Here are 1-2 brief analogies for Spruce Biosciences (SPRB):

• A focused, clinical-stage BioMarin Pharmaceuticals or Alexion Pharmaceuticals (both known for pioneering rare disease drugs), but exclusively dedicated to developing a treatment for a single rare endocrine disorder.
• It's a biotech aspiring to be the 'go-to' company for Congenital Adrenal Hyperplasia treatments, much like how Vertex Pharmaceuticals became a leader in Cystic Fibrosis treatments.

• Tildacerfont for Classic Congenital Adrenal Hyperplasia (CAH): An investigational oral, non-steroidal drug candidate designed to reduce excessive androgen production in patients with classic CAH.
• Tildacerfont for Polycystic Ovary Syndrome (PCOS): An investigational drug candidate currently being explored for the potential treatment of PCOS.

• AGC Biologics
• Thermo Fisher Scientific (Symbol: TMO)
• Lonza (Symbol: LONN)

Javier Szwarcberg, M.D., M.P.H. Chief Executive Officer

Dr. Javier Szwarcberg is a physician executive with over 18 years of leadership experience in the biotechnology and pharmaceutical industries. He has extensive experience in clinical research and drug development, having led more than 22 clinical trials and contributed to 4 successful drug approvals. Prior to joining Spruce Biosciences, Dr. Szwarcberg served as Group Vice President and Head of Program and Portfolio Development for BioMarin Pharmaceuticals. He also held positions as Senior Vice President, Head of Program and Portfolio Management at Ultragenyx Pharmaceutical and Vice President of R&D and Business Development at Horizon Pharma. He is currently a scientific advisor to Abalone Bio.

Samir Gharib, M.B.A. President and Chief Financial Officer

Samir Gharib has served as Chief Financial Officer of Spruce Biosciences since May 2020 and was promoted to President in January 2022. He is an experienced leader in the global biopharmaceutical sector, recognized for his success in strategy and execution of transformative capital raises, strategic transactions, and support of commercial product launches. Over his career, Mr. Gharib has raised nearly $1 billion from private and public capital markets, including two IPOs, to fund clinical development, pipeline expansion, and commercialization.

Michael Grey Executive Chairman

Michael Grey has over 40 years of experience in the pharmaceutical and biotechnology industries. He served as interim Chief Executive Officer of Spruce Biosciences, Inc. from November 2021 and has been the Executive Chairman of Spruce's Board since 2017. Mr. Grey has founded several biotechnology companies and currently holds chairman or executive chair roles at Mirum Pharmaceuticals, Inc., Plexium, Inc., Reneo Pharmaceuticals, Inc., Sorriso Pharmaceuticals, Inc., and Theolytics Ltd. He previously served as President and Chief Executive Officer at Lumena Pharmaceuticals, Inc., which was acquired by Shire Plc. He also led SGX Pharmaceuticals, Inc., acquired by Eli Lilly in 2008, and Trega Biosciences, Inc., acquired by Lion Bioscience in 2001. His experience also includes leadership roles at Amplyx Pharmaceuticals, Inc. (acquired by Pfizer) and Curzion Pharmaceuticals, Inc. (acquired by Horizon). Mr. Grey serves as a venture partner at Pappas Capital, a venture capital firm, indicating a pattern of involvement with companies backed by private equity firms.

Kirk Ways, M.D., Ph.D. Chief Medical Officer

Dr. Kirk Ways is an experienced endocrinologist with more than 30 years of pharmaceutical drug discovery and development experience. He previously served as Chief Medical Officer and a member of the Executive Board at Spruce Biosciences.

Dasharatha Reddy, Ph.D. Vice President, Pharmaceutical Development and Manufacturing

Dasharatha Reddy serves as the Vice President of Pharmaceutical Development and Manufacturing at Spruce Biosciences.

Key Risks to Spruce Biosciences (SPRB)

1. Clinical Trial Setbacks and Pipeline Dependence: Spruce Biosciences has experienced significant challenges with its clinical development programs, notably the discontinuation of the tildacerfont program for Congenital Adrenal Hyperplasia (CAH) after key trials failed to meet primary efficacy endpoints. This has resulted in a critical strategic shift and a highly dependent pipeline, with the company now largely relying on its recently acquired TA-ERT asset for Sanfilippo Syndrome Type B. The past execution challenges raise concerns about the company's ability to successfully navigate the complex landscape of drug development and regulatory approval for its new primary asset.
2. Financial Instability and Cash Runway: The company faces substantial financial challenges, characterized by declining revenues, persistent losses, and a significant cash burn rate. As of December 31, 2024, Spruce Biosciences reported cash and cash equivalents of $38.8 million, with an anticipated cash runway extending only through the end of 2025. Other analyses indicate an even shorter cash runway, suggesting a critical need for additional funding to sustain operations and further develop its product candidates.
3. High Stock Volatility and Potential Delisting: Spruce Biosciences' stock has demonstrated high volatility, experiencing substantial price fluctuations and reaching a 52-week low. The company was delisted from Nasdaq in April 2025 due to not meeting the minimum bid price requirement, though it later regained compliance. This history of significant price swings and past delisting issues indicate a high-risk investment profile.

