Spruce Biosciences Reports Third Quarter 2026 Financial Results and Advances TA-ERT Toward Planned BLA Submission
Spruce Biosciences, a late-stage biopharmaceutical company focused on developing and commercializing innovative treatments for neurological disorders with significant unmet medical needs, has announced its financial results for the third quarter ended September 30, 2026, alongside several important corporate and clinical development updates. The company highlighted continued progress in advancing its lead investigational therapy, TA-ERT, for mucopolysaccharidosis type IIIB (MPS IIIB), also known as Sanfilippo Syndrome Type B, with a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) remaining on track for December 2026.
The company also provided updates on its manufacturing activities, regulatory preparations, expanded access initiatives, and plans for a confirmatory clinical study. In addition, Spruce announced changes to its financing arrangements and the separation of its CRHX-101 program into a newly established subsidiary, Adrenyx Biosciences, Inc. These developments are intended to strengthen the company’s financial flexibility, streamline its strategic priorities, and support its efforts to advance TA-ERT toward potential regulatory approval and commercialization.
Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences, stated that the company is making disciplined progress toward its planned December BLA submission for TA-ERT. He described the upcoming regulatory filing as a potentially defining milestone for Spruce and for children and families affected by MPS IIIB.
According to Dr. Szwarcberg, the company’s pre-BLA meetings with the FDA during the second quarter of 2026 provided alignment regarding the expected content and format of the application. Spruce remains focused on completing its second Process Performance Qualification (PPQ) manufacturing batch and initiating the TrAnsform confirmatory study in December 2026.
He also emphasized the company’s efforts to strengthen its financial position and concentrate its resources on its lead development program. The amended Avenue Loan Agreement provides additional near-term access to debt financing and extends the interest-only period, offering greater financial flexibility as Spruce prepares for regulatory review and a potential U.S. commercial launch.
Furthermore, the separation of CRHX-101, previously known as SPR-202, into Adrenyx Biosciences establishes a dedicated organization to pursue the program with independent financing. Through the planned distribution of Adrenyx shares, Spruce shareholders are expected to retain a direct ownership interest in the program while Spruce focuses its resources on TA-ERT.
TA-ERT Program Advances Toward December 2026 BLA Submission
Spruce Biosciences continues to advance TA-ERT as its primary clinical and regulatory priority. The company expects to submit a BLA to the FDA in December 2026, seeking accelerated approval for the treatment of MPS IIIB.
MPS IIIB, also referred to as Sanfilippo Syndrome Type B, is a rare inherited metabolic disorder characterized by the accumulation of heparan sulfate in the body due to a deficiency in the enzyme alpha-N-acetylglucosaminidase. The condition primarily affects the central nervous system and can result in progressive neurological deterioration, developmental delays, cognitive impairment, and loss of previously acquired abilities.
Currently, there are no FDA-approved therapies specifically available to treat MPS IIIB. Treatment options are largely limited to supportive care aimed at managing symptoms and addressing the complications associated with disease progression. Consequently, the development of disease-targeting treatments represents an important unmet medical need for affected children and their families.
Spruce intends to pursue accelerated approval of TA-ERT based on its ability to reduce cerebrospinal fluid heparan sulfate non-reducing ends (CSF HS-NRE). The company considers this biomarker a reasonably likely surrogate endpoint for predicting clinical benefit in patients with MPS IIIB.
If TA-ERT receives approval, the therapy could also qualify for a Rare Pediatric Disease Priority Review Voucher, subject to applicable regulatory requirements. Such a voucher could provide additional strategic and financial value to the company while supporting future development activities.
The planned December 2026 submission follows regulatory discussions with the FDA during the second quarter. These meetings helped establish alignment regarding the structure and content of the BLA, supporting Spruce’s preparations for the upcoming filing.
U.S. Expanded Access Program Initiated for TA-ERT
In another important development, Spruce initiated its U.S. Expanded Access Program (EAP) for TA-ERT in November 2026. The program is designed to provide access to the investigational therapy for children in the United States living with attenuated and severe forms of MPS IIIB who are not eligible to participate in the planned TrAnsform confirmatory study.
The open-label, single-arm program is expected to enroll approximately 10 participants. Through the initiative, eligible children may gain access to TA-ERT while the company continues its regulatory and clinical development activities.
