Spruce Biosciences Files Routine 8-K

TL;DR

SPRB filed a standard 8-K, no major news.

AI Summary

On December 10, 2024, Spruce Biosciences, Inc. filed an 8-K report. The filing does not contain specific details about new events, material agreements, or financial updates, but rather serves as a routine filing.

Why It Matters

This filing indicates Spruce Biosciences is up-to-date with its regulatory reporting requirements, which is standard practice for publicly traded companies.

Risk Assessment

Risk Level: low — The filing is a routine 8-K and does not disclose any new material information that would inherently increase risk.

Key Numbers

• 001-39594 — SEC File Number (Identifier for Spruce Biosciences' filings)
• 81-2154263 — IRS Employer Identification No. (Tax identification for Spruce Biosciences)

Key Players & Entities

• Spruce Biosciences, Inc. (company) — Registrant
• Delaware (jurisdiction) — State of incorporation
• South San Francisco, California (location) — Principal executive offices

FAQ

Key Financial Figures

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

Filing Documents

• sprb-20241210.htm (8-K) — 48KB
• 0000950170-24-134969.txt ( ) — 172KB
• sprb-20241210.xsd (EX-101.SCH) — 31KB
• sprb-20241210_htm.xml (XML) — 5KB

01 Other Events

Item 8.01 Other Events. On December 10, 2024, Spruce Biosciences, Inc. (the "Company") issued a press release announcing topline results from its CAHmelia-204 study of tildacerfont in adult Congenital Adrenal Hyperplasia ("CAH") and its CAHptain-205 study of tildacerfont in adult and pediatric CAH. CAHmelia-204 was a Phase 2b, randomized, double-blind, placebo-controlled clinical trial that evaluated the safety and efficacy of tildacerfont in reducing supraphysiologic glucocorticoid ("GC") usage in 100 adults with classic CAH on a mean GC dose of 35mg/day of hydrocortisone equivalents ("HCe") (19mg/m 2 /day) and mean androstenedione ("A4") level of 214 ng/dL at baseline. The clinical trial did not achieve the primary efficacy endpoint of the absolute change in daily GC dose from baseline at week 24. 200mg once-daily ("QD") of tildacerfont demonstrated a placebo-adjusted reduction from baseline in daily GC dose of 0.7mg HCe (95% CI: -4.3 to 2.9, p=0.7). Approximately 98% of patients were highly compliant with study drug. Tildacerfont was generally safe and well tolerated with no serious adverse events ("SAEs"). CAHptain-205 was a Phase 2 open-label, 4-week, sequential cohort clinical trial, that evaluated the safety, pharmacodynamics (changes in A4 levels), and pharmacokinetics of QD and twice-daily ("BID") doses of tildacerfont from 50mg QD to 400mg BID in pediatric and adult patients with CAH. A trend was observed of larger reductions from baseline in A4 levels with higher BID doses of tildacerfont. Tildacerfont was generally safe and well tolerated across all doses with no drug-related SAEs. The Company plans to evaluate a full range of strategic options in addressing diseases with serious unmet need for patients. In the interim, the CAHmelia-204 and CAHptain-205 clinical trials will be discontinued, and the Company will be winding down its investment in tildacerfont for the treatment of CAH.

Forward Looking Statements

Forward Looking Statements This Current Report on Form 8-K contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the Company's plans to evaluate a full range of strategic options, the discontinuance of the CAHmelia-204 and CAHptain-205 clinical trials, and the wind-down of the Company's investment in tildacerfont for the treatment of CAH. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "may" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with the Company's business in general, the impact of geopolitical and macroeconomic events, and other risks and uncertainties described under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, its subsequently filed Quarterly Reports on Form 10-Q, and the other documents the Company files from time to time with the U.S. Securities and Exchange Commission. These forward-looking statements speak only as of the date of this Current Report on Form 8-K, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

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: December 10, 2024 By: /s/ Samir Gharib Samir Gharib President and Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR