Spruce Biosciences — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash and cash equivalents were $87.7 million as of September 30, 2026, compared to $48.9 million as of December 31, 2025.
• Research and development (R&D) expenses were $18.1 million for the third quarter of 2026, up from $5.0 million in the same period in 2025; for the first nine months of 2026, R&D was $37.9 million compared to $15.4 million in 2025.
• General and administrative (G&A) expenses were $5.8 million for the third quarter of 2026, up from $3.2 million in the same period in 2025; for the first nine months of 2026, G&A was $14.6 million compared to $10.0 million in 2025.
• Total operating expenses were $24.0 million for the third quarter of 2026, compared to $8.2 million in the same period in 2025; for the first nine months of 2026, total operating expenses were $52.5 million compared to $25.4 million in 2025.
• Non-cash stock-based compensation expense was $1.1 million for the three months ended September 30, 2026, and $2.7 million for the nine months ended September 30, 2026.
• Net loss was $24.0 million, or $(8.51) per share, for the third quarter of 2026, compared to $8.2 million, or $(14.58) per share, for the third quarter of 2025.
• Net loss was $52.5 million, or $(23.71) per share, for the first nine months of 2026, compared to $24.3 million, or $(41.25) per share, for the first nine months of 2025.
• Total assets were $91.9 million as of September 30, 2026, compared to $53.0 million as of December 31, 2025.
• Total liabilities were $25.7 million as of September 30, 2026, compared to $10.5 million as of December 31, 2025.
• Debt, current portion, was $4.0 million as of September 30, 2026, with no debt current portion as of December 31, 2025.
• Debt, net of current portion, was $3.8 million as of September 30, 2026, with no debt net of current portion as of December 31, 2025.
• Total stockholders' equity was $66.3 million as of September 30, 2026, compared to $42.5 million as of December 31, 2025.
• Weighted-average shares of common stock outstanding were 2,821,316 for the three months ended September 30, 2026, compared to 563,066 in the same period in 2025.

Guidance and Future Outlook:

• The company anticipates submitting a Biologics License Application (BLA) for TA-ERT in December 2026.
• Spruce expects to complete the second Process Performance Qualification (PPQ) batch in December 2026.
• The TrAnsform confirmatory study is expected to initiate in December 2026.
• The company believes its cash and cash equivalents as of September 30, 2026, will be sufficient to fund planned operations and debt obligations into the second half of 2027.
• The Distribution of Adrenyx common stock is expected to be completed in the first half of 2027.
• A private placement of Adrenyx equity securities is expected to be completed in connection with the Distribution.

Business Segments and Product Lines:

• The TA-ERT program for MPS IIIB remains on track for a December 2026 BLA submission seeking accelerated approval.
• An Expanded Access Program (EAP) for TA-ERT was initiated in November 2026 to treat children with attenuated and severe MPS IIIB, expected to enroll approximately 10 participants.
• The first PPQ batch was completed in July 2026 and will be included in the BLA.
• The TrAnsform confirmatory study is a randomized, single-blind, parallel-group, controlled, multicenter study expected to enroll approximately 14 participants aged 1 to 5 years.
• The CRHX-101 program (formerly SPR-202) was separated into Adrenyx Biosciences, a newly formed wholly-owned subsidiary.
• Adrenyx entered into a secured convertible note purchase agreement allowing for up to $10.0 million in aggregate principal amount, with $5.0 million issued at initial closing on November 6, 2026.

Market and Competitive Landscape:

• There is currently no FDA-approved therapy for the treatment of MPS IIIB; disease management consists of limited supportive care.
• 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.
• If approved, TA-ERT may be eligible for a rare pediatric disease priority review voucher.
• Data from Study 250-902, a natural history study of severe, non-attenuated MPS IIIB, was presented at the 55th Child Neurology Society Annual Meeting in October 2026.

Risks and Challenges:

• Actual results may differ materially from forward-looking statements due to risks including the need for substantial additional capital, ability to continue as a going concern, and risks related to the Separation and Distribution.
• There is no assurance that the Distribution, subsequent closing of Adrenyx notes, or the private placement will be completed on the anticipated timeline, terms, or at all.
• The Distribution is expected to be a taxable transaction for U.S. federal income tax purposes.
• Approval by Spruce stockholders is not required for the Distribution, but board approval and SEC registration statement effectiveness are conditions.
• The TrAnsform confirmatory study is a condition of potential FDA accelerated approval.

Management Commentary and Tone:

• CEO Javier Szwarcberg stated the company is "executing with discipline" as it completes final steps toward the BLA submission.
• Management noted that pre-BLA meetings with the FDA in the second quarter provided alignment on the content and format of the BLA.
• Dr. Szwarcberg highlighted deliberate steps to strengthen the balance sheet and sharpen strategic focus through the amended loan agreement and the separation of CRHX-101.
• Management believes these actions position the company to unlock value for shareholders while working to bring the first FDA-approved therapy to families with MPS IIIB.

Other Key Points:

• The Avenue Loan Agreement was amended to increase Tranche 2 availability to $15.0 million (drawable between January 1, 2027, and March 31, 2027) and extend the interest-only period through March 31, 2027, with potential extensions through October 31, 2028.
• The separation of CRHX-101 into Adrenyx Biosciences allows Spruce to concentrate capital and focus entirely on TA-ERT while enabling shareholders to retain a stake in CRHX-101 through a planned stock distribution.
• Spruce will provide specified services to Adrenyx for up to 12 months following the Distribution, compensated at cost without markup.
• The EAP is partially funded by a $5.5 million strategic investment from the Cure Sanfilippo Foundation and the National MPS Society completed in August 2026.
• Spruce launched MPS3BStudy.com in August 2026 as a resource for families and caregivers regarding the EAP and TrAnsform study.
• Adrenyx intends to use proceeds from its convertible notes to develop and commercialize the CRHX-101 program and for general corporate purposes; Spruce is not permitted to use these proceeds.
• The number of shares issued and outstanding increased from 1,372,043 as of December 31, 2025, to 2,874,013 as of September 30, 2026.