US Market News
4週前
Spruce Biosciences Announces Long-Term Tralesinidase Alfa Enzyme Replacement Therapy Data in Sanfilippo Syndrome Type B (MPS IIIB) Presented at the 18th International MPS SymposiumJune 8, 2026 4:05 PM
Business Wire Data Highlight TA-ERT’s Potential as the First Disease-Modifying Treatment Option for MPS IIIB, a Fatal Condition With No Approved Therapies Treatment With Weekly TA-ERT Demonstrated Rapid and Durable Normalization of CSF Heparan Sulfate Non-Reducing End (CSF HS-NRE), a Surrogate Endpoint Reasonably Likely to Predict Clinical Benefit TA-ERT Stabilized and Preserved Cognitive and Non-Cognitive Outcomes, Including Communication and Motor Skills, Over a Six-Year Period Relative to Natural History Patients Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today announced that data demonstrating the long-term benefit of tralesinidase alfa enzyme replacement therapy (TA-ERT) in patients with Sanfilippo Syndrome Type B (MPS IIIB) were presented at the 18th International MPS & Related Lysosomal Diseases Symposium, which took place June 4-7, 2026 in Florence, Italy. The data show that long-term administration of TA-ERT resulted in rapid and durable reduction of heparan sulfate and preserved cognitive and non-cognitive outcomes relative to natural history patients. The presentation, which includes data previously presented at the 22nd Annual WORLDSymposium™, was delivered by Nicole Muschol, M.D., of the International Center for Lysosomal Disorders (ICLD) at the University Medical Center Hamburg-Eppendorf in Germany and Principal Investigator for the TA-ERT clinical development program. “In a progressive neurodegenerative disease like MPS IIIB, stability itself is a clinically meaningful outcome,” said Dr. Muschol. “Over six years of treatment, cerebral spinal fluid heparan sulfate fell rapidly and remained low, while cognition, communication, and motor function were preserved relative to the decline seen in untreated patients. These long-term findings support the potential of tralesinidase alfa enzyme replacement therapy as the first disease-modifying treatment option for a fatal condition that currently has no approved therapies, and they matter greatly to the affected children and families.” In an analysis of 22 patients who enrolled in interventional studies of TA-ERT with follow-up of up to six years, TA-ERT treatment: Rapidly and durably normalized levels of cerebral spinal fluid heparan sulfate non-reducing end (CSF HS-NRE), a surrogate endpoint reasonably likely to predict clinical benefit in patients with MPS IIIB; Stabilized cognitive function, as assessed by the Bayley-III Cognitive Raw Score (BSID-C), the cognitive subscale of the validated Bayley Scales of Infant and Toddler Development – Third Edition (Bayley-III), relative to declines seen in untreated natural history patients; Stabilized receptive and expressive communication, as well as fine and gross motor skills, compared with a decline in these outcomes in untreated natural history patients, as assessed by the Vineland Adaptive Behavior Scales – Second Edition (VABS-II); Stabilized cortical gray matter volume, which declined in untreated natural history patients, and normalized liver and spleen volume; and Was generally consistent with the safety profile of intracerebroventricular (ICV) administration; over the six-year study, approximately 6,000 doses were administered to 22 patients. For more information, the presentation can be found on the Spruce Biosciences website at https://investors.sprucebio.com/news-and-events/presentations. About Sanfilippo Syndrome Type B (MPS IIIB) Sanfilippo Syndrome Type B (MPS IIIB) is an ultra-rare, serious, and fatal genetic disease characterized by deficiency in N-Acetyl-Alpha-Glycosaminidase (NAGLU), an enzyme required for the catabolism of heparan sulfate (HS) in lysosomes. It is estimated that MPS IIIB affects fewer than one in 200,000 people in the United States, but the true incidence and prevalence are difficult to ascertain because MPS IIIB is a disease currently not included in newborn screening. The accumulation of toxic levels of cerebral spinal fluid heparan sulfate in the brain is the underlying pathophysiology of MPS IIIB. Although signs and symptoms of MPS IIIB can vary amongst affected individuals, progressive neurodegeneration typically follows a predictable path to brain atrophy, cognitive and developmental impairment, hyperactivity with aggressive and destructive behavior, delayed speech, hearing loss, and motor skill deficits. Somatic manifestations include coarse facial features, hepatosplenomegaly, and gastrointestinal symptoms. The final stage of MPS IIIB is typically marked by severe dementia, loss of motor function, and seizure activity, with patients largely bed-ridden and requiring constant care, requiring feeding tubes for hydration and nutrition, and ultimately leading to death. The estimated life expectancy of individuals with MPS IIIB ranges from 15 to 19 years of age. Currently, there are no FDA-approved therapies for MPS IIIB, and management of the disease consists