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Sangamo Therapeutics GAAP EPS of -$0.11 misses by $0.11, revenue of $0.6M misses by $33.8M (NASDAQ:SGMO)
Seeking Alpha· 2025-11-06 13:06
Group 1 - The article does not provide any relevant content regarding company or industry insights [1]
Sangamo Therapeutics(SGMO) - 2025 Q3 - Quarterly Results
2025-11-06 13:05
Financial Performance - Sangamo Therapeutics reported a consolidated net loss of $34.9 million, or $0.11 per share, for Q3 2025, compared to a net income of $10.7 million, or $0.04 per share, in Q3 2024[9]. - Revenues for Q3 2025 were $0.6 million, a decrease of $48.8 million from $49.4 million in Q3 2024, primarily due to the collaboration agreement with Genentech recorded in the previous year[11]. - Total operating expenses on a GAAP basis for Q3 2025 were $36.1 million, down from $38.8 million in Q3 2024, driven by lower personnel costs and licensing expenses[12][13]. - Revenues for Q3 2025 were $581 thousand, a significant decrease from $49,412 thousand in Q3 2024[26]. - Total operating expenses for Q3 2025 were $36,134 thousand, compared to $38,781 thousand in Q3 2024, reflecting a reduction in costs[26]. - Research and development expenses for the nine months ended September 30, 2025, were $81,232 thousand, down from $87,846 thousand in the same period of 2024[26]. - The net loss for Q3 2025 was $34,930 thousand, compared to a net income of $10,672 thousand in Q3 2024[26]. - The company reported a loss from operations of $35,553 thousand in Q3 2025, compared to an income of $10,631 thousand in Q3 2024[26]. Cash and Assets - Cash and cash equivalents as of September 30, 2025, were $29.6 million, down from $41.9 million as of December 31, 2024[14]. - Cash and cash equivalents as of September 30, 2025, were $29,616 thousand, a decrease from $41,918 thousand at the end of 2024[27]. - Total assets decreased to $88,643 thousand as of September 30, 2025, from $101,635 thousand at the end of 2024[27]. - Total stockholders' equity fell to $6,243 thousand as of September 30, 2025, down from $22,770 thousand at the end of 2024[27]. Future Outlook - The company expects total operating expenses in 2025 to be in the range of approximately $135 million to $155 million on a GAAP basis[15]. - Non-GAAP total operating expenses for 2025 are projected to be approximately $125 million to $145 million, excluding estimated non-cash stock-based compensation and depreciation[16]. - Sangamo's financial guidance for 2025 remains contingent on securing adequate additional funding[22]. Research and Development - Sangamo is preparing for a potential Biologics License Agreement (BLA) submission for isaralgagene civaparvovec as early as Q1 2026[10]. - The Phase 1/2 STAND study for chronic neuropathic pain has commenced patient enrollment, with the first patient expected to be dosed in the coming months[10]. - The mean annualized eGFR slope observed in the STAAR study for Fabry disease was 1.965 mL/min/1.73m²/year at 52 weeks across 32 patients[6]. - Sangamo is exploring collaborations and partnerships to advance its Fabry disease program and other initiatives[21]. Other Income - Sangamo received $6 million from Pfizer for the exercise of a buyout option related to a 2008 license agreement[6].
Sangamo Therapeutics Reports Recent Business Highlights and Third Quarter 2025 Financial Results
Globenewswire· 2025-11-06 13:01
Core Insights - The company is advancing its clinical pipeline, particularly focusing on isaralgagene civaparvovec for Fabry disease, with a meeting held with the FDA to discuss the use of eGFR slope as an endpoint for accelerated approval [1][12] - The registrational STAAR study has shown promising clinical data, indicating that isaralgagene civaparvovec may provide durable treatment benefits for Fabry disease, with patient recruitment ongoing for the Phase 1/2 STAND study in chronic neuropathic pain [2][4] - Financial results for Q3 2025 show a significant decrease in revenues and a net loss, with total revenues of $0.6 million compared to $49.4 million in Q3 2024, primarily due to a collaboration agreement with Genentech recorded in the previous year [9][10] Clinical Developments - The STAAR study reported a positive mean annualized eGFR slope of 1.965 mL/min/1.73m²/year at 52 weeks across 32 patients, indicating the treatment's effectiveness [6] - Improvements in disease severity were noted, with 22 patients showing enhancements in their total MSSI score at 12 months [7] - The company is preparing for a potential Biologics License Agreement (BLA) submission for isaralgagene civaparvovec as early as Q1 2026 [12] Financial Performance - The consolidated net loss for Q3 2025 was $34.9 million, or $0.11 per share, compared to a net income of $10.7 million, or $0.04 per share, in Q3 2024 [9][29] - Total operating expenses for Q3 2025 were $36.1 million, a decrease from $38.8 million in the same period in 2024, driven by lower personnel costs and licensing expenses [13][14] - As of September 30, 2025, cash and cash equivalents stood at $29.6 million, down from $41.9 million at the end of 2024, with expectations to fund operations into Q1 2026 [15][30] Regulatory and Corporate Updates - The company held a productive interaction with the Medicines and Healthcare products Regulatory Agency (MHRA) regarding a prion disease study, anticipating a Clinical Trial Application (CTA) submission [3][12] - A $6 million payment was received from Pfizer for a buyout option related to a 2008 license agreement, enhancing the company's financial position [6] - The company continues to focus on establishing partnerships for the commercialization of its Fabry disease program while advancing its neurology pipeline [17][21]
Sangamo Therapeutics Announces Third Quarter 2025 Earnings Call
Globenewswire· 2025-10-30 20:01
Core Insights - Sangamo Therapeutics, Inc. is set to release its third quarter 2025 financial results on November 6, 2025, before market opening [1] - A conference call will be held at 8:30 a.m. Eastern on the same day to discuss financial results and provide business updates [1] Company Overview - Sangamo Therapeutics is focused on genomic medicine, aiming to develop treatments for serious neurological diseases lacking adequate treatment options [4] - The company utilizes zinc finger epigenetic regulators and a capsid discovery platform to potentially address neurological disorders and expand delivery methods [4] - Sangamo's pipeline includes multiple partnered programs and opportunities for further partnerships and investments [4]
Sangamo Therapeutics Presents Detailed Data from Registrational STAAR Study in Fabry Disease at International Congress of Inborn Errors of Metabolism 2025
Globenewswire· 2025-09-04 12:05
Core Insights - The data supports the potential of isaralgagene civaparvovec as a one-time, durable treatment for Fabry disease, offering significant multi-organ clinical benefits compared to current care standards [1][6] - The STAAR study showed a positive mean annualized estimated glomerular filtration rate (eGFR) slope at 52 weeks across all patients, which the FDA has agreed will be the primary basis for approval [1][6] - Sangamo plans to submit a Biologics License Application (BLA) in 2026 under the Accelerated Approval pathway [1][6] Efficacy - The STAAR study included 32 dosed patients with a positive mean annualized eGFR slope of 1.965 mL/min/1.73m/year at 52 weeks, which is favorable compared to approved Fabry treatments [4] - At Week 104, a mean annualized eGFR slope of 1.747 mL/min/1.73m/year was observed for 19 patients [4] - Stable cardiac function was maintained over at least one year, with various cardiac metrics remaining stable [4] Safety - Isaralgagene civaparvovec demonstrated a favorable safety and tolerability profile, with most adverse events