents decreased to $24.487 million in 2022 from $42.748 million in 2021, a decline of approximately 42.5%[648] - The company used $41.7 million in cash for operating activities in 2022, up from $35.9 million in 2021, indicating a 16.5% increase in cash used[658] - The company reported a net cash decrease of $18.2 million in 2022, compared to a decrease of $114.4 million in 2021, indicating a significant reduction in cash outflow[658] Research and Development - Research and development expenses rose to $35.198 million in 2022, up from $30.698 million in 2021, representing an increase of approximately 14.9%[651] - Total operating expenses for 2022 were $47.283 million, compared to $42.066 million in 2021, marking an increase of about 12.5%[651] - Accrued research and development expenses increased to $7,449 thousand in 2022 from $3,837 thousand in 2021, indicating a focus on clinical trials and drug supply manufacturing[711] Financing and Future Needs - The company anticipates continued significant net losses as it progresses with clinical development and seeks regulatory approvals for its product candidate, tildacerfont[14] - The company expects to require substantial additional financing to develop tildacerfont and implement its operating plans[14] - The company anticipates needing to raise substantial additional financing in the future to support its operations, which may involve issuing additional equity or debt[665] Product Development and Risks - The company currently relies entirely on the success of tildacerfont, which is its only product candidate, and any delays in its clinical development could materially harm the business[14] - The company is subject to risks related to regulatory approvals and potential delays in clinical trials due to external factors such as the COVID-19 pandemic and macroeconomic uncertainties[670][671] - The company is focused on developing tildacerfont as a potential first non-steroidal therapy for classic congenital adrenal hyperplasia (CAH) and polycystic ovary syndrome (PCOS)[660] Stock and Compensation - The company incurred stock-based compensation expenses of $3.6 million in 2022, down from $4.0 million in 2021, reflecting a decrease of approximately 10.3%[658] - The total stock-based compensation expense for the year ended December 31, 2022, was $3.631 million, a decrease from $3.958 million in 2021[744] - The company has a total of $7.2 million of unrecognized stock-based compensation expense expected to be recognized over an estimated weighted-average vesting term of 2.4 years[744] Tax and Deferred Tax Assets - The federal statutory income tax rate for the company is 21.0%, with an effective tax rate of 0% for the years ended December 31, 2022, and 2021[749] - The Company recorded a valuation allowance against its U.S. net deferred tax assets, which increased by $17.0 million in 2022 due to an increase in net operating loss and capitalization of research costs[750] - The total gross deferred tax assets as of December 31, 2022, amounted to $50.75 million, with a valuation allowance of $50.36 million[750] Agreements and Collaborations - The Company entered into a Collaboration and License Agreement with Kaken Pharmaceutical, granting exclusive rights for tildacerfont in Japan, with an upfront payment of $15.0 million and potential milestone payments of up to $65.0 million[760] - The company is required to pay up to $23.0 million in milestone payments to Eli Lilly upon achieving certain clinical development and commercial sales milestones[746] Market and Investment Strategy - The Company utilizes a fair value hierarchy for financial instruments, classifying inputs into three levels: Level 1 (quoted prices in active markets), Level 2 (observable inputs), and Level 3 (unobservable inputs) [679] - The estimated fair value of the term loan is based on market observable interest rates, classified as Level 2 fair value measurement [679] - The Company has not recorded any impairment charges on securities related to other-than-temporary declines in fair value, indicating a stable investment strategy[708]

SPI'UCEBIOSCIENCES Focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need Corporate Presentation November 10, 2022 FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements about Spruce Biosciences, Inc. ("we," "Spruce" or the "Company"). All statements other than statements of historical facts contained in this presentation are forward-looking statements, including statements about our strategy, our expectations rega ...