The primary clear emerging threat to Spruce Biosciences (SPRB) is direct competition from other biopharmaceutical companies developing novel therapies for Congenital Adrenal Hyperplasia (CAH).

• Crinetics Pharmaceuticals (CRNX) is developing CRN04894, an oral, nonpeptide adrenocorticotropic hormone (ACTH) antagonist, which is currently in Phase 2 clinical trials for CAH. This drug directly targets the overproduction of ACTH, a key driver of CAH pathology, similar to the ultimate goal of SPRB's tildacerfont (reducing ACTH and androgen levels). If CRN04894 demonstrates superior efficacy, safety, or convenience in its clinical development, it could capture significant market share and diminish the commercial potential of tildacerfont, especially given SPRB's recent mixed results in adult CAH trials.
• Other companies like BridgeBio Pharma (BBIO) are also developing investigational ACTH receptor antagonists (e.g., BBP-671) for CAH, indicating a growing competitive landscape for innovative treatments in this rare disease space.

• Tralesinidase Alfa (TA-ERT) for Sanfilippo Syndrome Type B (MPS IIIB): Citizens, a research firm, models approximately $170 million in peak sales for TA-ERT. This figure represents the estimated addressable market for Spruce Biosciences' specific product, Tralesinidase Alfa, rather than the entire Sanfilippo Syndrome market. The region for this peak sales estimate is implicitly global, as it refers to the potential sales of Spruce's product.
• Tildacerfont/Cortibon for Major Depressive Disorder (MDD): The global Major Depressive Disorder (MDD) treatment market is estimated to be valued at USD 18.7 billion in 2025 and is projected to reach USD 33.3 billion by 2032. Another estimate for the global MDD treatment market projects it to grow from USD 12,000 million in 2025 to USD 15,800 million by 2035. The MDD market across the eight major markets (US, France, Germany, Italy, Spain, UK, Japan, and Canada) is forecast to grow from $4.7 billion in 2019 to $9.6 billion by 2029. Spruce Biosciences is developing Tildacerfont for MDD in partnership with HMNC Brain Health, utilizing a companion diagnostic called Cortibon to identify MDD patients more likely to respond to CRF1 receptor antagonism. This indicates that Spruce Biosciences is targeting a specific subset of the broader MDD market.

Spruce Biosciences (SPRB) is a clinical-stage biopharmaceutical company with several key developments anticipated to drive future revenue growth over the next 2-3 years. The primary focus for near-term revenue generation is centered around its lead product candidate, tralesinidase alfa (TA-ERT).

Expected Drivers of Future Revenue Growth:

1. Launch and Commercialization of Tralesinidase Alfa (TA-ERT) for Sanfilippo Syndrome Type B (MPS IIIB): The most significant driver of future revenue growth is the anticipated launch and commercialization of TA-ERT. Spruce Biosciences plans to submit a Biologics License Application (BLA) for TA-ERT in the first quarter of 2026, targeting accelerated approval. This therapy is positioned as a potential first-to-market enzyme replacement therapy for MPS IIIB, a severe neurodegenerative genetic disorder with no currently approved treatment options, addressing a significant unmet medical need. A potential U.S. commercial launch is aimed for late 2026, which would mark the company's entry into the market with a novel product.
2. Increased Patient Uptake and Market Penetration of TA-ERT: Following regulatory approval and launch, revenue growth will be directly driven by the adoption and uptake of TA-ERT by patients diagnosed with MPS IIIB. Given the lack of approved treatments, a successful commercialization strategy and demonstrated clinical benefits could lead to a rapid increase in the customer base, thereby growing sales and revenue. Analysts have modeled approximately $170 million in peak sales for TA-ERT with a 75% probability of success.
3. Revenue from Potential Priority Review Voucher (PRV): The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to TA-ERT, which could expedite its development and regulatory review. If TA-ERT qualifies for and receives a Priority Review Voucher upon FDA approval, the sale of this voucher could provide a substantial one-time revenue stream. Citizens analysts value a potential PRV at approximately $150 million, which would significantly contribute to the company's financial resources and revenue in the near term.

Share Issuance

• In October 2020, Spruce Biosciences completed its Initial Public Offering (IPO), issuing 6,900,000 shares of common stock at $15.00 per share, resulting in gross proceeds of $103.5 million.
• The company completed a private placement financing in February 2023, which generated approximately $53.6 million in gross proceeds.
• In October 2025, Spruce Biosciences raised approximately $50.0 million in gross proceeds through a private placement to fund the advancement of tralesinidase alfa (TA-ERT). The company also enacted a 1-for-75 reverse stock split in August 2025 to meet Nasdaq's minimum bid price requirement, reducing outstanding shares from approximately 42.2 million to 0.6 million.

Inbound Investments

• Spruce Biosciences secured $103.5 million in gross proceeds from its Initial Public Offering (IPO) in October 2020.
• In February 2023, the company received approximately $53.6 million from a private placement financing, with participation from new and existing investors.
• A private placement financing in October 2025 brought in approximately $50.0 million in gross proceeds from dedicated healthcare investors, intended to advance the tralesinidase alfa (TA-ERT) program.