of limited palliative care to improve quality of life. About Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) is a fusion protein comprised of recombinant human alpha-N-acetylglucosaminidase (rhNAGLU). TA-ERT is intended as an enzyme replacement therapy for the treatment of patients with Sanfilippo Syndrome Type B (MPS IIIB) who lack rhNAGLU enzyme activity. TA-ERT is expected to restore rhNAGLU enzyme activity in the central nervous system following intracerebroventricular injection. rhNAGLU typically lacks the mannose-6 phosphate residues that are essential for efficient cellular uptake via the M6P receptor pathway. As a result, the naked enzyme is poorly absorbed by cells, including neurons. To address this challenge, TA-ERT is fused to an insulin-like growth factor 2 peptide, which binds to the cation-independent mannose-6-phosphate on cell surfaces. This fusion enables the enzyme to be internalized and delivered to the lysosome, thereby enhancing its therapeutic potential for treating MPS IIIB. By restoring NAGLU enzymatic activity and promoting clearance of lysosomal heparan sulfate and heparan sulfate non-reducing end in the brain, TA-ERT therapy is expected to preserve neuronal cell health and potentially halt or slow the neurological decline and improve clinical outcomes in affected patients. TA-ERT has been evaluated in three clinical studies in participants with MPS IIIB: the interventional study 201 and extension studies 202 and 401. TA-ERT has been administered to 22 individuals diagnosed with MPS IIIB, and has demonstrated an adequate safety profile based on integrated six years of safety data. 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 mucopolysaccharidoses 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. To learn more, visit www.sprucebio.com and follow us on X, LinkedIn, Facebook and YouTube. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the ability to seek accelerated approval of TA-ERT for MPS IIIB based on existing clinical data; the timing and likelihood of regulatory filings and approvals for TA-ERT, including advancing this program through a biologics license application submission and potential U.S. FDA approval; the potentially transformative clinical impact for TA-ERT; and TA-ERT’s potential to be the first and best-in-class disease-modifying therapy to treat MPS IIIB. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “will,” “potential,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Spruce’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Spruce’s business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Spruce’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Spruce undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260608285348/en/ Media
Carolyn Hawley
Inizio Evoke Comms
Carolyn.Hawley@inizioevoke.com
media@sprucebio.com Investors
Samir Gharib
President and CFO
Spruce Biosciences, Inc.
investors@sprucebio.com Original: Spruce Biosciences Announces Long-Term Tralesinidase Alfa Enzyme Replacement Therapy Data in Sanfilippo Syndrome Type B (MPS IIIB) Presented at the 18th International MPS Symposium
US Market News
1月前
Spruce Biosciences Announces Data Presentation at the 18th International MPS SymposiumMay 28, 2026 4:05 PM
Business Wire Nicole Muschol, M.D. to Present Long-Term Data on Tralesinidase Alfa (TA-ERT) in Sanfilippo Syndrome Type B (MPS IIIB) Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today announced that data on the long-term administration of its tralesinidase alfa enzyme replacement therapy (TA-ERT) for the treatment of Sanfilippo Syndrome Type B (MPS IIIB) will be presented at the 18th International MPS & Related Lysosomal Diseases Symposium, taking place June 4-7, 2026 in Florence, Italy. International MPS Symposium Presentation Details Title: Long-term administration of tralesinidase alfa enzyme replacement therapy (TA-ERT) results in profound and durable reduction of heparan sulfate (HS) and stabilization of cognitive function and cortical gray matter volume (CGMV) in patients with Sanfilippo Syndrome Type B (MPS IIIB)
Session Type: Oral Poster Presentation
Presentation Date & Time: June 6, 2026, 10:00-10:10 a.m. CEST
Poster No: 75
Presenter: Nicole Muschol, M.D., International Center for Lysosomal Disorders (ICLD) at the University Medical Center Hamburg-Eppendorf in Germany
Authors: Nicole Muschol, M.D.; Mona Lindschau, M.D.; Ilyas Okur, M.D.; Fatih Ezgu, M.D.; Maria J. de Castro Lopez, M.D.; Spyros Batzios, M.D.; Igor Nestrasil, M.D., Ph.D.; Saba Sile, M.D.; Ting Chang, Ph.D.; Jeffrey Zhang, Ph.D.; Javier Szwarcberg, M.D., M.P.H.; and Paul Harmatz, M.D. 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 mucopolysaccharidoses 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. To learn more, visit www.sprucebio.com and follow us on X, LinkedIn, Facebook and YouTube. View source version on businesswire.com: https://www.businesswire.com/news/home/20260528995547/en/ Media
Carolyn Hawley
Inizio Evoke Comms
Carolyn.Hawley@inizioevoke.com
media@sprucebio.com Investors
Samir Gharib
President and CFO
Spruce Biosciences, Inc.
