公司概况 - 专注开发和商业化针对罕见内分泌疾病的新型疗法[1] - 管理团队参与过40种产品的开发和商业推广[6] 疾病情况 - 经典先天性肾上腺皮质增生症（CAH）是慢性且可能危及生命的罕见病，美国约2 - 3万人、欧盟约5万人患病[9][10] - 约50年无获批的新型疗法，患者需在高肾上腺雄激素水平和过量使用糖皮质激素（GC）的危害间做选择[16] 产品情况 - Tildacerfont可抑制垂体分泌促肾上腺皮质激素（ACTH），减少雄激素分泌[21] - 在七项临床试验中，171名受试者对Tildacerfont耐受性良好，无药物相关严重不良事件[23] 研究数据 - 研究202中，疾病控制不佳组ACTH在第10周最大降幅84%，60%患者ACTH正常化；疾病控制良好组无肾上腺功能过度抑制[31][33] - 研究202中，疾病控制不佳组A4在第10周最大降幅79%，40%患者A4正常化；疾病控制良好组无肾上腺功能过度抑制[35][39] 商业机会 - 经典CAH全球市场机会超30亿美元，预计采用孤儿药定价[49] 里程碑 - 2021年上半年提交PCOS新药研究申请，下半年启动PCOS 2期概念验证试验和儿科经典CAH 2期试验[54] - 2022年上下半年分别公布成人经典CAH两项研究的 topline 结果，2023年目标提交成人经典CAH新药申请[6][54]

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, 2021 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 ...

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, 2020 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 ...

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, 2020 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 ...