being grade 1-2 [12] - The most common treatment-emergent adverse events included pyrexia (60.6%), COVID-19 (36.4%), headache (30.3%), and nasopharyngitis (33.3%) [12] - All treatment-emergent adverse events resolved with clinical management, and there were no safety-related study discontinuations or deaths [12] Regulatory Designations - Isaralgagene civaparvovec has received Orphan Drug, Fast Track, and RMAT designations from the FDA, as well as Orphan Medicinal Product designation from the European Medicines Agency [8] - The company is preparing for BLA submission while engaging in business development for potential commercialization [8] Study Design - The Phase 1/2 STAAR study is a global open-label, single-dose, dose-ranging, multicenter clinical study designed to evaluate isaralgagene civaparvovec in Fabry disease patients [10] - The study enrolled male and female patients, with a median age of 42 and a median follow-up duration of 24 months [7] Quality of Life Improvements - Statistically significant improvements in quality of life scores were observed, including role-physical (+14.8), vitality (+9.6), and bodily pain (+9.0) at week 52 compared to baseline [12] - Improvements in disease severity were reported in the Mainz Severity Score Index, with 22 patients showing total score improvements at 12 months [12]
What Makes Sangamo (SGMO) a New Buy Stock
ZACKS· 2025-08-14 17:01
Core Viewpoint - Sangamo Therapeutics (SGMO) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which are a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, suggesting that revisions in earnings estimates can lead to significant near-term price changes [4][6]. - For Sangamo, the Zacks Consensus Estimate has increased by 10% over the past three months, reflecting a positive trend in earnings expectations [8]. Zacks Rating System - The Zacks Rank system categorizes stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have averaged a +25% annual return since 1988 [7]. - Sangamo's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10].
Sangamo Therapeutics(SGMO) - 2025 Q2 - Earnings Call Transcript
2025-08-07 21:30
Financial Data and Key Metrics Changes - The company reported positive top-line results from the registrational STAR study in Fabry disease, with a mean annualized estimated glomerular filtration rate (eGFR) slope of almost 2 observed at 52 weeks across all 32 patients [7][8] - The FDA has agreed that the mean eGFR slope will serve as the primary basis for approval under the accelerated approval pathway [8][14] - The company completed an equity offering to bridge to an anticipated Fabry commercialization agreement, with the current cash runway expected to fund operations into 2025 [20] Business Line Data and Key Metrics Changes - The Fabry disease program showed a positive annualized eGFR slope of 1.7 for 19 patients who achieved two years of follow-up, compared to an average untreated decline of -3 to -4 [9][12] - The neurology pipeline program initiated its first clinical site for the Phase one/two STAND study in chronic neuropathic pain, with plans to dose the first patient in fall 2025 [15][19] Market Data and Key Metrics Changes - The company is engaging in business development negotiations for a potential Fabry commercialization agreement and broader discussions across its pipeline and platforms [20] - There is strong enthusiasm from both patients and physicians regarding the potential adoption of the Fabry treatment, with patients expressing a desire for better solutions compared to current standard care [40][41] Company Strategy and Development Direction - The company aims to secure a commercialization partner for its Fabry treatment while advancing its neurology genomic medicine pipeline [20] - The strategic focus includes addressing long-term funding needs to support the promising neurology pipeline and ensuring successful clinical trial outcomes [20] Management's Comments on Operating Environment and Future Outlook - Management expressed pride in the progress made despite a challenging environment, highlighting the importance of the recent clinical advancements [6][19] - The company anticipates preliminary proof of efficacy data for the STAND study in 2026 and is preparing for a BLA submission for the Fabry treatment as early as Q1 2026 [14][19] Other Important Information - The company held a productive meeting with the UK's MHRA regarding the prion disease program, aligning on planned studies and expected CTA submission by mid-2026 [16][17] - The company showcased its epigenetic regulation