investors@sprucebio.com Original: Spruce Biosciences Announces Data Presentation at the 18th International MPS Symposium
US Market News
2月前
Spruce Biosciences Announces Pricing of Public Offering of Common Stock and Pre-Funded WarrantsApril 20, 2026 11:45 PM
Business Wire
Spruce Biosciences, Inc. (“Spruce Biosciences”) (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today announced the pricing of its previously announced underwritten public offering of 1,150,000 shares of its common stock at a price to the public of $50.00 per share and, in lieu of shares of common stock to a certain investor, pre-funded warrants to purchase 50,000 shares of common stock at a purchase price of $49.99 per share, which equals the public offering price per share of the common stock less the $0.01 exercise price per share of each pre-funded warrant.
The gross proceeds to Spruce Biosciences from the offering are expected to be $60 million, before deducting underwriting discounts and commissions and other offering expenses payable by Spruce Biosciences. The offering is expected to close on April 22, 2026, subject to the satisfaction of customary closing conditions. In addition, Spruce Biosciences has granted the underwriters a 30-day option to purchase up to an additional 180,000 shares of common stock.
Leerink Partners, Guggenheim Securities, and Oppenheimer & Co. are acting as joint book-running managers and Jones and Craig-Hallum are acting as co-managers for the offering.
The shares of common stock and pre-funded warrants are being offered by Spruce Biosciences pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed with the Securities and Exchange Commission (the “SEC”) on October 29, 2025 and subsequently declared effective by the SEC on November 26, 2025. The offering is being made only by means of a prospectus supplement and the accompanying prospectus that will form a part of the registration statement. These documents can be accessed for free through the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus, when available, may also be obtained from: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, by telephone at (212) 667-8055, or by email at EquityProspectus@opco.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Spruce Biosciences
Spruce Biosciences, Inc. (Nasdaq: SPRB) is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “proposed,” “seek,” “should,” “suggest,” “target,” “on track,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the expected gross proceeds from the offering and the closing date of the offering. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to, among other things, market conditions and the satisfaction of customary closing conditions related to the public offering. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the preliminary prospectus supplement and the accompanying prospectus, the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260420707326/en/
Investor Contact:
Monique Kosse
Gilmartin Group
Monique@GilmartinIR.com
investors@sprucebio.com
Media Contact:
Carolyn Hawley
Inizio Evoke Comms
Carolyn.Hawley@inizioevoke.com
media@sprucebio.com
Original: Spruce Biosciences Announces Pricing of Public Offering of Common Stock and Pre-Funded Warrants
US Market News
2月前
Spruce Biosciences Announces Proposed Public Offering of Common Stock and Pre-Funded WarrantsApril 20, 2026 4:01 PM
Business Wire
Spruce Biosciences, Inc. (“Spruce Biosciences”) (NASDAQ: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today announced that it has commenced an underwritten public offering of shares of its common stock or pre-funded warrants to purchase shares of its common stock in lieu thereof. All of the securities are being offered by Spruce Biosciences. In addition, Spruce Biosciences expects to grant the underwriters a 30-day option to purchase additional shares of its common stock in an amount of up to 15% of the aggregate number of shares sold in the offering at the public offering price, less underwriting discounts and commissions. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.
Leerink Partners, Guggenheim Securities, and Oppenheimer & Co. are acting as joint book-running managers and Jones and Craig-Hallum are acting as co-managers for the proposed offering.
The shares of common stock and pre-funded warrants are being offered by Spruce Biosciences pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed with the Securities and Exchange Commission (the “SEC”) on October 29, 2025 and subsequently declared effective by the SEC on November 26, 2025. The proposed offering is being made only by means of a prospectus supplement and the accompanying prospectus that will form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus, when available, may also be obtained from: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105 or by email at syndicate@leerink.com; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544 or by email at GSEquityProspectusDelivery@guggenheimpartners.com; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, or by telephone at (212) 667-8055 or by email at EquityProspectus@opco.com. The final terms of the proposed offering will be disclosed in a final prospectus supplement to be filed with the SEC.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Spruce Biosciences
Spruce Biosciences, Inc. (Nasdaq: SPRB) is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “proposed,” “seek,” “should,” “suggest,” “target,” “on track,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about Spruce Biosciences’ proposed public offering and Spruce Biosciences’ intention to grant the underwriters an option to purchase additional shares. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to, among other things, market conditions and the demand for Spruce Biosciences’ securities. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the preliminary prospectus supplement and the accompanying prospectus, the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260420930919/en/
Investor Contact:
Monique Kosse
Gilmartin Group
Monique@GilmartinIR.com
investors@sprucebio.com
Media Contact:
Carolyn Hawley
Inizio Evoke Comms
Carolyn.Hawley@inizioevoke.com
media@sprucebio.com
Original: Spruce Biosciences Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants
US Market News
4月前
Spruce Biosciences Reports Full Year 2025 Financial Results and Provides Corporate UpdatesMarch 9, 2026 7:05 AM
Business Wire
Following Positive Type B Meetings with the FDA, BLA Submission for TA-ERT for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB) on Track for the Fourth Quarter of 2026
Appoints Dale Hooks as Chief Commercial Officer, Strengthening the Company’s Commercial Capabilities in Preparation for a Potential Launch of TA-ERT
Secured up to $50 Million in Growth Capital from Avenue Capital Group
Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today reported financial results for the year ended December 31, 2025 and provided corporate updates.