The EAP is partially supported by a $5.5 million strategic investment completed in August 2026 by the Cure Sanfilippo Foundation and the National MPS Society. The funding demonstrates the involvement of patient advocacy organizations in supporting development initiatives for rare diseases with limited treatment options.
In August 2026, Spruce also launched MPS3BStudy.com, an information resource intended to support families and caregivers of children affected by MPS IIIB. The website provides information about the Expanded Access Program and the planned TrAnsform confirmatory study.
Families and caregivers can use the platform to learn about the clinical development programs and register to receive updates as participating U.S. clinical sites become active and enrollment activities begin.
Additional information about the Expanded Access Program is available through its ClinicalTrials.gov listing.
Second Manufacturing PPQ Batch Expected in December 2026
Manufacturing readiness remains another important component of Spruce’s regulatory strategy for TA-ERT. The company confirmed that it completed its first Process Performance Qualification (PPQ) batch in July 2026. This manufacturing batch is expected to be included in the planned BLA submission.
Spruce is currently preparing to complete its second PPQ batch in December 2026. The company expects the manufacturing documentation and supporting information to be submitted ahead of the FDA’s anticipated mid-cycle review.
PPQ activities are designed to demonstrate that the manufacturing process can consistently produce a product meeting established quality standards. Successful completion of these activities is an important part of preparing a biologics regulatory application and establishing the manufacturing foundation necessary for potential commercialization.
By progressing with its second PPQ batch, Spruce aims to strengthen the manufacturing component of its regulatory submission and maintain alignment with its anticipated BLA timeline.
TrAnsform Confirmatory Study Expected to Begin in December
Spruce also expects to initiate its planned TrAnsform confirmatory study in December 2026. The study will evaluate the safety, tolerability, and efficacy of TA-ERT compared with standard of care in young children with severe, non-attenuated MPS IIIB.
The clinical trial is designed as a randomized, single-blind, parallel-group, controlled, multicenter study. It will investigate TA-ERT administered through intracerebroventricular (ICV) delivery, a method that enables administration directly into the cerebrospinal fluid.
The study is expected to enroll approximately 14 children between 1 and 5 years of age with severe MPS IIIB.
The primary objective will be to assess the effect of TA-ERT on cognitive function. Additional evaluations will examine the therapy’s safety, tolerability, and potential clinical effects compared with standard care.
The confirmatory study is particularly important because the FDA has requested that Spruce initiate the trial while the planned BLA application is under review as a condition of potential accelerated approval.
Accelerated approval pathways can allow certain therapies addressing serious conditions and unmet medical needs to reach patients based on surrogate endpoints that are reasonably likely to predict clinical benefit. However, companies may be required to conduct post-approval confirmatory studies to verify the anticipated clinical benefit.
For Spruce, the TrAnsform study represents an important part of its broader regulatory strategy and its efforts to establish the potential clinical value of TA-ERT in children affected by MPS IIIB.
Further details about the study are available through its ClinicalTrials.gov registration.
MPS IIIB Natural History Findings Presented at Neurology Meeting
In October 2026, Spruce reported additional scientific progress through the presentation of natural history data from Study 250-902 at the 55th Child Neurology Society Annual Meeting.
The research was presented in a poster titled “In-depth Analyses of Cognition, Motor, Communication, and Adaptive Natural History Disease Course in Participants with MPS IIIB.”
Study 250-902 is a prospective, multicenter, multinational, noninterventional, longitudinal natural history study involving pediatric participants with severe, non-attenuated MPS IIIB.
Natural history studies provide important information about how a disease develops and progresses over time without an investigational treatment. These findings can help researchers understand the expected progression of neurological and functional symptoms and identify meaningful endpoints for clinical trials.
The study’s analyses examined several important areas, including cognition, motor function, communication abilities, and adaptive functioning.
These domains are particularly relevant to MPS IIIB because the disorder can progressively affect multiple aspects of neurological development and daily functioning.
The information generated through natural history research may help support clinical trial design, inform the selection of outcome measures, and provide context for evaluating treatment effects in future studies.
Spruce Biosciences Amends Avenue Loan Agreement to Strengthen Financial Flexibility
Beyond its clinical and regulatory activities, Spruce announced an amendment to its existing loan and security agreement with Avenue Capital Management II, L.P. and Avenue Venture Opportunities Fund II, L.P. (collectively, Avenue).