and capsid delivery technology at a recent conference, emphasizing the potential of its prion disease treatment [17] Q&A Session Summary Question: Has the team held the pre-BLA meeting with the FDA regarding the one-year eGFR data? - The company has not yet held the pre-BLA meeting but plans to do so in the future, with the FDA previously agreeing that one-year eGFR data could suffice for accelerated approval [24][25] Question: What additional insights should be anticipated at the upcoming presentation? - The company plans to present top-line data with additional details compared to previous releases, but individual patient data will not be shown [26][27] Question: How does the efficacy of ST-503 compare to recent small molecule Nav1.8 inhibitors? - Management remains convinced that targeting NaV1.7 is the right approach, citing evidence of its fundamental role in pain signaling [32][34] Question: Have any surveys been conducted to understand potential adoption rates for the Fabry treatment? - Feedback from patient advocacy groups indicates a strong desire for the treatment, with patients eager for a one-time injection solution compared to the burdensome current standard of care [39][40] Question: What is the status of discussions with potential partners? - All potential partners have expressed excitement about the data and are reassured by the company's interactions with the FDA, which have de-risked the product [43][45]
Sangamo Therapeutics(SGMO) - 2025 Q2 - Earnings Call Presentation
2025-08-07 20:30
Neurology Focus and Technology - Sangamo is focused on developing genomic medicines for debilitating neurological diseases[3, 135] - The company utilizes potent zinc finger epigenetic regulation technology and an industry-leading AAV capsid discovery platform for brain delivery[4, 136] - STAC-BBB capsid has demonstrated robust penetration of the blood-brain barrier and widespread transgene expression throughout the brain in NHPs, showing up to 700-fold higher transgene expression than benchmark capsid AAV9[22, 24, 98] Pipeline and Milestones - Phase 1/2 STAND study of ST-503 for idiopathic small fiber neuropathy (iSFN) has initiated, with patient dosing expected in Fall 2025 and preliminary proof of efficacy data anticipated in Q4 2026[12, 16, 33, 38] - CTA submission for ST-506 in prion disease is anticipated as early as mid-2026, with clinical trial enrollment and dosing expected in late-2026 and preliminary clinical data in mid-2027[12, 19, 33, 38, 94] Fabry Disease Program - Positive topline results from the registrational STAAR study in Fabry disease showed a positive mean annualized eGFR slope of 1.965 mL/min/1.73m2/year at 52 weeks across all 32 dosed patients[12, 29, 33, 38, 131] - A BLA submission for isaralgagene civaparvovec is expected as early as Q1 2026, with ongoing business development negotiations for a potential commercialization agreement[12, 27, 33, 38, 130, 131] Financial Status - The company had approximately $38.3 million in cash and cash equivalents as of June 30, 2025[34, 40] - Approximately $21 million in net proceeds were raised from an underwritten registered equity offering[34, 38] - Cash received from partners to date is $88 million[25] - Up to $4.6 billion in potential future milestones and exercise fees assuming exercise of all options and targets[25]
Sangamo Therapeutics(SGMO) - 2025 Q2 - Quarterly Report
2025-08-07 20:05
PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) The company presents unaudited financial statements reporting significant net losses and substantial doubt about its ability to continue as a going concern [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $38,344 | $41,918 | | Total current assets | $49,893 | $51,691 | | Total assets | $97,558 | $101,635 | | **Liabilities & Equity** | | | | Total current liabilities | $47,659 | $45,805 | | Total liabilities | $77,956 | $78,865 | | Total stockholders' equity | $19,602 | $22,770 | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Statements of Operations Highlights (in thousands, except per share amounts) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $18,306 | $356 | $24,743 | $837 | | Total operating expenses | $36,161 | $37,440 | $72,226 | $89,447 | | Loss from operations | ($17,855) | ($37,084) | ($47,483) | ($88,610) | | Net loss | ($19,986) | ($36,128) | ($50,583) | ($85,217) | | Basic and diluted net loss per share | ($0.08) | ($0.18) | ($0.21) | ($0.44) | [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($44,307) | ($75,547) | | Net cash (used in) provided by investing activities | ($24) | $35,967 | | Net cash provided by financing activities | $36,748 | $21,589 | | Net decrease in cash, cash equivalents, and restricted cash | ($3,574) | ($18,918) | [Notes to Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail accounting policies, revenue recognition, restructuring, and substantial doubt about the company's ability to continue as a going concern - Management has **substantial doubt** about the company's ability to continue as a going concern due to significant losses and limited liquidity[40](index=40&type=chunk)[41](index=41&type=chunk) - In April 2025, Sangamo entered a license agreement with Eli Lilly, receiving an **$18.0 million upfront payment** recognized as revenue in Q2 2025[83](index=83&type=chunk)[84](index=84&type=chunk)[88](index=88&type=chunk) - Pfizer terminated its collaboration agreement, resulting in a final **$5.0 million** in revenue recognized in the first half of 2025[109](index=109&type=chunk)[115](index=115&type=chunk) - The company undertook **significant restructuring**, including workforce reductions, to reduce costs and focus on neurology[140](index=140&type=chunk)[143](index=143&type=chunk) - A May 2025 underwritten offering generated aggregate net proceeds of **$21.1 million**[132](index=132&type=chunk)[133](index=133&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's severe liquidity crisis, recent business highlights, and the urgent need for additional capital to continue operations [Overview and Recent Business Highlights](index=30&type=section&id=Overview%20and%20Recent%20Business%20Highlights) The company reports positive clinical data and recent financing but reiterates its 'going concern' risk with cash sufficient only into Q4 2025 - The company announced **positive topline results** from the Phase 1/2 STAAR study for its Fabry disease gene therapy and plans a BLA submission[161](index=161&type=chunk) - The company is advancing its preclinical neurology programs, with the first patient in its chronic neuropathic pain study expected to be dosed in **fall 2025**[158](index=158&type=chunk)[159](index=159&type=chunk) - The company continues to seek a collaboration partner for its hemophilia A program following the termination of its agreement with Pfizer[162](index=162&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) Financial results show a significant revenue increase from a licensing deal, while restructuring efforts have reduced overall operating expenses Revenue Comparison (in thousands) | Period | 2025 | 2024 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Three Months Ended June 30 | $18,306 | $356 | $17,950 | 5,042.1% | | Six Months Ended June 30 | $24,743 | $837 | $23,906 | 2,856.0% | - The revenue increase was primarily due to an **$18.0 million** upfront payment from the Lilly agreement and a **$5.0 million** payment from the terminated Pfizer collaboration[175](index=175&type=chunk)[176](index=176&type=chunk) Operating Expense Comparison (in thousands) | Expense Category | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $53,090 | $60,114 | ($7,024) | (12%) | | General and administrative | $19,136 | $23,812 | ($4,676) | (20%) | | Impairment of long-lived assets | $0 | $5,521 | ($5,521) | (100%) | | **Total operating expenses** | **$72,226** | **$89,447** | **($17,221)** | **(19%)** | [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) The company details its severe liquidity constraints, with cash reserves sufficient only into Q4 2025, raising substantial doubt about its going concern status - As of June 30, 2025, the company had cash and cash equivalents of **$38.3 million**, down from $41.9 million at year-end 2024[193](index=193&type=chunk) - The company raised approximately **$21.1 million** from an underwritten offering and **$17.6 million** from its ATM program in the first half of 2025[194](index=194&type=chunk)[150](index=150&type=chunk) - Management concludes there is **substantial doubt** about the company's ability to continue as a going concern, as existing cash funds operations only into Q4 2025[197](index=197&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, this disclosure is not required [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal controls during the quarter PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=41&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material pending legal proceedings [Item 1A. Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) Key risks include substantial doubt about going concern, potential Nasdaq delisting, and regulatory or trade policy disruptions - The company's financial position raises **substantial doubt** about its ability to continue as a going concern, risking cessation of operations or bankruptcy[218](index=218&type=chunk)[219](index=219&type=chunk) - Sangamo received a **Nasdaq deficiency notice** for its stock price falling below the $1.00 minimum bid requirement and faces potential delisting[225](index=225&type=chunk) - A new risk factor addresses potential **disruptions at the FDA**, which could adversely impact the Accelerated Approval pathway for its product candidates[234](index=234&type=chunk)[235](index=235&type=chunk) - The company identifies risks related to **international trade policies**, which could increase expenses and disrupt its supply chain[230](index=230&type=chunk)[231](index=231&type=chunk) [Items 2-6. Other Required Information](index=44&type=section&id=Items%202-6.%20Other%20Required%20Information) This section confirms no unregistered equity sales, defaults, or other material information, and lists the exhibits filed with the report
Sangamo Therapeutics(SGMO) - 2025 Q2 - Quarterly Results
2025-08-07 20:02
[Sangamo Therapeutics Q2 2025 Earnings Release](index=1&type=section&id=Sangamo%20Therapeutics%20Q2%202025%20Earnings%20Release) Sangamo Therapeutics reports significant Q2 2025 progress in its Fabry disease and neurology pipelines, alongside improved financial results driven by increased revenues and reduced net loss [Business Highlights](index=1&type=section&id=Recent%20Business%20Highlights) Sangamo Therapeutics announced significant progress across its pipeline in Q2 2025, including positive Fabry disease study results, new clinical site initiation for neuropathic pain, and productive discussions for its prion disease program, alongside a $21 million equity offering [Corporate Updates](index=1&type=section&id=Corporate%20Updates) The company successfully raised approximately $21 million in net proceeds from a recent equity offering - Raised approximately **$21 million** in net proceeds from an underwritten registered equity offering[5](index=5&type=chunk) [Fabry Disease Program (isaralgagene civaparvovec / ST-920)](index=1&type=section&id=Fabry%20Disease) Positive topline results from the STAAR study for Fabry disease gene therapy support an accelerated approval pathway with the FDA - Announced positive topline results from the registrational Phase 1/2 STAAR study for isaralgagene civaparvovec (ST-920) in adults with Fabry disease[1](index=1&type=chunk)[6](index=6&type=chunk) Key Efficacy Endpoints from STAAR Study | Endpoint | Result | Follow-up Period | Patient Count | | :--- | :--- | :--- | :--- | | **Mean Annualized eGFR Slope** | +1.965 mL/min/1.73m²/year | 52 weeks | 32 | | **Mean Annualized eGFR Slope** | +1.747 mL/min/1.73m²/year | 104 weeks | 19 | | **α-Gal A Activity** | Maintained elevated expression | Up to 4.5 years | Longest treated patient | | **Plasma lyso-Gb3 Levels** | Remained generally stable | Post-ERT withdrawal | N/A | - The FDA has agreed that the positive mean annualized eGFR slope at 52 weeks will serve as the primary basis for a Biologics License Application (BLA) submission under the Accelerated Approval pathway, anticipated as early as Q1 2026[1](index=1&type=chunk)[6](index=6&type=chunk)[11](index=11&type=chunk) - The treatment demonstrated a favorable safety and tolerability profile without the need for preconditioning, with most adverse events being grade 1-2[11](index=11&type=chunk) [Core Neurology Pipeline](index=2&type=section&id=Core%20Neurology%20Pipeline) Sangamo initiated its first clinical site for chronic neuropathic pain and aligned on study design for its prion disease program - **Chronic Neuropathic Pain (ST-503):** The first clinical site has been initiated for the Phase 1/2 STAND study, with the first patient expected to be dosed in fall 2025 and preliminary efficacy data anticipated in Q4 2026[2](index=2&type=chunk)[11](index=11&type=chunk) - **Prion Disease (ST-506):** Held a productive meeting with the UK's MHRA, aligning on study design, with a Clinical Trial Application (CTA) submission expected as early as mid-2026[2](index=2&type=chunk)[11](index=11&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) For Q2 2025, Sangamo reported significantly increased revenues to $18.3 million and a narrowed net loss, with cash and equivalents of $38.3 million expected to fund operations into Q4 2025 [Key Financial Metrics](index=2&type=section&id=Key%20Financial%20Metrics) Sangamo's Q2 2025 revenues significantly increased