“2025 was a very productive year, and our team continues to execute and drive towards key milestones with our tralesinidase alfa enzyme replacement therapy (TA-ERT) program, especially our planned biologics license application (BLA) submission in the fourth quarter of this year and potential commercial launch in MPS IIIB,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “Our recent productive interactions with the FDA have provided clear next steps that strengthen our conviction in the development of TA-ERT for patients and families living with MPS IIIB, for which currently there are no approved therapies. Our appointment of Dale Hooks as Chief Commercial Officer further reflects our conviction and commitment to building our capabilities and commercial infrastructure, as we position ourselves to capitalize on the next chapter of growth at Spruce.”
Recent Corporate Updates
Held Positive Type B Meetings with the FDA. In February 2026, the company announced the successful completion of two Type B meetings with the FDA regarding its planned upcoming BLA submission for TA-ERT for the treatment of MPS IIIB. The FDA confirmed that the integrated study data from interventional clinical studies of TA-ERT and the available natural history data could potentially serve as an adequate and well-controlled study for purposes of the FDA’s review of the effects of TA-ERT on cerebral spinal fluid heparan sulfate non-reducing end, which could serve as a reasonably likely surrogate endpoint of clinical benefit supporting an accelerated approval. The BLA submission for TA-ERT is anticipated in the fourth quarter of 2026.
Appointed Dale Hooks, an Accomplished Rare Disease Commercial Leader, as Chief Commercial Officer. Today, the company announced the appointment of Dale Hooks as Chief Commercial Officer, who brings over three decades of biopharmaceutical marketing and commercialization expertise to drive the potential commercial launch of TA-ERT.
Secured Up to $50 million in Growth Capital from Avenue Capital. In January 2026, the company entered into a loan facility for up to $50 million in growth capital to support the continued advancement and potential commercial launch of TA-ERT. The loan facility has a 42-month term and includes an initial tranche of $15 million, which was fully funded in January 2026, and three additional tranches totaling up to $35 million, subject to the satisfaction of certain terms and conditions of the loan and security agreement.
Presented Long-term Data of TA-ERT at the 22nd Annual WORLDSymposium™. In February 2026, data from two different analyses were presented highlighting TA-ERT as potentially the first disease-modifying treatment option for MPS IIIB. One presentation showed that long-term administration of TA-ERT resulted in rapid and durable reduction of heparan sulfate and preserved cognitive and non-cognitive clinical outcomes in patients with MPS IIIB relative to natural history patients. The second presentation included analyses of two siblings diagnosed with MPS IIIB showing that, in an age-matched comparison, one sibling treated with TA-ERT appeared to display higher cognitive, language, and motor functioning relative to the untreated sibling at a similar age. For more information, the two poster presentations can be found on the Spruce Biosciences website at https://investors.sprucebio.com/news-and-events/presentations.
Added Regulatory and Clinical Development Expertise to the Executive Leadership Team. In February 2026, the company appointed Daven Mody, Pharm.D., as Senior Vice President, Regulatory and Quality, and Bruno Gagnon, B.Pharm., M.Sc., as Senior Vice President, Clinical Development Operations.
Reauthorization of the Rare Pediatric Disease Priority Review Voucher (PRV) Program. In February 2026, the PRV program was reauthorized through September 30, 2029. This five-year extension restores a key incentive to develop therapies for rare pediatric diseases, allowing companies to receive a fast-track review voucher for approved drugs. TA-ERT has secured Rare Pediatric Disease Designation and is eligible for a PRV, if approved by the FDA.
Appointed Keli Walbert, a Proven Pharmaceutical Commercial Leader, to the Board of Directors. In December 2025, the company appointed Keli Walbert to its Board of Directors. Ms. Walbert has decades of commercial leadership experience and a proven track record of successful product launches in rare diseases.
Full Year 2025 Financial Results
Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2025 were $48.9 million, which excludes the receipt of $15.0 million in gross proceeds under the loan facility with Avenue Capital. The company expects its cash and cash equivalents to fund its current operating plan into early 2027, beyond the anticipated BLA submission for TA-ERT.
Research and Development (R&D) Expenses: R&D expenses for the year ended December 31, 2025 were $19.5 million compared to $46.4 million for the same period in 2024. The decrease in R&D expenses was primarily related to the cessation of development activities of tildacerfont for the treatment of congenital adrenal hyperplasia (CAH), offset by development activities related to TA-ERT for the treatment of MPS IIIB and the acquisition of SPR202, an anti-corticotropin releasing hormone monoclonal antibody for the treatment of CAH.
General and Administrative (G&A) Expenses: G&A expenses for the year ended December 31, 2025 were $17.0 million compared to $14.6 million for the same period in 2024, primarily driven by increased professional service fees, offset by a decrease in stock-based compensation expense.
Total Operating Expenses: Total operating expenses for the year ended December 31, 2025 were $36.5 million compared to $61.1 million for the same period in 2024. Operating expenses include non-cash stock-based compensation expenses of $2.6 million for the year ended December 31, 2025 compared to $5.3 million for the same period in 2024.
Net Loss: Net loss for the year ended December 31, 2025 was $39.0 million compared to $53.0 million for the same period in 2024.
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. To learn more, visit www.sprucebio.com and follow us on X, LinkedIn, Facebook and YouTube.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the ability to seek accelerated approval of TA-ERT for MPS IIIB based on existing clinical data; the content, timing and likelihood of regulatory filings and approvals for TA-ERT, including advancing this program through a BLA submission and potential FDA approval; the potentially transformative clinical impact for TA-ERT; TA-ERT’s eligibility for a PRV; and TA-ERT’s potential to be the first disease-modifying therapy to treat MPS IIIB. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “could,” “potential,” “on track,” “expect,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Spruce’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Spruce’s business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Spruce’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date.
SPRUCE BIOSCIENCES, INC.
BALANCE SHEETS
(in thousands, except share and per share amounts)
December 31,
2025
2024
ASSETS
Current assets:
Cash and cash equivalents
$
48,906
$
38,753
Prepaid expenses
353
3,177
Other current assets
2,853
2,276
Total current assets
52,112
44,206
Right-of-use assets
666
934
Other assets
243
69
Total assets
$
53,021
$
45,209
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
943
$
1,295
Accrued expenses and other current liabilities
9,143
12,329
Term loan, current portion
—
1,622
Total current liabilities
10,086
15,246
Lease liabilities, net of current portion
419
736
Term loan, net of current portion
—
124
Other liabilities
—
282
Total liabilities
10,505
16,388
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.0001 par value; 10,000,000 shares authorized and no shares issued or outstanding as of December 31, 2025 and 2024
—
—
Common stock, $0.0001 par value; 200,000,000 shares authorized as of December 31, 2025 and 2024; 1,372,043 and 563,042 shares issued and outstanding as of December 31, 2025 and 2024, respectively
—
—
Additional paid-in capital
331,750
279,089
Accumulated deficit
(289,234
)
(250,268
)
Total stockholders’ equity
42,516
28,821
Total liabilities and stockholders’ equity
$
53,021
$
45,209
SPRUCE BIOSCIENCES, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
Year Ended December 31,
2025
2024
Collaboration revenue
$
—
$
4,911
Operating expenses:
Research and development
19,522
46,418
General and administrative
16,991
14,644
Total operating expenses
36,513
61,062
Loss from operations
(36,513
)
(56,151
)
Interest expense
(90
)
(307
)
Change in fair value of warrant liability
(3,500
)
—
Interest and other income, net
1,137
3,422
Net loss and comprehensive loss
(38,966
)
(53,036
)
Net loss per share, basic and diluted
$
(50.83
)
$
(96.40
)
Weighted-average shares of common stock outstanding, basic and diluted
766,598
550,146
View source version on businesswire.com: https://www.businesswire.com/news/home/20260309462150/en/
Media
Carolyn Hawley
Inizio Evoke Comms
Carolyn.Hawley@inizioevoke.com
media@sprucebio.com
Investors
Monique Kosse
Gilmartin Group
Monique@GilmartinIR.com
investors@sprucebio.com
Original: Spruce Biosciences Reports Full Year 2025 Financial Results and Provides Corporate Updates
iHub News
4月前
Spruce Biosciences Reports Positive FDA Meetings as It Prepares TA-ERT Filing for Rare Pediatric DisorderFebruary 18, 2026 8:23 AM
IH Market News
