Spruce Biosciences Files 8-K

TL;DR

SPRU filed an 8-K for 'Other Events' on 6/2. Details TBD.

AI Summary

Spruce Biosciences, Inc. filed an 8-K on June 3, 2024, reporting an event that occurred on June 2, 2024. The filing is categorized under 'Other Events' and does not specify any material changes or agreements.

Why It Matters

This filing indicates Spruce Biosciences is making a regulatory disclosure, though the specific nature of the 'Other Events' is not detailed, requiring further investigation for material impact.

Risk Assessment

Risk Level: low — The filing is a standard disclosure and does not immediately indicate negative news or significant financial events.

Key Players & Entities

• Spruce Biosciences, Inc. (company) — Registrant
• June 2, 2024 (date) — Date of earliest event reported
• June 3, 2024 (date) — Filing date
• Delaware (jurisdiction) — State of incorporation
• 611 Gateway Boulevard, Suite 740 (address) — Principal executive offices
• South San Francisco, California (location) — Principal executive offices location

FAQ

Key Financial Figures

• $0.0001 — ch registered Common Stock, par value $0.0001 per share SPRB Nasdaq Global Select

Filing Documents

• sprb-20240602.htm (8-K) — 107KB
• 0000950170-24-067650.txt ( ) — 236KB
• sprb-20240602.xsd (EX-101.SCH) — 31KB
• sprb-20240602_htm.xml (XML) — 5KB

01 Other Events

Item 8.01 Other Events. On June 3, 2024, Spruce Biosciences, Inc. (the "Company") issued a press release that included final results from the Company's Phase 2 POWER proof-of-concept clinical trial evaluating its product candidate tildacerfont for the treatment of polycystic ovary syndrome ("PCOS"). On June 2, 2024, the Company presented these results at the 2024 Annual Meeting of the Endocrine Society. The POWER clinical trial was a randomized, placebo-controlled, dose-escalation trial that evaluated the safety and efficacy of tildacerfont titrated to 200 mg QD compared to placebo at 12 weeks of treatment in 27 female subjects with PCOS. Phase 2 POWER Study Results The POWER study enrolled 27 women with a confirmed diagnosis of PCOS. Participant demographics and baseline hormone levels are detailed in Table 1 below. Table 1. Summary of Demographics and Baseline Hormones; Intent to Treat Analysis Population Key Variables Mean (SD) Tildacerfont (n = 17) Placebo (n = 10) Total (n = 27) Age 28.4 (5.6) 29.3 (5.5) 28.7 (5.4) Age at PCOS Diagnosis 22.6 (6.3) 21.6 (6.0) 22.3 (6.1) BMI (kg/m 2 ) 32.1 (5.8) 32.4 (12.5) 32.2 (8.6) DHEAS (g/dL) 351.3 (90.5) 387.8 (107.2) 364.8 (96.7) 17-OHP (ng/dL) 83.2 (86.3) 62.1 (54.1) 75.4 (75.5) ACTH (pg/mL) 23.9 (11.9) 22.3 (12.0) 23.3 (11.7) A4 (ng/dL) 185.2 (75.2) 130.0 (66.0) 166.8 (75.6) T (ng/dL) 61.0 (22.0) 61.1(27.0) 61.0 (23.4) Screening DHEAS > ULN, N (%) Yes No 12 (70.6%) 5 (29.4%) 7 (70.6%) 3 (29.4%) 19 (70.4%) 8 (29.6%) In women with elevated baseline DHEAS, a significant reduction in DHEAS versus placebo was observed (p = 0.020). Table 2. Change from Baseline in DHEAS ( g/dL) at Week 12; Modified Intent to Treat Analysis; Baseline DHEAS > Upper Limit of Normal (ULN) Tildacerfont (n = 12) 1 Placebo (n = 7) 1 n 11 2 5 3 Mixed Model of Repeated Measures Least Squares (LS) Geometric Mean Ratio (% Chan

Forward-Looking Statements

Forward-Looking Statements

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. SPRUCE BIOSCIENCES, INC. Date: June 3, 2024 By: /s/ Samir Gharib Samir Gharib President and Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR