Latest news with #TA-ERT
Business Wire
4 days ago
- Health
- Business Wire
Spruce Biosciences Announces Integrated Long-Term Clinical Data of Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) Demonstrating Profound and Durable Efficacy and Safety in Patients with Sanfilippo Syndrome Type B (MPS IIIB)
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Spruce Biosciences, Inc. (OTCQB: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today announced results from a long-term data integration of tralesinidase alfa enzyme replacement therapy (TA-ERT) clinical program in patients with Sanfilippo Syndrome Type B (MPS IIIB). Spruce integrated and evaluated group-level efficacy data for cerebral spinal fluid heparan-sulfate non-reducing end (CSF HS-NRE), cortical grey matter volume (CGMV), and Bayley-III Cognitive Raw Score (BSID-C), the cognitive subscale of the Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III), as well as safety data over a five-year period from clinical studies 201, 202, and 401. Data from treated patients (n=22) in the studies 201, 202, and 401 was compared with data from untreated patients with MPS IIIB in natural history studies 901 and 902. 'These data demonstrate a rapid, profound, and durable effect of ICV-administered TA-ERT on normalizing CSF HS-NRE, the pathogenic factor leading to neurodegeneration, and in stabilizing CGMV and cognitive function, relative to the declines observed in untreated children with Sanfilippo Syndrome Type B (MPS IIIB) in the natural history studies,' said Paul Harmatz, M.D., Principal Investigator in studies 901, 201, and 202 and Professor in Residence, Department of Pediatrics, University of California, San Francisco (UCSF) and UCSF Benioff Children's Hospital Oakland. 'This is an important development toward relief for children and families whose lives are impacted by this devastating condition.' 'Convincing positive outcomes have been experienced by families who resoundingly state that the benefits of TA-ERT outweigh risks in their real-world experiences,' said Cara O'Neill, M.D., FAAP, Co-Founder and Chief Science Officer of Cure Sanfilippo Foundation. 'Biomarker data, along with promising clinical outcomes, are significant and meaningful from the perspective of the patient community. Currently, there is no U.S. FDA-approved therapy for the treatment of MPS IIIB, and disease management consists of limited palliative care. We are eager to see TA-ERT advance under the accelerated approval pathway.' Cerebral Spinal Fluid Heparan-Sulfate Non-Reducing End (CSF HS-NRE) Integrated group-level data from clinical studies 201, 202, and 401 demonstrate that TA-ERT therapy significantly reduced to normal or near normal CSF HS-NRE levels over a five-year period (Figure 1). At 240 weeks, CSF HS-NRE decreased 91.5 ng/mL from baseline (95% CI: -102.10, -80.90; p<0.0001). Most participants experienced normalization of CSF HS-NRE levels eight weeks after initiating therapy. In a 2024 meeting with the U.S. Food and Drug Administration (FDA), the FDA confirmed that CSF HS-NRE is a surrogate biomarker reasonably likely to predict clinical benefit and could serve as a basis for accelerated approval. Cognitive Function In untreated patients with MPS IIIB, cognitive function peaks at around four years of age and then declines over time. In contrast, children with established disease treated with TA-ERT experienced stable cognitive function over time (Figure 2). Untreated children in the natural history studies showed a decline in cognition beginning at approximately five years of age that progressively worsened over time, while cognition in the TA-ERT treated group remained stable. Using a model-based approach, the mean (95% CI) BSID-C over six to 10 years of age was significantly higher in patients treated with TA-ERT, relative to untreated, age-matched children, with differences evident at six years of age (group difference: 10.67, 95% CI: 3.23, 18.11; p=0.005). At 10 years of age, the difference in BSID-C scores between groups increased to 34.66 (95% CI: 24.38, 44.93; p<0.0001). Although TA-ERT treatment stabilized BSID-C scores on average, increases in BSID-C scores were more commonly observed in subjects who initiated therapy at younger ages with higher baseline cognitive function and prior to the establishment of meaningful neurodegeneration. The BSID-C is anticipated to be the primary endpoint for the post-marketing clinical trial. Cortical Grey Matter Volume (CGMV) TA-ERT therapy was also associated with stabilization of CGMV, relative to the decline in CGMV observed in untreated children due to the progressive neurodegenerative nature of MPS IIIB (Figure 3). While CGMV should increase with age in children up to five years of age, there was an average loss of ~32 mL over 48 weeks in untreated children with MPS IIIB observed in study 901. Consistent with TA-ERT's mechanism of action, decreases in CGMV were observed during the initial 24 weeks of TA-ERT treatment, likely reflecting intracellular clearance of cerebral spinal fluid heparan sulfate (CSF HS) and CSF HS-NRE. CGMV stabilized from weeks 48 to 240 with TA-ERT treatment. Safety TA-ERT therapy exposure for up to 7.3 years has demonstrated an adequate safety profile in a serious and fatal disease for which no treatment is currently available. The mean (SD) exposure to TA-ERT was 4.2 (2.0) years. No deaths occurred throughout study 201 and its long-term extension studies 202 and 401. The most frequent treatment-emergent adverse event (TEAE) by preferred term (reported in ≥40% of participants) was vomiting (22 [100%]), followed by pyrexia (20 [90.9%]), upper respiratory tract infection (17 [77.3%]), pleocytosis (11 [50.0%]), COVID-19 infection (10 [45.5%]), and diarrhea (9 [40.9%]). Four (18%) patients discontinued treatment, although three (14%) discontinuations were due to hydrocephalus, a known complication of MPS IIIB. Adverse events related to the ICV device were consistent with other therapies administered by the ICV route. About Sanfilippo Syndrome Type B (MPS IIIB) 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 1:200,000 people in the United States (U.S.), 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 MPS IIIB (Sanfilippo Syndrome Type B) 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. Twenty-two individuals with MPS IIIB have been administered TA-ERT therapy. TA-ERT has demonstrated an adequate safety profile based on integrated five 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 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. 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.
Business Wire
06-05-2025
- Business
- Business Wire
Spruce Biosciences Reports First Quarter 2025 Financial Results and Provides Corporate Updates
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Spruce Biosciences, Inc. (OTC: 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 first quarter ended March 31, 2025 and provided corporate updates. 'With no FDA-approved treatments currently available to treat MPS IIIB, TA-ERT has the potential to be a groundbreaking advancement for patients and families impacted by this devastating disease,' said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce. 'Across the landscape, this is an incredibly important and exciting time for patients and families affected by neuropathic MPS diseases. Looking ahead, we remain focused on pursuing accelerated approval of TA-ERT and filing the BLA in the first half of 2026. We also plan to initiate a confirmatory study prior to potential accelerated approval of TA-ERT and enable expanded access programs to ensure that patients have access to therapy.' Corporate Updates TA-ERT for the Treatment of MPS IIIB. Spruce entered into an Asset Purchase Agreement under which the company acquired an exclusive worldwide license agreement for TA-ERT and other enzyme replacement therapy products. TA-ERT is a fusion protein comprised of recombinant human alpha-N-acetylglucosaminidase (rhNAGLU) with modified human insulin-like growth factor 2 via an amino acid linker. TA-ERT is intended as an enzyme replacement therapy for the treatment of patients with MPS IIIB who lack rhNAGLU enzyme activity. In March 2024, in a Type C meeting with the U.S. Food and Drug Administration (FDA), the FDA confirmed that HS-NRE is deemed to be a surrogate biomarker reasonably likely to predict clinical benefit and could serve as a basis for accelerated approval. The FDA also confirmed that the completed clinical and non-clinical studies of TA-ERT were sufficient for a BLA submission and provided guidance around key design elements of a confirmatory trial, which must be initiated prior to potential accelerated approval of TA-ERT. TA-ERT has received Fast Track Designation, Rare Pediatric Disease Designation, and Orphan Drug Designation in the U.S. and EU. Spruce intends to submit the BLA of TA-ERT for the treatment of MPS IIIB in the first half of 2026. Tildacerfont and Cortibon for the Treatment of Major Depressive Disorder (MDD). Spruce entered into a license, development and option agreement (the 'HMNC Agreement') with HMNC Holding GmbH ('HMNC'). Under the terms of the HMNC Agreement, HMNC will fund and conduct a Phase 2 proof-of-concept study of tildacerfont, a potent and highly selective, oral, small-molecule antagonist of the CRF 1 receptor, in patients with MDD who will be screened using Cortibon, HMNC's proprietary genetic test. HMNC has initiated the Phase 2 TAMARIND study, which will explore the efficacy of 400mg twice-daily tildacerfont versus placebo in improving depressive symptoms in MDD patients. Topline results from TAMARIND are anticipated in the first half of 2026. First Quarter 2025 Financial Results Cash and Cash Equivalents: Cash and cash equivalents as of March 31, 2025 were $25.6 million. Cash and cash equivalents are expected to allow the company to fund its current operating plan through the end of 2025. Research and Development (R&D) Expenses: R&D expenses for the three months ended March 31, 2025 were $10.8 million compared to $10.3 million for the same period in 2024. R&D expenses for the three months ended March 31, 2025 include $5.7 million in costs related to the acquisition of SPR202, an anti-corticotrophin releasing hormone monoclonal antibody for the treatment of congenital adrenal hyperplasia. General and Administrative (G&A) Expenses: G&A expenses for the three months ended March 31, 2025 were $3.7 million compared to $4.3 million for the same period in 2024, primarily driven by a decrease in stock-based compensation expense. Total Operating Expenses: Total operating expenses for the three months ended March 31, 2025 were $14.5 million compared to $14.6 million for the same period in 2024. Operating expenses include non-cash stock-based compensation expenses of $0.5 million for the three months ended March 31, 2025 compared to $1.6 million for the same period in 2024. Net Loss: Net loss for the three months ended March 31, 2025 was $14.0 million compared to $11.6 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 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 anticipated timing and conduct of Spruce's confirmatory trial for TA-ERT; the timing and likelihood of regulatory filings and approvals for TA-ERT, including the anticipated BLA Submission of TA-ERT for MPS IIIB in the first half of 2026; Spruce's expectation that topline results from the TAMARIND study will be available in the first half of 2026; and Spruce's intended focus on serious diseases with significant unmet medical need and clear biology, are forward-looking statements. 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. March 31, 2025 2024 ASSETS Current assets: Cash and cash equivalents $ 25,615 $ 38,753 Prepaid expenses 2,899 3,177 Other current assets 2,062 2,276 Total current assets 30,576 44,206 Right-of-use assets 869 934 Other assets 204 69 Total assets $ 31,649 $ 45,209 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 1,879 $ 1,295 Accrued expenses and other current liabilities 12,442 12,329 Term loan, current portion 1,345 1,622 Total current liabilities 15,666 15,246 Lease liabilities, net of current portion 659 736 Term loan, net of current portion — 124 Other liabilities — 282 Total liabilities 16,325 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 March 31, 2025 and December 31, 2024 — — Common stock, $0.0001 par value; 200,000,000 shares authorized as of March 31, 2025 and December 31, 2024; 42,231,285 shares issued and outstanding as of March 31, 2025 and December 31, 2024 4 4 Additional paid-in capital 279,629 279,085 Accumulated deficit (264,309 ) (250,268 ) Total stockholders' equity 15,324 28,821 Total liabilities and stockholders' equity $ 31,649 $ 45,209 Expand SPRUCE BIOSCIENCES, INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) (in thousands, except share and per share amounts) Three Months Ended March 31, 2025 2024 Collaboration revenue $ — $ 2,002 Operating expenses: Research and development 10,837 10,317 General and administrative 3,655 4,318 Total operating expenses 14,492 14,635 Loss from operations (14,492 ) (12,633 ) Interest expense (36 ) (97 ) Interest and other income, net 487 1,105 Net loss and comprehensive loss (14,041 ) (11,625 ) Net loss per share, basic and diluted $ (0.32 ) $ (0.28 ) Weighted-average shares of common stock outstanding, basic and diluted 43,944,946 41,096,231 Expand
Yahoo
15-04-2025
- Business
- Yahoo
Spruce Biosciences Announces New Corporate Strategy and Acquisition of Tralesinidase Alfa for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB)
Biologics License Application (BLA) Submission to U.S. FDA for Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) Anticipated in 1H 2026 Spruce to Host Conference Call Today at 8:30 a.m. ET SOUTH SAN FRANCISCO, Calif., April 15, 2025--(BUSINESS WIRE)--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 the company's new corporate strategy and acquisition of tralesinidase alfa enzyme replacement therapy (TA-ERT) for the treatment of Sanfilippo Syndrome Type B (MPS IIIB). "This is truly a transformative moment for Spruce as we focus our expertise in rare disease on a potential near-term commercial opportunity with TA-ERT in MPS IIIB," said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce. "As a result of the strategic process initiated last year, Spruce acquired TA-ERT for the treatment of children with MPS IIIB, a neurodegenerative and ultimately fatal genetic disease. This new strategy opens a new chapter in our mission to provide transformative and life-changing therapies to patients affected by serious conditions with significant unmet medical need." Dr. Szwarcberg continued, "In clinical studies, TA-ERT has been shown to significantly and durably normalize cerebral spinal fluid (CSF) heparan sulfate non-reducing end (HS-NRE) levels over a five-year period. Alignment has been achieved with the U.S. Food and Drug Administration (FDA) that HS-NRE could be used as a biomarker that may reasonably predict clinical benefit and serve as a basis for accelerated approval. Based on the existing clinical and non-clinical data, we anticipate submitting a BLA for TA-ERT to the FDA in the first half of 2026. We extend our gratitude to the patient and caregiver advocates, clinicians and industry leaders who have contributed to the TA-ERT program. With no FDA-approved treatments currently available, TA-ERT has the potential to be a groundbreaking advancement for patients and families impacted by MPS IIIB." "The vision of the Spruce leadership team and their unrelenting commitment to serving patient communities with meaningful unmet need is on full display with the acquisition of TA-ERT," said Mike Grey, Executive Chairman of Spruce. "The confidence and support shown by our Board underscore the immense potential of the company's new portfolio and direction." Corporate Strategy Seek regulatory approval and maximize the U.S. commercial potential of TA-ERT for the treatment of MPS IIIB. Spruce intends to seek U.S. accelerated approval of TA-ERT for MPS IIIB based on existing non-clinical and clinical data. As a condition of seeking such approval of a BLA from the FDA, Spruce will initiate a confirmatory trial. If the BLA is approved, Spruce intends to build a highly specialized commercial and medical affairs organization to support the commercialization of TA-ERT. Given that a relatively small number of clinicians and specialists treat most of the patients with MPS IIIB, the company believes this market can be effectively addressed with a modest-sized and targeted patient-centric field team, alongside various high-touch patient initiatives. Commercialize globally through a patient-focused organization. Spruce seeks to commercialize TA-ERT and its other investigational products throughout the developed world, including North America, the European Union (EU), the United Kingdom (U.K.), Latin America, Turkey, Asia, and other international markets. The company intends to establish its own commercial organization in the U.S., EU, and the U.K., and seek regional strategic collaborations and a network of third-party distributors in other international markets. Focus on serious diseases with significant unmet medical need and clear biology. Spruce focuses on diseases that have biology that is well understood. The company believes that developing drugs that directly impact known disease pathways will increase the probability of success of its development programs. TA-ERT for the Treatment of MPS IIIB Spruce entered into an Asset Purchase Agreement under which the company acquired an exclusive worldwide license agreement with BioMarin Pharmaceutical Inc. for TA-ERT and other enzyme replacement therapy products. TA-ERT is a fusion protein comprised of recombinant human alpha-N-acetylglucosaminidase (rhNAGLU) with modified human insulin-like growth factor 2 via an amino acid linker. TA-ERT is intended as an enzyme replacement therapy for the treatment of patients with MPS IIIB who lack rhNAGLU enzyme activity. In March 2024, in a Type C meeting with the FDA, the FDA confirmed that HS-NRE is deemed to be a surrogate biomarker reasonably likely to predict clinical benefit and could serve as a basis for accelerated approval. The FDA also confirmed that the completed clinical and non-clinical studies of TA-ERT were sufficient for a BLA submission and provided guidance around key design elements of a confirmatory trial, which must be initiated prior to potential accelerated approval of TA-ERT. TA-ERT has received fast-track designation, rare pediatric disease designation, and orphan drug designation in the U.S. and EU. Spruce intends to submit the BLA of TA-ERT for the treatment of MPS IIIB in the first half of 2026. Financial Update Spruce Biosciences also reported financial results for the year ended December 31, 2024. As of December 31, 2024, Spruce had cash and cash equivalents of $38.8 million. The company expects its cash runway to fund its current operating plan through the end of 2025. 42.2 million shares of common stock are issued and outstanding and 21.4 million shares of common stock are reserved for issuance of warrants and equity securities as of December 31, 2024. Please refer to Spruce's 2024 Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission today for the company's full annual 2024 financial results. Conference Call Details Spruce's management team will host a conference call today at 8:30 a.m. ET to discuss the business update. Analysts and investors can participate in the conference call by registering here. An archived replay of the call will be available on the events section of the company's investor relations website for approximately 90 days. 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 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 anticipated timing and conduct of our confirmatory trial for TA-ERT; the timing and likelihood of regulatory filings and approvals for TA-ERT, including our anticipated BLA Submission of TA-ERT for MPS IIIB in the first half of 2026; our ability to commercialize TA-ERT, if approved, in the United Sates and in international markets; the anticipated market opportunity and level of sales for TA-ERT for MPS IIIB, if approved; our ability to establish a commercial organization in the United States and leverage regional partnerships and a network of third-party distributors in international markets; our intended focus on serious diseases with significant unmet medical need and clear biology; and our expected future financing needs, are forward-looking statements. 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", "continue", "will", "potential", "on track", "can", "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 Contacts Media Katie Beach OltsikInizio Evoke Comms(937) media@ Investors Samir GharibPresident and CFOSpruce Biosciences, Sign in to access your portfolio