Spruce Biosciences, Inc. (NASDAQ:SPRB) said it has completed two Type B meetings with the U.S. Food and Drug Administration (FDA), clearing key regulatory discussions ahead of its planned biologics license application (BLA) submission for tralesinidase alfa enzyme replacement therapy (TA-ERT), its experimental treatment for Sanfilippo Syndrome Type B (MPS IIIB).The company met with the FDA in December 2025 to review clinical data and regulatory strategy, followed by a January 2026 meeting focused on chemistry, manufacturing and controls (CMC).During the December meeting, the FDA indicated that integrated data from TA-ERT interventional studies, together with available natural history data, could potentially qualify as an adequate and well-controlled dataset to evaluate the therapy’s effect on cerebrospinal fluid heparan sulfate non-reducing end (CSF HS-NRE). The agency said CSF HS-NRE could serve as a reasonably likely surrogate endpoint (RLSE) to support accelerated approval.The FDA also provided recommendations to strengthen the use of CSF HS-NRE as a surrogate marker, which Spruce said it is incorporating into its planned BLA submission. The company and the agency additionally aligned on the timing and design of a required confirmatory study, agreeing that the study could begin during the BLA review period.At the January CMC meeting, the FDA reviewed Spruce’s approach to drug product process performance qualification (DP PPQ) batch requirements. According to official meeting minutes received on February 12, 2026, the agency requires one DP PPQ batch at the time of BLA filing and data from a second batch before the mid-cycle review.As a result, Spruce now expects to submit its BLA for TA-ERT in the fourth quarter of 2026.“The company appreciates the productive and constructive engagement with FDA as we gain clarity on specific clinical and CMC requirements expected of us by the Agency for our planned upcoming BLA submission of TA-ERT,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “While the timing of our submission is now expected in the fourth quarter of this year, we believe in the strength of our long-term data for TA-ERT which demonstrates that reductions in CSF HS-NRE are associated with meaningful clinical benefits across cognition, communication, and motor skill acquisition. TA-ERT has the potential to provide a meaningful option to change the course of this fatal disease, and we are motivated every day to bring forward a treatment for families and patients with MPS IIIB who currently have no treatment options.”Dr. Szwarcberg added that the recent reauthorization of the Rare Pediatric Disease Priority Review Voucher (PRV) program through September 2029 restores an important incentive for companies developing treatments for rare childhood diseases.“As we work to bring TA-ERT to the market as efficiently as possible, I want to commend the tireless advocacy on behalf of patients that led to the reauthorization of the Rare Pediatric Disease Priority Review Voucher (PRV) program through September 2029, restoring a key incentive to develop therapies for rare pediatric diseases. The reauthorization of the PRV program has provided hope and renewed optimism to the Sanfilippo community and will enable us to successfully position TA-ERT, if approved, as potentially the first disease-modifying treatment option for MPS IIIB.”
About Sanfilippo Syndrome Type B (MPS IIIB)
Sanfilippo Syndrome Type B is an ultra-rare, inherited lysosomal storage disorder caused by a deficiency in the enzyme N-acetyl-alpha-glucosaminidase (NAGLU), which is necessary to break down heparan sulfate in cells. The accumulation of toxic levels of heparan sulfate in the brain drives progressive neurodegeneration.The condition is estimated to affect fewer than one in 200,000 people in the United States, though the true prevalence is uncertain because it is not included in newborn screening programs. Patients typically experience cognitive decline, developmental delay, behavioral disturbances, speech impairment, hearing loss and motor deterioration. In advanced stages, severe dementia, loss of mobility and seizures are common, with most patients requiring full-time care. Life expectancy is generally between 15 and 19 years. There are currently no FDA-approved treatments.
About TA-ERT
TA-ERT is a fusion protein composed of recombinant human alpha-N-acetylglucosaminidase (rhNAGLU) designed to replace the deficient enzyme in patients with MPS IIIB. Administered via intracerebroventricular injection, the therapy is intended to restore enzyme activity in the central nervous system.Because rhNAGLU alone is poorly taken up by cells, TA-ERT is fused to an insulin-like growth factor 2 peptide to facilitate cellular uptake and lysosomal delivery. By restoring NAGLU activity and promoting clearance of heparan sulfate and its non-reducing end fragments in the brain, the therapy aims to slow or halt neurological decline.TA-ERT has been studied in three clinical trials—Study 201 and extension studies 202 and 401—and has been administered to 22 patients. Spruce reports an acceptable safety profile based on six years of integrated safety data.The therapy has received Breakthrough Therapy, Fast Track and Rare Pediatric Disease designations from the FDA.