The amendment, referred to as the Avenue Amendment, was executed on November 6, 2026, and introduces changes to the availability and timing of certain debt financing tranches.
Under the amended agreement, the amount available under Tranche 2 has been increased to up to $15.0 million. The company may draw on this tranche between January 1, 2027, and March 31, 2027, subject to the satisfaction of specified conditions.
The amendment also revises the availability of Tranche 3. This financing tranche will be available between July 1, 2027, and December 31, 2027. However, Tranche 3 will be discretionary and will require approval from Avenue’s investment committee at the time of any borrowing.
Additionally, the amount available under Tranche 3 will be reduced by the amount of any Tranche 2 borrowings exceeding $10.0 million. This arrangement ensures that the aggregate commitment amount across Tranches 1, 2, and 3 remains unchanged.
Another significant modification involves the interest-only period. Under the amendment, the existing interest-only period has been extended through March 31, 2027. Subject to certain conditions, the period may be extended further through October 31, 2027, and subsequently through October 31, 2028.
The revised financing structure is expected to provide Spruce with greater flexibility as it progresses through the BLA review process and prepares for the potential commercial introduction of TA-ERT in the United States.
CRHX-101 Program Separated Into Newly Formed Adrenyx Biosciences
On November 6, 2026, Spruce completed the separation of its CRHX-101 program, formerly known as SPR-202, into Adrenyx Biosciences, Inc., a newly formed wholly owned subsidiary.
CRHX-101 is an investigational anti-corticotropin-releasing hormone monoclonal antibody program. The separation is intended to establish a dedicated corporate structure for the program, allowing it to pursue its own development strategy and financing arrangements.
In connection with the transaction, Spruce and Adrenyx entered into a separation and distribution agreement and a transition services agreement. Spruce contributed the assets and liabilities associated with the CRHX-101 program to Adrenyx, effective November 6, 2026.
Spruce currently intends to distribute all outstanding shares of Adrenyx common stock to its shareholders on a pro rata basis. The proposed transaction is designed to create two independent public companies with separate strategic priorities and investment opportunities.
Following completion of the distribution, Spruce expects to concentrate its resources and management attention on TA-ERT and the MPS IIIB opportunity. Meanwhile, Adrenyx will independently pursue the development and potential commercialization of CRHX-101.
Spruce has agreed to provide specified transition services to Adrenyx for up to 12 months following the distribution, subject to possible extension. Adrenyx will compensate Spruce for these services at cost, without an additional markup.
Adrenyx Secures Initial $5 Million Convertible Note Financing
As part of its financial preparations following the separation, Adrenyx entered into a secured convertible note purchase agreement with a leading institutional biotechnology investor on November 6, 2026.
Under the agreement, Adrenyx may issue secured convertible promissory notes with an aggregate principal amount of up to $10.0 million.
At the initial closing on November 6, 2026, Adrenyx issued notes representing $5.0 million in aggregate principal amount. Additional notes may be issued through subsequent closings, subject to the terms and conditions of the agreement, including the investor’s consent.
The proceeds from the financing must be used to support the development and commercialization of CRHX-101 and other general corporate purposes of Adrenyx. The agreement specifically prohibits Spruce from using these funds to finance its own operations.
The separation and planned distribution are expected to be completed during the first half of 2027. A private placement of Adrenyx equity securities is also expected to take place in connection with the distribution, with up to $50 million expected to be funded by the convertible note investor, inclusive of its note funding.
However, several conditions must be satisfied or waived before the transaction can be completed. These include approval of the distribution by Spruce’s board of directors, the effectiveness of a registration statement to be filed by Adrenyx with the U.S. Securities and Exchange Commission (SEC), and approval for the listing of Adrenyx common stock on Nasdaq.
Spruce’s board has not yet approved the distribution or established a record date. Until the transaction is completed, Adrenyx will continue operating as a controlled subsidiary of Spruce.
Stockholder approval from Spruce shareholders is not required as a condition for completing the distribution. The transaction is expected to be taxable for U.S. federal income tax purposes.
The company cautioned that there can be no assurance that the distribution, subsequent note issuances, or private placement will be completed according to the anticipated timeline or terms, or that these transactions will be completed at all.
