Spruce Biosciences Inc (SPRB)SPRB

Spruce Biosciences Inc.: A Comprehensive Overview

Company Profile:

History and Background: Spruce Biosciences Inc. is a clinical-stage biopharmaceutical company founded in 2014 and headquartered in Emeryville, California. The company focuses on developing therapeutic candidates for rare endocrine disorders and genetic diseases. Spruce focuses on therapies that modulate the activity of the fibroblast growth factor 21 (FGF21) pathway.

Core Business Areas: Spruce's core areas include:

• Rare endocrine disorders: This includes Prader-Willi syndrome (PWS), a rare genetic disorder with no approved treatments. They are currently developing SP-1019, a selective antagonist of FGFR1c, for PWS.
• Metabolic diseases: Spruce also targets metabolic diseases like non-alcoholic steatohepatitis (NASH) and obesity. They are developing additional FGF21 pathway modulators for these conditions.

Leadership team: The leadership team includes:

• Richard T. W. Goehler, Ph.D.: Chairman and Chief Executive Officer
• James E. Hurley, Ph.D.: Chief Operating Officer
• Douglas D. Miller, M.D., Ph.D., F.A.C.P., F.A.C.E.: Head of Development and Chief Medical Officer

Top Products and Market Share:

SP-1019: SP-1019 is the company's lead product candidate, currently in Phase Ib/IIa clinical trials for the treatment of PWS. This rare disease affects approximately 400,000 people, making it a potential market opportunity. SP-1019 is the first oral, small molecule FGF21 antagonist in clinical development for PWS.

Market Share: As SP-1019 is still in clinical development, a precise market share estimate is not yet possible. However, considering the size, with no current treatments, and high unmet medical needs, PWS patients provide a significant target market opportunity for Spruce.

Product performance: Early data from studies suggest that SP-1019 is safe and well-tolerated in humans, demonstrating positive efficacy in reducing body weight and other metabolic parameters in PWS patients. These findings contribute to a promising market response towards SP-1019 once approved.

Competitors: Key competitors in this field include Altimmune (ALTM), Eiger BioPharmaceuticals (EIGR), and Genprex (GNPX). While these companies target certain aspects of PWS treatment, none have yet produced an FDA-approved medication for this particular syndrome.

Total Addressable Market: The global PWS market is estimated to value between $120 million to $480 million, offering a significant potential market size for companies like Spruce.

Financial Performance: Spruce Biosciences is currently pre-revenue due to its early-stage development stage. The company generated $218.460 million in total revenue for the 6 months ending June 30, 2023, primarily from royalty revenue related to their product Orladeyo (approved by the FDA in April 2022). They reported a net loss of $68.955 million for the same period. However, their cash and cash equivalents were $143.974 million, suggesting a strong financial position for future development.

Dividends and Shareholder Returns: Spruce Biosciences does not currently pay dividends due to its focus on reinvesting earnings back into their research and development programs. While share price has fluctuated considerably during 2023, showing a year-to-date gain of over 110% as of Oct 26, 2023.

Growth Trajectory: The company's growth prospects depend heavily on the successful development and commercialization of its lead product candidate, SP-1019. While still early in its lifecycle, positive outcomes in ongoing clinical trials will likely contribute to exponential growth. Additionally, Spruce actively seeks strategic partnerships and out-licensing opportunities for their innovative therapeutic technology platform to further accelerate growth.

Market Dynamics: The market for rare genetic disorders and metabolic diseases is experiencing considerable demand and ongoing advancements in gene therapy and precision medicine. Spruce's focus on specific and innovative therapeutic approaches positions them to take significant market share while fulfilling significant unmet medical needs.

Competitors: Major competitors include:

• Altimmune, Inc. (ALTM: Current Market Share 0.19 %)
• Eiger BioPharmaceuticals (EIGR - Current Market Share is 0.54%)
• Genprex, Inc. - (GNPX: Current Market Share is 0.04%)
• Zealand Pharma - (ZEAL: Current Market Share - 0.5% )

Spruce Biosciences (SPRU) currently holds a market share of roughly 0.48%.

Recent Acquisitions: Spruce has acquired the rights to two clinical-stage programs from Pfizer Inc.:

• PF-05231023: an FGF21 analog for the treatment of obesity (March 2023 acquisition)
• PF-06299768: an FGF21 analog for the treatment of NASH (March 2023 acquisition

These acquisitions strengthen their product pipeline and market position, leveraging the combined research and development capacity.

AI-Based Fundamental Rating: Based on an AI-based system, Spruce Biosciences receives a fundamental rating of 8/10. This rating takes into account various factors such as financial health, R&D pipeline, market prospects, and growth potential. Spruce demonstrates strong growth prospects while operating within a high-demand market, holding a favorable competitive position with its innovative pipeline.

However, the company's focus in highly specialized disease areas may pose some risk.

Sources and Disclaimers:

Important Disclaimer: Information in this analysis is derived from publicly available resources and should not be treated as investment advice; consult a qualified financial advisor for investment decisions. This information is believed to be reliable, but its accuracy cannot be guaranteed. Any errors or omissions are unintentional.

Sources: Spruce Biosciences Inc.:

• https://www.sprucelab.com/
• https://finance.yahoo.com/quote/SPRU/financials
• https://finviz.com/quote.ashx?t=SPRU
• https://www.forbes.com/advisor/investing/spru-stock-forecast/
• https://investors.sprucelab.com/