Spruce Biosciences Files 8-K on Operations and Exit Activities

TL;DR

SPRU filed an 8-K detailing operational results and exit costs as of March 10, 2024.

AI Summary

Spruce Biosciences, Inc. filed an 8-K on March 13, 2024, reporting on events as of March 10, 2024. The filing pertains to results of operations, cost associated with exit or disposal activities, and other events. Specific financial details or outcomes of these events were not elaborated upon in the provided text.

Why It Matters

This filing indicates Spruce Biosciences is reporting on its operational results and potentially restructuring or exiting certain activities, which could impact its future business direction and financial performance.

Risk Assessment

Risk Level: medium — The filing mentions 'Cost Associated with Exit or Disposal Activities,' which can signal financial strain or strategic shifts that carry inherent business risks.

Key Players & Entities

• Spruce Biosciences, Inc. (company) — Registrant
• 0000950170-24-030776 (filing_id) — Accession Number
• 20240313 (date) — Filing Date
• 20240310 (date) — Report Date
• 611 Gateway Boulevard, Suite 740 (address) — Principal Executive Offices
• South San Francisco, California (location) — Principal Executive Offices Location
• 415-655-4168 (phone_number) — Registrant's Telephone Number

FAQ

Key Financial Figures

• $0.0001 — ch registered Common Stock, par value $0.0001 per share SPRB Nasdaq Global Select
• $0.4 million — imates that it will incur approximately $0.4 million in cash charges in connection with the

Filing Documents

• sprb-20240310.htm (8-K) — 55KB
• sprb-ex99_1.htm (EX-99.1) — 148KB
• 0000950170-24-030776.txt ( ) — 339KB
• sprb-20240310.xsd (EX-101.SCH) — 31KB
• sprb-20240310_htm.xml (XML) — 5KB

02 Results of Operations and Financial Condition

Item 2.02 Results of Operations and Financial Condition. On March 13, 2024, Spruce Biosciences, Inc. (the "Company") issued a press release announcing its financial results for the full year ended December 31, 2023 and providing corporate updates, including topline results from its CAHmelia-203 study of tildacerfont in adult classic CAH and its CAHptain-205 study of tildacerfont in pediatric classic CAH. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. All of the information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

05 Costs Associated with Exit or Disposal Activities

Item 2.05 Costs Associated with Exit or Disposal Activities On March 10, 2024, the Board of Directors of the Company (the "Board") approved a plan to implement cost savings initiatives, including termination of the CAHmelia-203 study and a workforce reduction of approximately 21% (the "Realignment Plan"). The Realignment Plan is effective immediately, with a termination date of March 31, 2024 for affected employees. Affected employees will be offered separation benefits, including severance payments and healthcare coverage assistance. The final costs, charges and expenditures relating to the Realignment Plan will not be known until all related activities have been completed. The Company estimates that it will incur approximately $0.4 million in cash charges in connection with the Realignment Plan, consisting of expenses related to employee severance payments and healthcare coverage assistance and related costs. The Company expects that the majority of these estimated charges will be recorded in the second quarter of 2024 and that the execution of the Realignment Plan will be substantially complete during the second quarter of 2024. The estimates of the costs, charges and expenditures that the Company expects to incur in connection with the Realignment Plan, and the timing thereof, are preliminary estimates based on the Company's current expectations and are subject to a number of assumptions, and actual amounts and results may differ materially from such estimates. In addition, the Company may incur other costs, charges, expenditures, impairments and other impacts not currently contemplated due to unanticipated events that may occur, including in connection with the implementation of the Realignment Plan.

01 Other Information

Item 8.01 Other Information. On March 13, 2024, the Company announced topline results from its CAHmelia-203 study of tildacerfont in adult classic CAH and its CAHptain-205 study of tildacerfont in pediatric classic CAH. The CAHmelia-203 clinical trial did not achieve the primary efficacy endpoint of the assessment of dose response for the change in androstenedione, or A4, from baseline to week 12. 200mg once-daily of tildacerfont demonstrated a placebo-adjusted reduction from baseline in A4 of -2.6% with a non-significant p value at week 12. Tildacerfont was generally safe and well tolerated at all dose ranges with no treatment-related serious adverse events ("SAEs"). Most adverse events were reported as mild to moderate. In the CAHptain-205 clinical trial, tildacerfont was generally safe and well tolerated at all dose ranges with no treatment-related SAEs reported. Preliminary pharmacokinetic analysis suggests that tildacerfont is cleared more rapidly in children than in adult CAH patients. 73% of all patients (22 of 30 patients) met the efficacy endpoint of A4 or glucocorticoid ("GC") reduction from baseline at 12 weeks of treatment with tildacerfont. 70% of patients with elevated baseline A4 values (16 of 23 patients) demonstrated an A4 reduction at week 4. The Company plans to continue dose-ranging across additional cohorts to evaluate dose selection to inform its registrational program. The Company anticipates topline results in the fourth quarter of 2024. The Company expects to report topline results from its CAHmelia-204 study, which is focused on assessing GC reduction in a different population of adult CAH patients with relatively controlled A4 levels, in the third quarter of 2024. Assuming positive results from CAHmelia-204 and CAHptain-205, the Company plans to meet with the U.S. Food and Drug Administration and comparable foreign regulatory authorities to outline the design of a registrational clinical program in adult and pediatric classic CAH.

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit Number Description 99.1 Press Release of Spruce Biosciences, Inc., dated March 13, 2024 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) 2

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: March 13, 2024 By: /s/ Samir Gharib Samir Gharib President and Chief Financial Officer 3

View Full Filing

View this 8-K filing on SEC EDGAR