PART I Financial Statements Q1 2025 financial statements show reduced net loss and expenses, but declining cash and equity raise substantial doubt about the company's going concern Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2025 ($ in thousands) | December 31, 2024 ($ in thousands) | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | 25,180 | 41,918 | ▼ $16,738 | | Total assets | 86,166 | 101,635 | ▼ $15,469 | | Total liabilities | 81,260 | 78,865 | ▲ $2,395 | | Total stockholders' equity | 4,906 | 22,770 | ▼ $17,864 | Condensed Consolidated Statements of Operations (Unaudited) | Account | Three Months Ended Mar 31, 2025 ($ in thousands) | Three Months Ended Mar 31, 2024 ($ in thousands) | Change | | :--- | :--- | :--- | :--- | | Revenues | 6,437 | 481 | ▲ $5,956 | | Research and development | 26,006 | 35,891 | ▼ $9,885 | | General and administrative | 10,059 | 11,767 | ▼ $1,708 | | Loss from operations | (29,628) | (51,526) | ▲ $21,898 | | Net loss | (30,597) | (49,089) | ▲ $18,492 | | Net loss per share | (0.14) | (0.27) | ▲ $0.13 | Condensed Consolidated Statements of Cash Flows (Unaudited) | Activity | Three Months Ended Mar 31, 2025 ($ in thousands) | Three Months Ended Mar 31, 2024 ($ in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | (26,149) | (48,663) | | Net cash provided by investing activities | — | 35,840 | | Net cash provided by financing activities | 8,134 | 22,122 | | Net (decrease) increase in cash | (16,738) | 8,629 | - The company has substantial doubt about its ability to continue as a going concern due to a history of significant losses, negative cash flows, and limited liquidity, with existing capital resources as of March 31, 2025, at only $25.2 million3639 - Subsequent to the quarter end, on April 3, 2025, Sangamo entered into a global capsid delivery license agreement with Eli Lilly, receiving an $18.0 million upfront payment and eligible for up to $1.4 billion in future milestones and royalties136137 - The collaboration with Pfizer for giroctocogene fitelparvovec was terminated for convenience by Pfizer, effective April 21, 2025, with Sangamo recognizing a final $5.0 million in revenue from this agreement in Q1 2025100107 Management's Discussion and Analysis of Financial Condition and Results of Operations Management reiterates going concern risk, with current capital funding operations only into early Q3 2025, emphasizing the critical need for a Fabry disease program partner and additional funding - There is substantial doubt about the company's ability to continue as a going concern, as cash on hand as of March 31, 2025, plus subsequent proceeds from the Lilly agreement ($18.0M) and ATM sales ($5.1M), is only sufficient to fund operations into early Q3 2025144184 - Securing a commercialization partner for the Fabry disease program is critical, as failure to do so in the near term will substantially impair the company's ability to raise the additional capital needed to continue operations145186 - Key clinical milestones include a pivotal read-out for the Fabry disease program (isaralgagene civaparvovec) expected by the end of Q2 2025, with a potential BLA submission as early as Q1 2026, and the company is also seeking a partner for its hemophilia A program following Pfizer's termination151156 Revenue and Operating Expense Changes (Q1 2025 vs Q1 2024) | Item | Q1 2025 ($ in thousands) | Q1 2024 ($ in thousands) | Change ($ in thousands) | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Revenues | 6,437 | 481 | +5,956 | $5.0M from Pfizer termination, $1.0M from Sigma license. | | Research & Development | 26,006 | 35,891 | (9,885) | Lower headcount, program reprioritization, lower overhead. | | General & Administrative | 10,059 | 11,767 | (1,708) | Lower headcount, lower professional services fees. | | Impairment of long-lived assets | — | 4,349 | (4,349) | No impairment in 2025; charge in 2024 related to restructuring. | - Net cash used in operating activities decreased to $26.1 million in Q1 2025 from $48.7 million in Q1 2024, primarily due to a lower net loss and changes in working capital188189 Quantitative and Qualitative Disclosures about Market Risk As a smaller reporting company, Sangamo is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Sangamo is not required to provide quantitative and qualitative disclosures about market risk195 Controls and Procedures Management concluded the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2025198 - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, these controls200 PART II Legal Proceedings The company reports it is not a party to any material pending legal proceedings - Sangamo is not currently involved in any material pending legal proceedings202 Risk Factors New risks include a Nasdaq deficiency notice for low stock price, potential delisting, and the impact of FDA policy changes or international trade policies on product approvals and supply chain - On April 30, 2025, Sangamo received a deficiency notice from Nasdaq because its common stock bid price had closed below $1.00 per share for 30 consecutive business days, with the company having until October 27, 2025, to regain compliance or face potential delisting204 - A potential delisting from Nasdaq could adversely affect the stock's liquidity and market price, and would substantially impair the company's ability to raise additional capital and continue as a going concern204207 - The company faces risks from potential disruptions at the FDA, including workforce reductions or policy changes, which could delay product approvals, with a specific risk being the potential discontinuation of the Accelerated Approval program, the planned regulatory pathway for its Fabry disease candidate, isaralgagene civaparvovec213215 - International trade policies, including tariffs and sanctions, may adversely affect the business by increasing costs for materials, disrupting the supply chain, and creating a complex and unpredictable trade landscape208209210 Other Information (Items 2-6) This section covers standard reporting items, including no unregistered equity sales, no defaults on senior securities, no mine safety disclosures, and no other material information - Item 2: No unregistered sales of equity securities were reported for the period216 - Items 3, 4, and 5 were marked as 'Not applicable' or 'None', indicating no defaults on senior securities, no mine safety disclosures, and no other information to report217218219
Sangamo Therapeutics(SGMO) - 2025 Q1 - Quarterly Report