Company Overview

Name: Spruce Biosciences, Inc.

Industry: Biopharmaceuticals

Founded: April 2016

Location: South San Francisco, California

Employees: 21 (as of December 31, 2024)

Revenue: No product revenue to date

Financial Performance:

• Net Losses (2024): $53.0 million
• Net Losses (2023): $47.9 million
• Total Assets (Cash and equivalents): $38.8 million as of December 31, 2024
• Accumulated Deficit: $250.3 million

Core Business and Focus

Spruce Biosciences is a late-stage biopharmaceutical company dedicated to developing and commercializing innovative therapies for neurological disorders and other rare diseases with high unmet medical needs. The company is focused on diseases with clear biological pathways, either lacking approved treatments or having only suboptimal options.

Key Product Candidates & Development Programs

1. TA-ERT for Mucopolysaccharidosis Type IIIB (MPS IIIB or Sanfilippo Syndrome B)

• Type: Enzyme Replacement Therapy (ERT)
• Composition: Fusion protein of recombinant human alpha-N-acetylglucosaminidase (“rhNAGLU”) linked to modified human insulin-like growth factor 2.
• Approach: Administered directly into the central nervous system (CNS) via intracerebroventricular (“ICV”) infusion to bypass the blood-brain barrier.
• Clinical Stages:
  • Completed Phase 1/2, multinational, dose-escalation study (Study 201)
  • Extension studies (Studies 202 and 401) – discontinued in October 2023 due to financial constraints
  • Ongoing prospective natural history studies (Studies 901 and 902) to assess disease progression
• Regulatory Status:
  • Confirmed as a biomarker for accelerated approval by FDA in March 2024
  • Planned submission of Biologics License Application (BLA) in first half of 2026

2. Tildacerfont and Cortibon for Major Depressive Disorder (MDD)

• Target: Subset of MDD patients with hyperactive hypothalamus-pituitary-adrenal (“HPA”) axis and elevated corticotropin releasing hormone (“CRF” or “CRH”).
• Drug: Tildacerfont, a selective oral CRF1 receptor antagonist.
• Diagnostics: Cortibon, a companion genetic test to identify patients likely to respond.
• Partnership:
  • In May 2024, formed a partnership with HMNC for Phase 2 trial (“TAMARIND”) to evaluate efficacy in corticosteroid-positive MDD patients
  • Topline results expected in first half of 2026
  • Possible in-licensing of Cortibon rights upon positive trial results

3. SPR202 for Congenital Adrenal Hyperplasia (CAH)

• Target: Rare genetic disorder affecting steroid biosynthesis, leading to cortisol deficiency and excess androgen production.
• Approach: Licensing of an anti-CRH monoclonal antibody (SPR202) from HBM Alpha Therapeutics.
• Development Status: In late stages of preclinical/early clinical development.

4. SPR204 for Post-Bariatric Hypoglycemia (PBH)

• Target: Condition resulting from excessive GLP-1 response in patients post-bariatric surgery.
• Development: License from Twist Bioscience; investigational stage. Plan to evaluate as a treatment for PBH.

Licensing & Collaborations

• BioMarin: Acquired rights to develop enzyme replacement therapies for Sanfilippo syndrome type A and other lysosomal storage disorders, including rights for TA-ERT.
• Eli Lilly: License for CRF1 receptor antagonist compounds (including tildacerfont) and related IP.
• Kaken Pharmaceutical: Responsible for Japanese development and commercialization of tildacerfont under license.
• HMNC: Partnership for development and trial of tildacerfont in psychiatry.
• Twist Bioscience: License for SPR204 monoclonal antibody antagonist.
• HBM Alpha Therapeutics: License for SPR202 anti-CRH antibody for CAH.

Market and Customer Base

• The primary focus is on rare and orphan diseases such as MPS IIIB, with fewer than 200 patients estimated in the U.S. and small target populations globally.
• For MDD and CAH, the approach involves identifying subpopulations that may respond to targeted therapies using companion diagnostics.
• There are no current commercial products or sales; the company is in the development stage.

Summary

Spruce Biosciences is a biotechnology company developing novel therapies primarily for rare genetic and neurological disorders, with a focus on enzyme replacement and small-molecule receptor antagonists. The company has no product revenue yet, extensive clinical programs, strategic licensing agreements, and collaborative trials in progress. It operates with a small team and has accumulated significant losses, relying on future financing and regulatory approvals to advance its product pipeline.