Spruce Biosciences plans BLA for rare disease therapy

SOUTH SAN FRANCISCO, Calif. - Spruce Biosciences Inc. (NASDAQ: SPRB), currently trading at $0.31 with a market capitalization of ~$13 million, outlined a new corporate direction with the acquisition of an enzyme replacement therapy, tralesinidase alfa (TA-ERT), targeting Sanfilippo Syndrome Type B (MPS IIIB), a rare neurodegenerative disorder. According to InvestingPro analysis, the stock appears to be trading below its Fair Value, suggesting potential upside opportunity for investors interested in the biotechnology sector. The company anticipates submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the first half of 2026.

The strategic acquisition aligns with Spruce’s focus on addressing unmet medical needs within neurological disorders. TA-ERT has demonstrated promising results in clinical studies, significantly reducing cerebral spinal fluid heparan sulfate non-reducing end (HS-NRE) levels over five years. The FDA has acknowledged HS-NRE as a biomarker that could expedite approval for TA-ERT.

Spruce’s CEO, Javier Szwarcberg, M.D., M.P.H., emphasized the potential of TA-ERT to transform treatment for MPS IIIB patients, a condition currently lacking FDA-approved therapies. The company’s strategy includes initiating a confirmatory trial as part of the accelerated approval process and creating a specialized commercial organization to support TA-ERT’s potential market entry.

The company’s approach to commercialization involves establishing its own commercial presence in the U.S., European Union, and the U.K., and forming strategic collaborations and distributor networks in other international markets.

The financial update reported cash and cash equivalents of $38.8 million as of December 31, 2024, with an expected cash runway through the end of 2025. InvestingPro data shows the company maintains a strong current ratio of 5.36 and holds more cash than debt on its balance sheet, though it’s quickly burning through cash. The company has 42.2 million shares of common stock issued and outstanding, with an additional 21.4 million shares reserved for future issuance.

Spruce Biosciences has received fast-track, rare pediatric disease, and orphan drug designations for TA-ERT in the U.S. and EU, underscoring its commitment to bringing new treatments to market for serious diseases with clear biological pathways and significant unmet needs. With analyst price targets ranging from $1 to $3 per share, the stock has attracted attention from institutional investors. For deeper insights into SPRB’s financial health, growth prospects, and 10+ additional ProTips, consider exploring the comprehensive research available on InvestingPro.

This announcement is based on a press release statement.

In other recent news, Spruce Biosciences announced a delay in filing its Annual Report for the fiscal year ended December 31, 2024. The company has submitted a Notification of Late Filing with the Securities and Exchange Commission (SEC), indicating that the report, initially due on March 31, 2025, will be postponed. Spruce Biosciences has provided preliminary estimates of its financial results for the past fiscal year, though these figures are provisional and not yet final. The company has not specified reasons for the delay, but it assured that the complete audited financial statements will be available once the Annual Report is filed. This delay is not uncommon in corporate reporting, and Spruce Biosciences aims to maintain transparency with the market through this notification. The company’s shares are listed on the Nasdaq Capital Market, and it continues to focus on drug development for rare endocrine disorders. Investors and stakeholders are advised to wait for the final audited results to make informed decisions.

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