About Spruce Biosciences
Spruce Biosciences is a late-stage biopharmaceutical company developing novel therapies for neurological disorders with significant unmet medical need.Spruce Biosciences stock price
Original: Spruce Biosciences Reports Positive FDA Meetings as It Prepares TA-ERT Filing for Rare Pediatric Disorder
US Market News
5月前
Long-Term Data Presented at the 22nd Annual WORLDSymposium™ Highlights Tralesinidase Alfa Enzyme Replacement Therapy’s Potential as the First Disease-Modifying Treatment Option for Sanfilippo Syndrome Type B (MPS IIIB)February 5, 2026 4:05 PM
Business Wire
Treatment with Weekly TA-ERT Demonstrated Rapid and Durable Normalization of Cerebral Spinal Fluid Heparan Sulfate Non-Reducing End (CSF HS-NRE), a Surrogate Endpoint Reasonably Likely to Predict Clinical Benefit
TA-ERT Treatment Stabilized and Preserved Cognitive and Non-Cognitive Outcomes, such as Communication and Motor Skills for Over Six-Year Period Relative to Natural History Patients
Safety Profile Consistent with Intracerebroventricular Administration with ~6,000 Doses Administered Over Six-Year Period
Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, announced that data from two different analyses presented today at the 22nd Annual WORLDSymposium™ demonstrate that the long-term administration of tralesinidase alfa enzyme replacement therapy (TA-ERT) resulted in rapid and durable reduction of heparan sulfate and preserved cognitive and non-cognitive outcomes in patients with Sanfilippo Syndrome Type B (MPS IIIB) relative to natural history patients.
“This long-term data supports tralesinidase alfa enzyme replacement therapy as potentially the first disease-modifying treatment option for individuals living with Sanfilippo Syndrome Type B, a fatal condition for which no approved therapies currently exist,” said Nicole Muschol, M.D., International Center for Lysosomal Disorders (ICLD) at the University Medical Center Hamburg-Eppendorf in Germany and Principal Investigator. “The stabilization and preservation of cognitive function, receptive and expressive communication, and fine and gross motor skills observed over six years of TA-ERT treatment are meaningful and provide hope for the families and patients affected by this devastating disorder.”
In an analysis of 22 patients who enrolled in interventional studies of TA-ERT and followed up to six years, TA-ERT treatment:
Rapidly and durably normalized levels of cerebral spinal fluid heparan sulfate non-reducing end (CSF HS-NRE), a surrogate endpoint reasonably likely to predict clinical benefit in patients with MPS IIIB;
Stabilized cognitive function as assessed by Bayley-III Cognitive Raw Score (BSID-C), the cognitive subscale of the validated Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III) scale relative to declines seen in untreated natural history patients;
Stabilized cortical gray matter volume, which declined in untreated natural history patients, and normalized liver and spleen volume; and
Was generally consistent with the safety profile of intracerebroventricular (ICV) administration; over the six-year study, approximately 6,000 doses were administered to 22 patients.
New analysis using the validated Vineland Adaptive Behavior Scales – Second Addition (VABS-II) scale also showed that TA-ERT was associated with a stabilization in receptive and expressive communication, as well as both fine and gross motor skills, compared to a decline in these outcomes in untreated natural history patients.
“This dataset represents an important milestone in the development of TA-ERT and reflects our commitment to generating the rigorous safety and efficacy data needed to deepen our understanding of this potential first- and best-in-class therapy,” said Kirk Ways, M.D., Ph.D., Chief Medical Officer of Spruce Biosciences. “Seeing sustained normalization of CSF HS-NRE alongside long-term stabilization of cognitive function, communication, and motor skills strengthens our confidence in the potential of TA-ERT and reinforces our dedication to working closely with the Sanfilippo community to responsibly advance this program through a biologics license application submission and potential U.S. FDA approval. We are incredibly grateful to the children, families, caregivers, and study investigators who participated in the TA-ERT clinical development program.”
A second presentation analyzed the course of disease in two siblings who were diagnosed with non-attenuated, severe MPS IIIB. One sibling participated in the interventional clinical trials of TA-ERT, while the other sibling was untreated. In an age-matched comparison, the sibling treated with TA-ERT appeared to display higher cognitive, language, and motor functioning relative to the untreated sibling at a similar age. At 12.1 years of age and one month after cessation of treatment, the sibling treated with TA-ERT was able to speak a few words, was toilet trained and could feed himself finger foods. The untreated sibling at age 11.7 years was nonverbal, was no longer toilet trained, and was dependent on caregivers for feeding.
