Spruce Bio's Strategic Pivot: Board Hire Signals Commercial Readiness

SOUTH SAN FRANCISCO, CA – December 15, 2025 – In a move signaling a decisive pivot from a development-focused firm to a potential commercial powerhouse, Spruce Biosciences (Nasdaq: SPRB) has appointed seasoned pharmaceutical leader Keli Walbert to its Board of Directors. The appointment comes at a critical juncture for the late-stage biopharmaceutical company as it prepares for a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for TA-ERT, a promising therapy for the rare neurological disorder Sanfilippo Syndrome Type B (MPS IIIB).

This strategic addition to the board is a clear indicator of Spruce's intent to build a robust commercial foundation for what could be the first-ever disease-modifying therapy for children suffering from the devastating condition. For investors and industry watchers, the move is less about the science—which has already shown promise—and more about the complex, high-stakes business of bringing a rare disease drug to market.

A Blockbuster Architect for a High-Stakes Launch

Keli Walbert is not just another board member; she is a commercialization specialist with a formidable track record in the rare disease space. Her recent tenure as Executive Vice President, U.S. Commercial, at Horizon Therapeutics is particularly noteworthy. There, she was a key architect behind the launch of TEPEZZA, the first and only FDA-approved medicine for thyroid eye disease, which rapidly achieved blockbuster status.

Her experience launching TEPEZZA at the very beginning of the COVID-19 pandemic provides a compelling case study in agile and effective commercial strategy. Faced with widespread clinic closures, Walbert's team rapidly pivoted, establishing a vast network of infusion centers and deploying a sophisticated digital and direct-to-consumer marketing strategy that successfully educated both physicians and patients. This ability to navigate unforeseen market disruptions and build access from the ground up is precisely the expertise Spruce will need.

In the company's official announcement, Michael Grey, Executive Chairman of Spruce Biosciences, highlighted this very point. “Her experience in successfully launching multiple drugs and her deep understanding of the rare disease commercial landscape will help support our transition into a commercial-stage organization,” he stated. Ms. Walbert added, “I look forward to working alongside the Board and management team to support Spruce’s strategic commercial planning and capitalize on the company’s momentum to prepare for a transformative year ahead.”

The Promise and Peril of TA-ERT

At the center of Spruce's strategy is TA-ERT (tralesinidase alfa), an enzyme replacement therapy targeting Sanfilippo Syndrome Type B. MPS IIIB is a brutal, progressive, and lethal genetic disorder that primarily affects children. It is caused by a deficiency of the NAGLU enzyme, leading to the toxic accumulation of heparan sulfate in the brain and other organs. Patients suffer from severe neurodegeneration, cognitive decline, behavioral issues, and a shortened lifespan. Currently, no approved disease-modifying treatments exist, leaving families with only palliative care options.

Spruce's clinical data for TA-ERT has been a source of significant optimism. The therapy received a coveted Breakthrough Therapy Designation from the FDA in October 2025, a status reserved for drugs that demonstrate substantial improvement over available therapies. The designation was supported by long-term data from 22 patients showing that TA-ERT led to a profound and durable reduction of heparan sulfate in the cerebrospinal fluid—a surrogate biomarker the FDA has agreed is reasonably likely to predict clinical benefit.

Crucially, the data also pointed to a stabilization of cognitive function and cortical grey matter volume, a stark contrast to the progressive decline seen in untreated patients. With plans to submit its BLA in the first quarter of 2026 seeking accelerated approval, Spruce is on the cusp of a major milestone. However, the company must also initiate a confirmatory Phase 3 study to secure full approval, adding another layer of operational and financial complexity.

Navigating the Commercial Gauntlet

While the clinical profile of TA-ERT appears strong, the path to commercial success for a rare disease drug is fraught with challenges. Spruce's own financial filings underscore the capital-intensive nature of this transition. As of its last quarterly report, the company's cash reserves stood at $60.1 million, with ongoing R&D and operational expenses necessitating substantial additional financing to fund the BLA submission, potential launch, and the required confirmatory trial.

Furthermore, Spruce does not operate in a vacuum. The competitive landscape for MPS IIIB, while nascent, includes other players like Abeona Therapeutics, which is developing a gene therapy, and JCR Pharmaceuticals, which is advancing its own enzyme replacement therapy using a proprietary technology to cross the blood-brain barrier. These parallel efforts highlight the urgency and competitive pressure to execute flawlessly.

The greatest hurdles, however, may lie in market access and pricing. Launching a first-in-class orphan drug requires navigating a complex web of payers, healthcare systems, and patient advocacy groups. Determining a price that reflects the drug's value and development cost while ensuring patient access is a delicate balancing act, one that is under increasing scrutiny from policymakers and insurers. This is where Walbert's experience in negotiating with payers and building patient support services will be invaluable.

By bringing in a commercial heavyweight like Keli Walbert well before a potential approval, Spruce Biosciences is sending a clear message to the market: it is not just focused on the finish line of FDA approval, but on the marathon of a successful commercial launch. The company is proactively building the strategic capabilities needed to translate a scientific breakthrough into a viable commercial product that can reach the children who desperately need it. The next 12 to 18 months will be transformative, as the company's clinical and nascent commercial strategies are put to the ultimate test.