Stoke Therapeutics(US:STOK)2025-11-04 21:16Financial Performance - Revenue for Q3 2025 was $10,632,000, a 117% increase compared to $4,894,000 in Q3 2024[18] - Net loss for Q3 2025 was $38,347,000, compared to a net loss of $26,430,000 in Q3 2024[18] - Basic net income (loss) per share for Q3 2025 was $(0.65), compared to $(0.47) for Q3 2024[18] - The company reported comprehensive income (loss) of $(37,997,000) for Q3 2025, compared to $(26,249,000) for Q3 2024[18] - For the nine months ended September 30, 2025, the company reported a net income of $51,049, compared to a net loss of $78,499 for the same period in 2024[26] - For the three months ended September 30, 2025, the company reported a net loss of $38.3 million, compared to a net loss of $26.4 million for the same period in 2024[122] - For the nine months ended September 30, 2025, revenue was $183.0 million, a significant increase of $169.1 million compared to $13.9 million in 2024[160] Expenses - Research and development expenses for Q3 2025 were $37,696,000, up 69% from $22,205,000 in Q3 2024[18] - Total operating expenses for Q3 2025 were $53,723,000, a 54% increase from $34,897,000 in Q3 2024[18] - Research and development expenses for the three months ended September 30, 2025, totaled $37.7 million, an increase from $22.2 million in the same period in 2024[145] - Sales, general and administrative expenses for the three months ended September 30, 2025, were $16.0 million, an increase of $3.3 million from $12.7 million in 2024[157] - Research and development expenses for the nine months ended September 30, 2025, totaled $96.2 million, an increase of $30.5 million from $65.7 million in 2024[161] - Sales, general and administrative expenses for the nine months ended September 30, 2025, were $45.9 million, up $9.9 million from $36.0 million in 2024[163] Assets and Liabilities - Total assets increased to $360,264,000 as of September 30, 2025, from $271,555,000 as of December 31, 2024[15] - Total stockholders' equity rose to $308,105,000 as of September 30, 2025, compared to $229,021,000 as of December 31, 2024[15] - Cash and cash equivalents decreased to $83,394,000 as of September 30, 2025, from $127,983,000 as of December 31, 2024[15] - Total accrued and other current liabilities as of September 30, 2025, were $30.1 million, an increase from $18.6 million as of December 31, 2024[59] - The company had an accumulated deficit of $439.8 million as of September 30, 2025[169] Cash Flow - Net cash provided by operating activities was $76,039 for the nine months ended September 30, 2025, a significant improvement from a net cash used of $63,658 in 2024[26] - Cash, cash equivalents, and restricted cash at the end of the period were $84,115, down from $150,585 at the end of September 2024[42] - For the nine months ended September 30, 2025, net cash provided by operating activities was $76.0 million, attributed to a net income of $51.0 million and non-cash charges of $25.6 million[174] - During the same period, cash used in operating activities in 2024 was $63.7 million, primarily due to a net loss of $78.5 million[175] Financing Activities - The company issued approximately 7.0 million shares of common stock under a Controlled Equity Offering Sales Agreement for net proceeds of $61.0 million as of September 30, 2025[30] - The company completed an underwritten public offering in April 2024, resulting in net proceeds of approximately $119.9 million after deducting underwriting costs[31] - The company completed a public offering of 5,555,557 shares at $13.50 per share, resulting in net proceeds of approximately $119.9 million after costs[117] Collaborations and Agreements - The Company entered into a License and Collaboration Agreement with Acadia Pharmaceuticals in January 2022, receiving an upfront payment of $60.0 million and is eligible for up to $245.0 million in milestone payments for the SYNGAP1 program[72][73]. - The Company entered into a License and Collaboration Agreement with Biogen on February 14, 2025, receiving an upfront payment of $165.0 million and is eligible for up to $50.0 million in development milestone payments and $335.0 million in commercial milestone payments[81]. - The Company recognized revenue of $162.3 million related to the Biogen collaboration for the nine months ended September 30, 2025[139] Clinical Development - The company initiated a Phase 3 study, EMPEROR, for its investigational new medicine zorevunersen in May 2025, with the first patient dosed in August 2025[113] - The company plans to enroll the first patient in a Phase 1 study for STK-002, targeting autosomal dominant optic atrophy (ADOA), in the second half of 2025[115] - The company is actively recruiting patients for the global Phase 3 EMPEROR study of zorevunersen, with over 150 patients identified as potential candidates[134] - The Clinical Trial Authorization (CTA) for STK-002 was authorized by the UK Medicines and Healthcare Products Regulatory Agency in April 2023, with the Phase 1 trial announced in August 2025[204] Risks and Uncertainties - The company is subject to risks and uncertainties typical of early-stage biotechnology firms, including competition and the need for significant capital for product development[34] - The company expects to incur net losses for the foreseeable future, with increasing research and development expenses as it seeks regulatory approvals for product candidates[123] - The company has a history of operating losses and anticipates continuing to incur losses for the foreseeable future, necessitating additional funding to support research and development efforts[206] - The company faces various risks, including the potential for significant delays in product development and regulatory approval processes[202] Market and Regulatory Considerations - The company plans to discuss expedited regulatory pathways for zorevunersen with the FDA, leveraging its Breakthrough Therapy Designation[134] - The success of zorevunersen and STK-002 depends on multiple factors, including regulatory approvals, market acceptance, and reimbursement status[206] - Clinical trials for zorevunersen and STK-002 must demonstrate safety and efficacy to satisfy regulatory authorities[213] Internal Controls - The company recognizes that internal controls over financial reporting may not prevent all errors or fraud, providing only reasonable assurance of achieving control objectives[199] - There have been no changes in internal control over financial reporting that materially affect the company's internal controls during the reporting period[198]