Third Quarter 2026 Financial Results
Spruce Biosciences also reported its financial performance for the third quarter and first nine months ended September 30, 2026, reflecting increased investment in the development and manufacturing activities associated with TA-ERT.
Cash and Cash Equivalents
As of September 30, 2026, Spruce reported cash and cash equivalents of $87.7 million, compared with $48.9 million as of December 31, 2025.
Based on its existing financial resources, the company believes that its cash and cash equivalents at the end of the third quarter will be sufficient to support planned operations and debt obligations into the second half of 2027.
Research and Development Expenses
Research and development expenses increased to $18.1 million in the third quarter of 2026, compared with $5.0 million in the corresponding period of 2025.
For the first nine months of 2026, R&D expenses totaled $37.9 million, compared with $15.4 million during the same period in 2025.
The increase primarily reflected higher spending to advance TA-ERT, particularly in manufacturing and clinical development activities. These costs were partially offset by lower one-time product acquisition expenses and the discontinuation of the company’s tildacerfont congenital adrenal hyperplasia development program.
General and Administrative Expenses
General and administrative expenses reached $5.8 million in the third quarter of 2026, compared with $3.2 million in the third quarter of 2025.
For the first nine months of 2026, G&A expenses totaled $14.6 million, compared with $10.0 million during the corresponding period of 2025.
The increase was primarily driven by higher personnel-related expenses and professional fees associated with organizational growth, pre-commercialization preparations, and activities related to the separation and planned distribution of Adrenyx.
Total Operating Expenses
Total operating expenses for the third quarter of 2026 were $24.0 million, compared with $8.2 million in the third quarter of 2025.
For the first nine months of 2026, total operating expenses reached $52.5 million, compared with $25.4 million in the same period of 2025.
These expenses included non-cash stock-based compensation of $1.1 million for the third quarter and $2.7 million for the first nine months ended September 30, 2026.
Spruce reported a net loss of $24.0 million, or $8.51 per basic and diluted share, for the third quarter of 2026. This compared with a net loss of $8.2 million, or $14.58 per basic and diluted share, in the third quarter of 2025.
For the first nine months of 2026, the company recorded a net loss of $52.5 million, or $23.71 per basic and diluted share, compared with a net loss of $24.3 million, or $41.25 per basic and diluted share, during the corresponding period of 2025.
The higher expenses and net loss reflect the company’s increased investment in TA-ERT development, manufacturing preparations, clinical activities, and corporate infrastructure as it approaches a major regulatory milestone.
Spruce Biosciences enters the final months of 2026 with several important milestones planned for its lead TA-ERT program. The company remains focused on completing its second PPQ manufacturing batch, submitting its BLA in December, and initiating the TrAnsform confirmatory study.
The initiation of the Expanded Access Program also represents an important step in supporting eligible children with MPS IIIB who cannot participate in the confirmatory clinical trial.
At the corporate level, the amended Avenue financing arrangement and planned separation of CRHX-101 into Adrenyx are intended to provide greater strategic focus and financial flexibility.
With $87.7 million in cash and cash equivalents reported at September 30, 2026, and financing arrangements designed to support its development plans, Spruce believes it has resources to fund operations and debt obligations into the second half of 2027.
The anticipated BLA submission represents the company’s most significant near-term objective. If successful, the regulatory process could bring Spruce closer to introducing a potential treatment for a rare and devastating neurological disorder for which no FDA-approved therapy currently exists.
Through its continued clinical, manufacturing, regulatory, and financial initiatives, Spruce is working toward advancing TA-ERT while establishing a focused development strategy centered on addressing the unmet needs of children and families affected by MPS IIIB.
About Spruce Biosciences
Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need. Spruce’s lead product candidate, tralesinidase alfa enzyme replacement therapy (“TA-ERT”), is in late-stage development for the treatment of mucopolysaccharidosis type IIIB (“MPS IIIB”), or Sanfilippo Syndrome Type B, a devastating pediatric neurodegenerative disorder for which there are no FDA-approved therapies. TA-ERT has received Breakthrough Therapy Designation, Rare Pediatric Disease Designation, Fast Track Designation and Orphan Drug Designation from the FDA, as well as Orphan Drug Designation in the European Union.