to $18.3 million, leading to a reduced net loss of $20.0 million Q2 2025 vs. Q2 2024 Performance | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | **Revenues** | $18.3 million | $0.3 million | | **Net Loss** | ($20.0 million) | ($36.1 million) | | **Net Loss per Share** | ($0.08) | ($0.18) | - The **$18.0 million** increase in revenues was primarily attributable to an upfront license payment received under a capsid license agreement with Eli Lilly and Company[10](index=10&type=chunk) [Operating Expenses](index=3&type=section&id=GAAP%20and%20Non-GAAP%20Operating%20Expenses) GAAP operating expenses decreased in Q2 2025 due to strategic realignment, while non-GAAP expenses slightly increased Operating Expenses for Q2 (in millions) | Expense Type | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | **GAAP Operating Expenses** | $36.2 | $37.4 | | **Non-GAAP Operating Expenses** | $33.0 | $31.9 | - The decrease in GAAP operating expenses was mainly due to cost reductions from strategic realignment, including lower headcount and facilities costs, partially offset by increased expenses for BLA readiness activities for the Fabry disease program[13](index=13&type=chunk) [Cash Position and Financial Guidance](index=3&type=section&id=Cash%20and%20Financial%20Guidance) Sangamo's cash and equivalents of $38.3 million are projected to fund operations into Q4 2025, with full-year 2025 operating expense guidance reiterated - Cash and cash equivalents were **$38.3 million** as of June 30, 2025, sufficient to fund planned operations into the fourth quarter of 2025 with recent at-the-market offering proceeds[14](index=14&type=chunk) Reiterated Full-Year 2025 Financial Guidance | Metric | Expected Range (in millions) | | :--- | :--- | | **GAAP Total Operating Expenses** | $135 - $155 | | **Non-GAAP Total Operating Expenses** | $125 - $145 | [Corporate Information and Events](index=3&type=section&id=Corporate%20Information%20and%20Events) Sangamo Therapeutics will participate in two investor conferences in September 2025 and held a conference call on August 7, 2025, to provide updates - Sangamo plans to participate in the Cantor Global Healthcare Conference and the Wells Fargo Healthcare Conference from September 3-5, 2025[17](index=17&type=chunk)[19](index=19&type=chunk) - The management team held a conference call on August 7, 2025, to discuss program and financial updates[18](index=18&type=chunk) [Financial Statements](index=6&type=section&id=SELECTED%20CONSOLIDATED%20FINANCIAL%20DATA) The consolidated financial statements detail Sangamo's Q2 2025 performance, showing increased revenues, reduced net loss, and a cash position of $38.3 million [Statement of Operations](index=6&type=section&id=Statement%20of%20Operations%20Data) The Statement of Operations shows a significant increase in revenues and a reduction in net loss for both the three and six months ended June 30, 2025 Consolidated Statement of Operations Data (Unaudited, in thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | **Revenues** | $18,306 | $356 | $24,743 | $837 | | **Total operating expenses** | $36,161 | $37,440 | $72,226 | $89,447 | | **Loss from operations** | ($17,855) | ($37,084) | ($47,483) | ($88,610) | | **Net loss** | ($19,986) | ($36,128) | ($50,583) | ($85,217) | | **Net loss per share** | ($0.08) | ($0.18) | ($0.21) | ($0.44) | [Balance Sheet](index=6&type=section&id=Selected%20Balance%20Sheet%20Data) The Balance Sheet indicates total assets of $97.6 million and cash and cash equivalents of $38.3 million as of June 30, 2025 Selected Balance Sheet Data (Unaudited, in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $38,344 | $41,918 | | **Total assets** | $97,558 | $101,635 | | **Total stockholders' equity** | $19,602 | $22,770 | [Disclosures](index=4&type=section&id=Disclosures) This section outlines forward-looking statements regarding financial risks and clinical uncertainties, and explains the rationale for using non-GAAP financial measures - **Forward-Looking Statements:** Key risks highlighted include the company's lack of capital resources, the need for substantial additional funding to continue as a going concern, the uncertain R&D process, and the unpredictable regulatory approval process[23](index=23&type=chunk) - **Non-GAAP Financial Measures:** The company presents non-GAAP operating expenses, which exclude items like depreciation, stock-based compensation, and impairment charges, to provide what it believes is a more meaningful comparison of its operational performance over time[25](index=25&type=chunk)