“This unique analysis enabled us to control for genetic, environmental, and socioeconomic variables in understanding how supportive care with and without administration of TA-ERT can impact the course of MPS IIIB,” said Irene Chang, M.D., Associate Professor at the University of California, San Francisco. “When we compare clinical observations at a similar age range between the treated and untreated siblings, we see a clear divergence in cognitive and functional ability, demonstrating the potential of TA-ERT to be a novel and clinically meaningful treatment option for children and families impacted by MPS IIIB.”
For more information, the two poster presentations can be found on the Spruce Biosciences website at https://investors.sprucebio.com/news-and-events/presentations.
About Sanfilippo Syndrome Type B (MPS IIIB)
Sanfilippo Syndrome Type B (MPS IIIB) is an ultra-rare, serious, and fatal genetic disease characterized by deficiency in N-Acetyl-Alpha-Glycosaminidase (NAGLU), an enzyme required for the catabolism of heparan sulfate (HS) in lysosomes. It is estimated that MPS IIIB affects fewer than one in 200,000 people in the United States, but the true incidence and prevalence are difficult to ascertain because MPS IIIB is a disease currently not included in newborn screening. The accumulation of toxic levels of cerebral spinal fluid heparan sulfate in the brain is the underlying pathophysiology of MPS IIIB. Although signs and symptoms of MPS IIIB can vary amongst affected individuals, progressive neurodegeneration typically follows a predictable path to brain atrophy, cognitive and developmental impairment, hyperactivity with aggressive and destructive behavior, delayed speech, hearing loss, and motor skill deficits. Somatic manifestations include coarse facial features, hepatosplenomegaly, and gastrointestinal symptoms. The final stage of MPS IIIB is typically marked by severe dementia, loss of motor function, and seizure activity, with patients largely bed-ridden and requiring constant care, requiring feeding tubes for hydration and nutrition, and ultimately leading to death. The estimated life expectancy of individuals with MPS IIIB ranges from 15 to 19 years of age. Currently, there are no FDA-approved therapies for MPS IIIB, and management of the disease consists of limited palliative care to improve quality of life.
About Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT)
Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) is a fusion protein comprised of recombinant human alpha-N-acetylglucosaminidase (rhNAGLU). TA-ERT is intended as an enzyme replacement therapy for the treatment of patients with Sanfilippo Syndrome Type B (MPS IIIB) who lack rhNAGLU enzyme activity. TA-ERT is expected to restore rhNAGLU enzyme activity in the central nervous system following intracerebroventricular injection. rhNAGLU typically lacks the mannose-6 phosphate residues that are essential for efficient cellular uptake via the M6P receptor pathway. As a result, the naked enzyme is poorly absorbed by cells, including neurons. To address this challenge, TA-ERT is fused to an insulin-like growth factor 2 peptide, which binds to the cation-independent mannose-6-phosphate on cell surfaces. This fusion enables the enzyme to be internalized and delivered to the lysosome, thereby enhancing its therapeutic potential for treating MPS IIIB. By restoring NAGLU enzymatic activity and promoting clearance of lysosomal heparan sulfate and heparan sulfate non-reducing end in the brain, TA-ERT therapy is expected to preserve neuronal cell health and potentially halt or slow the neurological decline and improve clinical outcomes in affected patients. TA-ERT has been evaluated in three clinical studies in participants with MPS IIIB: the interventional study 201 and extension studies 202 and 401. TA-ERT has been administered to 22 individuals diagnosed with MPS IIIB, and has demonstrated an adequate safety profile based on integrated six years of safety data.
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. To learn more, visit www.sprucebio.com and follow us on X, LinkedIn, Facebook and YouTube.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the ability to seek accelerated approval of TA-ERT for MPS IIIB based on existing clinical data; the timing and likelihood of regulatory filings and approvals for TA-ERT, including advancing this program through a biologics license application submission and potential U.S. FDA approval; the potentially transformative clinical impact for TA-ERT; and TA-ERT’s potential to be the first and best-in-class disease-modifying therapy to treat MPS IIIB. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “will,” “potential,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Spruce’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Spruce’s business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Spruce’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Spruce undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260205292673/en/
Media
Carolyn Hawley
Inizio Evoke Comms
Carolyn.Hawley@inizioevoke.com
media@sprucebio.com
Investors
Samir Gharib
President and CFO
Spruce Biosciences, Inc.
investors@sprucebio.com
Original: Long-Term Data Presented at the 22nd Annual WORLDSymposium™ Highlights Tralesinidase Alfa Enzyme Replacement Therapy’s Potential as the First Disease-Modifying Treatment Option for Sanfilippo Syndrome Type B (MPS IIIB)
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